Download Friday October 10, 2014 (SW41 2014)

Friday October 10, 2014 (SW41 2014)
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NEWS
WORLDWIDE
EUROPEAN UNION
FRANCE
EUROPE
RUSSIA & RELATED COUNTRIES
NORTH AMERICA
LATIN AMERICA
MIDDLE EAST
AFRICA
AUSTRALIA & NEW ZELAND
INDIA & ASIA
DISCOVERY - DESIGN - DEVELOPMENT
COSMETICS & BIOCIDES
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Parmi les sujets sélectionnés dans ce numéro :
5 Ways Google Could Transform Medtech, and Maybe
Cheat Death
p.2
Facebook to Enter Healthcare: Report
p.3
Latest Information on Health Canada Review and
Approval Times for MDEL Applications
p.33
New COFEPRIS Guidance on Technovigilance Report
Submissions
p.34
Brazilian Medical Device Regulators Take First Steps
toward Electronic Registration System
p.35
South African Draft Regulations based on IMDRF
Principles Released
p.36
Novel Self-Apposing Stents To Treat Coronary Heart
Disease
p.41
Les perturbateurs endocriniens et la reglementation
cosmetique europeenne
p.52
Insulin Pump Use Cuts Cardiovascular Deaths Compared
With Pens
p.5
EU agency adopts plan to cut clinical trial secrecy p.16
FDA seeks cybersecurity assessments from medicaldevice makers
p.23
FDA Issues Draft Guidance on LDTs
p.23
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© Adrien Tillet
«Beyond words, the world »
NEWS 
 Données cliniques des DM: l’étau se resserre
Le projet de règlement européen prévoie un renforcement de l’évaluation des données cliniques pré- et postmarquage CE. Les organismes notifiés ont déjà anticipé sur les mesures à venir et ont renforcé leurs contrôles,
notamment sur ce point.
Le Cabinet WHITE-TILLET, fort de sa longue expérience et de son expertise dans le domaine de l’évaluation clinique
des produits de santé, est à même de vous assister ou de réaliser à votre attention des prestations de type :
rédaction de rapport d’évaluation des données cliniques, analyse des données post-market (PMS) et gestion des
risques, réévaluation du rapport bénéfice/risque, veille ou expertise clinique, ….et remboursement (LPPR).
(Contact : M. Yves TILLET - Tel : 01 60 08 43 85)
 5 Ways Google Could Transform Medtech, and Maybe Cheat Death
1. Google Aims to Help Parkinson's Patients Eat with New Acquisition
2. Glucose Measuring Contact Lenses
3. Google Glass as a Surgical and Teaching Tool for Med Students
4. Why Google's Foray into Quantum Physics Could Reshape Medtech
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Google is on the verge of beginning the design and construction of their own hardware for a quantum
computer, a machine designed to use quantum physics to solve problems that conventional computers
cannot.
5. The Anti-Aging Effort
(Source: Qmed)
 Facebook to Enter Healthcare: Report
It was only a matter of time: Facebook reportedly has plans to enter healthcare, following the lead of
Silicon Valley giants Google and Apple. Facebook already knows a good deal about its 1.3 billion users
worldwide, and could soon know about their health, as Reuters puts it, citing three anonymous sources
who dished on Facebook's healthcare plans.
The company is considering forming online “support communities” for patients facing a range of diseases,
according to the report. In addition, the company may debut “preventative care” applications to help
users live healthier lifestyles.
The timing of official announcement is uncertain as Facebook is said to be in the “idea gathering stages,”
and is testing new health apps.
The idea certainly has potential, as a significant number of patients are already searching Facebook for
health information. Facebook, however, may have trouble allaying some patients’ privacy concerns,
convincing them to share personal health information.
Last week, a company named Ello received substantial attention by proclaiming itself as the antiFacebook: ad free and respecting of its users’ privacy. “Ello is a simple, beautiful and ad-free social
network,” the company extolled in its mission statement. “Ello doesn’t sell ads. Nor do we sell data about
you to third parties.”
The potential for an individual to have healthcare information used against them is a real one. Already, a
number of employers monitor their workers’ Facebook use. Several Facebook users have faced negative
repercussions for posting inappropriate comments or pictures on the social media site.
Workers who share private health information could face similar repercussions, says Wayne State
University communications professor Karen McDevitt in an interview with Benzinga. “Let's say you're
applying for a job and not only have you left that incriminating photo on your Facebook page, but you
also have information that says to your potential employer that you suffer from severe migraines on a
regular basis,” said McDevitt. … (Source: Qmed)
 Weaving Wearables into Clothing
Smart clothing could help transition wearables from being a separate device to being one that users
naturally wear. The technology, which is already getting the attention of athletes, features sensors that
disappear into clothing.
Wearables may need such a transition—because while they were all the rage at CES this year, it remains
to be seen how popular smartwatches, headset devices like Google Glass, and other body-worn devices
will be with mainstream consumers. While fitness trackers like the FitBit and the Jawbone have
proliferated, their popularity is limited to a relatively narrow demographic. What’s more, the bulk of
wearables developed so far have trouble presenting the data they collect in meaningful ways.
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Enter smart clothing, which itself is anything but new. With roots stretching back to NASA’s Human
Factors Group in 1985, smart garments have still not become mainstream. Even today, a NASA smart
garment—known as E-SEWT—looks like something out of a science fiction movie. Developed in
collaboration with the Pratt Institute, the University of New Hampshire, and the British firm Rotite, the ESEWT features an onboard battery and electronics. The technology could assist astronauts in monitoring
the spacecraft and performing emergency procedures while away from the cockpit.
It is worth pointing out that in the past several decades, many other government-sponsored technologies
have become a staple of modern day life. GPS technology was developed in the 1970s by the U.S.
Department of Defense. And U.S. government-collected weather data gives millions of consumers access
to real-time downloadable weather information and forecasts.
Perhaps NASA’s E-SEWT will ultimately provide the inspiration for smart garments for consumers that
could track health metrics, human performance, and other variables. … (Source: Qmed)
 Meet Seeq, Medtronic's Foray Into Wearables
When Medtronic acquired Corventis earlier this year, it led to a lot of speculation about how the
noninvasive cardiac sensor company would play into Medtronic's future products. This month, Medtronic
has announced it is finally getting into the wearable sensor game with the U.S. release of the Seeq Mobile
Cardiac Telemetry (MCT) System. Formally known as the Nuvant System under Corventis, the Seeq is an
adhesive, wearable cardiac sensor that can be worn up to 30 days for continuous cardiac monitoring.
Nina Goodheart, vice president and general manager of the diagnostics and monitoring business at
Medtronic, adds that the major contribution Medtronic has made to the technology is allowing it to
interface with Medtronic's patient monitoring center. “The Seeq MCT System records and stores every
heartbeat and can transmit cardiac event data via Bluetooth and cellular connections to the Medtronic
Monitoring Center,” she says. “The certified cardiographic technicians at the [center] continuously
monitor patients’ cardiac data 24 hours a day, every day, and send monitoring reports directly to patients’
physicians.”
Earlier this year, Medtronic also unveiled the Reveal Linq Insertable Cardiac Monitoring (ICM) System,
which can continuously monitor patients for up to three years for arrhythmia patients whose symptoms
are less frequent and might not be detected by short-term monitoring. “By adding a short-term cardiac
monitor to complement our insertable long-term Reveal Linq device, Medtronic is providing a
comprehensive portfolio of diagnostic tools to help patients with different types of symptoms,”
Goodheart says. … (Source: MD+DI)
4
 DIY Engineers Hack Healthcare
The do-it-yourself (DIY) movement is exploding, and intrepid consumers are developing custom code and
hardware for everything from smartphones to televisions. In recent years, the practice has made its way
into the medtech industry, as patients began opening the hood on devices like glucose monitors, insulin
pumps, hearing aids, and heart monitors just to name a few. These hackers aren’t only tweaking devices
for themselves; they’re illuminating the light bulb for the rest of the industry, sparking innovation and
improvement.
Take Jason Adams for example. The Wall Street Journal recently ran a piece detailing him and his
daughter Ella. She has Type 1–diabetes, and wears a glucose monitor made by Dexcom. The device
measures her blood sugar every five minutes and displays the information on a nearby receiver, providing
Jason with a huge advantage in helping him monitor his daughters condition for any dangerous spikes or
potentially fatal drops in blood-sugar levels. Unfortunately, the device cannot transmit the data to the
Internet, limiting the portability of the monitoring device.
That is, until Adams found NightScout, a system patched together by software engineers—many of whom
have diabetic children of their own—who refused to settle for the limitations of current technology. The
open-source system essentially hacks into the Dexcom device and uploads the data to the Internet, which
allows Adams to view his daughters blood-sugar levels on a smartwatch, regardless of her location.
However, the solution is far from perfect. It drains battery power with great efficiency, cuts out at times,
and does not have any sort of approval from the Food and Drug Administration. It does, however, serve a
need that many patients have been left without, and serves as a foundation for how the technology can
be improved in the future.
Of course Jason isn’t the first take matters into his own hands. Do-it-yourselfers have been inventing and
modifying medical devices for years, leading to advancements and improvements to devices across the
industry. From patients tweaking hearing aids to play music, to a cystic fibrosis patient crafting a device to
help treat his clogged airways, users across the globe continue to invent new devices, or revamp existing
technologies to improve treatments. There is also the case of the Argentine mechanic, who developed a
device that could save millions of lives. And then there is the British boiler engineer who created a device
to fix a pumping problem with his heart. … (Source: Qmed)
 Insulin Pump Use Cuts Cardiovascular Deaths Compared With Pens
The largest prospective observational study to date to compare hard clinical end points among patients
with type 1 diabetes using insulin pumps vs those using multiple daily insulin pen injections has shown a
large reduction, an almost halving, of fatal cardiovascular events among those using the pump.
Lead author of the study, Soffia Gudbjörnsdottir, MD, of the University of Gothenburg, Sweden, told
Medscape Medical News: "This is by far the largest study [to date] on end points. We saw that the main
effect was on fatal cardiovascular disease."
Dr. Gudbjörnsdottir presented her findings during a press conference here at the European Association
for the Study of Diabetes (EASD) 2014 Meeting, and she will also present them during an oral session
tomorrow.
"The results are quite dramatic," she said. "For fatal cardiovascular disease, the hazard ratio is 0.56 and
for total mortality 0.71, so 30% less risk [of any death] if you are treated with the pump."
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However, she cautioned that the patients using pen injections were different from those using pumps:
the former had a slightly lower educational level, were slightly older, had a longer duration of diabetes,
higher blood pressure, and more previous cardiovascular disease, although the same HbA1c. Although
they used propensity-scoring to balance the 2 groups and compare them fairly, they may not have
eliminated all confounding, she noted.
Asked if she thought the pump itself saves lives, she said: "I don't think it's the pump per se; it's
everything that comes with the pump. In our country, pump users are invited to diabetic school when
they start the pump, and it's easier to contact a doctor or nurse on weekends, so you have better care."
EASD president Andrew Boulton, MD, of the University of Manchester, United Kingdom, who chaired the
press conference, said: "This is an observational study, it isn't a randomized controlled trial, so it's difficult
to draw true conclusions. But I think that pump-delivered insulin is the best form of therapy we have
today. Nevertheless there are still safety concerns — there are problems occurring with pumps, but these
can be picked up by the patient if they have been educated."
Dr. Gudbjörnsdottir presented her findings during a press conference in which the safety of new devices,
such as insulin pumps, in diabetes was discussed, with a focus on the lack of regulation regarding approval
of these in the European Union. Even in the United States, although the Food and Drug Administration
has the MAUDE database for reporting of adverse events with devices, it's still difficult to drill down into
the reasons these occur, doctors at the briefing said. Indeed, the EASD and American Diabetes Association
intend to issue a joint statement on insulin pumps here at the meeting, and the American Association of
Clinical Endocrinologists has called for better training of both patients and providers in the use of insulin
pumps.
Dr. Gudbjörnsdottir told Medscape Medical News that "in Sweden, patients are carefully selected for
pumps."
"This is reassuring," she continued. "As patients are selected today [in my country], it seems to be a safe
treatment and even saves lives."… (Source: Medscape)
 Becton Dickinson to Buy CareFusion: the Next Medtech Megamerger
In but another sign of consolidation in the medical device industry, Becton Dickinson has announced it will
acquire CareFusion for $12.2 billion in cash and stock.
The combined companies’ complementary products would allow for medication preparation,
administration and monitoring, and would extend the companies’ markets, according to a
BD statement and a report by Reuters.
The BD-CareFusion deal joins a handful of other multibillion-dollar medtech mergers and acquisitions
dealst that have made news this year, including Medtronic’s planned $43 billion purchase of Covidien and
Zimmer Holdings’ plans for the $13.35 billion acquisition of the Biomet, the other big ortho device
company headquartered in Warsaw, IN.
Such mergers are likely spurred by the Affordable Care Act, President Barack Obama’s program of costcutting healthcare reforms. Medical device companies, which mostly supply hospitals, are looking for
ways to drive down costs and stay competitive.
Franklin Lakes, NJ–based BD is the 12th largest medical device company globally by total annual revenue,
while San Diego–based CareFusion is 25th, according MD+DI’s “Top 40 Medical Device Companies” list.
The new company would be in the top 10.
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Medtech giant BD makes medical supplies, devices, laboratory equipment and diagnostic products. Its
product lineup includes disposable needles, syringes and intravenous catheters. CareFusion’s flagship
product lines include patient identification systems, the Pyxis automated dispensing device, the Alaris IV
device, ventilators, skin prep products, infection surveillance systems and surgical instruments.
BD chairman, president and CEO Vincent A. Forlenza, said in the statement that the acquisition would also
allow BD to hasten its transition from a product-focused company to a customer-centric one that will
expand its presence in medication management and patient safety. The company said the transaction is
expected to provide double-digit earnings growth, on an adjusted basis, in the first full year, and will
improve to net earnings in fiscal 2018.
Kieran T. Gallahue, CareFusion’s chairman and CEO said the deal would offer his company growth in
worldwide market share and opportunities for employees.
CareFusion shareholders will receive $49.00 in cash and 0.0777 of a share of BD for each share of
CareFusion, or a total of $58 per CareFusion share based on BD’s closing price as of October 3, the BD
statement said. It added that shareholders in both corporations support the deal, which is subject to
regulatory and CareFusion shareholder approvals. If the deal closes as expected in the first half of 2015,
BD shareholders will own approximately 92% of the combined company and CareFusion shareholders will
own approximately 8%.
Not all of the news about CareFusion has been cheerful of late. … (Source: Qmed)
 The Cabinet WHITE-TILLET is now established in CHINA
(Beijing) and can provide secure and reliable local audits
The CHINA Director of our new office is Alban TACQUET. Alban is master on quality management and
project management.
At 43 years old, he has worked twenty years in health industry in France and overseas. His expertise
covers the job positions and abilities that he has developed during his working experience: Quality
Management, Quality Control, Manufacturing, R&D, Project Management, audit and Training.
He is now established in China, where he lives since 7 years and is married with a Chinese wife.
He has been general manager for a foreign company in china during the previous 7 years and has a real
and practical knowledge about Chinese environment.
Considering his experience, Alban has ability to conduct audits in ccordance to the followed referentials:
GMP, ISO 9001, ISO 13485, ISO 22716, for active substances and drug products as well as for medical
devices and cosmetics. He can also perform consulting, outsourcing, and training on behalf of the Cabinet
WHITE-TILLET.
WORLDWIDE
Government and Regulatory Bodies
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http://www.pharmweb.net/pwmirror/pwk/pharmwebk.html
http://www.who.int/en/
www.imdrf.org
 EASD/ADA to Lobby for Better Device Regulation in EU and US
The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA)
are collaborating to produce a joint statement on insulin pumps and other devices used to manage type 1
diabetes.
Such a document is required, experts told the recent European Association for the Study of Diabetes 2014
Meeting, "in recognition of the unacceptably low level of quality control and regulation of not just insulin
pumps but medical devices in general in Europe."
And the system in the United States, while better, is far from perfect, they noted.
EASD president Andrew Boulton, from the University of Manchester, United Kingdom and University of
Miami, Coral Gables, Florida, told a press conference at the meeting: "The registration and postmarketing
surveillance is completely different for devices and drugs in the EU."
"We've tried to raise the profile of the safety of devices in diabetes with the European Medicines Agency,
asking why we don't have a centralized European Devices Agency."
And although there is better surveillance of diabetes devices in the United States, with the Food and Drug
Administration (FDA) collating adverse events for medical devices via the MAUDE database, it is still
difficult to access and interpret the data reported, and it is subject to ascertainment bias, Anne Peters,
MD, of University of Southern California, Los Angeles, told assembled journalists.
Hence, the EASD and ADA have partnered to try to improve the situation on both sides of the Atlantic. …
(Source: Medscape)
 The 10 Greatest Medical Technologies of Our Time
1. Bare Metal and Drug Eluting Stents
2. Transcatheter Heart Valves
3. Genomics
4. mHealth
5. Telemedicine
6. Surgical Robotics
7. Bionics
8. Artificial Hearts
9. ICD
10. Insulin Pump
(Source: Qmed)
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 2014 Medtech Company of the Year Finalists
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Apple
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CardioMEMS
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Covidien
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Exact Sciences
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Google
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Illumina
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Medtronic
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Qualcomm
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Zimmer
(Source: MD+DI)
 11 Devices For Hacking Your Health
Beddit
Beddit is a sleep monitor that attaches to your bed, not you. Based on ballistocardiography (BCG) a
method for measuring body movement caused by hifts in the mass of blood and the heart, Beddit
measures night time sleep activity. The device uses an algorithm that tracks sleep cycles and can store this
information in your mobile device. It can also use your mobile device's microphone to track snoring. The
company has formed a partnership with Misfit Wearables and also has an API available for developers.
HeartMath
First established in 1991, HeartMath's products include a series of wearable sensors and a software
package aimed at measuring heart rate variability and giving users insight into their emotional and
physical wellbeing. Using a series of directed breathing exercises and positive emotional visualizations
HeartMath empowers users to self monitor and regulate stress. The company says it systems are in place
at a number of healthcare institutions nationwide including Gundersen Health System in Wisconsin, IU
Health Bloomington Hospital in Indiana, and Fairfield Medical Center in Ohio.
Gravity+
If you spend a lot of time at the gym, you've probably seen people wearing weighted vests. The idea is
simple, more weight equals more resistance which translates to fitness gains. Gravity+ (Gravity Plus)
Systems is taking this idea one step further with its full-body “gravity suit.” Consisting of a series of
“resistance packs” (company founder Jim Foster doesn't like to call them weights), wearers can add
anymore from one to 70 lbs of resistance to the suit. Regulated as a Class I medical device, Gravity
Systems says its suit can aid in rehabilitation and recovery, functional athletic training, and weight loss.
Marc Pro
The Marc Pro uses electrostimulation to support muscle recovery and conditioning. The Marc Pro consists
of a small power unit and electrodes that can be attached to any part of the body and deliver electrical
pulses at a user-controlled intensity. The company claims that consistent use of the device can reduce
downtime between workouts and increasing overall oxygenation and nutrient flow to the muscles. While
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available for home use, the company also boasts dozens of major sports teams among its users including
the LA Lakers, San Francisco 49ers, and the Miami Heat.
Muse
The Muse headband is a four-channel, six-sensor device that aims to let users improve memory, reduce
stress, and better manage conditions like attention deficit disorder (ADD), epilepsy, and Alzheimer’s. Apps
for the device can serve a variety of purposes including improving cognitive function and reduce stress.
The device captures near-clinical-grade ECG and communicates with a mobile device or desktop
computer. Interaxon, the company behind the device, says a study showed that only 20 hours of training
on this type of EEG technology have been proven to be as effective as Ritalin in managing ADD.
NeurOptimal
NeurOptimal is focused a neurofeedback system focused on mental fitness. Using a series of noninvasive
sensors attached to the scalp and ears, the NeuroOptimal system monitors brainwaves while users either
watch a visualization or listen to music and uses subtle cues to get the user's brain to switch between
various levels of awareness. The results, the company says, improve mental flexibility and enhance one's
ability to adapt to stress and environmental changes. NeuroOptimal says user feedback as reported
positive outcomes with clients dealing with ADD, ADHD, PTSD disorder, Alzheimer’s disease, autism, sleep
disorders, insomnia and cognitive dysfunction from chemotherapy.
OxyHealth – Portable Hyperbaric Chambers
Hyperbaric chambers recently came under fire from FDA because of companies and clinics making
unfounded claims about their ability to treat a variety of ailments including depression, Alzheimer’s, and
HIV/AIDS. OxyHealth sticks to FDA's list of approved conditions for hyperbaric treatment and wants to
make the technology more portable and affordable for patients and consumers. The company's portable
hyperbaric chambers are designed to fit into offices, clinics, and even homes with only a short set up time.
Pavlok
Even with a wearable device at hand, people still often have trouble adhering to their goals enough to
create real behavior change. Pavlok aims to be a wearable that truly coaches its users into changing their
habits...by shocking them. Whether your aim is to wake up earlier, accomplish a fitness goal, or even set
aside a focused time to get some work done, Pavlok will tap into the power of negative reinforcement
and literally shock you into action. The wristband also has social feature that can enable your friends to
help you along with your goals by sending remote shocks to you.
PowerLung
Think of PowerLung as a weight lifting program for your lungs. The small device offers variable resistance
when breathing through the device that the company says translates into better breathing, and thus
better athletic performance.
Spire
A unique idea among wearable trackers, Spire focuses almost entirely on breathing. A sensor that clips
onto your clothing detects body position, activity, and breathing using proprietary algorithms and can
notify you of whether you are “focused, tense, or frazzled” via an accompanying smartphone app. The
device can alert users throughout the day, reminding them to take deep breaths, resume activity, or take
other action to reduce their stress levels.
Zona Plus
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Zona is a device developed to treat resistant hypertension (high blood pressure that persists despite
treatment by two or more medications) and improve cardiac health. The Zona Plus allows users to
practice self-guided isometric handgrip therapy (i.e. squeezing the device) at home. In 2012 FDA
conditionally approved an investigational device exemption (IDE) for a pivotal clinical trial to evaluate the
device. According to the company, other clinical studies have demonstrated that isometric handgrip
therapy could provide “a significant reduction in blood pressure levels for the majority of hypertensive
patients.”. According to earlier data, 135 out of 136 study participants achieved significant blood pressure
drops in eight weeks or less. … (Source: MD+DI)
 Why the Future of Wearables Is Invisible
Think the future of health tracking will be dominated by wrist-worn and other wearable devices? Think
again, says Stuart Karten, founder and president of Los Angeles–based design firm Karten Design.
The future of wearables is invisible, Karten explained at the 2014 Body Computing Conference at the
University of Southern California on October 3. “‘Invisible’ means moving technology into the background.
It’s putting human interaction and emotion back in the mix and respecting both.”
The future destination of wearables is not the wrist (as is the case with the Apple Watch) or the head (as
is the case of Google Glass) but to fade into the background, Karten says. Wearable technology, if it is to
live up to the hype, is destined to disappear, Karten argues, becoming a seamless technology that can be
integrated into the fabric of our everyday living.
He’s right, of course. When you get down to it, it is impossible to make technology too easy or too
seamless to use. And to date, most health-tracking devices don’t excel in this regard. For instance, the
first-generation FitBits, while doing an admirable job of tracking activity levels, required users to clip the
device onto clothing each day. While it is easy to forget the device was there during the day, many users
inadvertently tossed the device into the laundry. The device, though popular, led many users to wonder:
“Why do I need a separate device to track the number of steps when I already have a smartphone in my
pocket?” As new smartphones debut with increasingly better motion tracking capabilities, that question
becomes more and more inescapable.
The wrist has emerged as the next destination for fitness trackers. Next-generation fitness trackers like
the FitBit Force and FitBit Flex and the JawBone Up look something like faceless rubber watches.
(JawBone recently announced its plans to ditch its wristworn fitness trackers. ) A number of smartwatches
with health-tracking functionality have also cropped up—most notably the forthcoming Apple Watch.
While wrist-worn devices have their advantages (and are less likely to be tossed into a washing machine),
they represent yet another item that the user must remember to put on everyday. Because the Apple
Watch is not a standalone device, a user also must remember to make it out of the house each morning
with their iPhone, too. Wrist-worn smartwatches and fitness trackers, like most wearables, must be
charged regularly. FitBit has run into trouble, too, with many of its users complaining of developing rashes
after wearing the device. Allergic reactions to the trace amounts of nickel in the surgical grade of the
device’s clasp was blamed as the culprit. FitBit ended up recalling the Force, while the U.S. government is
looking into similar complaints regarding its successor, the Flex.
Even without rashes, strapping a fitness tracker onto the wrist is not something most users will likely
manage to do consistently over the long term. Indeed, data regarding the long-term health benefits of
such technology are lacking.
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And then there is the challenge of convincing the user that wearing a rubberized wrist-worn device is
cool. “Today, there seems to be a force-fitting of technology into ‘things we wear’ in the service of
problems that don’t exist,” Karten says. “Today’s devices force a fashion statement. The design of such
products ignores the emotional decisions that drive your fashion choices.”… (Source: Qmed)
 How to Develop a Commercial Strategy for Medtech Start-Ups
Entrepreneurs who view their start-up as a mere technical project will eventually get into trouble. They
need to develop a commercial strategy as early as possible.
James Green is CEO and one of the four founders of Apica Cardiovascular, which has developed a
technology for placing valves in the heart. At MEDTEC Ireland this week, he gave advice on how to
successfully devise a market strategy.
Green pointed out that it is crucial for start-ups to have a commercial plan in place in a very early stage
“as it affects all aspects of the business, regulatory affairs, engineering, clinical trials, reimbursement
planning and manufacturing.” According to Greene, companies have to assess from the start all the
components that drive sales and ask themselves the following questions:




What clinical need are you addressing?
What is the current state-of-the-art technology, or is this truly a new technology?
What is the size of the market in terms of:
o Number of patients that can be treated with your product
o How will clinicians identify and access these patients?
o How many buyers would be interested in your technology if you are building it for
acquisition by a larger company?
Current competitive technologies:
o Who are they and how do they work? What is the gap your product will fill vs. theirs?
o What is your significant competitive advantage?
o Develop your IP plan to ensure you have freedom to operate (This should be step 1
before capital is spent) – If you cannot protect the idea or have freedom to operate, then
you cannot commercialize
After proof of concept, companies should think about how they will bring the products to market, the
specific regulatory path and clinical trial requirements, Green explained. “Very important is planning for
reimbursement – how much can you charge, how much would customers be willing to pay, and how
cheaply can you make the product? You need to reduce cost for hospitals and improve clinical outcomes.
Reimbursement in Europe is complex and different country to country. Data needed for building the value
proposition of your product should be built into your CE Mark study,” he said.
In order to be successful in the market, having the right pricing strategy is essential. “Evaluate your COGs
and determine your target price through achieving a 70-80% margin as the optimal price,” Greene
advises. “Your price should allow your customer to make your product the standard of care in the
hospital. Your price will also be determined on how it can improve clinical outcomes and how those
outcomes improve cost-effectiveness, both at the time of the procedure and downstream once the
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patient leaves the hospital; for example, does it decrease the frequency of hospital readmissions for the
same clinical problem?”
According to Greene, start-ups should monitor the competition’s pricing strategy and price their products
according to how their significant competitive advantage warrants a higher price. Companies need to
answer the questions: “Can you achieve reimbursement to allow hospitals to be paid for the device as a
new technology add-on in the beginning? Can it be reimbursed outside the diagnosis-related group (DRG),
or will it replace some technologies included in the current DRG?” Greene recommends to test-drive a
planned price strategy early in the process, prior to clinical trials, with both clinicians and administrators.
Companies regularly need to test if they are on the right track by involving key opinion leader clinicians
who will be using the product at each step. This way, they can provide constructive feedback on how the
product needs to perform in the clinical setting.
“Because your development time can take years before going to the clinic for trials, the market changes
over that period of time so you need to make sure you are always still meeting the markets expectations,”
Greene explained. “Attend the major conferences in your field to assess new competitors and their
technologies, meet with key strategic company marketing and business development people to build
relationships with key people. It’s important to understand how potential acquirers are thinking about the
space you’re working.” … (Source : EMDT)
 Robots with Super Dexterity Could Be Game Changer for Medtech
Robots—including those in both manufacturing and surgery—may end up showing more dexterity than
ever, thanks to a wave of sensor advances.
GelSight CEO Bill Yost, for example, sees potential in the space for the MIT-developed sensor technology
the Cambridge, MA–based company has been seeking to commercialize, even though the company is
concentrating on other sectors for now.
GelSight might show promise determining whether skin cells or cancerous, or conducting a prostate
exam, or even engaging in robotic surgery, according to Yost. The company is already working with
cosmetics and shaving supplies companies when it comes to using the sensors to determine the
effectiveness of their products.
“It’s not our resolution that makes us unique. It’s our ability to image surfaces without reference to their
optical properties,” Yost says.
GelSight uses a small block of elastomer with a reflective coating on one side to remove the optical
characteristics that would, say, make it difficult to visually capture a fingerprint.
13
“We cover over your finger or an object with a highly engineered membrane that is thin or compliant
enough that we can then call on some machine vision algorithms,” Yost says. The sensor is able to detect
the ridges and depressions of a three-dimensional structure. This trait is especially important when it
comes to biological materials because many such materials are translucent.
Researchers from MIT and Northeastern University recently demonstrated that GelSight technology could
allow a robotic arm unprecedented dexterity abilities, opening the door to a myriad of applications,
according to an MIT news release. GelSight could eventuall mean better robots for the manufacturing
industry, as well as possibly in the operating room.
While robots still lack a sense of touch—a human sense that is extremely hard to replicate—their level of
dexterity is steadily increasing. (Yost notes that GelSight is able to sense texture differences of a few
microns.) Other advances in dexterity include Machester, N.H.–based DEKA's Luke arm, a prosthetic limb
capable of grabbing an egg without inadvertently breaking it.
The groundbreaking research in robotic technology at MIT as well as Northeastern University could
improve robotic dexterity even more. … (Source: Qmed)
 Software Upgrades Make This Assembly Robot Ever-More Powerful
In a way, a two-armed robot called Baxter is similar to a smartphone. The capabilities of the robot can be
expanded through software updates. “We have developers coming up with software that enables Baxter
to do things we never dreamed of,” says Carl Palme, product manager at Rethink Robotics (Boston), which
developed Baxter.
For instance, researchers at Rensselaer Polytechnical Institute (Troy, NY) recently integrated the 165-lb.
robot in an electric wheelchair to create an assistive system that could be used by quadriplegics. Using a
mouth-based device known as Jamboxx, a quadriplegic could control Baxter without using their hands to
perform tasks traditionally performed by caregivers.
Software updates are making Baxter become increasingly adept in performing assembly operations, as
well. “We have upgraded Baxter recently with our third revision software update. Now, Baxter is three
times faster and two times as precise,” says Palme. “We also have done little things like create little
macros to make Baxter easier for people to train.” Unlike conventional manufacturing robots that require
a specialist to program, Baxter can be programmed to perform tasks in a matter of minutes.
This capabilities of Baxter’s new software upgrade, known as Intera 3, can be seen in the video below,
which shows a packaging operation that took 3:20 to perform in 2013 but 1:12 to perform with the latest
software update. … (Source: Qmed)
 Boehringer Ingelheim, Propeller Health team up for sensor-enabled
inhaler pilot
Boehringer Ingelheim is a pretty familiar name to people who follow mobile health moves from pharma
companies. The large, privately-owned German firm has been involved in pilots with game developer
Ayogo, smart pill bottle maker AdhereTech, and now-defunct behavior change platform Healthrageous.
While its partners have talked up these pilots, up until now the company itself has been pretty quiet
about its strategies in testing out innovative health technology.
14
At Health 2.0 last week in Santa Clara, California, Larry Brooks, the director of the New Business Model
and Healthcare Innovation group at Boehringer Ingelheim took the stage with Propeller Health CEO David
Van Sickle to talk about a newly announced pilot of Propeller’s technology.
“About three years ago, the company said patients, especially those with high risk diseases, shouldn’t be
treated with just medications,” Brooks said. “They should be treated more comprehensively. So we
started the New Business Model and Healthcare Innovation group, positioned within our business
development and licensing, because just as we have folks looking for new molecular markers, we really
wanted to find technology that we thought was going to shape the broader healthcare delivery and
financing system and have an impact on Boehringer and our prescription medication. So it continues to be
a learn-by-doing type of group that continuously is signing customer-based agreements to validate
whether there’s a particular technology we should be looking for, even if it’s in the longer two to five year
range, and not necessarily in the short term.”
Brooks says that as a privately owned company, Boehringer Ingelheim is able to take risks on small pilots,
then report back to the higher ups of the company to encourage larger implementations of pilots that
work. He said the rate is 50 to 75 percent of projects get taken on in a larger capacity. Although the
purpose of the unit is to be innovative, Brooks said, the mandate is not to look for totally new businesses.
… (Source : MobilHealthNews)
 Unilife inks 15-year deal with Sanofi for wearable injectors
Unilife, the injectable technology provider, has inked a deal with Sanofi to be the French drugmaker's sole
provider of cartridge-based wearable injectors for the next 15 years.
The deal is worth at least $50 million, the company said in a press release, and excludes Sanofi's insulins.
The agreement is for devices used to deliver large dose volume drugs. Unilife can continue to enter into
deals with other drug companies as long as Sanofi's nonexclusive access is maintained.
The wearable injectors market is expected to generate $8 billion in sales, averaging $24 a unit, by 2025,
the company said. Sanofi has between 5 and 10 molecules to be delivered to patients using wearable
injectors.
"Our wearable injectors are poised to generate substantial revenues and growth moving forward," Alan
Shortall, Unilife's chairman and chief executive, said in a statement.
Unilife's wearable devices allow for a viable option for using large molecules. With its "peel, stick and
click" steps of use, the device gives patients an at-home delivery platform for drugs. Normally, doses as
large as 15 milliliters must be administered intravenously, but because self-administered delivery
methods are becoming the norm, the biologics market is ready for a more patient-friendly option.
15
Sanofi earlier partnered with with Unilife for the use of its self-retracting automatic injectors. That deal
had Unilife providing at least 150 million of those devices a year for use with Sanofi's line, including the
blockbuster Lovenox for deep vein thrombosis. … (Source: FierceMedicaldevices)
 ISO 11607-2:2006 - Packaging for terminally sterilized
medical devices -- Part 2: Validation requirements for forming, sealing
and assembly processes
ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging
medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of
preformed sterile barrier systems, sterile barrier systems and packaging systems.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are
packaged and sterilized.
ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured
aseptically. Additional requirements may also be necessary for drug/device combinations. … (Source : ISO)
EUROPEAN UNION
 EU agency adopts plan to cut clinical trial secrecy
Europe's medicines regulator has endorsed a scheme to publish detailed clinical reports underpinning
new drug approvals from next year, though campaigners for full transparency said they were concerned
some data would still be missing.
The London-based European Medicines Agency (EMA) has been at the center of a row about divulging
trials data for the past two years, following concerns over undisclosed data for certain drugs such as
Roche's flu pill Tamiflu.
Critics of the pharmaceuticals industry argue that free access to such data is essential, so that
independent experts can test claims made about prescription drugs. But some companies have fought to
keep the information private.
The EMA -- Europe's equivalent of the U.S. Food and Drug Administration -- said on Thursday its
management board had unanimously adopted a policy to publish all clinical reports for new drugs from
2015.
16
Importantly, outside researchers will be free to download and save the information, allowing them to
reassess large data sets -- something the EMA had at one stage been reluctant to permit.
Tracey Brown, managing director of the group Sense About Science, which has campaigned against
clinical trials secrecy, said she was pleased the EMA had reversed a "ridiculous" proposal that would have
meant researchers could only see information from clinical trials on-screen in a sealed room.
"However, it is still the case that trial sponsors (drug companies) can cut out any information they don't
want others to see," she said.
The agency's new policy states that "in limited instances", information that may be considered
commercially confidential will be redacted from the clinical reports. … (Source: Reuters)
 LoneStar Heart wins CE Mark for hydrogel heart implant
LoneStar Heart wins CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant, a
hydrogel implant designed to treat heart failure.
Laguna Hills, Calif.-based LoneStar Heart said it won CE Mark approval in the European Union for its
Algisyl-LVR hydrogel implant for the treatment of advanced heart failure. … (Source : MassDevice)
 CRC test ColoMarker receives CE mark
ColoMarker, a blood test for the early detection of colorectal cancer, has received CE Mark approval.
The test, developed by EDP Biotech, will initially be introduced to the 30 member states of the European
Economic Area.
ColoMarker has been clinically tested in the United States. It has demonstrated 97 percent sensitivity, 86
percent specificity for colorectal cancer and a 48 percent detection rate of adenomatous polyps. …
(Source: BeckerSasc)
NBOG
http://www.nbog.eu/
 NBOG reports & News
http://www.nbog.eu/5.html
Le Cabinet WHITE-TILLET a 15 ans d’expérience et d’expertise dans le
domaine du marquage CE des DM (classe I à III et produits combinés).
Aujourd’hui, compte tenu du renforcement de la réglementation et des
contrôles, ces dossiers doivent être plus que jamais conformes,
notamment l’évaluation des données cliniques et la gestion des
données de post-production. Confiez-nous la rédaction ou la révision
de vos dossiers techniques de marquage CE à la lumière du PMS!
Y compris l’évaluation ou la réévaluation des données cliniques
17
France
Le Cabinet WHITE-TILLET s’est entouré de juristes de haut niveau
pour vous aider à affronter la nouvelle réglementation de la publicité
des DM. Leur expertise se combine à notre expérience réglementaire
et à notre maîtrise de la méthodologie clinique. Contactez-nous pour le
reviewing de vos documents publicitaires ou promotionnels!
http://ansm.sante.fr/
 Les 1ères Rencontres de l’ANSM sous le signe de l’innovation et de
la surveillance
L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a tenu le 26 septembre
2014 ses 1ères Rencontres sur le thème " Produits de santé : les nouveaux défis de l’innovation et de la
surveillance", en présence de plus de 600 participants, chercheurs, professionnels de santé,
institutionnels, industriels, représentants des patients. L’occasion pour l’Agence d’affirmer son ouverture
sur son environnement et son engagement scientifique pour stimuler et accompagner la mise à
disposition de l’innovation.
Ouvertes par Agnès Jeannet, présidente du Conseil d’administration de l’ANSM, Françoise Weber,
directrice générale adjointe de la Santé et Dominique Martin, directeur général de l’ANSM, ces rencontres
se sont organisées autour de quatre temps forts qui correspondent à des axes stratégiques de l’Agence :

l’innovation en santé

régulation des produits de santé et progrès scientifiques

progrès technologiques : maîtriser les nouveaux risques

de la vigilance à la surveillance
Les 1ères Rencontres de l’ANSM sous le signe de l’innovation et de la surveillance - Point d'information
(08/10/2014)
(57 ko)
Consulter le dossier participants, les enregistrements vidéos et les interventions des 1ères rencontres de
l'ANSM
(Source: ANSM)
18
http://www.has-sante.fr/portail/jcms/j_5/accueil
 ÉVALUATION DES TECHNOLOGIES DE SANTÉ

Evaluation de l'occlusion de l'appendice auriculaire gauche par voie transcutanée

Évaluation clinique et économique des dispositifs médicaux et prestations associées pour prise en
charge du syndrome d'apnées hypopnées obstructives du sommeil (SAHOS)

Evaluation du guidage échographique lors de la réalisation d'une anesthésie locorégionale
périphérique - Rapport d'évaluation
CNEDiMTS  Derniers Avis de la CNEDiMTS



Les Avis sur les dispositifs médicaux (et les synthèses)
Rapports d'évaluation des technologies de santé.
L’Évaluation des technologies de santé et des actes
Le Cabinet WHITE-TILLET a près de 15 ans d’expérience et d’expertise dans le
domaine du remboursement des dispositifs médicaux, incluant la maîtrise de la
méthodologie clinique. La rédaction de ces dossiers est un art complexe. Les
conséquences pour les firmes peuvent être cruciales. Confiez-nous vos
dossiers de remboursement et de demande d’acte!
CEPS
http://www.sante.gouv.fr/comite-economique-des-produits-de-sante-ceps.html
EUROPE
19
http://www.mhra.gov.uk/#page=DynamicListMedicines
 Landmark UK patent law change will boost clinical research
A major amendment to UK patent law has taken effect today (October 1) could help to attract drug
research back to the UK.
The amendment will remove the risk of infringement claims and allow companies to use a patented
product when carrying out clinical trials. The change is an addition to the existing ‘Bolar Exemption’, a
European Union directive which only protected generic drugmakers from the risk of infringement lawsuits
if they conducted trials on a patented product.
The new change now removes intellectual property barriers to the research-based pharmaceutical
industry carrying out clinical trials in the UK, putting the country on the same level as other EU countries
and with generics players.
Stephen Bennett, a partner in Hogan Lovells London IP practice, told PharmaTimes “one of the issues that
drives location for clinical trials is whether that work will escape the risk of patent infringement claims,
injunctions stopping trials part way through or ‘stop-go’ injunctions and damages imposed after the
event”. This is now “a much more straightforward exercise to clear trials in the UK for patent purposes”,
giving research-based companies “more certainty in the planning stage and removes one of the tricky
issues from the matrix of factors that need to be addressed to get trials off the ground”.
He added that “although this is a move that the innovator industry will welcome, it is not clear what effect
it will have when the new Unitary Patent Court comes into effect”, slated for 2015. Mr Bennett went on
to say that the legislation which sets up that system “has its own Bolar provision that is squarely aimed
only at trials to generate data for generic authorisation. Given that existing patents end up in this new
system by default, there is potential for the revised Bolar to have a short life”. … (Source: PharmaTimes)
http://www.nice.org.uk/
http://www.hpra.ie/
BfArM http://www.bfarm.de/DE/Home/home_node.html
http://www.fagg-afmps.be/fr/
20
http://www.agenziafarmaco.it/
http://www.aemps.gob.es/en/home.htm
http://www.legemiddelverket.no/English/Sider/default.aspx
http://www.lakemedelsverket.se/english/
SWISSMEDIC
http://www.swissmedic.ch/index.html?lang=fr
Le Management de la Qualité et l’Assurance de la Qualité sont au
cœur de nos préoccupation et dans notre champ de compétence.
N’hésitez pas à venir vers nous soit pour une certification ISO
9001 ou ISO 13485 soit pour réaliser vos audits. Nous avons un
réseau de correspondants locaux en Asie et aux Etats-Unis.
Ministry of Health of Ukraine
http://www.kmu.gov.ua/control/en/publish/article?art_id=88456
RUSSIA & RELATED COUNTRIES
Ministry of Healthcare of the Russian Federation
http://government.ru/eng/power/23/
NORTH AMERICA
21
 FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018
The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar
American consumers spend on products. This includes the safety and effectiveness of drugs, medical
devices, and vaccines, the safety of blood supply to food supply, cosmetics, dietary supplements, products
that emit radiation, and more recently, tobacco. This fact can be easy to gloss over, but if one pauses for a
moment to reflect on this fact, it is clear that the FDA’s regulatory role is large and truly meaningful to all
of our everyday lives.
When the FDA was first established, our regulated industries were predominantly local, the volume of
imported products was low, and even the movement of goods across country was minimal. But times
have changed, and so have the strategies we employ to address those changes. Over the last five years
alone, the FDA’s regulatory portfolio has increased to now include regulating tobacco products,
developing a new global system for protecting food safety, and addressing challenges created by the
global expansion of research, commerce and trade.
In fact, more often than not today, a drug or medical product that ends up on the shelves of an American
drugstore or in our hospitals will come, at least in part, from some foreign source. Nearly 40 percent of
finished medicines that Americans now take are made elsewhere, as are about 50 percent of all medical
devices. Approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the
United States are located outside our borders.
These and other new challenges and transformative developments in global science, technology and
trade are rapidly altering the environment in which we work to fulfill our broad public health mission. In
order to continue to carry out that mission, we need a set of clearly defined priorities and goals, as well as
the strategies for reaching them. Therefore, I am pleased to announce the release of a revised set of FDA
Strategic Priorities which will guide the agency in how we continue to promote and protect the health of
the American public.
The new Strategic Priorities document sets the path for our Agency over the next four years. It establishes
a framework for integrating our five strategic priorities – regulatory science, globalization, safety and
quality, smart regulation, and stewardship.
Although each priority is significant in and of itself, the priorities are also interconnected and must not be
addressed in isolation. In addition, this new roadmap sets forth FDA’s core mission goals and objectives,
such as improving and safeguarding access to the products FDA regulates – and promoting better
informed decisions about their use.
The Strategic Plan has been in development for more than a year and was created by a hard-working
team of talented and knowledgeable FDA employees representing programs from across the agency.
While this team drove the Plan’s creation, it is backed by the commitment of all of us at the FDA. My hope
is that these priorities, which will be repeatedly cited in our speeches, policies and writings, will serve as
our foundational guidepost, providing the strategic direction to help the agency continue to provide the
level of service and protection the American people deserve. … (Source: FDA)
22
 FDA seeks cybersecurity assessments from medical-device makers
The Food and Drug Administration has issued final guidance asking medical-device manufacturers to
address cybersecurity threats before and after their products are approved for sale. Cybersecurity is
critical as medical devices increasingly connect with each other, the agency said.
The FDA said manufacturers should identify what information or other assets hackers might target and
how they might get to it. The companies are asked to consider the tradeoffs between greater security and
usability and determine the risk level associated with a particular threat. The agency recommends
strategies that include limiting access through electronic authentication (such as passwords or biometric
scans) and physical locks to prevent tampering, as well as different levels of access based on a user's role.
For example, a technician might have more limited access to a program than a system administrator.
The agency recommends that manufacturers submit documentation to the FDA during the pre-approval
process explaining how they are addressing cybersecurity issues with the product and how they will
continue to address them after the product is on the market.
Although the agency notes increased vulnerability because of the proliferation of devices that connect to
one another and to other networks, it has seen no evidence so far that such products have been hacked.
“The FDA has neither an indication that specific devices or systems have been purposely targeted, nor
reports that any patients have been harmed as a result of cybersecurity breaches,” the agency said in a
statement accompanying the guidance.
The Advanced Medical Technology Association, a trade group representing devicemakers, said the
organization supports the FDA's efforts to raise awareness about cybersecurity threats, according to Jeff
Secunda, the group's vice president of technology and regulatory affairs. He added, though, that
manufacturers are already working to address the issue. … (Source: ModernHealthCare)
FDA - Final - Management of Cybersecurity in Medical Devices.pdf
 FDA Issues Draft Guidance on LDTs
The FDA today issued draft guidance detailing its plans for regulating laboratory-developed tests (LDTs)
that it deems as “high-risk” along the lines of Class III medical devices—setting up a showdown with
academic medical centers and other developers of the tests, which have opposed efforts at imposing new
rules.
23
In a few days, the agency said, it will launch a 120-day public comment period that will begin with
publication of a formal notice of the release of the draft guidances in the Federal Register. Released by
the FDA today were two draft guidance documents: Framework for Regulatory Oversight of Laboratory
Developed Tests (LDTs); and FDA Notification and Medical Device Reporting for Laboratory Developed
Tests (LDTs).
The FDA has historically exercised only enforcement discretion over LDTs designed and used within a
single laboratory, and had not sought to regulate their entry to market as is now required for Class III
medical devices.
FDA Commissioner Margaret A. Hamburg, M.D., and other agency officials have sought to justify the new
rules by saying that today’s LDTs differ from those that were around in 1976 when current rules took
effect.
Unlike then, the agency contended in the draft guidances, many of today’s LDTs are much more complex,
made with components not legally marketed for clinical use; used beyond local populations;
manufactured in high volume; used widely to screen for common diseases rather than rare ones; and
used for directing critical treatment decisions such as prediction of drug response.
“There is a wide range of risks associated with the wide variety of LDTs. Thus, FDA believes that a riskbased approach to regulatory oversight of LDTs is appropriate and necessary to protect patient safety,”
the FDA stated in its Framework draft guidance.
LDT developers maintain that the tests are “laboratory testing services” and not medical devices subject
to the Food, Drug, and Cosmetic Act (FDCA). At present, labs certified under the Clinical Laboratory
Improvement Amendments (CLIA) waiver program may develop and use their own diagnostic tests
internally, without FDA oversight.
“Subjecting LDTs to FDA regulation would eliminate the very characteristics which make LDTs and the
regulatory framework that presently govern them so vital: flexibility and nimbleness in their ability to
respond to unmet needs,” Alan Mertz, president of the American Clinical Laboratory Association, said
September 9 in written testimony to the U.S. House of Representatives Energy and Commerce Committee
Subcommittee on Health. “FDA regulation of LDTs as medical devices would dramatically slow not only
the initial premarket approval of new tests, but also improvements to existing tests, delaying access to
new and improved diagnostic testing services for patients and clinicians.”
As detailed in July, the FDA said it plans to begin premarketing approval (PMA) review requirements
within 12 months after a final guidance for the highest-risk devices and phase it in over four years for the
remaining high-risk devices. The devices would stay on the market during FDA review.
The agency said its focus on “high-risk” devices will begin with LDTs that have the same intended use as a
cleared or approved companion diagnostic, followed by LDTs with the same intended use as an FDAapproved Class III medical device, and some LDTs designed to determine the safety or efficacy of blood or
blood products.
All other LDTs will be prioritized for review using a public process with expert advisory panels “as
appropriate,” the FDA said. The agency promised to provide advanced notice on the timing of
enforcement of the new rules to manufacturers whose LDTs fall into high- and moderate- risk categories.
The FDA also said it “intends to” publish priority lists for its review of high-risk LDTs within 24 months of a
final guidance—with enforcement for the initial prioritized group beginning “no less than 12 months”
after the list is announced—as well as publish a priority list for “moderate-risk” LDTs within four years.
24
For “moderate risk” LDTs, which would be deemed Class II medical devices, labs would have to begin
registration, listing, and adverse-event reporting six months after a final guidance is set. PMA for these
LDTs would begin five years after final guidance, and be phased in over four years. FDA said it intends to
accredit and use third-party reviewers for premarket submissions “as appropriate.”
The FDA said it will hold a webinar on October 23 at 2:00 p.m. EDT, to address clarification questions on
the proposed framework. Details on dialing in and viewing the slide presentation are available here.
LDTs introduced to market on the date of publication of the final guidance, and for six months afterward,
will be subject to FDA enforcement discretion as is now the case. … (Source: GEN)
 FDA guides on custom devices
The FDA releases its final recommendations on legal exemptions for customized medical devices.
The FDA yesterday released its final recommendations for legal exemptions for customized medical
devices that deviate from already-approved systems by being tailored to the special needs of up to 5
patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very
tall people or infants that are otherwise unavailable in the correct size. … (Source : MassDevice)
 FDA - Draft
FDA - Brain-Computer Interface (BCI) Devices for Patients with Paralysis and Amputation.pdf
FDA - Custom Device Exremption.pdf
FDA - Draft - Certain Fluoroscopic Equipment Requirements.pdf
FDA - Draft - Framework Laboratory Developed Tests.pdf
FDA - Draft Laboratory Developed Tests.pdf
FDA - Final - Custom Device Exemption.pdf
 FDA Panel to Review New Watchman Data Wednesday
The Watchman left atrial appendage closure device (Boston Scientific) is making its third trip to
Gaithersburg, MD, Wednesday. Once again, the FDA's Circulatory System Devices Panel will review the
evidence supporting the safety and efficacy of the investigational device and make recommendations to
the agency as to whether it should be approved for the prevention of thromboembolism in patients with
nonvalvular atrial fibrillation.
It's been more than five years since the FDA's panel first reviewed the Watchman, as reported by
heartwire , voting 7 to 5 in favor of approval. The FDA then requested an additional study from the
sponsor, Boston Scientific, and that led to the PREVAIL study, which subsequently faced its own share of
controversy. In December 2013 an advisory panel review that included the PREVAIL data led to a vote of
13 to 1 in favor of approval. Once again, however, the FDA held off on a decision, most notably because
just 28% of the 18-month data from PREVAIL were ready for review.
Briefing documents for the panel posted online today make it clear that the panel is being asked to
consider the updated follow-up data provided to the FDA following the December 2013 review and in
particular the updated total number of ischemic strokes in the PREVAIL data set.
25
As recently reported by heartwire , Watchman investigators presented some of these data at last month's
TCT 2014 meeting, including the fact that eight new ischemic strokes have occurred in the Watchmantreated patients in PREVAIL and zero in the comparator group.
The briefing document does note that advisory panel members review the "totality of data" when
deciding whether it supports the safety and efficacy of the device and whether the probable benefits
outweigh the risks. … (Source: Medscape)
 FDA approves Gore's Viabahn for peripheral stent repair
The FDA adds an indication to its approval of W.L. Gore's Viabahn peripheral stent graft in treating failed
bare-metal stents.
W.L. Gore & Assoc. said the FDA granted pre-market approval for a new indication for its Viabahn
endoprosthesis, to treat failed bare-metal stents in the peripheral vasculature. … (Source: MassDevice)
 FDA's Device Approvals Come Under Fire, Again
A recent study concludes that most medical devices cleared via FDA’s 510(k) and PMA processes lack
sufficient evidence to show they are safe and effective. The report, which was published in JAMA Internal
Medicine, concluded that the 42 of 50 medical devices studied did not have sufficient data backing their
use.
In 2011, the Institute of Medicine (IOM) reached a similar conclusion regarding FDA’s 510(k) process,
which is used to clear the vast majority of non-Class I medical devices in the United States. The IOM
argued that the 510(k) process was so problematic that it should be scrapped entirely and replaced with a
new regulatory framework.
The United States’ regulatory approval process has come under fire from all sides in recent years. The
process is too slow and inefficient, according to industry. Many medical devices designed and developed
in the United States are first commercialized in Europe and elsewhere several years before they hit the
market here. Meanwhile, patient advocates claim that FDA’s process clearing/approving devices is
dangerous. In 2012, Consumer Reports released a report alleging that most medical implants are not
sufficiently tested. Especially controversial, in Consumer Reports’ eyes, is FDA’s 510(k) premarket
notification system, which enables many devices to be marketed owing to their “substantial equivalence”
to products already on the market.
“A lot of these are high-risk devices that get on the market with no studies at all,” said Rita Redberg, MD,
medical professor at the University of California, San Francisco, and chief editor of JAMA Internal
Medicine in the Wall Street Journal. “When there are studies, they’re not available” to review.
FDA has announced that it will retool the 510(k) process to address these concerns.
In recent months, the FDA itself has noted that the approval process should do a better job ensuring
medical devices are safe from a cybersecurity standpoint. Sister publication Information Week reports
that FDA is conventing “a collaborative industry-wide effort to bolster medical device cyber security.”
In addition, the FDA is mulling new regulation regarding the promotion of medical devices, following a
2013 reorganization at CDRH. … (Source: Qmed)
26
 FDA grants NEMARIS spine surgery planning software 510(k)
clearance
NEMARIS received 510(k) clearance from the U.S. Food and Drug Administration for the next-generation
SURGIMAP 2.0 platform.
The software is used to preoperatively plan spine surgery, and the new iteration of the software offers
advanced tools to determine and restore optimal spinal alignment for each patient. It also features case
and image sharing across users through cloud services.
The platform includes the UNiD plug-in, which was jointly developed with MEDICREA, one of NEMARIS'
strategic partners. The plug-in is embedded into the SURGIMAP 2.0 software interface and allows
surgeons an efficient option for planning and ordering the UNiD rods — patient-specific spinal
osteosynthesis rods currently available in Europe. … (Source: Becker’sSpine)
 Philips gets apps FDA-cleared, launches psoriasis device after
HealthTech refocus
Philips is getting serious about consumer health. In fact, it's staking the entire business on merging its
healthcare and consumer units into one company focused on what it's dubbed HealthTech. It will spin off
the lighting business into a separate company next year.
News of Philips' restructure and refocus came only about a week ago. But already the company has
announced a couple of consumer health-oriented advances: the FDA clearance of a pair of apps focused
on at-home patient care and the launch of the first wearable blue LED light therapy device to treat
psoriasis.
FDA has cleared Philips' eCareCoordinator and eCareCompanion. They are the first clinical apps from a
collaboration with Salesforce.com that was announced this June. Both are part of the Philips Transition to
Ambulatory Care (eTrAC) program, which is designed to help reduce hospital readmissions and healthcare
costs by focusing on effective chronic care management.
eCareCoordinator enables healthcare providers to conduct a daily review of health data for each of their
patients including vital signs, blood pressure and weight. It can also be used to collect subjective patient
responses via health questionnaires and to communicate with other members of a patient care team. …
(Source: FierceMedicaldevices)
27
 MindwaysCT gets 510(k) for bone density software
Software developer MindwaysCT said it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market a new version of its software that acquires bone mineral density
measurements from CT images.
The latest version of the company's quantitative CT (QCT) software works by using a previously acquired
calibration scan to convert a CT image into bone mineral density values, MindwaysCT said.
The software can be applied to any non-intravenous-contrast abdominal or pelvic CT scan, reducing
patient exposure to additional radiation. It can even be used to interrogate a PACS archive to find CT
scans of appropriate patient groups, MindwaysCT said.
The software is particularly useful when applied to CT colonography (CTC) scans, because the over-50
patient population that undergoes colorectal cancer screening is also at high risk for osteoporosis,
according to the company. … (Source: AuntMinnie)
 FDA clears Esaote's MyLab Gamma ultrasound unit
The U.S. Food and Drug Administration (FDA) has cleared ultrasound vendor Esaote North America's
MyLab Gamma ultrasound scanner.
The portable unit is laptop-sized and can be used in a variety of clinical environments, according to the
firm. It is ergonomically designed and can operate on battery power, and its two probe connectors can be
expanded to four with an optional cart. … (Source: AuntMinnie)
 Medical Device Quality System Surveillance Inspections Were Down
in 2013
FDA conducted 3% fewer medical device quality system surveillance inspections last year than in 2012.
Just-released device inspection results show that the agency performed 2201 quality system inspections
in 2013, 51 fewer than the 2252 conducted in 2012. This small decrease is likely attributable to an
increase in foreign inspections (460 in 2013 versus 393 in 2013), which require more agency resources,
according to FDA.
While the agency may have conducted fewer inspections, the number of overall inspectional observations
increased by 17% last year. According to the inspection report, the most frequent observations found in
2013 included:

Corrective and preventive action procedures (21 CFR 820.100(a)).

Complaint files, specifically establishing and maintaining procedures for receiving, reviewing, and
evaluating complaints (21 CFR 820.198(a)).
28

Quality audits to assure that the quality system is in compliance with the established quality
system requirements and determine the effectiveness of the quality system (21 CFR 820.22).
Additionally, warning letters with quality system citations fell 12% last year—from 164 in 2012 to 144 in
2013. Corrective and preventive action citations were the most cited infraction in warning letters, the
report says. … (Source: MD+DI)
 Intuitive Surgical wins FDA nod for new robotic 'wrist'
Intuitive Surgical says the FDA cleared a new robotic 'wrist' for hysterectomies and other procedures for
its da Vinci Si device. … (Source: MassDevice)
 FDA Clears Three Additional Targets for Luminex Gastrointestinal
Pathogen Panel
Luminex said after the close of the market on Monday that the US Food and Drug Administration has
cleared three additional targets for its xTAG Gastrointestinal Pathogen Panel.
The new targets are Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae. FDA also cleared the
assay for use with specimens in Cary-Blair medium, a common transport medium for collecting and
preserving microbiological specimens.
FDA originally cleared xTAG GPP in January 2013 for the Luminex 100/200 system for 11 common
gastroenteritis-causing viruses, bacteria, and parasites, including Campylobacter; Clostridium difficile
Toxin A/B; Escherichia coli 0157; Enterotoxigenic E. coli (ETEC) LT/ST; Shiga-like toxin-producing E. coli
(STEC) stx1/stx2; Salmonella; Shigella; Rotavirus A; Norovirus GI/GII; Giardia lamblia; and
Cryptosporidium.
Luminex said the assay now tests for more than 90 percent of the causative pathogens of infectious
gastroenteritis in one test, allowing clinicians to rapidly identify and treat the causative agent. Coinfections can also be more easily identified, the Austin, Texas-based company said. … (Source:
GenomeWeb)
 Judge tosses FDA whistleblowers lawsuit
A federal judge last week tossed a lawsuit brought by 6 of the so-called "FDA 9" whistleblowers accusing
the government of violating their constitutional rights with surveillance of their private email accounts.
The staffers alleged that the FDA spied on the private email accounts they accessed using their
government-issued computers, after they warned Congress and the president that unsafe medical devices
were being allowed onto the U.S. market.
The lawsuit, filed in 2011 in the U.S. District Court for the District of Columbia, leveled 12 counts against
the agency, its chief Dr. Margaret Hamburg, medical device chief Dr. Jeffrey Shuren, the Dept. of Health &
Human Services and its then-head, Kathleen Sebelius, and other government officials. It accused them of
enacting the secret surveillance after learning of a letter the staffers sent to then-President-elect Barack
Obama's transition team Jan. 7, 2009, and of using the information gleaned from the tapped email
accounts to harass and, in some cases, fire the whistleblowers.
After learning of the letter, the FDA set up a secret file on its database labelled "FDA 9" to collect the
surveillance data. The agency took screenshots of the staffers' computers as they accessed their private
29
Gmail accounts, according to the lawsuit. Although the government has the right to surveil any activity on
the computers it issues, it's unclear whether it's legal to secretly gain access to private email accounts
used on government-issued devices. … (Source: MassDevice)
 Attorney questions FDA's authority to regulate devices promoted on
social media
An attorney whose practice is focused on medical device law has called into question the FDA's authority
to regulate devices that are promoted on social media platforms like Facebook and Twitter.
Jeffrey Shapiro, writing in his firm's FDA Law Blog, cited the agency's power to regulate the labeling of all
devices and the advertising for restricted devices. However, he writes, the agency does have the authority
to take the advertising of nonrestricted devices into account in determining intended use. Beyond that,
though, the FDA doesn't have the authority to regulate the advertising of nonrestricted devices.
If you're not confused by now, throw in tweets, likes, Google Adwords, search engine optimization and
this past year's attempts by the FDA to clarify its policies on the use of social media by medical device and
drug companies. That was supposed to have been done back in July with the release of draft guidelines
that have most marketers in pharma scratching their heads. The medical device industry has waited
cautiously on the social media sidelines and watched as it changed how the world communicates.
Shapiro, like many observers, has been flustered by the FDA's grappling with the guidelines.
"What comes through most clearly, however, is that FDA has declined to forthrightly state its position,"
Shapiro wrote. "This coy approach is unfortunate, because the answer is crucial to whether the
enforcement position in these draft guidances applies to most medical devices."
In issuing guidance on social media platforms, he said, the FDA failed to indicate whether it considers
them (social media platforms) to be labeling or advertising. If you see social media platforms as a digital
public square where a company can promote its medical devices, then such communication would be
advertising. In that case, Shapiro said, the draft guidances wouldn't apply to nonrestricted medical
devices, which would include almost all Class I and Class II devices. … (Source : FierceMedicaldevices)
 Assistance with U.S. FDA Regulations
Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S.
Companies in the Food and Beverage, Medical Device, Drug, and Cosmetics Industries. … (Source :
Registrarcorp)
30
 Medtronic Will Buy Covidien Come Hell Or High Water
Medtronic is not backing away from the $42.9 billion deal to buy Ireland-based Covidien in response to
the U.S. Department of Treasury's move to make corporate inversions more difficult.
The medical device maker announced Friday that it will borrow $16 billion to help fund the acquisition
given that under new rules from Treasury it cannot use cash held overseas.
Initially the company said it would use $13.5 billion through an intercompany loan from an international
subsidiary and raise $2.5 billion in new debt, wrote Glenn Novarro, an analyst with RBC Capital Markets,
in a research note Friday.
The stock of both Medtronic and Covidien fell after the U.S. Treasury provided details on Sept. 22
regarding rules that were aimed to "reduce the tax benefits of — and when possible, stop — corporate
tax inversions."
But for Medtronic, the deal with Covidien was never about simply seeking a lower-tax haven overseas or
being able to access the billions of cash it had in foreign subsidiaries without paying US. taxes.
In teaming up with Covidien, the goal was to turn the challenges that the Affordable Care Act threw in the
direction of the medtech industry into an opportunity. An opportunity to widen Medtronic's reach here
and abroad, and move from having a transactional relation with hospitals to more of a collaborative
relationship. … (Source: MD+DI)
 Appeals court vacates FDA's rescission of ReGen's MenaFlex implant
A federal appeals court vacates the FDA's decision to rescind its 510(k) clearance for ReGen Biologics'
MenaFlex knee implant, ordering the watchdog agency to conduct "further proceedings." … (Source:
MassDevice)
 Medical device tax: A hat trick of futility
The medical device tax is like a bad public school teacher: It's a drain on the system and seemingly
impossible to get rid of.
In just 21 months, the 2.3% levy has achieved a unique hat trick of futility. How else could you describe a
tax that's highly inefficiant, fundamentally ineffective and disproportionately damaging to 1 of the few
net exporting industries left in the U.S.?
In recent months, we've learned that the following about the medical device tax:

The IRS collected only $1.4 billion in medtech tax revenues in 2013, as revealed in a
MassDevice.com exclusive, far shy of just about every estimate.
31

The IRS "cannot identify the population of medical device manufacturers" ought to be making
semi-monthly deposits on the tax, according to the U.S. Treasury Dept. The IRS collected a little
more than $913 million during the 1st half of 2013, well shy of the $1.2 billion it expected.

The IRS wildly overestimated the number of medical device tax returns filed during the 1st half
of 2013 (9,000-15,000) versus the roughly 5,100 returns medtech companies actually filed.
The Affordable Care Act forecast that the medical device tax would raise $30 billion over 10 years to help
defray the cost of providing health insuranceto millions of the uninsured. At this rate it will raise nowhere
near that amount. And another key rationale, that the cost of the tax would be offset for medtech firms
by increased business from the newly insured, has proven to be wildly off. Procedures are down overall
and medical device sales have tapered overall to the low single digits in the last few years.
Earlier this month, the House of Representatives approved the "Jobs for America Act," a package of bills
that included a measure that would roll back the medical device tax and issue a retroactive refund to
medical device companies.
There's even speculation that the collections gap indicates that some medtech companies are boycotting
on the tax.
"I'd be surprised to find many – if any – in our community who haven't paid the tax. We focused our
[device tax education] program on smaller and mid-size companies and made sure they had access to
expertise," LifeScience Alley CEO Shaye Mandle told the Minneapolis Star-Tribune. "Nobody is skirting this
tax."
Still, could you blame a company for at least flirting with the idea of a boycott?They won't get any help
from Washington before the mid-term elections; after the House rammed through its repeal-and-replace
measure, it promptly went on recess until after the November elections.
It's time to fix this mess once and for all. … (Source: MassDevice)
 Philips to Appeal $467 Million Patent Verdict
Royal Philips said Thursday that it will appeal a U.S. federal jury's decision to award Irvine, CA–based
Masimo Corp. $467 million in a patent infringement case against the Dutch multinational.
The federal jury in Delaware found Masimo patents are infringed by Philips products incorporating a
noninvasive pulse oximetry measurement technology that measures the level of oxygen saturation in a
patient's blood.
"We are very disappointed in the verdict of the jury and surprised by the magnitude of the proposed
award,” Frans van Houten, CEO Royal Philips, said in a news release. “Philips intends to pursue all avenues
of appeal of this verdict at both the District and Appellate courts in the U.S."
For now, Philips officials plan to include the $467 million as an exceptional charge in third quarter 2014
results. The company's stock fell 2.5% in value on the New York Stock Exchange on Wednesday, the same
day the jury verdict was announced, and it was down another 1.2%, to $30.65 per share, near the close of
trading Thursday.
The jury verdict news comes more than a week after Philips announced plans to separate its healthcare
and lighting businesses, with the possibility of spinning off the new lighting company with an IPO. The
company intends to combine its existing healthcare and consumer lifestyle businesses into one entity
known as HealthTech, the company said in a statement. … (Source: Qmed)
32
http://www.pcori.org/
http://www.ahrq.gov/
http://www.iom.edu/
SANTE CANADA/HEALTH CANADA
http://www.hc-sc.gc.ca/index-fra.php
 Latest Information on Health Canada Review and Approval Times for
MDEL Applications
Health Canada regularly publishes performance data with respect to Medical Device License applications
(Class 2-4); however, the data publically available for Medical Device Establishment License (MDEL)
applications has generally been limited. To gain a better understanding of MDEL applications, Emergo's
Vancouver office contacted Health Canada under Canada’s Access to Information Act asking for the
following information:
1. The number of active Medical Devices Establishment Licenses and where the license holders are
located.
2. The type of activity of the MDEL holders (Class 1 manufacturer, importer or distributor).
3. The average review time for a new MDEL submission over the period of 01 April 2013 to 31 March 2014
and the average review time for a MDEL renewal (Annual Review) over the same period.
4. The amount of total fees collected by Health Canada for MDEL holders and the average fees for MDEL
holders that were subject to fees.
Health Canada’s reply can be summarized as follows:
1. Health Canada disclosed that there were 2473 MDELs issued as of March 31, 2014, of which:
a.
1784 (72%) licence holders were based in Canada,
b.
581 (23%) license holders were based in the United States,
c.
the remaining 108 (4%) were spread across 24 other countries.
2. Regarding activity:
a.
602 (24%) of the MDEL holders were registered solely as Manufacturers of Class 1 medical
devices
b.
547 (22%) of the MDEL holders were importers only (the Health Canada definition of
“importer” means that they are based in Canada).
33
c.
Of the 378 (15%) MDEL holders that identified distribution as their only activity, 195 were
based outside of Canada (96% of these were based in the US).
3. For Health Canada’s last fiscal year (ending 31 March 2014), they reported that new MDEL applications
were taking an average of 53 calendar days to review. Over the same period, the average review
time for a MDEL Annual Review (renewal) was 44 days.
4. With respect to MDEL fees, Health Canada disclosed:
a.
2382 MDEL holders had initiated the renewal of their MDEL prior to 31 March 2014, of which
2118 MDEL holders paid a total of $8.9 Million.
b.
820 MDEL holders paid a full MDEL fee ($7344) [Note: the HC report mistakenly stated 870
companies.]
c.
1298 MDEL holders received some level of fee remission (based on sales).
d.
186 MDEL holders paid $0 (no sales).
e.
264 MDEL holders had their fees deferred to the next year (i.e. new licensees)
f.
Of the $8.9 million collected in MDEL fees, a total of $6 million was collected from those MDEL
holders that did not receive a fee remission Therefore, of the 1,298 MDEL holders that
received a fee remission the average fee was $2283, which equates to a reduction of
approximately $5000 for each MDEL holder in this scenario. … (Source : Emergo Group)
The key takeaways from the data collected from Health Canada on Medical Device Establishment Licenses
are:
(1) Health Canada takes between 40 and 55 days to review MDEL renewal and new MDEL applications,
respectively.
(2) Companies that apply for a fee remission as part of the MDEL Annual Review pay an average of $5000
less in fees for their MDELs.
LATIN AMERICA
SSA http://www.salud.gob.mx/
 New COFEPRIS Guidance on Technovigilance Report Submissions
Mexico’s medical device market regulator COFEPRIS has issued new guidance on its technovigilance
reporting program (link in Spanish) for medical device manufacturers commercialized in the country.
First announced in early 2013, the technovigilance system will support post-market device monitoring and
management of adverse event reporting and corrective actions.
Most importantly for manufacturers registered in Mexico, technovigilance reports must cover at least
four years of commercialization both in Mexico and in other countries where a device is marketed.
Previously, manufacturers had expressed confusion as to whether these reports would be required every
five years, which would coincide with COFEPRIS registration renewals. Documentation showing regulatory
approval of technovigilance reports will be required for registration renewals.
34
If, for example, a manufacturer is facing a sanitary registration renewal deadline of January 1, 2016, the
following time frame would apply:

Prepare and submit technovigilance report by May 5, 2015

Submit registration renewal request by August 4, 2015

Renewal of sanitary registration approved January 1, 2016
COFEPRIS is accepting comments on the technovigilance guidance through September 30. … (Source :
Emergo Group)
http://portal.anvisa.gov.br/wps/portal/anvisa/home
 Brazilian Medical Device Regulators Take First Steps toward
Electronic Registration System
ANVISA, Brazil’s medical device market regulator, has announced plans to implement a system for
electronic submission of registration applications based on guidelines from the International Medical
Device Regulators Forum (IMDRF).
The IMDRF system, known as Regulated Product Submission (RPS), is being developed to facilitate greater
uniformity of premarket device submissions and approvals across different national markets. ANVISA and
other participating regulators will begin their RPS implementation effort by defining and adopting a
“Table of Contents” within the next few years.
Emergo will provide further details of the RPS project in Brazil and other markets over the coming
months. … (Source : Emergo Group)
MIDDLE EAST
 Israeli devicemaker eyes lucrative sleep disorder market
As devicemakers cast an eye toward a lucrative sleep disorder market, Itamar Medical is joining the ranks
and anticipating positive third-quarter results buoyed by recent sales agreements and commercialization
efforts for its sleep monitoring devices.
The Caesarea, Israel-based company said it is on track to end three years of sluggish growth after signing
new sales deals in the United States and Japan and boosting its cash reserves, CEO Gilad Glick told
Reuters. Over the past half year, Itamar raised $16.3 million from Israel's largest institutional investors to
35
fund research, development and commercialization for its home sleep test, WatchPAT, and inked deals
with Medtronic, a Japanese unit of Philips, and Nihon Kohden, one of Japan's largest medical device
manufacturers.
"There is a lot of strategy on our part, but also a lot of really good timing, almost on all fronts," Glick said,
as quoted by Reuters.
Itamar's diagnostic devices use a fingertip sensor to track the health of nerves and blood vessels,
providing a noninvasive "window" to the cardiovascular system and the autonomic nervous system, the
company said on its website. Patients can wear the sleep monitor at home on the wrist with a small clamp
extending to one finger, while the larger cardiovascular system, EndoPAT, must be used in a clinic, Reuters
reports. … (Source: FierceMedicalDevices)
AFRICA
 South African Draft Regulations based on IMDRF
Principles Released
The South African Medicines Control Council (MCC) has issued draft regulations as well as Essential
Principles for the mandatory registration of medical and in vitro diagnostic devices. Currently, only listed
electro-medical devices and devices with pharmaceutical components require registration in the country.
The proposed legislative framework for device and IVD regulations employs recommendations from the
International Medical Device Regulators Forum (IMDRF), and would also recognize “local and
international medical device and IVD standards and conformity assessment standards” for South African
registration purposes.
Proposed registration components
In draft form, the South African medical device regulatory framework fortunately does not attempt to
reinvent the wheel in terms of registration requirements. Elements of the framework include:

A four-tier classification system based on risk (Classes A, B, C and D)

Authorized representation requirements for manufacturers with no presence in South Africa

Essential Principles covering medical device and IVD quality, safety and performance

Post-market surveillance of devices already registered for sale in the country
Registration applications would be submitted to the MCC’s Registrar of Medicines for approval; the MCC
would reserve the right to evaluate conformity assessment documents for Essential Priniciples
compliance.
Implications and questions
According to Brian Goemans, Country Manager for Emergo’s South Africa business, the new draft
guidance show promising signs, but also raises some significant questions.
“These guidances were released under the MCC rather than the South Africa Health Products Regulatory
Authority, as had been proposed, and closely follow IMDRF concepts,” says Goemans. “They also clearly
differentiate between medical devices and medicines.”
36
However, Goemans also points out issues raised by the new proposals: Mistakes such as referencing
defunct standards, inappropriate examples used for classification, and circulation of the proposals to
pharmaceutical manufacturers but not medical device manufacturers.
South African regulators have set up a three-month time period for comments on the draft regulations
and Essential Principles. … (Source : Emergo Group)
AUSTRALIA & NEW ZELAND
http://tga.gov.au/
 TGA international engagement strategy 2013-2015
Updated Annex 1 and Annex 2. … (Source: TGA)
 Electronic funds transfer agreement
Updated fax number and bank details on EFT forms… (Source: TGA)
 Payment options
Updated payment option details… (Source: TGA)
 Koning secures Australian breast CT clearance
Breast CT developer Koning has received the Australian Register of Therapeutic Goods Certificate for its
Koning Breast CT system and biopsy add-on option.
The approval allows the company to market the system throughout Australia, Koning said. … (Source:
AuntMinnie)
ANZTPA http://www.anztpa.org/
INDIA & ASIA
37
China SFDA | Hong Kong MDCO & PSDH | India CDSCO | Japan MHLW | Korea KFDA | Malaysia MOH | Philippines DOH
| Singapore HSA | Taiwan TFDA | Thailand FDA | Vietnam MOH
http://www.pmda.go.jp/english/
 Japan approves Infraredx's intravascular ultrasound Dx imaging
device
Infraredx isn't a big company yet. But the Massachusetts maker of an intravascular imaging system
designed to help diagnose and manage coronary artery disease continues to meet major goals for
international expansion. The latest: Japan's regulators granted approval for its signature device.
Specifically, Infraredx's TVC Imaging System and accompanying Insight catheter have a key sign-off from
the Japanese Ministry of Health, Labor and Welfare. But Infraredx won't be going it alone in rolling out
the product. Earlier this year, it began to put manufacturing and distribution partnership plans in place
with Nipro, a Japanese conglomerate focused on medical devices and pharmaceuticals. Nipro subsidiary
Goodman (which it partly owns) will distribute both the TVC Imaging System console and catheter.
Previously, Goodman has been key to expanding markets in Japan for intravascular ultrasound imaging
diagnostic devices for both Boston Scientific and Volcano, Infraredx said in a statement.
TVC is designed to seek out the details of coronary plaques that are connected to heart attacks and can
make stenting more difficult, the company explained. It uses both near-infrared spectroscopy (NIRS) to
spot lipid-core plaques and enhanced intravascular ultrasound (IVUS) to visualize the actual vessel
structure. … (Source: FierceDiagnostics)
38
http://www.sfdachina.com/?gclid=CIes_4rZnrMCFe_MtAod_0gAeA
MFDS
http://www.kfda.go.kr/eng/index.do;jsessionid=8WaGRaioTcYSanehB1hMj6KOHjYV58zMGvaefbMlRWUQqdgxsIWA05GwBX1zZoJG
Our partner in South Korea
HSA
http://www.hsa.gov.sg/publish/hsaportal/en/home.html#page=tab1
CDSCO
http://www.cdsco.nic.in/
DISCOVERY - DESIGN - DEVELOPMENT
 Paralyzed Rats Walk Thanks to Spinal Stimulation and Software
Swiss researchers have created a way to precisely control the motor functions of paralyzed individuals
through spinal stimulation, Science Translational Medicine reports.
39
Grégoire Courtine, MD, of the Center for Neuroprosthetic and Brain Mind Institute of the Life Science
School at the Swiss Federal Institute of Technology, Lausanne (EPFL), and his team used electric
stimulation devices to give rats with severed spinal cords the ability to walk. Courtine published the
results of the study last week in a paper called “Closed-loop neuromodulation of spinal sensorimotor
circuits controls refined locomotion after complete spinal cord injury.”
Electric implants in the rats’ spinal cords received altering electric signals, which controlled the
movements of the animals’ legs via computer. Researchers filmed the rats walking and uploaded the
images to software that adjusted the stimulation pattern to synchronize stepping movements. With their
upper body supported, the rats walked more than 1000 steps on their hind legs.
The findings could help people suffering paralysis from spinal injury. Other groups are pursuing ways to
achieve a similar goal.
Earlier this year, a Medtronic spinal stimulator helped four people regain some control over their legs.
Combining the RestorAdvance spinal implant with physical therapy marked a shift in thought about
treating paralysis, which previously had focused on healing or replacing injured neurons to rebuild motor
function. Researchers conducting the successful experiment said in their abstract, “[they] have uncovered
a fundamentally new intervention strategy that can dramatically affect recovery of voluntary movement
in individuals with complete paralysis even years after injury.”
In another study this year, a quadriplegic man was able to move his hand with the help of a brain implant
called Neurobridge. The chip connected brain to hand via an external cable, bypassing damaged nerves
that caused paralysis. An algorithm trained on the patient’s neurological signals translated thoughts of
movement into motor command.
Continuing on this path, NeuroRecovery Technologies is creating spinal-cord stimulator devices to restore
lower limb function. The company wants to create, “highly programmable devices to address the specific
needs of these patients,” according to CEO Nick Terrafranca.
The newest study focused on using software to send signals that mimic brain activity interrupted by injury
to the spinal cord. Courtine and his researchers had success with encouraging paralyzed rats to walk on
treadmills, with the help of electric and chemical (serotonin agonist) spinal stimulation, and released
progress on their studies last year. But, as Courtine said in a November 2013 TED talk, “It is locomotion
without the brain.”
“The animal appeared to have no control over the legs. Clearly, the steering system was missing.”
Courtine felt compelled to give more control to the rats via software, letting the animals walk in any
direction, on any surface. His team connected a robot above each rat during the experiment and the
animals began to lead their own movement. A harness supported each rat learning to walk. After the rats
progressed through physical therapy with the support system, their bodies began to repair themselves by
generating pathways through the nervous system.
“This novel training paradigm encouraged the brain to make new connections, some relay circuits, that
relay information from the brain, past the injury and restore cortical control over the locomotor networks
below the injury,” Courtine said. The repair occurred beyond the injury to the greater central nervous
system, including the brain stem.
“My hope here is to create a completely personalized condition to boost the plasticity of the brain and the
spinal cord.” Courtine feels this could lead to a radically new way of repairing serious injury, with what he
calls “personalized neuroprosthetics” to help the brain help itself.
40
The software incorporation could help individuals walk with more balance and natural movement.
Courtine’s group hopes to test in humans next year. … (Source: Qmed)
 Novel Self-Apposing Stents To Treat Coronary Heart Disease
A French medtech company has developed the first self-apposing stent to treat acute myocardial
infarction. It might represent the start of a new era in the treatment of coronary heart disease.
As the world's leading cause of death, heart disease is a major public-health issue. In the EU alone, 85
people an hour die of sudden occlusion of the coronary artery caused by a clot, while one American
citizen a minute dies of a heart attack. And every year, 5.5 million coronary stents are implanted
worldwide, partly to fight coronary artery stenosis. “But conventional fixed-size stents cause
malapposition problems, especially in blood vessels that are bifurcated, tapered, or with ambiguous or
fluctuating diameters,” observes Gonzague Issenmann, CEO and cofounder of the start-up Stentys.
Issenmann’s company spends over 2 million euros per year on R&D for this technology, which is protected
by 28 patents. The first two patent families describe a stent whose structure is partially separable after
deployment in the lumen, and a self-expanding system with separation zones, one section of which can
continue to dilate after separation. The third and fourth patent families protect the specific design of the
stent’s connector and delivery catheter, especially its shape and specific handle mechanism.The fifth
patent family covers a process for treating body ducts with undesirably reduced diameters by oversizing
the stent.
The superelastic titanium alloy (nitinol), a 68-micron strut width (one of the narrowest on the market),
and microconnecters spread all over the surface mean cardiologists can position the Stentys stent
anywhere without using a balloon.
Stentys recently acquired the American company Cappella Peel Away (Delaware, USA) and its novel stent
delivery system for 1 million euros. “We will now be able to integrate this technology into our new
generation of delivery catheters for our nitinol bare-metal and Paclitaxel-eluting self-apposing coronary
stents,” Issenmann says.
Stentys is currently the only medtech company in the world that has obtained CE marking for a selfapposing drug-eluting stent to treat acute myocardial infarction. This Nanterre-based medtech company
has just announced that over 10,000 stents have been implanted in patients. “We included over 2,000
patients in our clinical assessments and carried out nine international clinical trials. These demonstrated
the advantages of self-apposing technology compared to conventional stents,” continues Issenmann.
41
The final results of the Apposition III postmarket clinical study on 1,000 patients have just been made
public on 16 September 2014 at the Transcatheter Cardiovascular Therapeutics (TCT) conference in
Washington. They revealed a reduction less malapposed struts by the factor 1,72 and a much lower death
rate two years after treatment for acute myocardial infarctus than with conventional stents: 2%
compared with 4.9%.
Stentys, which employs 37 people (a third of whom are in R&D) in 10 countries, made the decision to
outsource all of its production to suppliers who are experts in their fields. These include the German
companies Admedes and Hemoteq, which manufacture nitinol stents and stent coatings, respectively, and
the American companies Tactx and Parter Sterilization Services, which supply extruded plastic tubing for
medical use and medical device sterilization processes. … (Source : EMDT)
 Study Compares Tissue-Based or Mechanical Replacement Heart
Valves
When the heart's aortic valves cease to work properly, surgeons often use replacement valves to help
restore proper cardiac function.
Now a new study compares two leading types of aortic valve replacements, and finds they have similar
performance in terms of long-term risk of stroke and death for patients.
However, the study also found significant differences between the two types of devices when it came to
rates of major bleeding and the need for another heart valve operation.
According to background information from the researchers, each year in the United States about 50,000
people receive an aortic valve replacement.
"Surgical aortic valve replacement is indicated for patients with symptoms of heart failure and a
dysfunctional aortic valve, either too narrow or too leaky," explained one expert, Dr. Chad Kliger, a
structural heart interventional cardiologist at Lenox Hill Hospital in New York City. He was not connected
to the new study.
"The types of replacement include mechanical, which are made of metal alloy disks attached by hinges, or
bioprosthetic [tissue], which are made from pig or cow tissue," he added.
In the new study, researchers led by Yuting Chiang, of Mount Sinai Hospital in New York City, analyzed
data from more than 4,200 patients, aged 50 to 69, who underwent aortic valve replacement with either
a bioprosthetic valve or a mechanical valve.
Reporting in the Oct. 1 issue of the Journal of the American Medical Association, they found that survival
rates after 15 years were about 61 percent in the bioprosthetic valve group and 62 percent in the
42
mechanical valve group. Stroke rates after 15 years were also similar, at 7.7 percent and 8.6 percent,
respectively. … (Source : Drugs)
 Medtech Biocompatibility Testing Is Seeing a Major Shift
There’s been a change afoot in the medical device industry in the way companies test for
biocompatibility—with a shift away from animal tests toward chemical characterization tests in the
laboratory, according to Thor Rollins, a biocompatibility expert at Nelson Laboratories.
“It was only …. in the last year and a half that there has really been a strong push by the FDA to get
involved. … It wasn’t until the FDA started asking for it that people have been doing it routinely,” said
Rollins, who is discussing biocompatibility and sterilization requirements during a series of sessions
October 16 at MD&M Chicago.
The FDA’s push for more chemistry behind leachables not only involves permanently implantable medical
devices (implanted over 30 days) but also IV sets and sleep apnea devices that are passing fluid or air into
the body, Rollins said. Class II and II is more of a concern than Class I.
Setting more standards for such testing was a top subject for a meeting of the Technical Committee 194
of ISO 10993 that Rollins attended last April.
The changes come amid greater concerns over the chemicals that leach into the body. One of the most
notorious situations of leaching going badly involved metal-on-metal hip implants releasing cobalt and
chromium into the body—producing tragic results in patients and billions of dollars in lawsuit payouts.
Leaching is likely to become even more of an issue because the more active babyboomer generation is
needing medical device implants earlier, at the same time that it is expected to live longer. Devices, then,
are going to be inside the body longer than in the past.
Animal tests are limited when it comes to figuring out whether chemicals leached from a device safe over
a patient’s lifetime, according to Rollins.
“We were limited on how aggressive on the solvents we could use in the animal tests, because we can’t
do something that’s toxic in the animal. We have to use things like saline and oils. … They’re not very
aggressive solvents,” Rollins said. … (Source: Qmed)
 Mitralign reports 1st-in-human tricuspid valve repair
Mitralign reports the 1st-in-human use of its minimally invasive device to treat tricuspid valve
regurgitation under a compassionate use allowance in Germany.
Mitralign said that surgeons in Germany implanted its tricuspid valve repair device in its 1st patient, under
a "compassionate use" allowance in Germany. … (Source : MassDevice)
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 Meet the Material Behind the World's Most Popular Artificial Heart
A person’s heart beats roughly 100,000 times in one day and more than 2.5 billion times in a typical life
span, according to PBS. Imagine the challenge of developing an artificial heart that can match that
durability.
One of the difficulties was finding a material that is up for the job. Total artificial heart maker SynCardia
Systems Inc. (Tucson, AZ) found that segmented polyurethane was ideal for the task. After testing the
material against an array of different materials, the company found that nothing could beat segmented
polyurethane when it came to stretching, strength, and shape memory. In particular, the biocompatible
material has remarkable flex life properties, making it well suited for use in artificial hearts.
A few years ago, however, the company’s supply of the material was threatened. SynCardia decided to
look around for alternatives. “We tried working with half a dozen different companies that specialize in
materials,” says Isaacs. They couldn’t find a material that could beat it.
SynCardia decided to buy the material’s formula, the equipment to make it, and everything else needed
to make it in house. SynCardia is now the only company to manufacture the material. “We now have a
whole team that does nothing but make the material for the SynCardia Total Artificial Heart,” says Don
Isaacs, the company’s vice president of communications.
The company’s artificial heart has always been made out of the material since the predecessors of the
modern SynCardia temporary total artificial heart were first implanted into human patients 30 years ago.
And now that it makes it in house, the company can retain control over its formulation. … (Source : Qmed)
 2 Mistakes You Should Avoid with Medical Plastics Sterilization
With 15 years of experience consulting on polymers in the medical device field, Stephen Spiegelberg has
spotted plenty of mistakes to avoid when it comes to sterilizing medical plastics.
Here are two major mistakes that Spiegelberg, president of Boston-based Cambridge Polymer Group, says
you should avoid:
1. Choosing the Wrong Sterilization Method
44
There are three major sterilization methods: ethylene oxide, gamma radiation, or electron beam
radiation.
“The common issue we see with companies new to this sort of process is that they’ll plunge into one of
the ionizing radiations, either gamma or electron beam, without consideration of what it is doing to the
plastic itself,” Spiegelberg says.
Use ethylene oxide, and the packaging will need to have permeability to the ethylene oxide, and some
devices just don’t lend themselves to ethylene oxide, which is more of a surface sterilization process.
The radiation sterilization might be cheaper, too.
But Spiegelberg says the advantages to be had from using radiation sterilization could be more than
cancelled out because brittleness or other changes to the properties of the plastic could potentially crop
up, immediately or over the longterm, with such radiation exposure.
2. Placing Sterilization above Clean
Your plastic medical device parts might be sterile, but are they clean?
That question became much more important after the roughly $1 billion in lawsuit settlements that Sulzer
Orthopedics, now part of Zimmer, made over a decade ago over faulty hip and knee implants.
Spiegelberg was involved with a taskforce that examined what went wrong.
“They changed their manufacturing process, which resulted in a series of things that happened
downstream. At the end of the day, it resulted in some manufacturing residue, some lubricants, being left
on the medical product that led to an adverse biological response,” Spiegelberg said.
The Sulzer issues changed the climate.
“Up until that point, manufacturers were certainly aware that how clean medical device components are
is important. But it certainly was second tier to how sterile medical products are. … As we say, ‘’You can
have sterile dirt, but it’s still dirt,’” Spiegelberg said.
Spiegelberg says the solution is more control and understanding of the manufacturing line: “They need to
know how much their residue load is—both in quantification and identification—so that if there’s a
problem down the road, they can get ask if residue levels changed.” … (Source: Qmed)
 Autism diagnosis could become clearer with sound/sight response
screening
Researchers have come up with a diagnostic approach that they say could improve how autism is both
identified and classified. The new technique, developed by a team at the Yeshiva University's Albert
Einstein College of Medicine, joins a number of efforts with a goal of finding better ways to spot and treat
the condition.
Details are outlined in the online edition of the Journal of Autism and Developmental Disorders.
The Albert Einstein College of Medicine researchers believe the better way to diagnose autism might be
measuring how quickly the brain responds to sights and sounds. This approach, they said, could make it
easier to diagnose the condition earlier and also objectively classify people on the autism spectrum.
Their study involved 43 children with autism spectrum disorders ages 6 to 17. Each was subjected to a
basic auditory tone, a visual image (red circle), or a tone combined with the image. Researchers told
45
patients to press a red button as son as they heard the tone, saw the image or saw and heard both the
image/sound at the same time. As this happened, the scientists made continual EEG recordings by way of
700 scalp electrodes on each patient.
The more time it took patients with autism spectrum disorders to process auditory signals, the worse
their autistic symptoms. There was a similar, but weaker correlation between how quickly patients
processed both audio-visual signals and their autism severity. But there wasn't an identifiable link
between what patients saw and their degree of autism symptoms.
Their work builds on an earlier study by some of the same researchers that suggested EEG recordings
could determine how badly an individual was affected by an autism spectrum disorder. That earlier study
concluded patients with autism spectrum disorders processed sound, touch and vision slower than
normally developing children, according to the research announcement.
While more research about this diagnostic approach is needed, the scientists said their work reflects
progress, considering that with autism, clinicians don't know how to classify patients into subgroups.
"This has greatly limited our understanding of the disorder and how to treat it," associate professor and
study leader Sophie Molholm said in a statement. "We clearly need a more objective way to diagnose and
classify this disorder." That would be key, because many believe an earlier intervention works better for
autism treatment. … (Source: FierceDiagnostics)
 Disposable EEG Face Mask to Diagnose Brain Disorders
Electroencephalography (EEG) is the current gold standard for measuring brain activity in the clinical
setting and is used routinely to determine alterations in brain activity as well as diagnose other
pathological conditions such as epilepsy, cerebral haemorrhage and determine brain death. In order to
measure the electrical activity accurately electrodes need to be attached to the scalp in specific places
within the hair line which is difficult, time consuming and requires a high level of experience to achieve
good recordings. As a result of this the EEG is rarely used in an acute setting such as following head
trauma and prolonged epileptic seizures. Within the treatment cascade gaining an immediate diagnosis of
pathology with an EEG is highly advantageous and can result in rapid treatment options which inevitably
will result in a positive impact on outcomes and prognosis.
With this in mind the development team has designed a new type of electrode which is much easier to
apply to the skin, doesn’t require any skin preparation or any additional conducting gel. The EEG
electrodes have been designed using screen printing technology onto a flexible polyester film using silver
impregnated ink. The electrodes are coated using a hydrogel, and uniquely placed on to the face rather
than the scalp, which means that positioning of the device onto the patient is rapid and simple. Further to
this, the use of silver in the new type of electrodes seems to have introduced a ‘shielding’ effect which
means that there is a reduction in external interference of signal from other modalities which are used in
the clinical environment such as MRI or CT scans. This means that patients can have continuous EEG
monitoring of their condition while other procedures take place. And from a commercial view point the
46
electrodes can be applied to other measurement electrodes produced in a similar manner. The fact that
the patient doesn’t need to be moved in order to apply the mask also means that patients with suspected
back and neck injuries can benefit from its’ use without the risks adding to injury. … (Source: EMDT)
 Novel Blood Test Shows Who Has and Who May Get Cancer
Scientists at the University of Bradford in West Yorkshire, U.K. say they have developed a new blood test
that can determine if an individual has cancer. The lymphocyte genome sensitivity (LGS) test could not
only detect some cancers earlier than ever before, but it may eventually eliminate the need for some
types of biopsies, as well as identify those more likely to develop cancer in the future, according to the
research team.
The study (“Sensitivity and specificity of the empirical lymphocyte genome sensitivity assay: implications
for improving cancer diagnostics”) was published in the FASEB Journal.
To develop this test, Diana Anderson, Ph.D., and colleagues took blood samples from a group of people
that included healthy individuals, cancer patients, and people believed to be at a higher risk than normal
to develop cancer. Lymphocytes in these samples were examined in a comet test, by embedding the cells
in agar on a microscope slide. In this test, damage to the DNA of the cells was caused by treatment with
ultraviolet (UVA) light. This damage was observed in the form of DNA pieces being pulled within the agar
in an electric field toward the positive end of the field. This caused a comet-like tail, and the longer the
tail, the more DNA damage.
Different thicknesses of the agar were applied to the slides. In healthy people, as different thicknesses
were added, DNA-damaged tail responses returned to normal levels. In cancer patients, DNA-damaged
tail responses remained high, and in those people who might develop precancerous diseases, tail
responses were in between. This means that people with cancer have DNA which is more easily damaged
by UVA than do other people, so the test shows the sensitivity to damage of all the genome in a cell,
explained Dr. Anderson. The LGS test has been used to examine blood samples from cancer patients with
melanoma, colon cancer, and lung cancer, and all gave the same outcomes. … (Source: GEN)
 Researchers Hope to Diagnose Deadly Ebola Virus with Nanotech
With more than 6,500 cases of the Ebola virus in West Africa, 3,000 deaths and now one confirmed case
here in the United States, scientists are trying to find a way to detect the deadly virus more quickly,
cheaply and easily.
47
And they’re increasingly using nanotechnology to do it.
A team of researchers at Boston University’s College of Engineering and its School of Medicine has been
working for the past five years to develop a portable device that uses a silicon chip to diagnose a patient
with Ebola, or other hemorrhagic fever diseases like the Marburg virus or Lassa Fever.
What’s potentially important about this diagnostic device is that it could easily be used in remote areas
with limited electrical and medical resources.
Scientists have built a prototype of a device that can diagnose the deadly Ebola virus by shining light on
viral nanoparticles on silicon.
“What motivates us is that there are some really good tests to diagnose these diseases but none of these
tests are easily transported where they are needed,” said John H. Connor, an associate professor in BU’s
Department of Microbiology and a virologist on the research team. “They have to fly in heavy, electricityrequiring machines that require specialized training and special ingredients to make the diagnostics work
properly. They’re expensive, time intensive and, most importantly, they’re pretty much locked to a clinical
lab.”
That’s a problem for countries like Liberia, which has suffered more than 3,400 cases of Ebola and more
than 1,800 deaths in this outbreak, according to the Centers for Disease Control and Prevention (CDC).
The World Health Organization (WHO) has reported that the Ebola virus, once known as Ebola
hemorrhagic fever, is one of the world's most virulent diseases, with a fatality rate of approximately 90%.
Spread by direct contact with the blood, fluids and tissues of infected animals or people, authorities have
attempted to contain the outbreak, which began in Guinea and has spread to other countries, including
Liberia and Nigeria, which have both declared health emergencies because of it.
Liberia, for example, simply doesn’t have the resources to dot the countryside with well-equipped, hightech clinics that can run traditional diagnostic machines.
Connor said his research team, which includes scientists from the University of Texas Medical Branch, are
even more focused after learning that there’s a patient in the U.S. with Ebola. But, he said, people around
the world have been suffering from hemorrhagic fever diseases for a long time and that has motivated
them all along.
“We would love to be able to provide technology where it could be taken out from the clinical lab and
provide it at the point of care, the point of need,” he added. “The number of problems that face diagnosis
and care are minimized in the United States but they’re huge overseas.” Connor explained that the
researchers put antibodies on a silicon chip. The antibodies, a naturally occurring protein used by the
immune system to identify and attack viruses and bacteria, can grab onto the Ebola virus.
Researchers then can flow a patient’s blood over the chip and, if there’s Ebola virus present in the blood,
the antibody will capture it. Field workers could then tell if there’s virus on the chip by shining light from
multicolor LED sources on the viral nanoparticles.
“When we bounce the light off of it, you see a spectrum that changes when there’s a virus particle
present,” Connor told Computerworld, adding that the spectrum acts as a distinct signal denoting the
specific size and shape of each nanoparticle. “The spectrum changes based on the virus. It’s large enough
for us to very easily see.”
With enough funding, the diagnostic device could be ready to be used in six months, but, Connor said, it’s
more realistic to expect it to be in official use in about two years.
48
The BU-based team isn’t the only one using nanotechnology to try to fight the 2014 Ebola outbreak,
which is the largest in history and the first Ebola epidemic the world has ever known, according to the
CDC. … (Source: CIO)
 Ovarian Cancer DNA Detected in Vaginal Fluid, Researchers Report
Researchers have found it's possible to detect ovarian cancer gene mutations in vaginal fluid samples -- a
finding they hope is a step toward an effective screening test for the disease.
In a pilot study, researchers were able to detect tumor DNA in tampons from several women with
advanced ovarian cancer. It's a "proof of principle" that genetic evidence of the cancer can be uncovered
in vaginal samples, they noted.
Ovarian cancer is highly treatable if it's caught in the early stages, but most women are diagnosed only
after the cancer has advanced. Because of that, only 44 percent of women with the disease survive for
five years, according to the American Cancer Society.
"Ovarian cancer does cause some symptoms early on. The problem is, they're non-specific," said Dr.
Charles Landen, the senior researcher on the new study, which appears in the November issue of
Obstetrics & Gynecology.
A woman might have abdominal bloating or urinary symptoms, for instance -- but those problems are
much more likely to have causes other than ovarian cancer. And right now, there is no effective screening
test for the disease.
"Ovarian cancer is relatively uncommon," said Landen, a gynecologic cancer specialist at the University of
Virginia in Charlottesville. "So any screening test would have to be very good."
That is, it would have to be sensitive enough to reliably catch early ovarian cancer, but have a low risk of
false alarms -- and unnecessary invasive procedures.
"We have to be sure we're not going to harm more women than we help," said Dr. David Mutch, a
professor of obstetrics and gynecology at Washington University in St. Louis.
The new findings lay the groundwork for future research, according to Mutch, who wrote an editorial
published with the study.
"Will this become a screening test?" Mutch said. "It shows promise. But we still need to go through the
necessary steps to validate it."
In the United States, about 22,000 women will be diagnosed with ovarian cancer this year, and almost
14,300 will die, according to the American Cancer Society. The risk goes up with age (most cases develop
after menopause), and women with a family history of ovarian cancer are at higher-than-average risk.
Researchers have long sought a good screening test for the disease; it's considered the "holy grail" in
battling gynecologic cancers, Mutch said.
But only recently has there been the technology capable of detecting tiny bits of tumor DNA in vaginal
fluid. To put it to the test, Landen's team analyzed fluid samples -- obtained with tampons -- from eight
women with advanced ovarian cancer.
Three of those women had had their fallopian tubes "tied," and there was no evidence of tumor DNA in
their vaginal fluid. But of the five women with intact fallopian tubes, three had tumor DNA in their
samples.
49
"That's a 60 percent rate, and that's not good enough," Landen said. So one of the next steps, he noted, is
to try to refine the test to make it more sensitive. … (Source : Drugs)
 Researchers identify blood biomarker to predict diabetes risk
Scientists have discovered a blood biomarker useful in identifying patients at risk for developing diabetes.
The current method is to conduct a glucose challenge test that can take as long as three hours, but it is
not often used in clinical practice. The researchers found that fasting levels of the serum marker alphahydroxybutyrate (a-HB) measured as part of a blood draw could be used as an accurate surrogate for the
existing standard-of-care.
The test could identify patients at-risk for diabetes before they develop the condition known as
prediabetes, which itself is associated with a 50% lifetime risk of developing the disease. More than 38%
of U.S. adults are prediabetic, with less than 10% of them having a formal diagnosis, according to the
Centers for Disease Control. Even among U.S. diabetics, 30% are unaware that they have the condition.
Even without hyperglycemia, insulin resistance and creatic beta-cell dysfunction raises the risk for
cardiovascular disease, retinopathy, neuropathy, microalbuminuria, certain cancers, pulmonary disease,
depression, dementia, hospitalization and early death. All of this makes the earliest detection of
associated disease processes crucial for prevention of metabolic disease that can culminate in diabetes.
In the study, researchers from Health Diagnostic Laboratory and the University of Utah examined 217
patients who were evaluated for diabetes risk via a one-hour oral glucose tolerance test and a blood
panel of fasting biomarkers. They found that elevated levels of a-HB were strongly predictive of
abnormalities in glucose regulation, even after controlling for various known risk factors including age,
gender, body-mass index, fasting glucose and hemoglobin A1c.
Even in patients considered low risk by other conventional measures, a-HB was predictive of an impaired
early insulin response during the glucose challenge test.
"Our findings suggest that a-HB may have broad application as a rapid, sensitive, and inexpensive tool for
detecting states of subclinical hyperglycemia, insulin resistance, and pancreatic beta-cell dysfunction
indicative of increased risk for diabetes and cardiovascular disease," Dr. Maciek Sasinowski, VP of Clinical
Affairs at HDL and co-author of the study, said in a statement. … (Source: FierceMedicalDevice, Study)
50
Le Cabinet WHITE-TILLET est enregistré pour la formation et agréé pour
le Crédit Impôt Recherche (lorsque les prestations le justifient)
51
COSMETICS & BIOCIDES
Corinne BENOLIEL, Docteur en pharmacie et Directrice scientifique des laboratoires SCIENTIS
vous présente « SCIENTIFIQUEMENT VOTRE » :
LES PERTURBATEURS ENDOCRINIENS
COSMETIQUE EUROPEENNE
ET
LA
REGLEMENTATION
 A la recherche d’une définition
Selon l’OMS: Les perturbateurs endocriniens sont « des substances chimiques d’origine naturelle ou
artificielle étrangères à l’organisme. Elles peuvent interférer avec le fonctionnement du système
endocrinien et induire des effets néfastes sur l’organisme d’un individu ou sur ses descendants ».
40% des cosmétiques contiendraient au moins un PE
Comme elle l’avait annoncé, la Commission européenne vient de mettre en consultation jusqu'au 16
janvier 2015 la définition des critères d'identification des perturbateurs endocriniens (Source: EC)
 La stratégie nationale et la feuille de route européenne relative aux
perturbateurs endocriniens
La France a publié en avril 2014 sa Stratégie Nationale sur les Perturbateurs Endocriniens précisant
notamment les catégories de produits prioritaires, dont les produits cosmétiques, au regard de l’objectif
de prévention de l’exposition des populations. … (Source: Developpement-durable.gouv)
La Commission Européenne a publié en juin 2014 sa feuille de route pour la définition des critères
d’identification des perturbateurs endocriniens. … (Source: EC)
 L’évaluation de la sécurité des produits cosmétiques:
Le Règlement n°1223/2009 relatif aux produits cosmétiques en vigueur depuis le 11 juillet 2013 impose
de s’assurer de la sécurité de tous les produits mis sur le marché dans l’Union Européenne.
52
Pour y répondre, les produits cosmétiques doivent faire l’objet d’une évaluation de la sécurité dans les
conditions normales et raisonnablement prévisibles d’utilisation.
Les données d’exposition sont alors prises en compte, à savoir notamment la population cible, la quantité
de produit utilisée à chaque application, le site d’application…
Les données toxicologiques et les propriétés de pénétration cutanée de l’ensemble des substances
présentes dans le produit cosmétique doivent être étudiées, si elles existent… sachant que le recours à
l’expérimentation animale est devenue impossible…
Des marges de sécurité doivent être calculées pour chacune d’entre elles.
 Les femmes enceintes: populations cibles des perturbateurs
endocriniens
Les perturbateurs endocriniens peuvent interférer avec le fonctionnement du système endocrinien et
induire des effets néfastes sur l’organisme d’un individu ou sur ses descendants.
Les femmes enceintes font parties des populations les plus sensibles aux perturbateurs endocriniens
(troubles de la fonction reproductrice féminine, risque de mortalité intra-utérine, retard de croissance
fœtale).
Comment mener l’évaluation de la sécurité d’un produit cosmétique destiné aux femmes enceintes ?
Quelles sont les études à réaliser ?
Comment identifier les perturbateurs endocriniens susceptibles d’être présents dans les produits
cosmétiques ainsi que dans leur conditionnement primaire ? Comment appréhender leur passage
systémique ?
De nombreuses questions à ce jour non élucidées.
Le but de cette évaluation spécifique restant d’essayer d’exclure tout risque d’exposition à un ingrédient
toxique pour le fœtus. Aucun effet systémique risquant d’entraîner une perturbation du système
endocrinien ne doit résulter de l’application de ces produits à destination superficielle du corps humain.
 Le règlement Cosmétiques, les autres réglementations et les
perturbateurs endocriniens:

La Commission Européenne révisera le Règlement cosmétiques en ce qui concerne les substances
présentant des propriétés perturbant le système endocrinien lorsque des critères convenus par la
Communauté ou au niveau international relatifs à leur identification seront disponibles, ou au
plus tard le 11 janvier 2015.

Une résolution sur la protection de la Santé Publique contre les Perturbateurs Endocriniens fixe
au 1er juin 2015 la modification des législations en vigueur (Règlements REACH, CLP, cosmétiques,
biocides, pesticides, phytopharmaceutiques) afin d’appréhender et de réduire l’exposition
humaine, en particulier des groupes vulnérables que sont les femmes enceintes, les bébés, les
enfants et les adolescents, aux perturbateurs endocriniens
Cette résolution souligne notamment l’importance de protéger les femmes contre les risques potentiels
que représentent les perturbateurs endocriniens ayant des effets œstrogènes ou anti-œstrogènes pour
leur santé reproductive et préconise la mise en œuvre des méthodes d’essais recommandées et
53
récemment validées par l’OCDE (Cadre Conceptuel pour les Essais et l’Evaluation des Perturbateurs
Endocriniens révisé en 2011 et Ligne Directrice 455 adoptée en octobre 2012).
 REACH et les perturbateurs endocriniens
Les perturbateurs endocriniens, en tant que substances extrêmement préoccupantes, (SVHC) sont
couverts par le règlement REACH (article 57F) .
Une substance peut être qualifiée d’extrêmement préoccupante (SVHC) lorsqu’elle remplit l’une au moins
des caractéristiques suivantes:

substances cancérogènes, mutagènes ou toxiques pour la reproduction (CMR)

substances persistantes , bioaccumulables et toxiques (PBT);

substances très persistantes et très bioaccumulables (vPvB) conformément aux critères de
l’annexe XIII du règlement REACh ;

substances possédant des propriétés perturbant le système endocrinien
(Source: INERIS)
Les industriels doivent mener une analyse de risque et définir via des méthodologies l’existence d’un
seuil d’exposition éventuel.
 Les allégations « sans » et les perturbateurs endocriniens
Comme les allégations "sans conservateur", "sans colorant" et "sans parfum", l’allégation « sans
perturbateur endocrinien » risque d’être très précisément encadrée …
Un certain nombre d'Etats membres, dont la France, considère que les allégations "sans" même
lorsqu'elles répondent aux critères de l'ARPP seraient dénigrantes et donc prohibées dès à présent.
Mais il n'existe aucune jurisprudence en ce sens.
Afin de contribuer à une image valorisante des produits cosmétiques, la publicité doit être
essentiellement consacrée aux arguments positifs.
Sachant que l’ARPP dans son bilan 2012 indique :
« A ce titre, l’utilisation d’une allégation indiquant l’absence d’un ou de plusieurs ingrédients ou d’une
catégorie d’ingrédients n’est possible que si cette allégation respecte les conditions spécifiques suivantes
:
- Elle ne constitue pas l’argument principal du produit mais apporte au consommateur une information
complémentaire ;
- Elle n’est pas dénigrante, notamment elle ne met pas en avant un risque ou un danger pour la santé ou
l’environnement ;
- Elle est loyale et non mensongère, en particulier lorsque l’ingrédient ou la combinaison d’ingrédients
peuvent être
apportés de manière indirecte, notamment par l’intermédiaire d’une autre matière première. »
Pour s’assurer qu’une allégation puisse être mise en avant, il faut donc respecter les 6 critères retenus par
la Commission et détaillés dans le règlement allégations par le Règlement (UE) n°655/2013 :
Pour mémoire :
54
- conformité avec la législation
- véracité
- éléments probants
- sincérité
- équité
- choix en connaissance de cause.
Pour mettre en avant l’absence d’une substance, il faut se référer aux critères « véracité », « éléments
probants » et « équité ». L’absence doit être totale y compris dans les matières premières.
Les autres critères communs ne sont cependant pas à négliger .
Un texte (règlement, lignes directrices ? ) est en cours de préparation au niveau de la Commission
Européenne afin de réglementer les allégations « sans » sont un des sujets en cours de discussions au sein
de la Commission Européenne.
En 2016 est attendu le rapport du parlement sur l’impact des critères communs sur le marché.
Il a été beaucoup discuté ces derniers temps de l’allégation ‘sans perturbateurs endocriniens ».
Dans la mesure où l’article 15 s’applique de la même manière à tous les industriels de la cosmétique,
cette allégation serait dénigrante vis-à-vis de la concurrence.
Art15-4.
Lorsque des critères convenus par la Communauté ou au niveau international pour l’identification des
substances présentant des propriétés perturbant le système endocrinien sont disponibles, ou au plus tard
le 11 janvier 2015, la Commission révise le présent règlement en ce qui concerne les substances présentant
des propriétés perturbant le système endocrinien.
Cependant à ce jour, il n’existe pas dans les textes réglementaires de liste d’allégations autorisées ni
même de liste de tests à réaliser.
SCIENTIS : ORGANISME DE FORMATION
Assistez à notre prochaine formation :
Cosmétiques-Biocides-Dispositifs médicaux : Formulation, Microbiologie et Réglementation /
27 & 28 octobre 2014
Fiche pédagogique 27 octobre 2014 - PRODUITS COSMETIQUES
Fiche pédagogique 28 octobre 2014 - PRODUITS BIOCIDES et DISPOSITIFS
MEDICAUX
Bulletin d'inscription
55
Cosmétiques - Détergents – Désinfectants - Probiotiques
Laboratoire de recherche appliquée et d’expertise scientifique
FORMATIONS SCIENTIS 2014
COSMETIQUES
Microbiologie
 M1C La microbiologie des produits cosmétiques
 M2C La gestion d’un laboratoire de microbiologie : microorganismes et cultures selon la norme
EN 12353 (formation pratique)
 M3C Comment analyser le risque de contamination d’un produit cosmétique : ISO 29621?
 M4C Comment réaliser un challenge test selon la norme ISO 11930 sur un produit cosmétique?
(formation pratique)
 M5C Comment réaliser les contrôles de propreté des produits cosmétiques selon les normes ISO
en vigueur ? (formation pratique)
Règlementation
 R1C La règlementation des produits cosmétiques
 R2C Le Dossier d’Information Produit cosmétique (DIP)
 R3C L’évaluation de la sécurité des produits cosmétiques
 R4C La notification des produits cosmétiques
Formulation
 F1C Les bonnes pratiques de Fabrication des produits cosmétiques : ISO 22716
 F2C La formulation des produits cosmétiques (formation pratique)
BIOCIDES
Microbiologie
 M1B La microbiologie des produits biocides désinfectants et détergents désinfectants
 M2B La gestion d’un laboratoire de microbiologie : microorganismes et cultures selon la norme
EN 12353 (formation pratique)
 M3B Les normes européennes d’efficacité antimicrobienne des antiseptiques et désinfectants
 M4B Comment réaliser une norme d’efficacité antimicrobienne sur un antiseptique, un
désinfectant ou un détergent désinfectant? (formation pratique)
Règlementation
 R1B La règlementation des produits biocides
 R2B La pré-expertise toxicologique des produits biocides à destination cutanée
 R3B Les exigences réglementaires des produits biocides en période transitoire
 R4B Comment créer une fiche de données de sécurité ? (formation théorique et pratique sur
logiciel)
Formulation
 F1B Le bionettoyage en milieu industriel
 F2B La formulation des produits biocides à destination cutanée, désinfectants et détergents
désinfectants (formation pratique)
DISPOSITIFS MEDICAUX
Microbiologie
 M1DM La microbiologie des dispositifs médicaux désinfectants et détergents désinfectants
56


M2DM Les normes européennes d’efficacité antimicrobienne des antiseptiques et désinfectants
M3DM Comment réaliser une norme d’efficacité antimicrobienne sur un antiseptique, un
désinfectant ou un détergent désinfectant) ? (formation pratique)
Règlementation
 R1DM La règlementation des dispositifs médicaux
 R2DM Comment créer une fiche de données de sécurité ? (formation pratique sur logiciel)
Formulation
 F1DM La formulation des dispositifs médicaux désinfectants et détergents
désinfectants (formation pratique)
DETERGENTS
Règlementation
 R1D La règlementation des détergents
 R2D Les réglementations transversales (REACH, CLP)
 R3D Comment créer une fiche de données de sécurité ? (formation pratique sur logiciel)
 R4D Les labels écologiques
Formulation
 F1D Le bionettoyage en milieu industriel
PROBIOTIQUES ET COMPLEMENTS ALIMENTAIRES

CA1 Les généralités, la réglementation, le marché, la formulation
Formations intra et interentreprises/Web conférences.
Les formations pratiques intègrent une partie théorique.
Descriptifs et tarifs communiqués sur demande en nous écrivant à l’adresse
[email protected] ou par téléphone au +33 (0)1 41 50 59 89 (référence de la formation à
indiquer).
Programmes ciblés sur demande.
Organisme de formation enregistré sous le n°11 93 06199 93
Parc Biocitech-102 av Gaston Roussel
93230 Romainville
www.scientis.fr
[email protected] / 01.41.50.59.89
AGENDA
COSMETOLOGIE
 27 & 30 OCTOBRE - IFSCC, PARIS
(Lien)
57
 27/28/29 OCTOBRE – LUX PACK, MONACO
(Lien)
 20 NOVEMBRE 2014
3e conférence "Advances in natural products analysis"
Les experts de l'analyse des produits naturels se donnent rendez-vous à Grasse le 20 novembre 2014 pour
la 3e édition de la conférence internationale "Advances in natural products analysis". (Lien)
DIVERS
 7/8/9 octobre 2014 CPhI, Villepinte
(Lien)
 16-20 novembre 2014 : Le salon Equip’Hôtel
Porte de Versailles, Paris (Lien)
58
SCIENTIS NOTRE PARTENAIRE POUR LES PRODUITS COSMETIQUES & BIOCIDES
59
60
Cosmétiques - Détergents - Désinfectants
Laboratoire de recherche appliquée et d’expertise scientifique
VOUS VENDEZ DES PRODUITS DETERGENTS, DESINFECTANTS, COSMETIQUES ?
POUR LE MILIEU PROFESSIONNEL OU POUR LE GRAND PUBLIC ?
VOS ETIQUETTES & FICHES DE DONNES DE SECURITE SONT-ELLES CONFORMES?
Outil indispensable de communication
entre le fabricant
et l’utilisateur de produits chimiques.
Elle informe sur les risques humains et
environnementaux liés à l'utilisation
de substances (matières premières) et
de mélanges (produits finis).
La fiche de données de sécurité (FDS)
une mine d’informations !
Elle fournit aussi les informations
concernant le stockage, la manipulation
et l’élimination du produit.
Elle permet ainsi de connaître les
mesures nécessaires à prendre en
matière de gestion de risques.
REACH
Règlement n°1907/2006
Enregistrement, Evaluation et
Autorisation des produits
chimiques.
FDS
Règlement n°453/2010
Exigences concernant
l'établissement de la fiche de
données de sécurité.
CLP
Règlement n°1272/2008
Classification, Etiquetage et
Emballage des substances et
mélanges.
A NOUVEL ETIQUETAGE...
.nouvelles classes de danger :
Nature des dangers physiques, pour la santé et pour l’environnement.
.nouveaux pictogrammes :
Losanges blancs sur fond blanc
.nouvelles mentions : danger (H), mise en garde (P), avertissement (EUH)
CALENDRIER DES MISES A JOUR: Êtes-vous prêt ?
1er déc 2012
1er Juin 2017
1er juin 2015
C
L
P
Double étiquetage DPD/CLP
autorisé sur les FDS des
Passage au CLP obligatoire
mélanges
R
E
A
C
H
La FDS doit être en conformité
avec le Format 2010-I
la FDS doit être en
(Pour les produits mis sur le marché avant conformité avec le
le 01/12/2010, passage au nouveau Format Format 2010-II
au 1er/12/2012)
Parc Biocitech-102 av Gaston Roussel
93230 Romainville
www.scientis.fr
[email protected] / 01.41.50.59.89
61
Cosmétiques - Détergents - Désinfectants
Laboratoire de recherche appliquée et d’expertise scientifique
Le Règlement cosmétique européen (1223/2009 du 30/11/2009)
a été publié le 22 décembre 2009.
Il est entré en vigueur le 11 janvier 2010 et est en application
depuis le 11 juillet 2013.
Description du produit cosmétique
Rapport sur la sécurité
Partie A: informations sur le produit
Partie B: évaluation de la sécurité
Dossier d’information
Produit
Méthode de fabrication selon les BPF
Preuves de l’effet revendiqué
Dossier
cosmétique
Données relatives aux expérimentations
animales
Règlement n°1223/2009
Notification
Portail CPNP
Personne
responsable
de la mise sur
le marché
Calcul
d’exposition
et marge de
sécurité
Évaluation
de la
sécurité
Microbiologie
Profil
toxicologique
des substances
Impuretés
(substances et
emballage)
Compatibilité
contenu /
contenant
Cosmétovigilance
européenne
Stabilité
L’effet rétroactif prévu dans le Règlement implique que tous les dossiers
cosmétiques des produits déjà sur le marché doivent être mis à jour.
Organisme de formation enregistré /agrément du Ministère au Crédit Impôt Recherche
Parc Biocitech-102 av Gaston Roussel
93230 Romainville
www.scientis.fr
[email protected] / 01.41.50.59.89
62
Experience & Expertise
Associate Consultants & Experts
Tel : + 33 1 600 843 85
E-mail : [email protected]
Website: www.white-tillet.com
Pour abonner vos ami(e)s écrire à : [email protected]
Pour vous désabonner écrire à : [email protected]
63