Download Medical devices

Medical Devices —
Pharmaceuticals progress and innovative technology
Table of Contents
4
6
8
Plasters & More
Paths & Targets
Health & Technology
10
12
14
Stars & Starlets
Regional & Global
Experience & Technology
16
18
20
Competition & Partnership
Milk & Honey
Class & Mass
foreword
Dear Readers,
Innovative medications, patient-oriented therapies, and modern medical science. All
this would be impossible without modern medical devices. One prime aspect is that
the medical profession has adopted a new viewpoint from which to look at therapy.
The patients with their needs, wishes and everyday routine have long since moved to
the focus. To meet those needs, we need intelligent aids — to inject medication, for
instance. This is not only because many of today’s active ingredients are large proteins produced by way of biotechnology. Consequently, they can reach their targets
in the body only by way of injection. In addition, patients are demanding greater
autonomy in the treatment of their conditions. One example is diabetes. Therapy
without insulin injection aids and without smart blood glucose meters is difficult to
imagine. As a whole, diabetics manage their own condition nowadays — but they
need innovative medical devices to do so.
Within the past few years, Sanofi has evolved from a maker of pharmaceuticals to
a global healthcare company. Since modern pharmaceuticals, novel active agents,
and new therapies are increasingly dependent on medical devices, we offer more
than just innovative medications. Above all, we offer therapy options suitable for
everyday use. Our injectable medications, such as our insulins, are highly valued in
large part because we have developed pens that are precise, safe, easy to handle,
and customised to suit the particular effective ingredient. They are the basis for a
global story of success in the service to the patient. In the autumn of 2013, we produced the billionth SoloSTAR® insulin pen in Frankfurt. This reinforces the concept
that motivates us all: The human being is at the centre, in everything we do.
Yours,
Dr Martin Siewert
Vice-President Pharma Injectables, Managing Director Sanofi Germany
Plasters & More
Medical devices are the
products used to alleviate
illness and injury — and the field
is far larger and broader than
most would expect. In fact, more
than 400,000 medical devices and
aids have been approved for
use in Europe — everything from
canes to defibrillators.
4
If you were to ask people on the street to describe
medication. Quite often, the device will determine
a medical device, they would often merely shrug.
whether a medicine can be administered correctly,
Every­one uses them, though. When putting a plaster
safely and conveniently. For Sanofi, injectable medi-
on a wound, you are using a medical device. This is
cations and the specific varieties of insulin are im-
also true when donning your reading glasses or put-
portant. There will be more and more injectable
ting in your contact lenses. Thermometers, dental fill-
pharmaceuticals in future. Most new medicines are
ings, and X-ray machines are all included, as are the
therapeutically active proteins requiring just the right
diagnostics used to measure blood glucose or to test
medical device. No matter whether these are inhal-
for pregnancy.
ers, blood glucose meters or injection aids — all
these innovations serve the objective of improving
Medical device: a complex term
Consequently, the field of medical devices covers
patients’ quality of life.
Example: insulin pens
a wide and very heterogeneous range of products,
products that are involved with nearly every medical
Among insulin pens, distinction must be made be-
activity. This term is defined in Germany by the Medi-
tween disposable and reusable units. A disposable
cal Devices Act.
pen is automatically a pharmaceutical product, since
Medical devices are categorised in one of four risk
inseparably connected with the medical device —
a medicine — the insulin in the glass cartridge — is
classes. Support stockings are in the lowest catego-
the pen. A reusable pen, in contrast, is a medical
ry while all active implants, such as cardiac pacers,
device. The medicine can be inserted into the empty
are in the highest risk class. Between these are the
insulin pen as needed, and the pen can be replaced
medium and high risk classes.
at any time.
Growing economic importance
The global market for medical devices and combination products, comprising a medical device and a
medication, is growing very quickly. In 2012, sales
A medical device is
involved in some
manner in nearly any
medical activity.
came to roughly 220 billion euros, which already
makes this an important factor in the German economy. The importance of such devices will continue
to grow.
Developing medical devices and combination products perfectly matched to medications is of strategic
importance to the success of a new and innovative
5
Paths & Targets
Medicine should always act in the body exactly where it is needed. A plaster would be useless
if not put over the wound and, similarly, medicine will not work if it does not reach its target in
the body. Only the right application form will turn an active ingredient into a safe and useful
medicine. The path to the destination is just as important as the destination itself.
Finding the right path to one’s goal is often quite difficult. Everyone who has gone looking for a specific
Biopharmaceuticals:
inspired by nature
building with a street map of a strange city will know
all about this. There are different ways to reach the
Small molecules can easily be made up as tablets or
objective: on foot, by train or by car. It is similar for
capsules that will dissolve in the gastrointestinal tract.
medicinal products. When developing them, you
The active pharmaceutical ingredient, once dis-
have to decide early on which path to take — small
solved, will reach the circulatory system through the
or large molecules. These two large classes of active
intestinal wall. From there, the small molecules can
medicines will reach their destinations on entirely
be on their way to nearly any desired place of de-
different paths.
ployment. Large molecules are different. These are
biopharmaceutical products, therapeutically active
6
proteins. Usually, these are copies or optimised
Injection instead of swallowing
versions of human proteins that occur naturally in
the body, such as insulin. These biopharmaceuti-
Biopharmaceuticals also have a downside. They
cal products inspired by nature permit very closely
cannot be administered orally. Well, they could be
targeted and highly efficient therapies. They are
swallowed, but it wouldn’t do any good. Like any
produced in biotechnology procedures using geneti-
other protein, these highly specific medicines would
cally engineered cells of microorganisms or mam-
be digested in the gastrointestinal tract before they
mal cell lines. Many process steps are needed to
ever reached the bloodstream and their intended tar-
put together these complex products.
get. This path is not an option. Therefore, parenteral
administration is the path of choice. This term comes
There are many biopharmaceutics today. In 2013,
from the Greek and roughly means “bypassing the
about 200 such medicines have been approved
intestine”. Biopharmaceuticals are usually injected,
for use in the German market alone. Vaccines are
either intravenously — right into the bloodstream,
among them, just as are monoclonal antibodies
intramuscularly — into the muscle, or subcutane-
and hormones such as insulin. The benefits of bio­
ously — into the connective and fat tissue under the
pharmaceuticals also include fewer adverse effects,
skin. Subcutaneous injections in particular can be
since they are generally substances that belong in
performed by the patients, usually using an injection
the body or at least are similar to the body’s own
aid called a pen. This medical device facilitates sim-
products. As always, the dosage is critical. As me-
ple injection of a pre-set amount of a medicine such
dieval physician Paracelsus knew: “sola dosis facit
as insulin. In this way, the costly effective substance
venenum” — “The dose alone makes it poisonous.”
will quickly and accurately find its destination in the
human body, with the assistance of a high-quality
medical device.
Only the right form of
administration turns an
active ingredient into a safe
and useful medication.
7
Health &
Technology
One of the world’s most important subjects —
One old question prevails: How much technology
one that affects everyone — is human health.
can the patient deal with? In life-threatening situa-
People are taking better care of their health,
tions, everyone is willing to accept technical monitor-
especially as our society ages. After all, every-
ing in the intensive care unit, right down to the very
one wants to grow as old as possible and at
last detail. What about everyday life, though? Let us
the same time be as healthy as possible. This
use diabetes as the example.
requires not only individual therapies matched
to the patient, but also intelligent digital support
in everyday life. One example is blood glucose
Everyday technology
measurement combined with modern smartphones. Good health needs medical technol-
The era in which diabetes mainly affected older peo-
ogy — innovative medical technology.
ple is long past. Most type 2 diabetics in the USA are
younger than 55. They have got used to the presence
of technology in everyday life. They are used to trusting it. They accept the fact that technology makes
8
Smart medical devices
help people with
diabetes to better handle
their condition.
Dr Christoph Heinemann,
Strategy & Portfolio Management,
Diabetes Division
decisions for them. If we stop to think about it, we
diabetics deal with the disease 8,760 hours a year —
notice just how much technology we use without ever
around the clock — even though they usually see the
noticing. Who bothers to check the road map when
doctor for less than two hours a year. Smart medical
the GPS navigator in the car can point the way? Who
devices help manage the condition. In future, they
still knows phone numbers by heart?
will archive and submit data even more extensively
than at present. They will not only make suggestions
Medical devices for greater
quality of life
about insulin dosage, but also on nutrition and exercise. They will incorporate sensors to determine
when the patient last injected insulin, and how much.
In future, they will thus enhance the physician’s in-
The situation is quite similar in medicine. Technol-
sights into the patient’s condition and needs.
ogy has become firmly entrenched there, not only
in diagnosis, but also in therapy, aftercare, and rehabilitation. These areas are continuing to merge, as
well. Individualised treatment concepts are gaining
Medical devices are
growing smarter
in importance, with interest focused on patients and
their needs. Medical technology and medical de-
An innovative blood glucose meter that estimates
vices make important contributions to better patient
the value for glycated haemoglobin and provides
care and better quality of life. Finally, they increase
information on insulin management is expected to
personal autonomy and support social interaction —
be launched by Sanofi in 2014, in the form of the
and not just in old age.
MyStar® Extra. Smart insulin-injection aids will replace diabetes journals in future. Experience shows
Extending the physician’s reach
that such journals are only rarely kept properly. Electronic recording is more reliable and trustworthy,
both for the patient and for the attending physician.
Diabetics of all ages want to assimilate their condi-
Perhaps the near future will see an insulin patch, ap-
tion better into everyday life. They want to blend in,
plied to the skin just once a week. This will represent
not stand out. This is only possible when patients
another technical innovation. Even an artificial pan-
take their medication regularly and properly, and
creas that uses a complex pump and sensor system
manage medications independently. Compliance
to control the two antagonists, insulin and glucagon,
is the goal and it is to be further improved. After all,
has already started clinical development.
9
Stars & Starlets
What started in 2007 with a single star, the SoloSTAR ® insulin pen, has now developed into a
remarkable technology platform. New developments in pens and blood glucose meters are only
the beginning of the success story written with medical devices.
Sanofi and its predecessor companies are by no
Three stars, three success stories
means newcomers to the medical devices market.
For decades now, insulin pens and other medical
In 2009, the disposable SoloSTAR® was followed by
devices have been part of the company’s portfo-
the reusable ClikSTAR® and, in 2012, the AllSTAR®.
lio. Things have nonetheless changed since 2007.
The latter was also reusable and was designed by
When it launched the SoloSTAR , the company mar-
an international team under German leadership. It is
keted the first insulin pen that it had developed in­
produced in India, specifically for the emerging mar-
de­pend­ently. This pen quickly assumed a leadership
kets. Three stars, three different insulin pens, three
position among this kind of injection aids. It can be
success stories.
®
operated easily and safely, without applying great
force, and with superb dosage precision. The pen is
colour-coded to correspond to the company’s insulin
varieties — long-term, quick-acting, and hu-
Smart measurement
of blood glucose
man insulin. It steadily made its way
Other stars in the Sanofi firmament are not
into the world’s markets.
among the injection aids, but are blood
Three stars — three
different insulin
pens — three
success stories.
Dr Paul Gerhard Kibat,
Frankfurt Devices,
Industrial Affairs
glucose meters: the BGStar® and the
iBGStar®. The iBGStar® — like the injection aids — has received awards
for its skilful combination of design
and function, since the option
of coupling it with a smartphone
permits uncomplicated but secure
data transfer to the attending physician at any time. Of course, the “normal”
BGStar® can do this, too — though not with
the mobile phone but rather more classically, using a computer. The next generation of Sanofi blood
glucose meters, under the name of MyStar® Extra,
are now ready for launch. They will be even smarter
and calculate the insulin dose or estimate the HbA1c
value — the mean blood glucose value of the last
eight weeks, sometimes referred to as glycated haemoglobin or the blood glucose memory.
10
New active pharmaceutical
ingredients in ready-to-use pens
A pen designed to inject another peptide — a small
protein — was launched in Europe in 2013 and is
the next star among the injection aids. It was developed to accommodate an active ingredient. This
medication is an option for adult type 2 diabetes
mellitus patients for whom a change in diet and exercise level cannot sufficiently reduce the elevated
New stars in sight
blood glucose level. In contrast to the insulin pens,
the pen for this GLP-1 receptor agonist is a dispos-
Another starlet will appear in early 2014. The
able unit containing 14 fixed doses: 10 micrograms
JuniorSTAR®, designed for young type 1 diabetics,
of effective substance per dose in the green pen,
can set insulin doses in half units — which is impor-
20 micrograms per dose in the burgundy one. These
tant for children and teens. A special medical device
pens use an entirely different technology, even
is now being developed for the new formulation of
though the basic principle is comparable to that in
the long-term insulin, with its far greater concentra-
the SoloSTAR®. There is yet another pen, in orange,
tion. If a 1.5-millilitre cartridge holding insulin at
made for this product and based on the SoloSTAR
three times the normal concentration is used instead
®
technology. It is specifically for the Japanese market
of a 3-millilitre cartridge with a standard insulin solu-
and its special feature is that the dosage volume can
tion, then a special pen will be needed. Finally, auto-
be varied. The company received design awards for
injectors are being engineered to administer active
these pens, as well. Current development work is be-
substances developed in cooperation with a U.S.
ing devoted to combining the long-term Sanofi insu-
company, Regeneron, to treat cardiovascular dis-
lin with the GLP-1 receptor agonist in a single pen.
eases and rheumatoid arthritis.
11
Regional
& global
The world is changing and opinions on the subject of health care are changing along with it.
Sanofi has advanced to become a healthcare company with new growth platforms. The markets
in emerging countries such as India, Russia and China are becoming ever more important, as is
the company’s proximity to the markets.
What started with independent development of
medical devices in Frankfurt has long since attained
global dimensions. Worldwide networking, augmented by production sites outside Germany, ensures
both the company’s success and the future of the
medical devices made by Sanofi.
A crucial aspect:
proximity to the market
Decisive competitive factors in the production of
medical devices are quality and quantity, costs and
speed. Diabetes and insulin provide one example.
It is impossible to supply the entire world with these
important medical products and medical devices
from Frankfurt. Consequently, though Sanofi may
still produce the insulin in Frankfurt, and there only,
the ampoules are filled and the insulin pens are produced elsewhere as well. Production sites already
exist or are being planned in Russia, India and
China. The Frankfurt site with its advanced technology and unique expertise holds a key position as a
technology crossroads. New molecules, new developments, and new procedures evolve here. This new
production strategy is the key to sustainable growth
and success.
12
The AllSTAR ® is
particularly suitable
for diabetics in the
emerging markets.
Dr Volker Korger,
Diabetes Device Projects,
Medical Device
Development
An open mind for new sites
• Sanofi produces all of
its insulins in Frankfurt am
Main, bottles them, and produces the SoloSTAR®
No business is entirely global. Every country, every
region has local requirements and needs. All of
them share the wish for high-quality, affordable
therapeutic solutions that meet the highest production and manufacturing standards. Only by respond-
and ClikSTAR® insulin pens as well as the new pen
designed to inject another peptide.
• The long-term Sanofi insulin is bottled in Anagni,
Italy.
• In the Russian town of
Orel, Sanofi bottles all its
ing to this as quickly as possible can we be among
insulins, maintains a pen assembly line, produces
the leaders. This is why Sanofi is building more
packaging, and from this point supplies the mar-
and more sites outside of Germany: in Europe and
specifically in Asia.
ket in Russia.
• Sanofi
is expanding its site in China, where the
SoloSTAR® insulin pen is produced. Thus we
can supply the local market quickly and costefficiently from Beijing. In future, the company
plans to produce additional ampoules in China to
meet local market demand. Export from Beijing to
other Asian countries is also under consideration.
• Since 2012, the reusable AllSTAR
®
insulin pen has
been produced in Ankleshwar, in western India.
This unit was developed in Frankfurt and readied
for industrial production in less than three years.
It is light in weight, slender and short. That makes
it very discrete and easy to operate and carry. It
is also cost-efficient and thus particularly suitable
for diabetics in the emerging markets.
All our sites, both individually and collectively, guarantee quality, reliability and efficiency at the very
highest level.
13
Experience &
Technology
Lean production processes are more important than ever before. High-technology precision
and speed are needed. Implementing these in complex process chains takes more than just the
right technology. Quality can be achieved through a corporate culture in which improvement is
desired and where motivated employees are willing to assume responsibility. The best optimisation
approaches are, as always, developed right on site.
The path to the finished insulin ampoule comprises
many steps. After biotechnology production of the
active pharmaceutical ingredient, a solution or suspension is produced from this, filtered under sterile
Lean –
Continuous improvement of
quality and processes
conditions, filled in bottles or cylindrical vials under
Wherever possible, employees themselves exercise
aseptic conditions, and then — in an automated
direct control over their production lines for the insu-
procedure — is inspected for particles and other de-
lin ampoules and bottles, set demanding improve-
fects. Sanofi thus produces several hundred million
ment targets, and introduce their own ideas. They
bottles and vials each year. Outstandingly trained
document the currents status every day on a large
and experienced employees, a culture of improve-
board so that they can compare it to objectives and
ment, and the use of high-performance technology
initiate improvement measures. This visual manage-
are the prerequisites for ensuring that quality targets
ment concept lets operations managers and others
are achieved.
take in the situation at a single glance during their
daily site tours and make changes as required.
14
Challenge: speed
and flexibility
at a cost of 60 million euros. During the design and
layout work for the new operation, particular importance was attached to fast and efficient communi-
Sanofi uses fully enclosed pro-
cations. This approach will also be reflected in the
cesses and barrier technologies
light-filled design of the new plant. High-tech pro-
to guarantee the sterility of its fin-
cesses achieve efficiency and provide the greatest
ished liquid preparations. Thus, crit-
assurance of product sterility and quality. This is in
ical steps in the process take place
the interest of patient protection. Dedicated employ-
under special clean-room conditions.
ees and a high training level, coupled with innovative
These technologies make it possible to
factories and optimised production processes, thus
combine robust production processes,
automation, and high bottling speeds with
contribute to patients’ satisfaction with our products,
all around the world.
best assurance that truly sterile products leave
the factory.
When pursuing developments and creating new
products, versatility is the watchword. Flexible production lines incorporating the restricted access
barrier system (RABS) are beneficial here. They are
more readily accessible, permit quick conversion of
products and formats, and thus are especially suitable for production of small amounts.
New aseptic processing section:
additional high-performance lines
A high-technology site such as the one Sanofi today
operates in Frankfurt is the product of decades of
experience, augmented by continuous change
and improvement in techniques. Responding to increasing demand for liquid medicines, Sanofi is investing in a new aseptic processing section in Frankfurt. In
this project, existing preparation and
filling areas are being expanded
by adding two further lines, using
state-of-the-art isolation technology,
Outstandingly trained and
experienced employees, a
culture of improvement, and the
use of high-performance
technologies are the prerequisites
for ensuring that quality
targets are achieved.
Dr Malte Greune, Diabetes, Oncology
& Devices, Pharma Injectables
Frankfurt
15
Competition
& Partnership
The group that comes together under the Medi-
Specialists are needed in many fields — injection
cal Devices roof is very heterogeneous, made
moulding of plastic parts, automated assembly, de-
up of employees with new insights and outside
sign, software, electronics, system integration, and
firms. This group has the shared objective of de-
so on. Whereas in the past they were usually the
veloping innovative products. Small and large
classic suppliers and subcontractors, close partner-
companies from many different industries are
ships have developed in the meantime. Sanofi used
closely associated with this success: plastic
the time in the interim to mirror the acquisition of this
manufacturers, tool engineers, machinery sup-
knowledge in the company. After all, you must have
pliers, pharmaceutical companies, information
the appropriate expertise if you wish to assess the
technology, and design and engineering offic-
work of external partners.
es. New alliances are created and competitors
and suppliers often become partners.
New employees – new partners
Progressing from a pharmaceuticals company to a
global healthcare corporation requires new insights
The Medical Devices Development section at Sanofi
and new partners — primarily in the area of medi-
had about 130 staff members in mid-2013. Two
cal devices. Finally, the necessary expertise will not
years before that, there were just 80. A few years ear-
appear in the company overnight. What’s more, a
lier, it started out with just a handful of employees.
good cooperative atmosphere makes things simply
The nearly 50 engineers who today contribute to the
work better.
company’s development of medical devices were re-
16
cruited not only from renowned medical technology
A question of standards
companies, but also from “outside” sectors, such as
the automotive or consumer goods industries. They
The question of which standards will prevail is by
are the new partners within the company, bringing
no means insignificant. What traveller has not won-
special know-how with them, as do new employees
dered whether the plug on an electrical device will
with special expertise in the fields of industrial de-
match the power sockets abroad? Who still remem-
sign or information technology.
bers floppy discs, the storage medium computers used 20 years ago? What technological horse
should we place our bets on? The decision is by no
Aligning differing
technology cycles
means easy!
New partners are also available externally, e.g. for
Build or buy?
blood glucose meters. With the iBGStar®, Sanofi
launched an unrivalled device in 2011. Coupled
When developing medical devices at Sanofi, as in
with a modern smartphone, it permits outstanding
many other areas, a recurring question is whether
diabetes management as well as direct and quick
the required knowledge should be accumulated in-
data transmission from the patient to the doctor. IT
house or bought in. Partnership or competition? In
industry partners, however, have entirely different
the end, the decision is made by answering these
technology cycles. For them, a device will be out-
questions: Where and how will the best solution be
dated after half a year, or a year at most. The situ-
developed? How important is it for the company to
ation is quite different for medical devices such as
own the expertise? How important is that knowledge
blood glucose meters and insulin pens. Here the de-
in terms of innovation, costs and quality?
velopment times there are far longer. What is needed? The cycles in the different industries will need
to be aligned with each other to be in the
technological forefront. This necessity
means that Sanofi makes use of
so-called technology platforms
when developing medical devices. This is much faster
than starting from scratch
every single time.
Sanofi makes
use of technology
platforms when
developing medical
devices. This is much faster
than starting from scratch
every single time.
Frank Oelgarth,
Device Development &
Innovation, Medical
Devices
17
Milk & Honey
Two worlds meet at the interface of pharma-
of development takes three to four years. This has to
ceuticals research and medical device devel-
start early, if possible parallel to the clinical studies
opment. These two worlds speak very different
phase which is a part of pharmaceuticals develop-
languages and have very different properties —
ment. It is good when the medical device can al-
like milk and honey. It is a great challenge to
ready be used in phase III of the clinical studies, i.e.
harmonise these two worlds, resulting in an in-
when the medicinal product is tested with a larger
novative medication that forms a perfect fit with
patient group over an extended period of time.
the appropriate medical device.
The development of a medical device today ideally
takes place parallel to the development of a new active pharmaceutical ingredient. This was not always
the case. At one time, the situation was more like
this: Here is the new active agent — now go
and develop a matching medical device.
This was still the case for the SoloSTAR®
insulin pen. After all, a known medicinal
product with known properties was to
be administered. Today, developing
a medical device is more complex.
The new U300 insulin, now in the
development phase, involves a
high concentration of the active
ingredient. This would be impossible to dose without a medical
device that matches it exactly.
Start early!
Here is another example. It was necessary to develop a disposable pen with a
fixed dose but several administration options to handle a specific peptide. This kind
18
Milk or honey:
the mix does the trick
Auto-injectors are another example. These are
ready-to-use syringes for one-time injection in which
the patient only needs to push a button and will never
see the needle. Such auto-injectors are developed
for antibodies that have to be injected, at high dosage, once every two or four weeks. It is important to
ensure the stability of the effective substance here.
The formulation, i.e. the mixture and concentration of
the active ingredients and the excipients that ensure
that the effective substance will reach its target in the
human body, is decisive. Some formulations, insulins
being one example, are liquid like milk. Others, such
Pharmaceutical
researchers, engineers
and designers of medical
devices must be brought
together for roundtable
discussions early on.
Galina Hesse,
Project Leadership & Portfolio
Management, Industrial
Development, Support
& Launches
as antibodies, viscous like honey. This influences the
injection aid to be developed. Therefore, the basic
parameters — milk or honey — should be determined as early as possible. Development of the
matching medical device will be all the faster.
A product of two worlds
and it is of course refined until it perfectly suits the
All in all, researchers and engineers must be
patient’s needs. This is unusual for pharmaceutical
brought together around the table early on —
researchers, since the medicine is already present
in spite or specifically because there are very
in its final form. In short: Research and development
different development times. Medical device
are responsible for the medicine and its administra-
development takes ten years on average. The
tion method; the engineers are responsible for tech-
medicine can no longer be modified once clini-
nology and innovation in the medical device. Con-
cal phase III has started. The medical devices,
sequently, representatives of these two worlds meet
such as injection aids, however, can. Development
very early on at Sanofi — to ensure that the end result
here takes three to four years. The device is still in
is a combination of medicine and medical device
a state of flux during the clinical phases. It can be
that is perfect for patients.
19
Class
& Mass
Some believe that a device produced by the
hands have to has to be able to understand and cor-
millions is quite simply a mass-production
rectly apply an injection aid at once. Imagine similar
item. That’s true enough. But the assumption
requirements for the approval of smartphones.
that the product will be of poor quality is by
no means true. The medical devices at Sanofi
are produced by the million, but this does not
Avoiding errors from the first
impact their quality. This is due in part to their
having to go through a complex quality assur-
How to achieve this quality? First, by looking very
ance system in which the patient is the deci-
closely at the things patients complain about before
sive benchmark.
even starting the development of a medical device.
This can be done using patient forums. In the USA,
The requirements are extremely high. No mistakes
there even is a public database for complaints.
are allowed when using an injection aid. Approving
authorities demand this. Zero error means that during the study, 70-year old diabetics who have hardly
any feeling in their fingertips and little strength in their
Target: user-friendly, suitable for
everyday use and safe
The target is eliminating any cause for complaints
from the very outset. Therefore, even during development of a medical device, Sanofi deals intensely
with questions of whether the product is user-friendly,
suitable for everyday use and safe and reliable. An
injection aid for patients with rheumatoid arthritis
has to be far different from an insulin pen.
This is not only because the first group
of patients only injects a fixed dose
every two weeks, while the second
The injection aid must
be built so that it can be
handled by the patients.
Anke Liewald,
Operations & Project
Management, Medical Device
Development
20
uses the device every day. The injection aid literally needs to built
so that it can be handled by the
patients. To determine what people with rheumatoid
arthritis can grip best, different basic shapes — such
as a ball, rod and cylinder — are tested very early on.
The patient is in the limelight
These and many other indicators make it possible to
develop an injection aid matching the patients’ wishes, skills and abilities. One auto-injector currently
in development no longer requires pushing a button. It is enough to press the entire pen against the
skin, which makes application much easier. In other
injection aids, it is decisive that the dosage setting
can be easily read, how much or how little strength
is needed when pushing to inject, and how to best
determine whether a disposable pen has already
been used.
The best solution is determined by human factors
assessments performed by independent agencies.
Representative groups of patients, aides and doctors test the new medical devices there under observation. What works well and what does not will
quickly be determined. Based on this, application
safety and user-friendliness can be optimised. The
same applies for the package insert. They are also
examined for understandability. The pictures are often changed out to promote ready understanding is
any specific country.
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November 2013 | 331214
Sanofi-Aventis Deutschland GmbH
Communications Germany
Phone: +49-69-305-32255
[email protected]
www.sanofi.de