Download The Developing Market for Medical Robotics

INVITED
PAPER
The Developing Market for
Medical Robotics
Still in its infancy, the nascent medical robotics marketplace must overcome regulatory
barriers and the inertia of ongoing conventional medical practice.
By Yulun Wang, Steven E. Butner, Senior Member IEEE, and Ara Darzi
ABSTRACT
| This paper discusses the developing market for
medical robotics. It first describes some of the dynamics and
market drivers in health care, and then provides an outline of
the areas of consideration when developing a commercial
medical robot. The paper also offers three case studies of
robotic systems that have been commercialized. Finally, it
summarizes some of the key ingredients to be considered for
the commercialization process.
KEYWORDS
|
Medical robotics; remote presence; robotically
assisted surgery; telemedicine
I. INTRODUCTION
Health care is one of the basic needs of society, and
medical scientists and technologies have continued to
drive the development of new advances in order to improve
the quality of our health care system by: 1) inventing new
diagnostic capabilities, 2) developing new therapies, and
3) creating technologies that improve the overall quality
and cost effectiveness of our health care delivery system.
Medical robotics can contribute to all three of these areas,
and an early commercial marketplace for medical robotics
has already taken hold and is growing nicely.
Today’s health care system is continuing to evolve with
the changing world. Some market drivers are constants
and will continue to be key influencers. For example,
everyone wants the best health care available, regardless of
where they live, and at the lowest possible cost. We are far
from achieving this goal today, and will continue to
struggle with it, especially since health care treatments are
Manuscript received July 15, 2005; revised February 13, 2006.
Y. Wang is with InTouch Technologies Inc., Goleta, CA 93117 USA
(e-mail: [email protected]).
S. E. Butner is with the University of California, Santa Barbara, CA 93106-9560 USA.
A. Darzi is with the Imperial College London, London SW7 2AZ, U.K.
Digital Object Identifier: 10.1109/JPROC.2006.880711
0018-9219/$20.00 2006 IEEE
constantly advancing. However, over the past couple of
decades, two new dynamics have arisen that are profoundly shaping the evolution of today’s health care
system: 1) the aging population in developed countries and
2) the globalization of health care. Medical robotic
products have been developed and are under current
development, to offer value given these market drivers.
Over the last 100 years, tremendous advancements
have been made. In the United States, life expectancy over
the last 35 years alone has increased eight years, and is
continuing to increase at a rate of roughly one year for
every 4.5 calendar years [1], [2]. Technology has played a
major role in enabling this remarkable advancement in life
expectancy, and will continue to do so. More recent
advances in technologies where robotics can and will
continue to play a part, like minimally invasive surgery,
catheter-based therapies, and prosthetic implantables,
have been very helpful in delivering these results.
The health care system in the United States costs 16%
of gross domestic product [3]. Even with tremendous
pressure to contain costs, it is expected that costs will
continue to climb due largely to the aging population. In
order to curb escalating costs, health care payers such as
Medicare are continuing to reduce reimbursements rates
for existing treatments, providing incentive for health care
providers to explore new ways to reduce their costs while
maintaining or improving their quality of care. Developers
of new technologies, such as medical robotics, are now
provided with the opportunity to innovate new solutions
that will be adopted because they can offer solutions to
these challenges.
The medical robotics marketplace is beginning to take
hold, with an increasing number of robotic products that
perform a wide variety of tasks. Surgical robots have been
developed to assist surgeons in performing a wide range of
procedures, such as laparoscopic surgery [4]–[6], prosthetic joint replacement surgery [7], [8], neurosurgery [9],
and telesurgery [10], [11]. Robots have also been developed to improve the accuracy of radiation treatment for
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cancer patients [12], and to assist in rehabilitation therapy
[13]. The more traditional manufacturing type of robots
have also been applied in health care, with robots organizing and dispensing drugs [14], as well as transporting
drugs, food, and other materials about the hospital [15],
[16]. Finally, the use of robotics to provide a remote
presence of a physician has more recently entered the
marketplace [17].
By viewing this list of existing commercial medical
robotic products, it is easy to see that robotics technology
has broad application in the health care field. This list of
commercial systems covers only a fraction of the various
applications that are being researched in universities,
research and development labs, and start-up companies.
Even applications that combine robotic systems with other
technologies, such as image-guidance and dexterity
enhancement, preoperative planning with surgical execution, remote consultation through remote presence, and
electronic medical records, are all concepts that are
actively being worked on and pushed into the marketplace
as we speak.
Robotics is already offering benefit to our health care
industry, and is emerging as a significant technology component to our health care technology arsenal. Therefore, it
makes sense to provide a framework for this emerging
marketplace, which is the intent of this paper.
II. MEDICAL ROBOTICS TECHNOLOGY
Medical robotics refers to robotic systems applied within
the domain of health care. From the standpoint of science
and engineering, robotics is a highly evolved and wellunderstood discipline involving topics from mechanical
engineering, electrical engineering, materials science, and
computer science such as kinematics, closed-loop servo
control, software development methodology, and digital
embedded system design. The application of robotic
systems to the medical health care industry requires that
we bring together a diverse set of disciplines, including the
all-important requirement of human compatibilityV
medical robotic systems must coexist and interoperate
safely and effectively within a human environment.
In order to be successful in the marketplace, a medical
robotic system must also be user-friendly and interactive.
Its value-added features often come from an applicationspecific user interface. Building such an interface requires
expertise from the health care discipline as well as from the
underlying robotics and engineering disciplines. The difficulty in putting together a team of designers and developers that spans the requisite fields of knowledge needed
to create a medical robotic system is one of challenges
limiting the emergence of medical robotics today.
One might expect that recent gains made by the
computer industry are of direct benefit to medical robotics.
Indeed, many recent advances and contributions have
been highly beneficial, e.g., the development of wireless
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networking equipment and infrastructure, cryptographic
technology, and, of course, the performance and cost
improvements due to Moore’s Law technology scaling.
Some developments emerging from the computer industry
are not helpful, however. Competitive pressures within the
personal computer marketplace have a strong influence on
a product’s design lifetime, as well as on its cost and
quality. These influences can shorten product lifecycles
and lower quality such that devices are not compatible
with the reliability and life cycle requirements of medical
robotic systems and products. Consequently, the decision
of whether or not to design consumer-oriented products,
such as computers and displays, as components of a
medical robot should be made very carefully.
Real-time embedded systems that control the operation
and maintain the reliability and safety of medical robotic
products must be built from commercially available
components that have a sufficiently long design life and
are available from multiple vendor sources so that the
overall system reliability and maintenance goals can be
achieved. Trends within the personal computer marketplaceVoften based solely on features, packaging, or
pricingVcan lead to very short product lifetimes and low
overall subsystem quality, especially in so-called plug’n
play peripherals of various kinds. The needs of a real-time
embedded system are often in conflict with the forces
driving the personal computer marketplace. This can have
the effect of increasing the system price and/or reducing
the profit margins of a medical robotic product, since the
economics governing the components from which such
systems are built are not always following the more
advantageous pricing trends of the PC marketplace.
I II . SAFETY AND RELIABILITY
Because human life is often at stake, successful medical
robotics products must be safe, effective, and reliable
systems. There are many techniques available for improving the reliability of systems. These are quite well
understood by the engineering community. Examples
include the incorporation of redundancy, the use of both
online and offline testing, software validation methodology, design considerations for single-point failures, failsafe strategies, and many more [18]. Each of these
techniques was developed to eliminate or, at a minimum,
detect and appropriately deal with a distinct set of possible
failure scenarios. Their incorporation within a medical
robotics product, though it often significantly increases
cost and development time, is necessary to ensure correct
behavior throughout the system’s lifetime.
A. Regulatory Requirements
In order to maintain high standards of quality, safety,
and effectiveness, various regulatory agencies have been
put into place. Within the United States, the U.S. Food and
Drug Administration (FDA) controls the development,
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testing, and evaluation of any system that is considered to
be a medical device. There are several categories within
the FDA’s regulatory system. Chief among those pertaining
to robotic systems that are medical devices (not necessarily
all medical robotics) are the PMA and 510 K requirements.
1) FDA Premarket Approval (PMA): The FDA’s PMA
process is designed to ensure the safety and effectiveness
of Class III medical devices (those that support or sustain
life or which present a potential risk for causing illness or
injury to a patient). Achieving premarket approval is
necessary in order to be able to market any medical robotic
device that is classified as a Class III device in the United
States. The daunting task of achieving premarket approval
involves:
• extensive documentation of product design, testing, and manufacturing;
• thorough hazard analysis demonstrating that the
product is single-component fail-safe;
• scientifically rigorous clinical trials performed
under an FDA approved Investigational Device
Exemption (IDE)Vusage of the candidate system
under carefully controlled and monitored conditionsVwith hypothesis testing and statistically
analyzed end results;
• final review by a scientific advisory panel.
The FDA will review a PMA submission within
180 days, but the process usually extends much longer due
to the duration of the clinical trial and the requirement
that clinical trials must be performed using the final
version of the equipment being offered for premarket
approval. In addition to the clinical trials, there are strict
regulations on manufacturing facilities, parts quality
assurance, packing, storage, installation, and other aspects
of overall product quality.
The purpose of a clinical trial is to prove the safety and
effectiveness of a medical system before it is promoted,
sold, and approved for general use. Some medical robotic
systems, such as Integrated Surgical Systems Robodoc [8]
and Accurays Cyberknife [12], have needed to go through
this more demanding PMA process before they could offer
their products commercially.
2) FDA 510 K: In an attempt to streamline the approval
process for devices that can be shown to be substantially
similar to already-approved devices, the FDA allows
certain device exceptions. The 510 K Medical Device
Exception regulates devices in groups, called device
classes. By showing equivalency or substantial similarity
to a device or device class, a company can apply for a 510 K
exception and thus achieve a simpler approval than the
more rigorous PMA process described previously. For
many 510 K clearances, an FDA-approved IDE clinical
study, much like that used for a PMA, may still be
required. Both the minimally invasive surgical robots
ZEUS [5] and da Vinci [6] required clinical trials in order
to obtain 510 K clearance from the FDA. In fact, da Vinci
was tested through multiple clinical trials in order to
obtain various procedural clearances.
3) Underwriter’s Labs (UL Listing) and CE Mark: Underwriters Laboratories Inc. (UL) is an independent, nonprofit organization providing worldwide conformity
assessment programs and services. Besides its role in
providing product safety certification services, UL is a
world leader in standards development. UL standards are
recognized nationally and internationally as benchmarks
for product safety.
UL standards for safety are published documents that
identify safety requirements for evaluating materials,
components, products, and systems. Such standards are
essential in helping to insure public safety and confidence,
reducing costs, and improving quality in commercial
products and services. At the time of publication, there are
more than 800 distinct UL standards for safety, organized
by specific field or function.
The UL listing mark on a product indicates that the
completed product has been tested by UL to recognized
safety standards and found to be free from reasonably
foreseeable risk of fire, electric shock, and related hazards.
In the field of medical robotics, there are several
applicable UL standards.
• UL544 Medical and Dental Equipment covers
electric medical and dental equipment that is
intended for professional use in hospitals, nursing
homes, medical care centers, and medical and
dental offices and includes apparatus intended to
be used with oxygen-administering equipment.
The UL544 requirements cover both cordconnected and battery-operated products.
• UL1740 Standard for Safety for Robots and Robotic
Equipment, a broad category covering robotic
equipment and systems intended for use in
clinical/diagnostic applications, pharmaceutical
applications, surgery, and a wide variety of other
areas.
• UL60601-1 Medical Electrical Equipment: General
Requirements for Safety.
In addition to UL, there are many other standards
organizations, e.g., International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), American National Standards Institute
(ANSI), National Association of Standardization and
Certification for the Electrical Sector (ANCE), and
Canadian Standards Association (CSA).
Most countries have regulations for products entering
into their country. Some countries may allow selfdeclaration; others may require a manufacturer to obtain
third-party certification in order to be accepted into the
marketplace. The CE mark is a marking which signifies
declaration by the responsible party that a product is
compliant with all appropriate European Union New
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Approach Directives, such as the Low Voltage, EMC, and
Machinery Directives.
4) Health Insurance Portability and Accountability Act
(HIPAA): Integration within the health care system of the
United States means exchanging information with insurance companies, hospitals, doctor’s offices, and others. In
turn, this means building hardware and software systems
that can interact and meaningfully exchange data via
computer networks while keeping control over privacy and
accessibility. In 1995, the U.S. government passed the
HIPAA. Compliance with HIPAA requires that all regulated entities must securely store, maintain, and transmit
private health information. In a nutshell, the HIPAA
requirement for a health care information system is that
the privacy of medical records be adequately protected. It
means unauthorized persons cannot see such information
so that it does not get misused. Additionally, authorized
persons using private health information can be identified.
IV. CASE STUDIES
A. AESOP
The Automated Endoscope System for Optimal Positioning (AESOP) is an example of one of the earliest
medical robots. AESOP received a 510 K FDA clearance in
1993, making it the first medical robotic system approved
by the FDA for the commercial marketplace. AESOP lies
within the category of assistive technologies because it
serves in a role much like that of a surgical assistant by
holding and controlling the location and orientation of the
endoscope (an instrument used for viewing the surgical
site) during minimally invasive laparoscopic or endoscopic
procedures. A photograph of an AESOP system is shown
in Fig. 1.
The idea for AESOP emerged from many conversations
with laparoscopic surgeons during the early 1990s, when
minimally invasive surgery was in a period of rapid development. The task of holding an endoscope during
sometimes-lengthy and complex minimally invasive surgical procedures was done by a surgical assistant. The
assistant stood directly next to the patient and the
operating tableVoccupying space in the very area where
it was least availableVholding the endoscope steady and
occasionally moving it in response to directions given by
the surgeon. The primary view of the surgical site, via the
endoscopic camera positioned through a very small incision inside the patient, is presented to the surgeon on a
nearby video monitor. For periods of time, the endoscopic
view is static. When a different view is needed, the surgeon
must communicate with the surgical assistant to describe
the desired change. The task of positioning and holding
an endoscopic camera and of responding to commands
from a surgeon was a natural fit to robotics. AESOP is able
to: 1) give the surgeon direct control of the endoscopic
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Fig. 1. The AESOP system.
image; 2) hold the endoscope for hours without tiring; and
3) provide a steady image for the surgeon.
One of the challenges in the design of AESOP was in
the area of the surgeon’s interface. During laparoscopic
procedures, the surgeon’s hands are part of the sterile field
and are fully occupied with the needs of performing the
surgery. Any sort of buttons or knobs or other handoperated controls are simply not compatible with the
needs of the surgical procedure. Thus, early AESOP
models were designed using foot pedals as the interface.
This satisfied the requirement of providing a means to
control AESOP without requiring the surgeon’s hands, but
it created a rather uncomfortable interface for surgeons.
Standing with their weight primarily on one foot for any
significant period was not comfortable, and the need to
look away from the surgical site in order to ensure correct
foot position on an AESOP control pedal was not an
optimal human interface either.
The next step in the evolution of the AESOP medical
robot was the development of a voice-controlled surgeon’s
interface. The incorporation of safe and reliable voiceactivated control for endoscope position and orientation
required a significant development effort in the field of
speech recognition. Ultimately, through the use of a
limited specialized vocabulary and parameterized surgeonspecific voice recognition models, a robust and highly
accurate voice control system was developed. This new
interface required an additional 510 K FDA clearance
before it could be commercially marketed.
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B. Case StudiesVZEUS
The ZEUS system is a surgical robot, as seen in Fig. 2.
The main features of the system are three robotic arms
(two instrument-manipulator positioners and one AESOPlike camera positioner) and a surgeon’s control console.
The robotic arms are mounted onto rails on the sides of the
operating room table and are positioned according to the
needs of the procedure to be performed. By directly
attaching to the operating room table, the relation of the
robotic equipment to the patient remains invariant even
though the operating room table may be tilted, raised, or
lowered during the surgery. The surgeon control console
is attached to the robotic positioners through manyconductor cables. It is located within the operating room a
few meters away from the OR table. The surgeon is nearby
should any manual conversion of the procedure become
necessary.
The goal of ZEUS was to significantly enhance a
surgeon’s capabilities during minimally invasive surgical
procedures by providing features such as scaled motion,
articulation for greater degrees of freedom at the
instruments’ tips, hand tremor elimination, and an
ergonomic interface. These goals are achieved via robotics,
by providing a master–slave remote-control interface from
the surgeon’s console to the nearby arms and manipulators. The da Vinci system, which is the market-dominant
minimally invasive operative surgical robot system today,
was also designed with similar goals in mind.
Fig. 2. The Zeus system.
Many challenges arose during the development of the
ZEUS system. Chief among them was the requirement for
fail-safe operation, including the detection of all possible
single-point failures. The design therefore involved
redundant componentsVsome with fully parallel and
independent design approachesVso that there was always
detection of single-point failures. An additional challenge
was that the procedures for which surgeons would be using
the ZEUS system were being developed at the same time
that the ZEUS system design was evolving. The codevelopment of new procedures, new treatments, and new
medical-related hardware is a continuing trend within the
health care community. Successful medical robotic products must have sufficient flexibility and adaptability that
they can incorporate and support new procedures and
treatments. At the same time, the regulatory process will
always take a more cautious view of new developments,
requiring carefully monitored and documented experiments, clinical trials, and case studies. ZEUS, and da Vinci,
were approved by the FDA via the 510 K process, claiming
substantial equivalence to AESOP. However, the FDA
required IDE clinical trial results with the 510 K
submission, demonstrating safety and efficacy.
C. Case StudiesVRP-6
The RP-6, shown in Fig. 3, is a medical robot whose
intended purpose is to enable health care professionals to
be in two places at once. The aging population is causing
health care needs in developed countries to expand
rapidly. Today there is a tremendous shortage of physicians
and nurses, and this shortage is only getting worse.
RP-6Vfor Remote Presence, Sixth GenerationVallows a
physician or nurse to beam in to a hospital intensive care
unit, emergency department, or medical/surgical ward,
from their home or office or clinic. Since one of the main
bottlenecks of the hospital system is waiting for the
patient’s physician to round and consult so that medical
treatment can be advanced, by enabling the physician to
more easily and frequently beam in to their patient’s bedside, each physician can be more productive and hospital
care is advanced with fewer delays, improving the quality
of care for the patient.
A physician can access a patient’s electronic medical
record while interacting with a patient remotely, as shown
in Fig. 3. The advantage of also accessing the medical
record is that the physician can view the patient’s medical
data, such as radiological images, lab work, and progress
notes while interacting with the patient. The physician can
also make new notes and orders into the medical record,
enabling the advancement of care which was previously
only possible when the physician was by the patient’s
bedside.
There are two main components to the overall system:
the RP-6 robot and the Control Station, the equipment
from which the remote professional accesses the RP-6.
RP-6 is a communication device and not a medical device;
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Fig. 3. The RP-6 system. Left: control station. Right: RP-6 robot.
therefore, an FDA clearance is not necessary. RP-6 combines robotics with telecommunications technology, and is
designed to be operated inside hospitals and by health care
professionals. The robot design was specific for this
environment. For example, room around hospitals beds
can be very tight, which necessitated a holonomic drive
system to maximize maneuverability. An array of infrared
proximity sensors are placed to prevent RP-6 from colliding with people and obstacles. The height of the system
was chosen so that one could communicate naturally with
patients that are lying in bed, sitting, or standing.
The telecommunications component uses broadband,
the Internet, and wireless networks to connect the RP-6
with the remote control station. This network needs to
provide a constant reasonable bandwidth (i.e., 9 300 kb/s
symmetric bandwidth) at low latency (i.e., less than 200 ms).
Fortunately, broadband is becoming pervasive and the
Internet is truly global with ample bandwidth. Wireless
networks have also become quite standard within hospitals. One of the biggest challenges has been dealing with
the priorities of hospital IT departments and the fact that
their firewalls and security systems are constantly changing. These technologies are still in a state of rapid
evolution, which will surely continue for the coming years.
V. T HE CL I NI CAL PE RS PECT IVE
Robotics has been introduced to minimally invasive
surgery as a means of providing improved visualization
and greater dexterity. It may follow that surgical robotics
has and will continue to have a significant impact upon the
growth of minimally invasive surgery.
The first procedure to be performed using a telerobot
was by Cadiere et al. [19] in March 1997, using a prototype da Vinci to complete a laparoscopic cholecystectomy
(i.e., gall bladder removal). In June 1998, Falcone et al.
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[20] performed a laparoscopic tubal reanastomosis (i.e.,
reconnecting fallopian tubes), which required microsurgery in a minimally invasive format. Cadiere followed this
with reports of telerobotic laparoscopic gastric bypass (i.e.,
obesity surgery) [21], Nissen fundoplication (i.e., heartburn surgery) [22], and also fallopian tube reanastomosis
[23]. A paper by the same group published in 2001
detailing 146 cases of robotic laparoscopic surgery
concluded it to be feasible and especially useful for intraabdominal microsurgery or for manipulations in very small
spaces [24]. They reported no robot-related mortality.
Similar results have been published by Marescaux et al.
[25] in a prospective study of 25 telerobotic laparoscopic
cholecystectomiesV24 were performed successfully and
one was converted to a traditional laparoscopic cholecystectomy. Again, the robotic procedure was found to be safe
and feasible.
Since November 2000 the Department of Surgery at
Imperial College London has performed over 120 procedures using the da Vinci robot and has recently reported
the results of complex procedures such as Hellers
cardiomyotomy [26], adrenalectomy [27], and rectopexy
[28]. All procedures were completed successfully with the
robot, without major complication or death. Mean
operating time and hospital stay were comparable to
traditional laparoscopic procedures. However, patient and
machine setup time took longer than in standard
laparoscopic surgery.
Proponents have shown that it is entirely feasible to
perform telerobotic laparoscopic surgery, but is the added
expense justifiable? Once the robot has been positioned
and the instruments are within the abdomen, the
operation performed is the same as in traditional
laparoscopic surgery. Hence, there may be no advantages
conferred to the patient by having a robotic, rather than a
standard laparoscopic, approach.
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However, the improved dexterity and better visualization afforded by the robot may enable more accurate
procedures to be performed. For example, in laparoscopic
rectopexy it may be possible to reduce the complication of
pelvic nerve injury and in Hellers cardiomyotomy the
incidence of oesophageal perforation may decrease. The
Department of Surgery at Imperial College has also shown
experimentally that the learning curve for robotic surgery
is shorter than for laparoscopic surgery when performing a
complex task such as laparoscopic suturing [29]. This can
not only reduce the time taken to achieve expert levels of
skill, but also reduce the number of complications
occurring at the expense of the learning curve.
An important area where robotic surgery is making
significant strides forward is in procedures which cannot
be performed by a laparoscopic approach. This includes
cardiac surgery and urology. In cardiac surgery it is now
possible to perform a coronary artery bypass graft (CABG)
from the left internal mammary (LIMA) artery to the left
anterior descending (LAD) artery without the need for a
sternotomy. Numerous groups have reported successful
results with this procedure and favorable short term
outcomes [30]–[32]. For example, two-month follow-up of
32 patients having undergone robotic CABG surgery revealed a good graft patency rate of 93% [30]. Furthermore,
these procedures are now being performed off-pump, i.e.,
on a beating heart and thus avoiding the complications of
cardiopulmonary bypass. In a series of 37 cases, the
authors reported a low (3.4%) conversion rate to median
sternotomy [33]. The procedure where robotics has gained
the greatest commercial success is laparoscopic radical
prostatectomy [34]. Menon et al. showed that although this
procedure can take longer than the conventional open
procedure, patients experience less pain and are discharged from the hospital earlier; and clinical outcomes
are comparable. Hundreds of centers around the world are
now offering this procedure on a routine basis.
The clinical perspective regarding the communication
robot, the RP-6, has tremendous potential though is less
well developed. This is predominantly due to the fact that
this product has been on the market for a very short time.
However, telemedicine and video conferencing have been
used in medical practice for many years now. The
advantage of the RP-6 robot is that it is freely mobile,
enabling the controller to interact at a personal level with a
number of people present in a particular space. The initial
use of this system has been for telerounding, enabling the
doctor to converse with patients without physically being
in the same space.
Ellison et al., in a preliminary study, enrolled 85
patients undergoing elective surgical procedures and
assessed the effects of telerounds on patients satisfaction
with their hospitalization [35]. The intervention was
reported to improve patient satisfaction in terms of
physician availability and overall quality of care. The
authors conclude that it may be possible to translate these
findings into improved patient outcomes such as reduced
hospital stay, because decisions regarding patient care can
be made without delay. Furthermore, the technology can
link up with the hospital electronic databases, enabling
physicians to access the results of patient investigations
remotely [36]. A future of this technology lies in its ability
to enable remote physicians to log into the RP-6 from a
PDA, or even a mobile phone. Other improvements are in
the areas of integrating remote presence with diagnostic
tools, like a stethoscope or blood pressure monitor.
A further perspective upon the clinical application of
robotic technology is in the sphere of microrobotics. These
are miniature robots, no larger than a thumbnail, which
can be delivered into body cavities, and manipulated from
a master console [37]. The eventual aim is to perform
diagnostic and therapeutic procedures via the gastrointestinal tract, i.e., incisionless surgery. Microrobotic prototypes currently exist, and these can navigate their way,
from a transanal approach, along the human colon [38]. In
the near future, it should be possible to perform
microprocedures such as removal of a mucosal lesion
using microinstruments delivered directly from the
microrobot, while controlled from a master system similar
to the da Vinci console.
VI . COMMERCIALIZATION
The continued development of the medical robotics
marketplace will require entrepreneurs, either within
larger companies or as a start-up, who are willing to put
their careers/livelihoods behind their ideas, and successfully convince investors and teammates who are willing to
back them. From a business perspective, starting a medical
robotics company is not fundamentally different from
starting any other technology-based health care company,
and many good books have been written about this process
(e.g., Crossing the Chasm [39], The Innovators Solution:
Creating and Sustaining Successful Growth [40], Only the
Paranoid Survive [41]). The assembly of a qualified
management team, the selection of the correct sales and
marketing channels, the proper staffing of technologists,
regulatory specialists, production specialists, and financial
experts, are all critical to commercial success.
We are beginning to see successes in the medical
robotics space, where markets are developing and investors
are generating a return on their investment. These past
successes will likely influence the investment community
and other larger companies to continue to explore new
opportunities using robotic technologies. Those who can
formulate and articulate unique robotic solutions to
significant problems, develop a viable business plan
around this concept, and sell this plan to investors and
the marketplace will continue to drive this fledgling field
forward.
The pathway to market new medical robotic products is
still in an early phase of development. However, significant
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unknowns are much clearer than before. There are now
multiple examples for FDA clearance and other regulatory
clearances that can help guide the regulatory strategy of a
new medical robotic product development.
A new medical robotic system should be developed and
brought to market with the help of appropriate medical
expertise. For example, surgical robots are used by
surgeons, and consequently it is advisable to include
surgeon expertise in both the development as well as the
marketing of the product. Historically, a large percentage
of medical devices are conceived of and conceptually
designed by physicians, since they are the ones who have
the in-depth understanding of the problems to be solved.
Medical robotics, being technically complex, requires a
stronger leadership role from engineers. However, the
appropriate clinical input and support remains crucial.
Intellectual property is an important component to the
commercialization process in medical robotics. The health
care industry as a whole can be quite litigious; consequently, gaining intellectual property protection is often
an important step. This is particularly important if the
business opportunity will require a significant amount of
investor capital. It is advisable that proper intellectual
property expertise be consulted at an early stage of the
business development.
The health care industry is often criticized for being
slow to adopt new technologies, and that the barriers to
entry are too onerous. The typical reasons given are the
challenging and time-consuming regulatory barriers, and
clinicians not wanting to experiment on their patients. A
less obvious but often significant reason is the inertia
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ABOUT THE AUTHORS
Yulun Wang received the Ph.D. degree in electrical engineering from the University of California,
Santa Barbara.
He is an accomplished entrepreneur and
authority on medical robotics and telemedicine.
In 1989, he founded Computer Motion, a medical
robotics company that created the first FDAapproved surgical robot. He was the principal
architect and inventor of the voice-controlled
robotic arm called AESOP, as well as the ZEUS
robotic surgical system. The Computer Motion product line generated
over $100 million in revenue and performed several hundred thousand
surgical procedures before the company merged with Intuitive Surgical.
In 2002, he founded InTouch Health (ITH), Goleta, CA, a company that has
created a mobile robotic telecommunications system being used in
health care and incorporating a concept called Remote Presence. He has
more than 40 publications and over 60 patents issued and pending in the
area of medical robotics and computers.
Dr. Wang has received numerous awards for his accomplishments,
including being selected as one of the nations top engineers by the
National Academy of Engineering. In October 2002, ITH received an
Investors Choice Award and was voted one of the ten companies most
likely to succeed in California.
Steven E. Butner (Senior Member, IEEE) received
the Ph.D. degree in electrical engineering from
Stanford University, Stanford, CA.
He has been a Member of the Technical Staff
at Bell Northern Research and a Lead Program
Engineer for Honeywell’s Process Automation
Products Division. He is currently with the
Department of Electrical and Computer Engineering at the University of California, Santa Barbara.
He is also a consultant to the private and public
sector working with such companies as Advanced Micro Devices, AllenBradley, Computer Motion, DELCO Systems Division, InTouch Health,
Intuitive Surgical, Micron Technology, and Siemens. During 1999, he was
a visiting researcher at Siemens Research Labs in Munich, Germany. He
has taught courses at both the graduate and undergraduate level in
computer architecture, LSI/VLSI design, and integrated circuit testing.
He is active in research on the design of high-performance computers,
both general- and special-purpose, with a particular emphasis on realtime and fault-tolerant systems.
Dr. Butner is a member of the Association for Computing Machinery
and Tau Beta Pi.
Ara Darzi received his fellowship in surgery from
the Royal College of Surgeons in Ireland and the
M.D. degree from Trinity College, Dublin, Ireland.
He was subsequently granted the fellowships of
the Royal College of Surgeons and the American
College of Surgeons.
Currently he holds the Chair of Surgery Imperial College London, London, U.K., where he is
head of the Division of Surgery, Oncology, Reproductive Biology and Anaesthetics. His main clinical
and academic interest is in minimal invasive therapy, including imaging
and biological research together with investigating methods to measure
core competencies of surgery objectively. He has also contributed
substantially to the United Kingdom’s National Health System.
Prof. Darzi was knighted by the Queen as a Knight Commander of the
most excellent Order of the British Empire (KBE) in December 2002. He
was elected to the London Modernisation BoardVnow the National
Leadership NetworkVby the Secretary State for Health and currently
advises the government on modernizing the NHS. He is also advisor in
surgery to the Department of Health.
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