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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 Vol. 94, No. 9, September 2006 | Proceedings of the IEEE 1763 Wang et al.: The Developing Market for Medical Robotics 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 1764 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, Proceedings of the IEEE | Vol. 94, No. 9, September 2006 Wang et al.: The Developing Market for Medical Robotics 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 Vol. 94, No. 9, September 2006 | Proceedings of the IEEE 1765 Wang et al.: The Developing Market for Medical Robotics 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 1766 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. Proceedings of the IEEE | Vol. 94, No. 9, September 2006 Wang et al.: The Developing Market for Medical Robotics 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; Vol. 94, No. 9, September 2006 | Proceedings of the IEEE 1767 Wang et al.: The Developing Market for Medical Robotics 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. 1768 [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. Proceedings of the IEEE | Vol. 94, No. 9, September 2006 Wang et al.: The Developing Market for Medical Robotics 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 Vol. 94, No. 9, September 2006 | Proceedings of the IEEE 1769 Wang et al.: The Developing Market for Medical Robotics 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 REFERENCES [1] National vital statistics reports, V.53(6). (2004, Nov. 10). [Online]. Available: www.cdc.gov/nchs/data/nvsr/nvsr53/ nvsr53_06.pdf. [2] World Health Organization, 50 facts: Global health situation and trends 1955-2025. [Online]. 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A surgeon, for example, may have perfected his particular technique over the course of several hundred procedures. Asking him to change an established process that has been well-tuned for success can be difficult. These reasons are understandable and appropriate, and so ample time and funding needs to be allotted to overcome these hurdles. VII. SUMMARY The value proposition for medical robotics is as varied as the various value propositions for technical innovations in the field of health care. Some robots improve the dexterity of a surgeon, some extend the reach of a clinician to a remote location, some improve hospital efficiency by moving material or drugs about autonomously, some improve the quality of treatment for a patient, and many more are yet to be invented and will provide a value proposition that has not been thought of yet. The exciting thought is that robotics technology has now reached a state of maturity where it can quantifiably improve our health care system and the society in which we live. The need and appetite for innovation in health care will undoubtedly continue, as we all want to be cared for in the least invasive, most convenient, and cost-effective way possible. The continued growth of this industry will be amplified by the fact that our society is rapidly aging and will continue to want the best quality care we can afford. Medical robotics, which brings forth a new set of capabilities, will surely continue to find an expanding role in the health care world. h [7] Baden-Württemberg Agency for International Economic Cooperation, GWZ, Stuttgart, Germany, Publisher. (1998, Sep.). High tech in Germany: Focus on Baden-Württemberg. [Online]. Available: www.business.germanysouthwest.de/englisch/pdf/Focus8uk.pdf. [8] H. Paul, W. L. Bargar, B. 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Rayner, The Innovators Solution. Boston, MA: Harvard Business School Press, 2003. A. S. Grove, Only the Paranoid Survive, 1st ed. New York: Currency, 1996. 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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