Medical technologies are an integral part of our daily lives. More than a simple user, the physician has a crucial role to play in the innovation of these technologies. By evaluating new instruments, it can guide manufacturers towards solutions leading to a real clinical impact. Moreover, through its daily practice, it has the ability to identify the real needs not met by current technologies. However, innovation and development are not part of current medical education. In order to fill this gap, new centres for training in innovation in medical technology flourish in Europe, following the success of American centres.
WHAT IS INNOVATION IN MEDICAL TECHNOLOGY?
Innovation is the process by which scientific discoveries that could solve a clinical problem are brought from the experimental to the clinical setting.
By medical technology, we mean what the WHO defines as a medical device: any article, instrument, apparatus or equipment used to prevent, diagnose or treat a condition or disease, or to detect, measure, restore, correct or modify Structure or function of the body for health purposes. In theory, the action of a medical device is not achieved by pharmacological or immunological means or by metabolism.
Innovation in the field of medical technology ( Medtech Innovation in English) is, therefore, the development of new devices or instruments intended for clinical use.
ROLE OF THE DOCTOR IN INNOVATION
Historically, advances in the field of medical devices were often the product of clinicians: from ECG to scatterometer, to extracorporeal circulation and Dr Kocher's Swiss contributions. For surgeons, the legacy of the Bernese Theodore Kocher most often rhymes with the Kocher maneuver (detachment of the duodenal framework, described in Mobilisierung des Duodenum ) or with the forceps he developed, bearing his name, Rather than with his work on the thyroid, for which he received the Nobel Prize in medicine in 1909. Son of an engineer, The latter was able to demonstrate to us that a more fundamental research activity on physiological and physiopathological phenomena does not exclude an important contribution to innovation in medical technologies. And while medical research and academic circles have, for several decades, given pride of place in fundamental work, innovation in medical technology, halfway between basic research and clinical application, is beginning to find its place in hospitals And faculties of medicine or engineering.
Since the time of Dr Kocher, the increase in the technological content of the new devices, as well as the regulatory and financial constraints, have significantly increased the complexity of the innovation process and especially that of the placing on the market of these devices products. This makes it almost impossible for a doctor or an isolated researcher to develop, test and commercialise an invention without outside help. And while this process often requires multidisciplinary teamwork, the clinician keeps and must retain, a central role in this process at many levels.
Indeed, innovation in the large multinationals of the sector is mostly iterative. These companies are extremely efficient in improving existing devices and marketed by themselves or their competitors, but companies that are able to produce a breakthrough innovation internally are very rare. To do so, they either make use of collaborations with clinicians or university institutes, or they acquire these new technologies through the purchase of startups. These small companies are more or less advanced in the development of an innovative concept and seek to be acquired in order to benefit from the financial and logistical resources necessary for the commercialization and wide dissemination of their device. The system thus allows significant risk taking in small companies, and in the (too few) cases where these companies succeed in demonstrating the effectiveness of their technology, the inflow of capital at the time of the redemption allows to support this economic chain. Moreover, it also allows the large companies in the sector to integrate and distribute quickly and globally interesting novelties. In a way, these companies retrospectively subcontract part of their research and development. It also allows the big companies in the sector to integrate and distribute quickly and globally interesting novelties. In a way, these companies retrospectively subcontract part of their research and development. It also allows the big companies in the sector to integrate and distribute quickly and globally interesting novelties. In a way, these companies retrospectively subcontract part of their research and development.
An example among others is the purchase by Medtronic of the renal denervation system for the treatment of refractory hypertension. In 2010, Medtronic acquired Ardian, a pioneering technology company developed by a group of innovators (the Foundry) specialising solely in the development of medical technology with high potential for rupture. The concept, idea and demonstration of clinical efficacy, therefore, belong to the young company that has been able to take these important risks. The acquisition of Ardian, for more than 800 million dollars, has made a great noise and, for the anecdote, since that buyout, more than 60 startups have embarked on this market in order to develop a competing technology.
MEDICAL INNOVATION IN SWITZERLAND
The medical technology sector employs more than 51,000 people in Switzerland in 1,600 companies, with growth forecasts for the sector about four times that of the rest of the economy. With a significant activity in the areas of implants, in particular, Switzerland also hosts many small, highly innovative companies. These companies are also often looking for the expertise of clinicians: either at the level of development, with university collaborations, notably with EPFL (Ecole Polytechnique fédérale de Lausanne) or ETHZ (Swiss Federal Institute of Technology) But also for the evaluation of newly developed technologies. Indeed, 59% of Swiss medical devices manufacturers collaborate with academic institutes for their research and development activities. In addition, 55% collaborate with their clients or users, namely doctors.
In this context, the Swiss government also seeks to promote this promising sector of the economy and foster collaborations. Notably thanks to the CTI (Commission for Technology and Innovation), which promotes these collaborations and also provides funding to more than 30 projects per year, with a program called CTI Medtech.
One of these was the financing of the collaboration project between the young Bern-based company Fascination and the university medical centers of Geneva, Bern and Lausanne in 2011 in order to assess the effectiveness and usefulness of a navigation device Surgical procedure for open hepatic surgery, allowing real-time guidance of surgical instruments in 3D, after ultrasound tracking of structures (Figure 1).
DEVELOPMENT OF A TRAINING CURRICULUM
The process of innovation can obviously take many forms. But, as discussed above, innovation from the single, isolated surgeon, as could be seen in Dr Kocher's time, has become almost utopian.
To fill this gap, a learning curriculum was developed and put into practice at Stanford University in the United States with the launch of a program named Stanford Biodesign 12 years ago. This university program is specifically dedicated to innovation in the field of medical technologies. This course aims to develop innovations that will have a real clinical utility and that meet a real need on the part of the patients. It is broken down into several phases (figure 2):
- Identification of clinical problems by direct observation;
- Selection of the most significant problems;
- Creation and selection of new concepts;
- Manufacture and development of prototypes (preclinical tests);
- Ultimately, clinical testing and marketing.
The initial practice of this curriculum took the form of postgraduate fellowship training. This one-year program brings together two multidisciplinary teams of four people, consisting of a doctor and three engineers and/or a person with training in the business community. This program includes theoretical training, including the basis of intellectual property, the regulation of medical devices (FDA in the USA and CE mark in Europe), the way in which they operate and the financing of such projects.
The Fellows then practice the principles described above by following a phase of clinical immersion in order to identify unresolved clinical problems on their own. After the identification of several hundred problems observed in the various hospital departments, the latter is defined more generally by a need statement. This mini-specification summarises in one sentence what the project will seek to accomplish, in short, the essence of the problem to be solved. Then there will be a rigorous selection phase of these problems, based on multiple clinical criteria but also economic and market, in order to choose the ideal targets on which to lean. It was only from that point on, After several months of identification and selection of problems, the stage of invention and generation of new concepts takes place. The best ones are again selected to give rise to one or two main projects. During the fellowship by one of the authors, Dan Azagury, two concepts were created and allowed the creation of two California startups, one in the field of urology and the other one working on the development of a Prevention of aspiration pneumonia in patients under mechanical ventilation.
The Biodesign program celebrated its twelve years of existence and published its results: 26 companies were created and raised more than 200 million dollars of funds, creating more than 500 jobs. But more importantly, the medical devices invented have enabled more than 150,000 patients to benefit from these new technologies. The program has since expanded to include pre-graduate training and international collaborations (eg India and Singapore).
EUROPEAN CENTERS FOR INNOVATION IN MEDICAL TECHNOLOGY
In recent years, this concept has been adaptable to other medical centres and specialities. Similar training programs have flourished around the world, particularly throughout Europe. These programs or innovation centres usually offer, in addition to the traditional curriculum, resources for physicians or other professionals wishing to develop an idea in the field of medical technologies. These resources range from targeted and short-term courses to personalised advice with contacts with appropriate entities (industrialists, intellectual property specialists, engineers, etc.) (Table 1). Each program has its peculiarities but they have in common to bring innovation in medical technology closer to the academic sphere.
- In the first place, to guide innovation towards problems that represent a real clinical need, by integrating clinicians more extensively and early in development, while fostering multidisciplinary academic and industrial collaboration.
- Secondly, these programs and centres allow physicians in training to become more aware and familiar with innovation and the creation of new devices and, if they wish, to offer them a structured learning curriculum.