medtech devices

Ischemic stroke is the leading cause of long-term disability worldwide, affecting over 13 million people each year and costing tens of billions of dollars. Sensome, a French medtech that offers connected medical devices, has developed micrometric AI-powered impedance sensors that can identify the biological nature of the tissue they touch in real-time. Integration of this proprietary technology into a probe to guide medical devices in arteries (a guidewire) has given rise to Sensome’s first product, Clotild®, which recognizes blood clot types in ischemic strokes so clots can be treated faster to improve patients’ chances of a full recovery. The Sensome technology also helps transform the current standard of care in oncology.SEMI spoke with Franz Bozsak, CEO and co-founder of Sensome, about innovative medical technology trends and how microelectronics plays a crucial role.SEMI: When did your adventure with Sensome start? Bozsak: My former Ph.D. advisor Abdul Barakat and I spun-out Sensome from the Ecole Polytechnique in Paris in early 2014 after receiving a 200.000 Euro grant from the French government. We then developed a micrometric impedance sensor that coupled to machine-learning algorithms to identify biological tissues on contact. We are still integrating this sensing technology with existing medical devices in order to create a new category of smart medical devices that provides physicians with relevant insights during their interventions and treatments. These additional insights aim to render healthcare treatments more effective by reducing the risk of complications and the cost of interventions while improving patient monitoring.SEMI: How are strokes typically treated? Bozsak: Before 2014 the almost exclusive way of treating ischemic stroke was by injecting tissue plasminogen activator (tPA) intravenously in order to chemically dissolve an arterial clot. This treatment approach has severe limitations and can only be used in the first 4.5 hours following the onset of a stroke. In 2015, several randomized clinical trials demonstrated the efficacy of a new treatment modality: mechanical thrombectomy.Medical devices that allow a clot to be removed mechanically either using a grid-like structure (a stentriever) or by aspirating the clot using an aspiration catheter completely changed the paradigm in the treatment of ischemic stroke for up to a third of all patients. This new intervention removes the clot in up to 90% of all cases and can for certain patients be used up to 24 hours after the onset of the stroke.Mechanical thrombectomy is now one of the most effective medical treatments in the world. The clinical data gathered over the past years also shows that, in order to maximize the patient’s chances to lead a life free from disability after a stroke, it is not only a question of getting the clot out but also about how the clot was removed. Removing the clot on the first attempt significantly increases the patient’s chances of recovery – the first-pass-effect that is now the objective when treating ischemic stroke patients. And this is exactly where Sensome wants to help since clot removal after several attempts increases risk for patients. SEMI: How did you improve mechanical stroke treatments?We have integrated our sensor technology into a guidewire, the first device to enter a patient’s blood vessels for navigation to the clot. Once in place, the smart guidewire – called Clotild® – guides the thrombectomy device to provide the physician with information on the clot to help the physician choose the thrombectomy device with the highest chances of achieving the first-pass-effect. SEMI: Medical technology has made astonishing advances over the years. How did Sensome develop the micrometric AI-powered impedance sensors?Bozsak: The development of a product like Clotild® would have not been possible five years ago, and many people considered what we wanted to achieve simply incredible. Today, we can answer those same people: We knew it was almost impossible and therefore we just did it. By combining diverse semiconductor technologies, we were able to build the smallest impedance meter in the world. This was then integrated into a guidewire that can be connected via a transmitter to a tablet that serves as the interface with the physician. The guidewire provides impedance measurements that can be analyzed by a machine-learning algorithm, which in turn identifies the tissue in contact with the sensor. A very diverse team of people, collaboration and several different disciplines such as micro-electronics, data science, biology and engineering were required to make this happen.Our ambitious team has been able to flourish and accomplish their ideas in the very stimulating and resourceful environment of the Ecole Polytechnique, while being embedded into the rich and fertile start-up ecosystem of Paris. It is the combination of all these factors taken together that have made our innovation possible.SEMI: What are the main challenges and what are the market opportunities? Bozsak: Bringing semiconductor technology into the medical field is not a straightforward process. The primary hurdle is the simple fact that medical device production volumes are not comparable with consumer electronics volumes and that development cycles are much longer due to regulatory constraints. Both factors are, at first sight, not necessarily compatible with today’s business model of the semiconductor industry. At the same time, this is also a unique opportunity for the semiconductor industry to diversify and expand into a new field – sensors and, in particular, their seamless integration into the healthcare workflow, are a key driver for the healthcare sector of the future. And to achieve this objective, semiconductor technologies are key. What is beneficial, in my opinion, is that the quality standards and requirements of the semiconductor industry are highly compatible with the needs of the medical device industry.SEMI: Are market fragmentation and the high level of regulation making medtech innovation harder?Bozsak: Both are challenging but very rewarding to pursue since the impact on a patient’s life can be profound. Innovation is harder because many stakeholders are involved in ensuring the success of a medical device launch. The involved, milestone-driven, highly regulated process of developing a medical device and bringing the device to the market assures its eventual success. The development process differs very much from those for normal consumer devices. In our case the beneficiary, the patient, is not necessarily the user of the device but rather the physician. The physician is not necessarily the buyer of the device, but the hospital. The hospital is not necessarily paying the device, but ideally the government.The interests of all these stakeholders need to be satisfied to bring a successful device to the market.SEMI: What are your expectations regarding the future of medtech digital innovation? Bozsak: This is the right moment for the medical device and semiconductor industries to come together. The healthcare sector is not low on medical needs for which innovative ideas exist, and the semiconductor industry has many technologies that can enable these ideas to generate solutions. But to make this happen, both sectors need to collaborate. Working together requires both sides to understand their respective needs and constraints. The earlier the knowledge exchange starts, the more powerful the solutions. SEMI MedTech Forum at SEMICON Europa last year was a wonderful opportunity for Sensome to get this discussion going. We are looking forward to continuing the exchange and push the frontiers of the possible further to create the future of digital healthcare.Franz Bozsak, CEO and co-founder at Sensome, obtained a M.S. in Aerospace Engineering from the University of Stuttgart and a Ph.D. from the Ecole Polytechnique in Biomedical Engineering on the optimization of stents. He is a graduate of the Stanford Ignite/Polytechnique business program. In 2014, he co-founded Sensome and has since built a team of renowned scientists, engineers and doctors to realize his vision of connected medical devices. He was named Innovator Under 35 by the MIT Technology Review in 2016. Serena Brischetto is a marketing and communications manager at SEMI Europe.

“A hundred years from now, someone’s going to look back and say, ‘Can you believe they waited until you got a disease, and then they did something?’” This observation from Dr. William Hait, the leader of Johnson Johnson’s External Innovation program, crisply sums up the SEMI Smart MedTech Summit, a two-day program at SEMICON Europa 2019, sponsored by GE Research and imecBenjamin Wiegand, PhD of Johnson Johnson, cited the quote in his opening presentation and added another pertinent question: “What if we could predict who was going to get a disease and then preempt it from happening?” Weigand’s conclusion is the first of six key takeaways from the summit.1. Accomplishing this vision could lead to a world without disease. Developing a disease-free world by exploring how the integration of advanced electronics and medical technology (MedTech) can enable new healthcare solutions is the very mission of the SEMI Smart MedTech Initiative. Various experts speaking at the MedTech Summit delved into a range of topics, from pan-European medical initiatives and artificial organs to new sensors and systems and start-ups’ need for funding and partners.2. All of us will have a digital twin (avatar), bringing together all relevant data that can impact our health and well-being.Several speakers illustrated the advantages of a digital human avatar that would start with an individual’s unique physical data and then be continuously updated with new data tracked by body-worn devices and from ongoing research findings. This would enable healthcare providers to extract insights and predict future physical performance or health issues.While, technologically, the avatar can already be constructed, the ability to make real changes to future human behavior is a significant outstanding question. Multiple speakers highlighted the various benefits of digital avatars at the MedTech Summit. 3. The MedTech sector’s need for cybersecurity looms large, as it does in every other digitally-driven, IOT-based framework.Further exploring the human-to-digital interface, Anthony Mathur of Bart’s Heart Center in the UK pointed to the importance of strict laws for safeguarding patient privacy, a cornerstone of healthcare digital policies, and the critical need for cybersecurity. He warned against an all-digital action network, citing the virus attack that shut down the UK’s National Health Service, rendering all patient records inaccessible for more than two weeks.4. MedTech devices, systems and other tools will radically change healthcare in the not-too-distant future.Almost every speaker touched on this point, including Franz Laermer of Bosch in his presentation The Future of Personalized Treatment. Laermer explored devices that will drive more patient-centric healthcare in areas including asthma therapy and molecular diagnostic testing and highlighted innovations in monitoring oncology therapies more effectively, less invasively and more accurately. Other presenters showcased their work in areas including silicon-based microfluidics, next-generation DNA sequencing and synthesis, lab-on-chip and cell arrays. 5. Startups and well-established companies will help advance digital tools and data to keep us healthier, happier and safer. Among the MedTech Summit highlights, several start-ups presented their business, financial and go-to-market plans. Notably, continuous glucose monitoring (CGM) is an especially active area of investment and innovation, as diabetes is among the world’s most widespread chronic diseases. The industry’s goal is to develop a non-invasive platform as a replacement for today’s prick-and-test approach to measuring blood sugar levels.6. Pan-European organizations are working to coordinate efforts and investments in digital healthcare. The European healthcare sector is large and diverse, as shown in the following slide provided by the organization MedTech Europe. Every country has its own legal framework, infrastructure, and health service structure medical technology companies must navigate. More than 27,000 medtech companies are located in Europe – 95% of them small to medium size businesses. Michael Stubin and Patrick Boisseau from MedTech Europe said concerted efforts to coordinate research and structural changes across the EU are underway to help spur medtech innovation and, with healthcare accounting for 10% of Europe's GDP, drive more market opportunity. This table shared by MedTech Europe points to the wide range of medical systems by country across the continent. Next StepsIs your company applying microelectronics innovations to change the way we approach medical care? If so, you’re invited to share your mission, roadmap and collaboration needs at a future MedTech Initiative Forum. For regular updates, join the MedTech interest list. In addition to the SEMI MedTech Initiative, our Nano-Bio Materials Consortium (NBMC) brings together scientists, engineers and business development professionals from industry, government and universities to collaboratively initiate research and development of electronic technologies to improve human performance monitoring and performance augmentation. Find out more at www.semi.org/collaborate/communities/NBMC.Michael Ciesinski is the Vice President of Technology Communities at SEMI.