The VIC Fellows Program provides an opportunity for individuals with relevant expertise and interest to learn how to identify and evaluate promising innovations from global sources. We are pleased to highlight the members of the 2023-2024 class of Fellows in our ongoing series of interviews, such as this recent discussion with Gopesh Tilvawala, PhD.
Please tell us a little bit about your background.
What initially attracted you to the field of medical device engineering?
It actually happened to be later in my educational journey. During the penultimate year of my undergraduate studies, I received a scholarship to conduct independent research. I was fascinated by the ability to directly apply my in-class learnings to a real-world problem. The experience inspired me to utilize fundamental science to develop solutions for challenging real-world problems that would have a positive socio-economic impact. At the time I was interested in renewable energy and medical technology, and was initially considering projects on both. I came across a few press releases about novel medical technologies translating from lab research to early adoption in hospitals and that was the turning point – because it gave a more tangible feel to the research outcomes. I then opted to work with the same professor in the press releases and was fortunate to have him as my PhD advisor.
How have your diverse educational experiences and international exposure influenced your overall approach to problem-solving and innovation?
There have been interesting learnings in all the continents, and since I lived in each of them at different phases of my life, the experiences have few parallels. Growing up in a third world country, one inherently gets to truly experience a lot of common socio-economic problems, and that imparts a mindset of not only being a problem solver but also ensuring they are meaningful solutions with tangible outcomes. Living and studying in Australia formed some of my technical foundations in engineering, and gave me the first exposure to working with people from diverse backgrounds. The cumulation of both experiences played an important role in my PhD experience in San Diego where I was fortunate to experience a confluence of very talented people, coming from very different backgrounds both in terms of ancestry and education, all enthusiastically working on meaningful problems that have positive socio-economic impacts, and having innovative approaches to pursue them. The culmination of these experiences is when considering new problems, I tend to bear in mind a more global or worldly view on the cradle to grave product life cycle and its potential margin for impact across the world.
Could you discuss your previous experience working in medical device development? What were some of the key projects you worked on?
Over the last 10 years I have developed a broad panoply of technologies for pulmonary drug delivery, rapid point-of-care diagnostics, measurement of intraocular pressure in ophthalmology, dexterous soft-robotic catheters for minimally invasive endovascular surgery, barrier enclosures to provide safe non-invasive ventilation therapy to COVID-19 patients, and recently cardiac pacing + defibrillation devices. My contributions to research have resulted in 14+ publications and over a dozen patents, notably a steerable micro-catheter that won a national award for inventiveness and the potential to treat stroke at the USPTO. The most challenging project would be the steerable microcatheter because it is a project that went from imagination to concept-design-prototyping-iterative validation and pre-clinical testing in a relatively short time span. In parallel, due to the nature of the project, I was also rapidly learning the peripheral arms entrepreneurship such as component sourcing, supply chains, business model development, market research and validation, go-to market strategies, and financials all at the same time.
Developing enclosures for COVID-19 patients was the most exciting project because we had to rapidly design, iteratively develop and deploy while co-ordinating with a group of engineers, doctors and volunteers in a matter of weeks. Given the initial pandemic setting, shutdowns and closures, it came with strong sense of urgency and unwavering motivation. At the time, clinicians were reluctant to using nasal high flow therapy due to the risk of viral contagion, and that led to ventilator shortages. The enclosures we developed enabled safe administration of nasal high flow therapy for patients with acute hypoxemic respiratory failure while preventing viral contagion, essentially providing a feasible solution. We made all the designs open source, the enclosures were initially implemented at UCSD health and later donated to a hospital in Tijuana.
What specific technical skills do you possess that you believe are most relevant to medical device engineering?
Having taken multiple different medical technologies from concept to pre-clinical testing, and some into commercialization, I am well versed in most stages of the product life cycle. True innovation occurs in the very early stages of development where there is room for creativity, ability to explore new materials, ideas while applying engineering fundamentals, and thus quite often resulting in generation of IP. My training and experience has involved learning manufacturing processes across different length scales macro-meso-micro-nano. As a result, I became familiar with a very broad set of design softwares as well machining and post-production processes that enable making parts at any length scale. It is difficult to pin point a particular process or material but generally if something new and complex needs to be designed and engineered, I would enjoy taking on the challenge, as opposed to making minor improvements to a previously solved problem.
Can you share an example of a challenging problem you encountered during a project and how you approached solving it?
The most challenging problem was in the development of the steerable microcatheter for neurosurgery. Working with different materials at the submilimeter length scale, we were poised with what I call a classic mechanical engineering problem – bonding rigid materials to highly elastic materials: I needed to bond an elastomeric material to a plastic material. It was significantly more challenging because I needed to bond these two dissimilar materials within a circular cross-section that has a diameter of less than a milimeter while maintaining delicate structures the width of a human hair. Solving this required learning chemical surface functionalization, surface metrology, and micro-scale machining processes. Implementing the learnings and a lot of trial and error were key to making it work. Quite often engineers solve problems because they have experience with a certain set of engineering techniques, but it becomes challenging when entirely new techniques interfacing different areas of science have to be developed and implemented.
In your opinion, what are some of the most significant challenges facing the medical device industry today, and how do you think they can be addressed?
There are many, but the main ones are appetite for risk, long and hurdled pathway to market entry, poorly directed fund allocation, and the valley of death between basic research and clinical development.
Most large medical device companies are too comfortable in market share they command for their respective technologies. Both start-ups and large companies face a long and hurdled pathway to market entry to meet regulatory guidelines and generally slow turnaround time associated with the same. The combination of being too comfortable and the long-drawn-out path to market results in lower appetite for risk. As a result, most large companies tend to focus on incremental development of existing products and prefer acquiring new promising players as opposed to developing novel technologies from inception.
For early stage technologies incepted via start-ups and basic university research, the biggest challenge is poorly directed fund allocation. More often than not, the judging panels for start-up business competitions largely comprise of judges who have never started a company, thus tend to make decisions based on their selective areas of expertise as opposed to the holistic view point. Similarly, peer reviewers for basic university research often comprise of panels that have not developed IP before. These two factors have inherently contributed, though not solely resulted in a well known and statistically backed saying that 90% of start-ups fail.
Many university research labs are able to de-risk problems to some extent but the transition through prototype design and discovery, and pre-clinical development falls in the valley of death. This is because the transition falls outside the domain of fundamental science, and at the same time is still not de-risked enough for commercial players or venture funds to back. Ultimately, the majority of meaningful starts to promising technologies fail to reach the development stage altogether.
While there are no easy solutions to these problems, large medical device companies should engage in early stage research by way of forming special project groups and venture arms that have the freedom to explore new technologies. The criteria of forming judging panels and peer reviewers would have to be overhauled and also made double-blinded as much as possible to enable technologies that demonstrate positive socio-economic merit to foster. While SBIR/STTR funding schemes exist, they are largely insufficient for the number of promising applications received. A new funding method with strong incentive perhaps in partnership with industry needs to be developed for technologies that fall in the valley of death.
What made you decide to become a VIC Fellow?
VIC has a unique leadership team and model that is actually addressing some of the challenging problems the medical device industry faces. I am passionate about seeing academic research/university inventions that tend to fall in the valley of death to instead foster and provide the much needed benefit to society. Having conducted basic research during my PhD, and seeing first hand the IP generated by universities, there is tremendous value in translating the research inventions to society. The VIC model helps overcome the valley of death for early stage technologies. In addition, the selection and vetting process is very thorough with a highly qualified leadership team and research fellows alike: learning this process and the finer details involved are appealing to me.
What are your goals for participating in the Fellows program?
Given the experience and calibre of the research team, it seemed valuable to learn and implement various factors that go into the due diligence process for technologies of interest. Once promising technologies are vetted, gaining a better understanding of the negotiations involved for new investment opportunities and participating in them. Learning about the cradle to grave process for new ventures, that includes but is not limited to fund raising pathways, early growth, expansion and mature age operations.
During my PhD I obtained a mini-MBA designed to gain business acumen, economics and business concepts of value creation and capture, market research and validation, go-to-market strategies, along with venture formation. The fellows program gives me an opportunity to apply the learnings for a broad set of life-science based technologies. From a holistic standpoint, one of the key motivations for participating in the VIC fellows program is it provides a great opportunity to learn, build, and apply the confluence of novel IP with business development to make a positive socio-economic impact on society.