Emphasizing Clinical Problem Solving

At the core of medtech innovation is addressing real clinical problems. Both MD Start and Exploramed focus on this principle. Anne Osdoit explained the approach of MD Start: "We rely and build on ideas that other people have. We typically don’t do the ideation part; instead, we interact with clinicians who have concepts that can tackle some of their daily limitations. We partner with these clinicians and build companies around them." This method ensures that the solutions developed are directly relevant to the needs of healthcare providers.

Dr. Josh Makower shared a similar sentiment for Exploramed: "We start with a blank slate and a big problem. We then try to understand it better en route to inventing a novel solution that has the potential to be a company." 

Navigating the 'Valley of Death'

Many successful medtech startups face significant challenges, often called the 'valley of death.’ Josh shared the arduous journey of Neotract: "Our first version of the device did not work. Our second version of the device worked, and we finally got some decent clinical data. At this point, we went to the FDA to get an IDE. With all of the back and forth and rework requested by the FDA, it took us literally three and a half years to finally begin our IDE in the United States." This period involved substantial perseverance and problem-solving to navigate regulatory and technical hurdles.

Anne provided a similar account with LimFlow: "We got five disapproval letters from the FDA on its IDE, and you have to keep the company afloat. In our case, it was two and a half years." These examples highlight the resilience required to succeed in the medtech market.

The Role of Perseverance and Team Dynamics

Perseverance and a strong team are essential for overcoming the inevitable challenges in medtech innovation. Anne emphasized the importance of the right team: "Do you have a group that's going to be able to overcome this challenge? Do you have a group of people who are okay with working in this environment? Because that's pretty much the daily life of a startup."

Josh highlighted maintaining focus on the vision: "Every day, there's another reason to give up right in front of you—but what makes a difference is being able to accept those things, learn from failures, and keep on going." The synergy between a dedicated team and a clear vision can drive a startup through difficult times.

Choosing the Right Investors

Selecting the right medical device investors is vital for the long-term success of a medtech startup. Josh stressed this point: "Choosing your investors very wisely is so fundamentally important. You need to work with people who share the same beliefs and values that you do and are willing to persevere. Look at their track record and see what they have persevered."

Anne added, "I think you can see it from experience. People will know that this is part of the life of a startup, and they'll have demonstrated that they can help in new situations." The right investors not only provide funding but also valuable support and guidance through challenging times.

Leveraging the Medtech Community

The medtech market thrives on community and peer support. Josh underscored the value of this network: "One of your greatest resources is standing right next to you. This community is what is so powerful."

Anne agreed, noting the role of shared experiences: "Benchmarking and working with experienced consultants who have that experience from other companies in the same space goes a very long way." Engaging with the medtech community can provide crucial insights and support for navigating complex challenges.

Conclusion

The full recording from this fireside session is available in LSI’s resource hub at the link below:

• Beating the Odds: Perseverance, Triumph, & Lessons Learned from the Leaders of Sofinnova MD Start & ExploraMed | LSI Europe '23

The insights shared by Anne Osdoit and Josh Makower at LSI Europe 23 illustrate the complexities and rewards of medtech innovation. Their experiences highlight the importance of a structured approach to solving clinical problems, the necessity of perseverance, and the value of building a supportive community. For medtech startups and investors, these lessons are invaluable in navigating the challenges of the medtech market.