4 Critical Lessons on Navigating Challenges in Medtech Start-ups

What I have learned as the CEO and co-founder of FastWave Medical, and having conducted hundreds of Medsider interviews, is that in an ever-evolving world of medical technology, medical device leaders need to stay sharp while navigating various hurdles.

I recently sat down with three innovative medtech entrepreneurs—Renee Ryan, Tristan Tieso, and Mara McFadden—whose experiences in the industry have led them to develop groundbreaking products that change lives.

Renee Ryan, investor turned CEO, spearheads a bioelectronic medicine company, Cala Health, offering a first-in-class wearable therapy platform to treat various chronic diseases. Tristan Tieso is the COO at FastWave Medical, a cardiovascular start-up revolutionizing the treatment of calcific arterial disease through cutting-edge IVL technology. And, finally, Mara McFadden, a tenacious CEO leading Endolumik, a company that’s enhancing GI surgery with their fluorescence-guided esophagogastric calibration system.

In this article, I’ll share their advice on overcoming the challenges in the field and charting a course to success in medtech.

Embrace Continuous Learning and Bias Yourself Towards Action

No one can dispute the importance of continuous learning in terms of personal and company growth, particularly in medtech, where rapid innovation, real-world evidence, and practical application are vital.

All three of our interlocutors advocate for a proactive mindset that pushes the envelope of what’s possible in the medical device field. Tieso admits that throughout her career, she had to dive into the unknown and learn as she went along. Actively pushing past her comfort zone, she pursued new responsibilities even as a novice in the field.

Renee’s golden advice for aspiring healthcare leaders is to proactively seek opportunities, reiterating that this approach has helped her land some of the most rewarding assignments in her career. Mara, too, underscores the importance of collaborative problem-solving, seeking out experts, remaining curious, and staying open to ideas that might be better than yours.

Be Intentional About Building a Strong Community

As a CEO, your job is to foster authentic relationships and cultivate a supportive community within your industry. This applies to your immediate team and external parties like regulatory bodies, investigators, collaborators, and investors.

When asked about the essential component of successful early-stage projects, Tieso doesn’t hesitate – it’s all about teamwork. She recommends joining forces with people with different backgrounds who are aligned with your mission and excited about what you’re building.

For Mara, leadership is about assisting team members to overcome obstacles. "If people are struggling, it’s my job to try and figure out the roadblocks and help remove them," she states. This ethos of empathy and problem-solving focuses on team success rather than individual achievement.

She also remarks that the medical device community is shockingly small, and you are likely to cross paths with many of your colleagues again. That’s why maintaining healthy professional relationships is sometimes equally as important as focusing on the specifics of any given project.

Finally, Ryan highlights the need to maintain open communication across company departments to ensure the teams operate as a unified body. “When I was an investor, I always said I invest in people, not companies. I still feel that the people part is really important.”

Define Success Based on Your Company’s Milestones

Next on Tieso’s list of priorities is defining what success looks like. A good executive must have specific metrics and milestones in place — only then can you clearly spot the risks on your way. Prioritizing true "needs" versus "nice-to-haves" is essential for start-ups to efficiently allocate resources and capital, especially in the beginning.

Mara also emphasizes the importance of understanding your value inflection points from multiple perspectives to ensure your decisions align with your stakeholders’ expectations. In Mara’s words, “The person who ends up driving the agenda is usually the person who shows up prepared.” This seemingly simple advice can save your company from potential costly setbacks and ensure a smoother path to progress.

Invest in Clinical Evidence and Prioritize Market Education

Clinical and scientific data are the foundation of a successful medtech venture. Tieso advises entrepreneurs to identify the genuine needs of the market first and only then decide on essential product features informed by these insights. This strategy helps you validate your product and makes it easier to convince healthcare providers, patients, and other stakeholders of its worth later down the line.

In Ryan’s case, prioritizing investment in clinical and scientific data to support their TAPS Therapy and Cala Trio device fueled its rapid expansion and helped solidify its position in the market.

Unfortunately, clinical evidence isn’t always enough to prove that your device adds value to people's lives. You also need to educate your audience on the real burdens of the disease or condition you’re providing a solution for, as well as your product's potential benefits and long-term value.

Lessons for Aspiring Medtech Leaders

Wrapping up this deep dive into the journeys of our three entrepreneurs, I’d like to underline the most important lessons to take from the experiences of these medtech trailblazers:

Nurture curiosity and stay proactive.

Being a lifelong learner is the only way to stay sharp. Don’t just do what you’re comfortable with; actively seek opportunities that are out of your comfort zone.

Cultivate a strong community.

Build the right team, forge connections with other parties in the field, set the theme for collaboration, and keep communication flowing within the company.

Define your objectives and potential risks.

You have to be able to see the road ahead clearly. Once you do, you can set realistic goals and bring the risks that could otherwise blindside you to light.

Get the data and proactive educate.

Develop your product based on what your audience is looking for, use clinical data to support it, and educate your potential customers about the disease or condition you’re trying to tackle.

For those eager to lead, innovate, and make your mark in the ever-evolving field of medtech, I hope these friendly tips stay with you on your journey.

Scott Nelson is the co-founder and CEO of FastWave Medical, a medical device start-up developing intravascular lithotripsy systems. He’s also the founder of Medsider, where he interviews CEOs of promising, early-stage medical device and health technology companies.