Notes from Your MedTech Co-Founder

Don’t Make the “Field of Dreams” Mistake

Innovating in today’s medical device industry is insanely hard. The majority of the MedTech industry consists of small companies – over 80% have fewer than 50 employees. The funding market has gotten significantly tougher in recent years. Most MedTech entrepreneurs are first timers, navigating unknowns with a long list of questions. Few go on to launch a second company, making veteran co-founders a rare breed.

If you’re a co-founder, or part of a MedTech startup, you’ve probably asked yourself (or been asked) one or more of the following questions:

Who will purchase my product, and what do they need to see? Do they need to be reimbursed?

Will health insurance payers cover a premium for my technology? And how do I get them to do that?

How do I develop and use my clinical trials to achieve reimbursement without overcomplicating things?

How do I convince future investors of our go-to-market plan?

When is the right time to start planning my reimbursement and market access strategy, given my limited budget?

These are just a few of the tough and complicated questions you’ll face. I struggled with them too at one point.

You’re probably also wondering, “Who is this guy, and why should I keep reading?” If I may take a moment to introduce myself: I’m Ryan Nolan, and I co-founded a pediatric medical imaging device company called PhotoniCare back in 2015. This was my first company, and I was, admittedly, a naïve biomedical engineer with aspirations to revolutionize pediatric ear healthcare. It’s a tale as old as time – my co-founders and I developed an innovative device and felt called to commercialize it for the betterment of patients (especially our own kids, who had suffered ear infections).

I led all clinical and reimbursement efforts for nearly ten years, as we conducted multiple multi-site clinical trials, and leveraged those results to establish new reimbursement coding, coverage, and payment. Along the journey, we learned from not only our wins and losses, but also from our veteran MedTech advisors.

Honestly, I wouldn’t be where I am today without the guidance of the reimbursement and market access mentors who supported me. Their expertise was instrumental in helping me avoid the “potholes” and navigate the vast complexities of establishing new medical device coding, coverage, and payment.

So, what’s the point of this? My hope for this series is to pay it forward to the next generation of MedTech innovators. Too many promising and innovative medical technologies fail before achieving their intended patient impact. If I can help even one technology avoid those potholes, I’ll be elated.

Show me the value PROOF, not the value proposition

For today’s post, I’d like to discuss that phrase, as it’s one of my favorites (copyright pending—but not really, haha).

In today’s MedTech market, the days of early acquisition post-FDA approval are gone. If you’re a startup looking to get acquired, you should expect—and plan—not just to launch your product but also to establish market traction and growth. So how do you do that?

The expectation in today’s U.S. healthcare system is that you’ll have robust, published clinical trial data—not just a compelling story about your value proposition. This data must clearly demonstrate how your proposed “future of care” compares to the current standard of care—not just clinically, but economically as well.

While raising funds or applying for grants to conduct such trials is challenging, this reality applies to all stakeholders—not just the clinical users of your technology, but also the financial stakeholders and potential strategic acquirers. I could go on for pages about this (and possibly will in a later post), but here’s the key takeaway:

Common misconception: My clinical trials on safety and efficacy for the FDA will be sufficient for going to market (and getting acquired).

Reality: You NEED to design your clinical trial strategy, and each study protocol, with input from ALL of your product stakeholders, and address their specific needs.

Don’t fall into the “pothole” of having to repeat a costly clinical trial. Too many companies with promising technologies have failed due to post-market adoption issues that could have been prevented with a market-access-informed clinical trial design.