Ep #009: Mark Domyahn

Jun 11

FDA Doesn't Write Checks: A Conversation with Mark Domyahn

What happens when a MedTech company successfully gets through FDA?

That is often when the real work begins.

In this episode of Bluestock Talk, Allison is joined by reimbursement expert Mark Domyahn, Partner at JD Lymon Group (and Bluestocking Health Advisory Board member), to explore one of the most important (and frequently misunderstood) aspects of MedTech commercialization: getting paid.

As Mark explains, regulatory approval is only one piece of the puzzle. Hospitals, physicians, payers, and investors all evaluate new technologies differently, and increasingly, investors want to understand not just whether a product can reach the market, but whether there is a realistic path to reimbursement and adoption.

One of Mark's most memorable observations:

"FDA doesn't write checks."

That simple statement becomes the foundation for a fascinating discussion about why reimbursement strategy should be considered alongside regulatory strategy from the earliest stages of development. Together, Allison and Mark explore how coding, coverage, payment, clinical evidence, and market access all influence whether innovative technologies ultimately reach patients.

Along the way, they discuss:

• Why reimbursement is often one of the most overlooked aspects of MedTech strategy

• How investors are changing the questions they ask startups

• The difference between FDA approval and payer adoption

• Medicare, Medicare Advantage, and healthcare payment dynamics

• Why clinical unmet need drives both reimbursement and innovation

• Why understanding the healthcare system is just as important as building great technology

The episode also features one of the most entertaining Bluestock Talk segments yet, as Allison challenges Mark to a game of "Is It a Regulated Medical Device?" featuring implantable microchips, smell tests, and other surprisingly real technologies.

Key Takeaways

• Regulatory and reimbursement strategies should be developed together

• FDA approval does not automatically lead to payment or adoption

• Investors increasingly want to understand long-term reimbursement pathways

• Clinical evidence requirements may differ between regulators and payers

• Mobility technologies and brain-computer interfaces may transform patient independence and quality of life

Chapters

00:00 Introduction to Mark Domyahn

02:00 Understanding reimbursement in MedTech

08:00 Why investors are asking different questions

13:00 Let’s play “Is It a Regulated Medical Device?”

24:00 Who pays for healthcare innovation?