Mark Domyahn on marketing, regulatory, and reimbursement strategies for neurotech companies

Neural Implant podcast - the people behind Brain-Machine Interface revolutions

Mark Domyahn is a partner at JD Lymon where they help companies develop healthcare strategies. They help companies understand their unique value proposition and optimize their market potential.

Top 3 Takeaways:

• "the FDA writes zero checks. They give you a license to hunt, but they don't guarantee you kill anything"
• "What I'm hearing more and more is the first question out of investor's mouth isn't what's your FDA pathway, it's what's your reimbursement strategy. Because FDA is at least a somewhat known entity. And they're the last entity that will tell you as a company "if you do this study, if you do this. We will get you to market. We will give you the clearance or the approval." Payers will never tell you that I've never had a payer say that if you do this randomized controlled study, or if you do this post-market registry, I will pay for your device at the price you want it. That doesn't happen. So you're guessing a little bit."
• "The three things is: Marketing is what do I want to be able to say about my product? Regulatory is what can I say without going to jail? And then reimbursement is who's going to pay. Those three things, in my opinion should be dictating what your clinical strategy is. Not one, not two, but all three of those things."

0:30 "Do you want to introduce yourself?"

1:45 "What are some costs and benefits of all of those different

options- VA, insurance, private payers?"

3:15 "What's the process of getting reimbursement approved?"

5:45 "What are some common timelines timeframes that we're looking at?"

9:30 "There are lots of insurance companies out there. So basically if you're able to get one code you got them all, or do you have to individually go after them?"

15:15 "What are some big issues that you see going on or things that, people I guess are messing up or are doing incorrectly either be it on the company side or the insurance?"

24:45 What is your role?

31:45 "So what are some big successes or failures that you've seen companies go through and maybe one of each?"

36:00 "How did you get into this field and what's been your path, your career path?"

38:15 "Is there anything that we didn't talk about that you wanted to mention?"

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