ABIG Health's Steve Farmer Joins NAMSA Panel on EU and US Device Market Entry
ABIG Health Senior Partner Steven A. Farmer, MD, PhD, FACC, FASE, spoke on September 22 at "EU vs. US: Which Market Fits Your Device Strategy?", a NAMSA webinar comparing how medical device companies enter the European and US markets. Dr. Farmer, a former Chief Strategy Officer at CMS, covered US coverage and payment.
He was joined by NAMSA Chief Medical Officer Adam E. Saltman, MD, PhD, a former FDA medical officer, and David Mandley, PhD, NAMSA's Senior Principal Regulatory Consultant. Marco Kalms, founder and CEO of the market-access consultancy KALMS, spoke on European reimbursement.
Takeaways
Approval starts the commercial process. Saltman described market authorization as necessary but not sufficient. A device also needs someone to pay for it and clinicians who will use it, and each of those audiences asks for different evidence.
The two regions are organized in opposite ways. One CE mark opens 27 EU markets, but reimbursement is decided country by country. In the US, one payer tends to lead. "There is one dominant player which tends to set the precedent for the other payers," Dr. Farmer said, "and that is Medicare CMS."
Medicare's standard trips up many devices. CMS covers what is "reasonable and necessary," and part of that test asks whether a device is appropriate for Medicare beneficiaries. Those patients tend to be older with more comorbidities. They are also often treated in settings unlike the ones where a device was studied.
Reimbursement planning starts during development. Dr, Farmer emphasized "the decisions that you make early on really determine your success," and that leaving them for later makes them "much more expensive and challenging to retrofit." Kalms made the same point for Europe, tying future reimbursement options to the intended use and indications a company sets during regulatory work.
The first market depends on the device's economics. For a high-cost device that needs US pricing to be viable, Dr. Farmer said the US would be the place to pursue a PMA first and use it as a "launching pad to go to Europe second." Saltman and Mandley urged companies to cost out each path before choosing, or in Mandley's words, "quantify that opportunity."
Event page: EU vs. US: Which Market Fits Your Device Strategy? (NAMSA)
