A Look Ahead at the Coming Medtech “School Year”: A Conversation with MDMA’s Mark Leahey

As the calendar turns from summer to fall, there is no shortage of issues important to the medical device industry emerging on all fronts, addressing legislative, regulatory and policy matters. No one is better aware of the state of play of these issues than Mark Leahey, CEO of MDMA. Here Mark touches all bases with Medtech Strategist/Market Pathways editor-in-chief Stephen Levin, including discussing:

• the potential long-term impact of the pandemic on the industry and the transition from EUAs to permanent approvals/clearances;
• an inside look at the current status of the MDUFA/user fee negotiations, including whether we could see an FDA “concierge” program;
• what we might expect from the CURES 2.0 legislation—is ARPA-Health in our future?;
• reimbursement challenges, including parallel review, coverage of advanced technologies such as AI, and the debate on site of service payment rules;
• is prior authorization dead?; and
• will the drug pricing debate spill over into medical devices?