We used every screen in the house to use to host a fabulous hybrid educational event on the FDA Breakthrough Device Designation and the Total Product Lifecyle Advisory Program (TAP), moderated by Fogarty regulatory advisor Peggy McLaughlin. The event featured remote presenters Laura Gottschalk, PhD, FDA TAP advisor, and Jane Noble, PhD, FDA Acting Team Lead, as well as remote and in-person leaders from two companies participating in the programs: Marc Powell, CEO at Reach Neuro, Inc., and Ankit S., VP marketing and Alexis Dineen, VP regulatory affairs at SetPoint Medical. While the Breakthrough Devices Program is intended to provide patients and providers with timely access to medical devices by speeding up development, assessment and review, TAP recognizes that companies have challenges beyond FDA marketing authorization that can prevent safe and effective new solutions from reaching patient care. Accordingly, TAP helps companies think about both their regulatory and larger business strategies. For companies that qualify, the programs offer significant benefits including early and enhanced communication with the FDA, an expedited review process, support around reimbursement including the potential for early payer feedback, and increased recognition that can help attract investors, partners and customers. In particular, speakers participating in TAP were delighted with the ability to have regular meetings with their TAP advisor and the lead reviewer. They also appreciated the breadth of different stakeholders that the FDA introduced them to, including patient advocacy groups and clinician groups, for the purposes of gathering feedback and making informed decisions Thank you to all the presenters and organizers for this information-packed program. If you missed out, we'll have a detailed write-up in the July issue of our newsletter!
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Alexis Dineen is a marketing guru!
Senior MedTech Leader | Go-to Market Strategist | Sales & Marketing Specialist | Early Stage Startups | Team & Culture Builder
3wGreat work Ankit S.!