ARTICLE SUMMARY:
In this week’s Pathways Picks: Former CDRHers launch a venture fund; FDA and industry reach a tentative user fee agreement, and more US agency updates; digital health market access updates from France, England, and Germany; the EU advances breakthrough and orphan pathways; Canada on “significant” change; and more global medtech policy updates.
Top Picks
Shuren starts venture fund, tentative MDUFA agreement:
Venture fund on TAP. Longtime CDRH Director Jeff Shuren and several former device center colleagues have co-founded a new medtech venture fund called White Oak 66 Capital. The founders—also including Doug Kelly, former deputy director and chief scientist; Ross (Rusty) Segan, who briefly ran CDRH’s Office of Product Evaluation and Quality; and Joel Brill, a reimbursement expert who consulted with FDA—seek to combine medtech investing with a heavy focus on helping firms proactively address reimbursement and other post-FDA commercialization risks, building on the TPLC Advisory Program (TAP) pilot they launched at CDRH. “We looked at the venture world and nobody was addressing a fundamental problem. It’s all about post-FDA risk,” Kelly said in an interview. (For more details, see “Venture Fund on TAP: Shuren and Former FDA Colleagues Launch New Firm.”)
