Hardware Podcasts

Building Your Regulatory Strategy for Commercialization

Global Medical Device Podcast · 14 Sept 2022 · 43m · Episode 280

What this episode covers

Duane Mancini, CEO and Managing Partner at Project Medtech, advises early-stage medtech founders on integrating regulatory strategy with fundraising and commercialization. He emphasizes that investors prioritize the team and the problem over the product, and warns founders to avoid 'bad' investors who may force premature exits. Mancini highlights that commercialization requires addressing three key hospital stakeholders: clinicians (especially nurses), patient outcomes, and economic benefit, while building a robust Quality Management System (QMS) early to maximize valuation for potential strategic acquisitions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Project Medtech, Green Light Guru, Silicon Valley Bank, Medtronic, Johnson and Johnson, Mimic, Texas Medical Center

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