Global Medical Device Podcast · 30 Apr 2024 · 40m · Episode 364
Christine Luk, Associate Regulatory Affairs Manager at Proxima, shares her journey from a failed women's health startup to navigating FDA regulatory pathways. She details the critical importance of aligning with regulatory consultants early, managing time-and-materials budgets, and structuring effective FDA interactions like pre-submissions. Luk emphasizes that founders must provide clear design inputs and roadmap context to avoid costly pivots and ensure efficient market entry.
early-stage companies and companies scaling up
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Daniel Scharff and Adam Yee discuss the launch of Startup CPG's 'Founders & Formulators' event in Chicago and the accompanying Product Developer Directory. Yee explains how formulators evaluate products through 'vibes' and technical inquiry, emphasizing the need for clear deliverables to avoid scope disputes. They highlight the directory as a tool for vetting consultants based on specialty, fee structure, and past work.
Devon Campbell, founder of Prodct LLC, discusses his advisory practice for early-stage biotech and medical device companies, drawing on his experience at Ventana Medical Systems, Quanterix, and Novartis. He explains how his background in machine shop operations and holistic product development—from design to field service—enabled his rapid rise to senior leadership roles. Campbell advocates for dual-career tracks in engineering, allowing brilliant technical contributors to become 'fellows' without becoming managers, and emphasizes the importance of integrating regulatory strategy (FDA, ISO 13485) from the earliest stages of product development to avoid costly rework.
Devon Campbell, Founder of Prodct LLC and CPO of myBiometry, explains his transition from exiting MedTech ventures to founding a consulting firm focused on medical devices and diagnostics. He details his 'year of saying no' strategy, which allowed him to curate high-impact startup engagements while avoiding the toxic consultant culture he previously experienced. Campbell emphasizes humility in leadership, arguing that arrogance is a primary source of team dysfunction and that effective consulting requires authentic, humble facilitation rather than just technical oversight. He also discusses the specific operational challenges early-stage startups face, such as underestimating regulatory and quality system needs.
Duane Mancini, CEO and Managing Partner of Project Medtech, discusses his transition from medicinal chemistry to medical device regulatory strategy at NAMSA and LabCorp. He explains the critical importance of integrating reimbursement strategy early in the development of combination products to avoid commercialization failures, noting that regulatory choices like 510(k) can negatively impact reimbursement pathways. Mancini details how Project Medtech supports startups through its podcasts, Startup Symposiums, and consulting services, focusing on capital raising, milestone mapping, and navigating the complexities of drug-device combinations like insulin patches.
Ted Newill, founder of Medical Device Success and SRD Vision, discusses the critical importance of 'Voice of the Customer' and the Technology Adoption Life Cycle Curve for medtech startups. He explains how engineers can bridge the gap between regulatory approval and commercialization by identifying early adopters and key opinion leaders before launch. Newill also shares advice on managing the pressure of venture-funded environments and the necessity of empathy and listening when collaborating with marketing and sales teams.
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