5 Tips for Hiring Medical Device Advisors

Global Medical Device Podcast · 5 Feb 2020 · 30m · Episode 132

What this episode covers

Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, joins host John Spear to discuss the pros and cons of hiring advisors for medical device companies. They highlight the risks of hiring advisors from large strategic companies who may not understand startup risk profiles, such as advising premature pivotal trials. The conversation emphasizes the importance of due diligence, looking beyond resumes to assess humility, cultural fit, and whether an advisor creates obstacles rather than solving them.

Other shows on the same ground, closest first.

  • Let's Combinate · 22m

    133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

    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.

  • Let's Combinate · 26m

    176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski

    Eric Sugalski, founder and CTO of Archimedic, explains that the fastest way to ruin drug-device development is premature concept lock and misaligned outsourcing strategies. He argues that companies must distinguish between needing overflow capacity versus specialized expertise, such as human factors or industrial design, to avoid the 'piecemeal approach' that destroys innovation. Sugalski emphasizes the importance of early, hands-on user research and open-source quality management systems to bridge the gap between engineering and clinical reality, warning that locking down requirements before validating use cases injects costly redo loops into the project.

  • Let's Combinate · 59m

    027 - "Become a Historian of the Problem" with Duane Mancini

    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.

  • Embedded.fm · 1h 12m

    185: Nice Mahogany Table

    Debby Meredith, venture partner at Icon Ventures and interim VP of engineering, explains her role in evaluating technical diligence for Series B investments and helping portfolio companies scale. She discusses hiring strategies, emphasizing employee referrals and backchannel references to avoid cultural fit issues, and clarifies the limited but critical power of startup boards in hiring and firing CEOs. Meredith also offers career advice for engineers, stressing the importance of associating with high-caliber talent and managing the 'engineer's curse' of excessive skepticism when advising startups.

  • Being an Engineer · 59m

    S5E27 Andy Schieber | Work Ethic, Medical Device Commercialization, & Ophthalmology Devices

    Andy Schieber, founder of Ingenarious Consultants and Head of Engineering at Rivermark Medical, discusses his journey from a farm upbringing to leading early-stage medical device development. He explains the challenges of commercializing Class III implantable devices, emphasizing the need to balance inventor vision with engineering feasibility and manufacturing constraints. Schieber advises young engineers to join startups rather than large corporations to gain broad experience and take risks, and highlights emerging innovations in ophthalmology such as stem cell and gene therapy delivery systems.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.