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Global Medical Device Podcast

Greenlight Guru's interviews with medical device founders, engineers and regulatory experts on design controls, quality systems and getting a device cleared and to market.

357 episodes · 239 hours · since 2019

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Global Medical Device Podcast is filed under medical devices, manufacturing, product development and interviews. Its most recent episode published on , so it is still actively publishing. Listeners have left 96 ratings on Apple Podcasts, averaging 4.8 out of 5.

Latest episodes

The 10 newest episodes of Global Medical Device Podcast, each with a summary and chapters.

  • · 34m

    #475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy

    Mike Drues, president of Vascular Sciences, explains that FDA guidance documents represent the agency's 'current thinking' rather than binding law, urging manufacturers to treat them as tactical starting points rather than immutable rules. He argues that while regulations (CFR) carry legal weight, guidance can be deviated from if justified, and recommends using the pre-submission process to address these deviations early. Drues highlights the limitations of the CDRH guidance database, noting it lacks revision history, and suggests using broader search tools like Google and direct engagement with the Office of Industry and Consumer Education (OICE) to track updates and in-development documents.

    Certification & complianceStarting a product company
    5 chapters

  • · 39m

    #470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova

    Lisa Voronkova, co-founder of OVA Solutions, draws on data from over 200 medical devices to outline the real costs and timelines of MedTech innovation. She details four engineering phases—Discovery, Proof of Concept, Design, and Development—and provides specific hour estimates for projects ranging from simple electronics to complex continuous glucose monitors (CGMs). Voronkova emphasizes the critical importance of validating devices in real clinical environments and explains why Design for Manufacturability (DFM) requires significant additional engineering investment to avoid costly late-stage redesigns.

    Validation & product-market fitDesign for manufacturing & NPI
    8 chapters

  • · 39m

    #469: Why Market Strategy Comes First in MedTech Development

    Shai Policker, Managing Partner at Edge Medical Ventures, explains how his firm reverses the traditional MedTech development paradigm by identifying validated clinical needs from multinational corporations before prototyping. He details how this approach allows for early mapping of reimbursement codes and regulatory pathways, citing examples like Urologic Health’s non-invasive urodynamics and Xero Medical’s smart surgical drains. Policker emphasizes that successful products must offer dramatic clinical improvements while maintaining familiar form factors to leverage existing 510(k) predicates and billing mechanisms.

    Validation & product-market fitPricing, margins & unit economics
    10 chapters

  • · 38m

    #471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap

    Michael Sprauve, president of Speck Design, explains how MedTech startups often fail by focusing solely on core technology while ignoring the complex web of user personas, including surgeons, nurses, and maintenance staff. He argues that AI-generated visuals frequently lack physical constraints and manufacturing realities, creating a gap between concept and market readiness. To bridge this, Speck Design uses a 'North Star' based on emotional and sensory attributes to guide design, engineering, and CMF choices, ensuring the device meets regulatory and usability needs for all stakeholders. Sprauve emphasizes involving manufacturing engineers from day one to avoid costly re-tooling and ensuring the final product is viable for production and FDA approval.

    Industrial & consumer product designDesign for manufacturing & NPI
    9 chapters

  • · 40m

    #472: Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates

    Chris Gates, founder and CEO of arsMedSecurity, explains why medical device manufacturers must right-size cybersecurity efforts early in the development lifecycle to avoid catastrophic financial and regulatory consequences. He argues that deferring security until the end of development leads to severe FDA delays, with a typical 180-day hold potentially destroying a startup's burn rate. Gates highlights the accelerating threat landscape driven by Large Language Models (LLMs), which reduce vulnerability exploitation windows from years to minutes, making reactive patching ineffective. He provides concrete steps for compliance, including performing system-level threat modeling before hardware freeze and aligning software development SOPs with ISO/IEC 81001-5-1 and ISO 62304 standards.

    Security & privacyCertification & compliance
    7 chapters

  • · 42m

    #473: The MedTech Odyssey: Bridging Academic Science to Series A Success

    Jordi Martorell, CEO and co-founder of Aortyx, discusses his journey from mapping arterial blood flow at the Harvard-MIT Biomedical Engineering Center to raising a Series A for his Class III medical device company. He explains how Aortyx sustained its multi-year development of bioresorbable endovascular patches for aortic dissection by leveraging friends-and-family rounds, Capital Cell equity crowdfunding, and European Innovation Council (EIC) grants. Martorell details the structural challenges of managing a cap table with hundreds of retail investors via syndication and SPVs to maintain clean negotiation lines for institutional VCs. He also reflects on the realities of closing a Series A in a non-traditional VC hub, facing post-pandemic inflation, and the critical importance of resilience and visibility at conferences like LSI.

    Fundraising & investorsValidation & product-market fit
    8 chapters

  • · 33m

    #474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls

    Nikhil Mangale, Vice President of Quality at Kapstone Medical, discusses the real-world impact of the FDA's Quality Management System Regulation (QMSR) based on seven months of inspection data. He identifies the top five FDA citations as risk management, supplier controls, complaint handling, Unique Device Identification (UDI), and corrective actions, noting that inspectors now focus on operational processes rather than terminology updates like renaming Design History Files (DHF) to Design and Development Files (DDF). Mangale advises companies to implement a three-layer mapping strategy, prioritize risk management as a living process, and maintain open DDFs throughout the product lifecycle to avoid citations. He also clarifies that ISO 13485 certification does not exempt companies from FDA inspections and highlights the continued value of MDSAP enrollment for sites in multiple jurisdictions.

    Certification & complianceQuality & yield
    9 chapters

  • · 44m

    #468: SaMD Issues, Defects & Detection | Shawnnah Monterrey

    Shawnnah Monterrey, founder of Beanstalk Ventures and an FDA-accredited third-party reviewer, discusses post-market quality issues in medical devices, drawing on her experience at ZEISS and Illumina. She explains how inadequate upstream characterization, such as neglecting shipping stresses or subsystem-level DFMEAs, leads to costly 'dead on arrival' failures and field complaints. The conversation highlights the importance of robust unit testing, clear design documentation, and structural post-market surveillance to prevent catastrophic recalls, using a Class 1 ventilator case study to illustrate software-hardware interaction failures. Monterrey also addresses the challenges of integrating AI-generated code into maintainable systems and the critical need for open communication loops between R&D, manufacturing, and post-market teams to feed field intelligence back into product design.

    Debugging & failure analysisQuality & yield
    10 chapters

  • · 35m

    #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

    Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

    Certification & complianceDesign for manufacturing & NPI
    8 chapters

  • · 31m

    #466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth

    Malte Knowles Schmidt, Global Portfolio Lead for Medical Device Software, AI, and Cybersecurity at TÜV SÜD, explains how early-stage medtech startups can demonstrate regulatory maturity to investors before achieving full certification. He advocates for 'leaving the ivory tower' by engaging notified bodies early, implementing an enterprise Quality Management System (eQMS), and pursuing partial ISO 13485 certification for core design processes. Schmidt warns against 'Pyrrhic certifications' where commercial viability is sacrificed for regulatory approval and suggests using external testing as strategic evidence of progress.

    Validation & product-market fitCertification & compliance
    6 chapters

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