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 13 Oct 2026, so it is still actively publishing. Listeners have left 96 ratings on Apple Podcasts, averaging 4.8 out of 5.

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Where to begin with Global Medical Device Podcast: full episodes about building physical products, award winners first.

9 Mar 2023 · 21m
Understanding the 'Compliance Manager' Role
Maryann Mitchell, a Solutions Engineer at Greenlight Guru with 15 years of medical device experience, explains the role of a Compliance Manager and the cultural barriers between engineering and quality teams. She details challenges in managing multi-site quality systems, such as right-sizing procedures for sites ranging from 11 to 1,000 employees, and the pain of losing traceability when engineers iterate without documentation. Mitchell contrasts paper-based systems with electronic Quality Management Systems (eQMS), highlighting how eQMS improves audit defense and reduces administrative bottlenecks like lost physical documents.
Quality & yield Certification & compliance
9 chapters
27 Nov 2019 · 39m
Why Supplier Quality Management Is So Important For Medical Device Companies
Mike Drues of Vascular Sciences joins host John Spear to discuss supplier quality management, emphasizing that medical device companies retain ultimate responsibility for third-party services even when work is delegated. They use Ethylene Oxide (EtO) sterilization as a case study for supplier failure, noting that relying solely on EtO vendors creates a single point of failure when capacity is constrained by environmental regulations. Drues advocates for a risk-based approach to supplier criticality, suggesting multiple levels of assessment rather than a binary critical/non-critical classification, and highlights the business necessity of creating win-win partnerships with backup suppliers to ensure supply chain resilience.
Manufacturing partners & offshoring Quality & yield
6 chapters
7 Sept 2022 · 37m
Packaging Validation Best Practices
Jeff Barrett, CEO of J-Pac Medical, explains the complexities of ISO 11607 packaging validation for sterilized medical devices, emphasizing that over a third of validations fail transit testing due to a lack of understanding regarding shipping modes. He details how companies can avoid costly 510(k) delays by conducting feasibility testing, using worst-case scenarios for sterilization, and managing labeling risks, which account for 40% of FDA recalls. Barrett highlights that sterilization validations can cost $40,000-$80,000 and take 16-20 weeks, urging engineers to integrate packaging design early in the process to prevent revalidation issues as companies scale.
Packaging design Certification & compliance
12 chapters

Hear it in a few minutes

Single discussions from recent episodes, playing the show's own audio from where each begins.

Class 1 Ventilator Recall and Root Cause Analysis
5 min · Global Medical Device Podcast
From “#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey” at 10:47
21 CFR Part 4 and QMS Integration Challenges
4 min · Global Medical Device Podcast
From “#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment” at 4:59
Using External Testing as Evidence Breadcrumbs
5 min · Global Medical Device Podcast
From “#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth” at 11:29

Latest episodes

13 Oct 2026 · 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 & compliance Starting a product company
5 chapters
22 Sept 2026 · 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 fit Design for manufacturing & NPI
8 chapters
21 Sept 2026 · 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 fit Pricing, margins & unit economics
10 chapters
21 Sept 2026 · 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 design Design for manufacturing & NPI
9 chapters
21 Sept 2026 · 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 & privacy Certification & compliance
7 chapters
21 Sept 2026 · 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 & investors Validation & product-market fit
8 chapters
21 Sept 2026 · 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 & compliance Quality & yield
9 chapters
10 Aug 2026 · 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 analysis Quality & yield
10 chapters
3 Aug 2026 · 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 & compliance Design for manufacturing & NPI
8 chapters

Every episode

357 episodes with a summary and chapters, by year.

202636 episodes

202543 episodes

202447 episodes

202353 episodes

202255 episodes

202166 episodes

202043 episodes

201914 episodes

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