Hardware Podcasts

#429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown

Global Medical Device Podcast · 20 Oct 2025 · 22m · Episode 429

What this episode covers

Michael Nilo, President of Nilo Medical Consulting Group and former FDA Scientific Reviewer, explains how a U.S. government shutdown impacts the Food and Drug Administration (FDA) and medical device companies. He details that while new user-fee-supported submissions like PMAs and 510(k)s halt, essential activities such as IDE reviews, post-market safety surveillance, and active review of already-filed submissions continue using existing user fee reserves. Nilo advises MedTech leaders to treat the shutdown as an uncontrollable natural disaster, using the delay to improve submission quality, finalize process validation, and strengthen commercial strategies to emerge stronger once the FDA reopens.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Nilo Medical Consulting Group, Medtronic
Also
FDA, PMAs, 510(k)s, IDEs, MDUFA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 1h 16m

    012 - "Asking then Seeing" with Sara Waxberg Mcnew

    Sara Waxberg McNew, Chief Scientific Officer at Design Science, explains the human factors process for medical devices, emphasizing the distinction between formative studies and summative validation. She details how to interpret ANSI/AAMI HE75 and IEC 62366-1 standards, manage risk for combination products, and handle regulatory submissions with the FDA. The discussion covers specific challenges like testing rare patient populations, using surrogates, and conducting threshold analyses for generics.

    Medical & health devicesValidation & product-market fit
    12 chapters

  • Let's Combinate · 35m

    079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young

    Rumi Young, Director of Regulatory Policy at Becton Dickinson (BD), explains how the FDA reviews combination products, drawing on her previous tenure as Acting Assistant Director in CDRH’s Division of Drug Delivery. She details the inter-center consult process for products like auto-injectors and smart connected devices, highlighting the manual nature of current submissions and the critical need for clear device identification in NDAs and BLAs. Young discusses the role of industry in shaping policy, advocating for updated Essential Performance Requirements (EPRs) and international harmonization through IMDRF to address the gap between evolving technologies and outdated guidances.

    Connected products & IoTCertification & compliance
    8 chapters

  • Let's Combinate · 1h 12m

    024 - "Operating Under Constraints "with Naveen Agarwal

    Naveen Agarwal, a PhD polymer scientist and quality management consultant at Creative Analytics Solutions, discusses operating under constraints, drawing parallels between his 1,500-mile running challenge and risk management in medical devices. He explains the distinction between post-market vigilance and surveillance, advocating for a customer-experience-focused approach to quality improvement that goes beyond regulatory compliance. Agarwal introduces the SNIP framework (Strength, New, Importance, Preventable) for data-based decision-making in post-market surveillance and argues that safety performance should drive innovation and reimbursement rather than just meeting baseline safety standards.

    Quality & yieldCertification & compliance
    9 chapters

  • Let's Combinate · 33m

    106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott

    Michelle Lott, founder of leanRAQA, explains how to navigate eight FDA databases, including using FOIA requests to access redacted 510(k) summaries and reviewing 483 and Warning Letter databases to identify regulatory trends. She details the recent modernization of the 510(k) program, specifically new guidance on predicate selection and clinical data, and contrasts the 510(k) pathway with the De Novo process for novel devices. Lott also outlines the Pre-Submission and 513(g) classification processes, noting their timelines and costs, while advising companies to monitor draft guidance documents to anticipate FDA expectations during submissions.

    Certification & complianceSourcing & supply chain
    8 chapters

  • The Pragmatic Embedded Podcast · 51m

    Closing the gap between Regulatory and Development with Milton Yarberry

    Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS), discusses bridging the gap between engineering and regulatory teams in medical device development. He identifies key friction points such as process lag, software stacking, and the cognitive burden on developers, arguing that regulatory processes should be viewed as support rather than compliance burdens. Yarberry advocates for a 'regulatory concierge' model where regulatory staff handle administrative overhead, allowing engineers to focus on building safe and effective products through incremental, value-driven processes.

    Medical & health devicesQuality & yield
    6 chapters

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.