Hardware Podcasts

How to Construct an Effective Regulatory Strategy

Global Medical Device Podcast · 27 May 2020 · 41m · Episode 148

What this episode covers

Mike Drues of Vascular Sciences, joined by host Jon Speer of Greenlight Guru, explains that a regulatory strategy is a dynamic communication tool, not merely a pathway like 510(k) or De Novo. Drues details the components of a Regulatory Strategy Executive Summary, including device description, labeling matrix, classification, risk assessment, and potential pathways, emphasizing its use in investor pitch decks and internal stakeholder buy-in. The discussion highlights the importance of bringing regulatory experts in early to avoid costly design changes and demonstrates how to balance short-term speed with long-term strategic goals using a 'future features list.'

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Vascular Sciences
Also
FDA, 510 K, De Novo, PMA, HDE

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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.

    Crowdfunding & preordersValidation & product-market fit
    8 chapters

  • Being an Engineer · 51m

    S1E13 A Holistic View on Product Development | Devon Campbell

    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.

    Starting a product companyCareers & education
    7 chapters

  • Let's Combinate · 1h 19m

    031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

    Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

    Certification & complianceQuality & yield
    11 chapters

  • Let's Combinate · 1h 10m

    165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

    Marta New, CEO of Radyus Research, explains the anatomy of a Target Product Profile (TPP), a strategic document that aligns clinical, regulatory, and commercial goals early in drug development. She details the 10 critical sections of a TPP, including target indication, efficacy benchmarks, safety/toxicology thresholds, and go/no-go criteria, emphasizing that it serves as a roadmap from discovery to development. New highlights how integrating these elements early prevents costly failures and ensures that manufacturing, quality, and regulatory strategies are aligned with the final product's label.

    Validation & product-market fitQuality & yield
    9 chapters

  • Let's Combinate · 1h 23m

    022 - "What Chapter are you in?" with Susan Neadle

    Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen and Johnson & Johnson, discusses the regulatory and engineering challenges of combination products. She details the implementation of 21 CFR Part 4, the importance of harmonizing terminology between drug and device sectors, and her work with standards bodies like ASTM and AAMI on TIR 48 and TIR 105. Neadle explains her strategic planning frameworks, including the Merlin Exercise and Design to Value, to navigate complex quality systems and global regulatory differences.

    Certification & complianceLeadership, teams & culture
    8 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.