Hardware Podcasts

014A - "The First P: Product" with Larry Mager

Let's Combinate · 5 Jan 2022 · 1h 12m

What this episode covers

Larry Mager, Principal and Founder at Mgmt-Ctrl, explains the 'Product' phase of his Predictive Quality Management (PQM) framework, arguing that companies must first ensure their marketed devices are safe and effective before remediating broader quality systems. He details how to use post-market surveillance data, specifically FDA MAUDE and upcoming EU EUDAMED databases, to identify safety signals and compare them against competitive products to establish the 'State of the Art' (SOTA) benefit of patient safety. Mager describes a workflow where statistical analytics identify concerning product groups, triggering post-market risk assessments and CAPAs to improve risk control measures, thereby aligning the product with regulatory expectations and preventing recalls.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Mgmt-Ctrl, FDA
Also
MAUDE, EUDAMED, ISO 14971, EU MDR

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 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

  • Global Medical Device Podcast · 50m

    #410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures

    Regulatory expert Mike Drues joins host Etienne Nichols to critique the FDA’s MAUDE database, arguing that widespread late reporting and poor data hygiene undermine its safety mission. Drues highlights that nearly 30% of reports are late, with major manufacturers like Medtronic, Becton Dickinson, and Dexcom accounting for a disproportionate share of violations. The discussion covers the legal risks of non-compliance, the misuse of MAUDE data for competitive analysis, and recommendations for modernizing the system with AI-driven cross-referencing and tiered reporting urgency.

    Quality & yieldCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 18m

    #458: What the FDA Actually Says About AI in Medical Devices

    Etienne Nichols explains how the FDA's adoption of its internal AI tool, Elsa, signals that AI in medical devices is a regulated reality requiring strict adherence to new standards. He argues that companies should view AI like electricity, focusing on building a robust Quality Management System (QMS) rather than marketing the technology itself. Nichols details the regulatory distinctions between locked and adaptive algorithms, emphasizing the critical role of Predetermined Change Control Plans (PCCPs) and post-market surveillance for AI-based Software as a Medical Device (SaMD).

    AI & machine learningCertification & compliance
    1 chapters

  • Global Medical Device Podcast · 36m

    How does EU MDR impact your Quality Management System?

    Monir El Azzouzi, founder and CEO of Easy Medical Device, explains how the EU MDR impacts quality management systems (QMS) for medical device manufacturers. He details the specific procedural changes required by Article 10.9, the critical differences between ISO 13485 and EU MDR, and the necessity of proactive post-market surveillance. El Azzouzi also warns against relying on unaccredited certification bodies and discusses the logistical challenges of notified body audits during the pandemic.

    Certification & complianceQuality & yield
    6 chapters

  • Global Medical Device Podcast · 1h 03m

    #422: ISO 14971 and the Road to Risk Management with Edwin Bills

    Edwin Bills, a lead expert in medical device risk management and key contributor to ISO 14971, explains how his background as a submariner and manufacturing quality engineer informs his approach to patient safety and cost of quality. He details the critical link between manufacturing process capability (CPK), supplier quality, and financial risk, arguing that quality failures directly impact a company's bottom line and reputation. Bills critiques common industry practices, such as late-stage FMEA and manual spreadsheet-based traceability, advocating for early hazard analysis, industrial statistics, and integrated software solutions to manage complex risks in medical devices and combination products.

    Quality & yieldCertification & compliance
    10 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.