Hardware Podcasts

014C - "The Final P: People" with Larry Mager

Let's Combinate · 5 Jan 2022 · 49m

What this episode covers

Larry Mager, Principal and Founder of Mgmt-Ctrl, discusses the 'People' pillar of his Predictive Quality Management (PQM) framework for medical device companies. He argues that achieving a strong culture of quality requires ensuring personnel are skilled, trained, and proven competent, rather than just checking boxes. Mager illustrates how leadership must foster communication, trust, and personal accountability to move beyond mere compliance, citing a successful turnaround at a large organization that resolved a corporate warning letter by engaging employees directly.

Most relevant to

established companies

Topics

Mentioned

Companies
Mgmt-Ctrl, Toyota
Also
FDA, MDIC

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 45m

    Building a Culture of Quality

    Dan Purvis, CEO and co-founder of Velentium, discusses building a quality-centric culture in medical device engineering that moves beyond mere regulatory compliance. He outlines a 'three-legged stool' model integrating people, business, and quality, emphasizing that true quality aligns with risk and safety rather than just adherence to standards. Purvis shares insights on hiring for teachability, fostering high-performance teams, and the importance of proactive preventive actions in quality management systems.

    Leadership, teams & cultureQuality & yield
    9 chapters

  • Global Medical Device Podcast · 50m

    #352: Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former quality leader at Medtronic, Boston Scientific, and Johnson & Johnson, discusses the strategic role of quality and regulatory professionals in the medical device industry. She emphasizes that effective quality management requires strong project management skills, proactive stakeholder influence, and a deep understanding of human factors to prevent post-market failures. Mascioli-Tudor also advocates for building a culture of psychological safety and continuous improvement, arguing that quality teams must act as business partners rather than just compliance police.

    Leadership, teams & cultureValidation & product-market fit
    7 chapters

  • Global Medical Device Podcast · 42m

    #324 Management Responsibility: The most important part of a QMS

    Sara Adams, a Lead Auditor and Quality Engineer at Greenlight Guru, explains the critical role of management responsibility in a medical device Quality Management System (QMS). She details how top management must establish a meaningful quality policy, provide adequate resources, and conduct rigorous management reviews to ensure regulatory compliance and a culture of quality. Adams emphasizes that without active executive buy-in and cross-functional engagement, even well-documented systems fail to protect patients or satisfy auditors.

    Certification & complianceLeadership, teams & culture
    5 chapters

  • Global Medical Device Podcast · 50m

    #440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory

    Jennifer Mascioli-Tudor, CEO of JMT Compliance Consulting and former VP of Quality at Medtronic and Boston Scientific, discusses the evolution of quality and regulatory roles in the medical device industry. She emphasizes that quality professionals must act as strategic influencers and project managers, using storytelling to connect compliance requirements with business outcomes like cost of poor quality. The conversation covers the importance of human factors in design, the nuanced concept of 'design freeze', and the necessity of proactive quality management to ensure patient safety and regulatory agility.

    Leadership, teams & cultureMedical & health devices
    5 chapters

  • Being an Engineer · 57m

    S7E7 Mike Romance | Industry 4.0, Production Transfers, & People-Centric Leadership

    Mike Romance, an operations and quality leader with experience at Quantum-Si, Illumina, and Dexcom, discusses scaling life sciences manufacturing from early development to high-volume production. He emphasizes the importance of proactive Design for Manufacturing (DFM) and Quality by Design (QbD) to avoid costly reactive fixes, using a modular-to-fixed architecture trade-off at Quantum-Si as a key example. Romance also advocates for 'Industry X.0' (Industry 4.0) focused on actionable data for predictive maintenance and decision-making, rather than just dashboards. Finally, he highlights 'people-centric leadership' and emotional intelligence as critical for retaining tribal knowledge and building resilient teams during scaling.

    Scaling productionLeadership, teams & culture
    9 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.