029 - "Purpose" with Marla Phillips

Let's Combinate · 20 Apr 2022 · 1h 34m

What this episode covers

Marla Phillips, President and CEO of Pathway for Patient Health, discusses her initiative to educate science students on quality culture and supply chain integrity before they enter the industry. She details the history of Xavier Health, where she co-led FDA collaborations on the Case for Quality and Good Supply Practices (GSP) initiatives, and explains how these programs evolved into the Supply by Design framework. Phillips also describes the transition of Xavier Health’s conferences to AFDO and RAPS, ensuring the continuation of industry-regulator dialogue on combination products and AI.

Mentioned

Companies
Pathway for Patient Health, Xavier Health, Merck, Proctor and Gamble, Eli Lilly, AstraZeneca
Also
FDA, USP, AFDO, RAPS

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 36m

    FDA is Expanding its Case for Quality Program... Should Your Company Participate?

    Mike Drues of Vascular Sciences and John Spear of Greenlight Guru discuss the FDA's expansion of the Case for Quality initiative, a pilot program involving the CMMI Institute and MDIC that shifts focus from mere compliance to true product quality. They analyze the benefits for participating companies, such as exemption from routine inspections and expedited PMA supplement reviews, while debating whether the program's inclusion of non-compliant companies constitutes helpful guidance or inappropriate micromanagement. The conversation highlights the tension between regulatory hurdles and the need for continuous improvement in medical device manufacturing.

  • 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.

  • 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.

  • Being an Engineer · 51m

    S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

    Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He details the evolution of regulatory frameworks, noting the shift toward stricter EU standards and the integration of AI and cybersecurity into device compliance. Gompertz emphasizes tailoring quality systems to company size, using a case study of a client who reduced FDA findings from dozens to zero by implementing a holistic, process-connected system rather than a checklist approach. He also advocates for concurrent engineering and cross-functional teams to accelerate development while maintaining rigorous safety standards.

  • The Builder Circle · 1h 01m

    S2 E8: Quality Engineering and Strategy for Hardware with Matt Lipsitz

    Matt Lipsitz, Head of Quality at Formlabs, explains that quality is a culture of managing risk to meet customer expectations, starting with Failure Modes and Effects Analysis (FMEA) in the design phase. He details how startups can build a low-touch quality infrastructure by defining clear specifications, validating them through testing, and implementing proactive control points in the supply chain to catch defects before they reach the field. Lipsitz emphasizes that successful quality requires deep knowledge transfer, often involving on-site supplier partnerships, and treating every downstream partner as a customer to ensure alignment on critical-to-quality metrics.

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.