254 - Saying No Is the Easy Part of Quality

Let's Combinate · 13 Sept 2026 · 12m

What this episode covers

Subhi Saadeh, founder of Let’s Combinate, outlines four scenarios where quality professionals must firmly say no, including real patient risk, insufficient evidence, requirement violations, and schedule pressure. He contrasts these with three weak reasons for saying no, such as personal preference, technical uncertainty, and applying excessive GMP rigor to early-stage development. Saadeh advocates for a flexible quality culture that distinguishes between rigid compliance and risk-based decision-making, using a drug delivery platform case study to illustrate evidence-based stops.

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 27m

    Past, Present, Future State (and World) of Quality in the Medical Device Industry

    Mark Alpert, Director of Quality at Greenlight Guru, discusses the current state of quality in the medical device industry with host Jon Speer. Alpert argues that complexity in quality systems guarantees mistakes and that companies have lost their way by focusing on compliance rather than continuous improvement. He advocates for a 'do versus don't do' mindset during audits to preserve creativity and simplify processes, noting that the industry is currently struggling with the transition to EU MDR and IVDR regulations.

  • Global Medical Device Podcast · 53m

    Guerilla Tactics for Quality Leadership

    Steve Gompertz, founder of QRx Partners, discusses implementing lean Quality Management Systems (QMS) and 'guerilla tactics' for quality leadership in the medical device industry. He argues that regulations are intentionally vague to allow for interpretation, advising companies to focus on the intent of requirements rather than just compliance. Gompertz advocates for 'lean documentation,' such as reducing 45-page quality manuals to single-page summaries, and using metrics that measure process effectiveness rather than just speed. He also shares strategies for influencing organizational culture without formal authority, such as 'hiding vegetables' by embedding best practices into existing workflows.

  • Global Medical Device Podcast · 37m

    #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

    Ashkon Rasooli, a quality and regulatory expert, joins host Etienne Nichols to outline four core principles for building an effective, non-burdensome Quality Management System (QMS) for medical device companies. Rasooli argues for 'Quality over Proceduralism,' 'Culture over Mandate,' 'Redundancy over Duplication,' and 'Conciseness over Verbosity' to ensure the QMS serves the business rather than just acting as a compliance checkbox. He advises new founders to engage quality and regulatory advisors early in the design phase to optimize architecture and avoid costly retrospective documentation. The discussion also covers the strategic decision of whether to treat quality as a minimum regulatory hurdle or a key business differentiator.

  • 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 · 31m

    Knowing vs. Doing as Medical Device Professionals

    John Kapitan, CEO of Kapstone Medical, joins host John Speer to discuss the gap between knowing and doing in medical device quality systems. Kapitan categorizes professionals into three buckets: the ignorant, the antagonistic, and the apathetic, arguing that quality is a mindset rather than just a compliance burden. He warns that pre-revenue startups often neglect quality documentation, which can severely damage valuation during M&A due diligence by strategic acquirers. Kapitan advocates for a pragmatic, modular approach to building quality systems, cautioning against over-engineering processes for small companies.

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.