Hardware Podcasts

#378: Who Owns the Design Controls Process?

Global Medical Device Podcast · 8 Aug 2024 · 34m · Episode 378

What this episode covers

Laura Maher, a design assurance professional at Greenlight Guru, discusses the critical role of ownership in medical device design controls with host Etienne Nichols. They explore the concept of a 'design assurance professional' who bridges the gap between product development, quality, and regulatory teams to create clear, audit-ready documentation. The conversation covers the importance of understanding user needs, the collaborative nature of risk management, and the distinction between technical design reviews and broader stage reviews.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Rook Quality Systems, Medtronic, Stryker
Also
ISO 13485, QMSR

Related episodes from other shows

Other shows on the same ground, closest first.

  • Being an Engineer · 52m

    S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons

    Jesseca Lyons, a mechanical engineer and customer success expert at Greenlight Guru, discusses her passion for engineering, particularly in the medical device sector. She explains how she uses precise documentation and design controls to ensure safety and efficacy, drawing on experiences at Beckman Coulter and CRI. Lyons emphasizes the importance of understanding the 'why' behind customer requirements, such as a specific color choice for a device handle, to avoid misinterpretation and ensure the final product meets the intended perception of quality. She also shares insights on design for manufacturability, highlighting the challenges of assembling complex tubing systems and the need for clear, unambiguous instructions to reduce labor costs and errors.

    Industrial & consumer product designDesign for manufacturing & NPI
    10 chapters

  • Let's Combinate · 50m

    014B - "The Second P: Process" with Larry Mager

    Larry Mager, Principal and Founder of Mgmt-Ctrl, explains the 'Process' component of quality management in medical device companies, distinguishing it from a basic Quality Management System (QMS). He outlines a five-step internal control framework: establishing a control environment, implementing risk mitigation, defining control activities, managing information flow, and conducting management review. Mager argues that this structured approach allows organizations to identify constraints and drive continuous improvement rather than just maintaining compliance. The discussion emphasizes that effective process management requires active leadership oversight and clear communication of objectives across all sites.

    Quality & yieldLeadership, teams & culture
    8 chapters

  • Let's Combinate · 58m

    002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager

    Larry Mager, founder of Management Control and author of 'The Quality Journey' and 'Seeing David in the Stone', explains his framework for Predictive Quality Management in the medical device industry. He distinguishes between 'Big Q' (the Quality Management System) and 'Little Q' (everyday quality owned by all employees), arguing that management responsibility is the critical driver of success. Mager emphasizes that organizations must shift from reactive compliance to proactive, predictable quality by focusing on process constraints, adequate resourcing, and post-market feedback loops rather than just design controls.

    Quality & yieldLeadership, teams & culture
    9 chapters

  • Let's Combinate · 21m

    157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura

    Chuck Ventura, founder of Ventura Solutions and CEO of HemoTek, explains why poor design inputs are a primary cause of delayed product development and verification failures in medical device and combination product projects. He advocates for spending 30% of project time on design inputs using concurrent engineering, where systems engineers collaborate with verification teams early to define clear acceptance criteria. Ventura also clarifies the structural relationship between user needs, risk controls, and design inputs, arguing that risk controls should serve as parent requirements to design inputs to ensure traceability and effective risk management.

    Mechanical engineeringQuality & yield
    8 chapters

  • Being an Engineer · 37m

    S1E12 Simplifying Quality Management | Jon Speer

    Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.

    Quality & yieldStarting a product company
    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.