Hardware Podcasts

Design Assurance: The Unsung Heroes of R&D

Global Medical Device Podcast · 13 Oct 2022 · 48m · Episode 284

What this episode covers

Orla Connaughton, founder of Aztek Medical, explains that Design Assurance (DA) is the quality engineering function of the R&D process, ensuring products meet regulatory requirements through controlled documentation rather than just technical prototypes. She argues that DA professionals must bridge engineering and regulatory needs, managing 'horizontal' standards like ISO 14971 risk management and 'vertical' device-specific standards to create a cohesive story for regulators. Connaughton highlights a current shortage of DA talent, noting that under the EU MDR, companies face hundreds of documentation-related questions per submission, often requiring expensive remediation because initial development lacked proper design controls. She emphasizes that DA 'packs the parachute' for product development, protecting companies from post-market failures and ensuring efficient clearance times.

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Aztek Medical, Green Light Guru
Also
ISO 14971, ISO 14155, ISO 10993, ISO 11607, ISO 13485, 21 CFR 820, EU MDR

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 · 1h 19m

    031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

    Michelle Lott, founder of Lean RAQA, discusses her journey from large manufacturer Baxter Healthcare to consulting for small-to-mid-size medical device companies, highlighting the gap in practical regulatory strategy. She details the 'five stages of regulatory grief' clients experience when facing FDA interactions, contrasting the US 510(k) process with the rigorous, ongoing costs of EU MDR compliance. Lott also explains the nuances of regulations versus guidance documents, the QMSR harmonization, and her unique perspective as an elected industry representative on the FDA Device GMP Advisory Committee.

    Certification & complianceQuality & yield
    11 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

  • EMS@C-LEVEL · 9m

    How Design-First Thinking Supercharges Manufacturing Performance with Clarity Design Founder Tom Lupfer

    Tom Lupfer, President and Founder of Clarity Design, explains how integrating engineering and manufacturing under one roof creates a competitive advantage for his Southern California-based EMS company. He details how data from Ko Young inspection systems (SPI and AOI) and Python-driven automation closes the loop between design intent and production reality, enabling rapid redesigns during the pandemic supply chain crisis. Lupfer also discusses the company's strategic focus on medical devices, leveraging ISO 13485 and FDA registration to serve regulated customers, while emphasizing a hiring philosophy that places engineers directly in front of clients to ensure manufacturability and speed.

    Design for manufacturing & NPIManufacturing partners & offshoring
    6 chapters

  • Let's Combinate · 17m

    217 - 5 Fixable Problems Holding Back Drug–Device Programs

    Subhi Saadeh, founder of Let’s Combinate BioWorks, outlines five critical quality issues in drug-device combination products, drawing on his experience at Pfizer, Gilead, and Baxter. He addresses documentation misalignment in design transfer, late manufacturing input, arbitrary sampling plans, unclear method transfer ownership, and supplier qualification gaps. Saadeh proposes solutions such as integrating pharma change controls with device design plans, embedding DFM/DFA reviews, and adopting PPAP frameworks for component qualification. The episode emphasizes harmonizing drug and device development processes to ensure scalable, compliant, and patient-ready solutions.

    Quality & yieldDesign for manufacturing & NPI
    1 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.