Hardware Podcasts

Understanding the Value of a Medical Device Guru

Global Medical Device Podcast · 26 May 2021 · 32m · Episode 208

What this episode covers

Tom Rish, Senior Medical Device Guru and manager of the Guru team at Greenlight Guru, explains how the company provides mentorship and regulatory support to medical device companies beyond its QMS software. He discusses the 'Guru Edge,' emphasizing a phased 'build as you go' approach to quality systems to help startups launch products and pass audits without being overwhelmed by paperwork. Rish highlights industry trends including the rise of wearables, software as a medical device (SaMD), and the impact of EU MDR and IVDR regulations on In Vitro Diagnostics (IVD).

Most relevant to

early-stage companies and companies scaling up

Topics

Mentioned

Companies
Greenlight Guru
Also
Tom Rish, John Sphere, FDA, ISO, EU MDR, IVDR, NIH, RADx

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 1h 03m

    021 - "Options" with Karandeep Singh Badwal

    Karandeep Singh Badwal, a QA/RA consultant and host of The MedTech Podcast, explains how defining 'intended use' determines whether a product is a regulated medical device or unregulated software, a critical distinction for startups. He details the specific regulatory challenges of Software as a Medical Device (SaMD), including cybersecurity, GDPR compliance, and the impact of the EU MDR on software classification. Badwal also discusses the strategic advantages for UK software companies post-Brexit, where they can still self-certify as Class 1 devices while EU counterparts face stricter notified body audits.

    Validation & product-market fitQuality & yield
    9 chapters

  • 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.

    Medical & health devicesQuality & yield
    10 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

  • Being an Engineer · 51m

    S6E19 Stuart Grant | MedTech Innovation

    Dr. Stuart Grant, founder of Archetype MedTech, discusses his 25-year career at Johnson & Johnson and DePuy Synthes before launching his consultancy to help startups navigate medical device development. He details the challenges of securing funding, managing regulatory differences between the EU's MDR and the US FDA, and the strategic importance of narrow clinical indications. Grant also explores future trends in surgical robotics and AI, emphasizing the need for modular platforms and the value of accumulated engineering knowledge.

    Starting a product companyMedical & health devices
    11 chapters

  • Let's Combinate · 1h 29m

    015 - "Would You Use it on a Family Member?" with Monir El Azzouzi

    Monir El Azzouzi of Easy Medical Device explains the transition from the EU Medical Device Directive (MDD) to the Medical Device Regulation (MDR), highlighting the shift from self-certification to notified body oversight and the impact on private labeling. He details the structural differences between US FDA pathways (510k, PMA) and EU classification rules, noting that MDR requires full technical files for brand owners rather than just distributors. El Azzouzi also discusses the role of notified bodies, the conflict of interest preventing them from offering pre-submission guidance, and the importance of the 'would you use it on your family?' mantra in quality assurance.

    Certification & complianceManufacturing partners & offshoring
    9 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.