Hardware Podcasts

#327 Understanding the ROI of an eQMS

Global Medical Device Podcast · 11 Jul 2023 · 51m · Episode 327

What this episode covers

Fran Cruz, Chief Customer Officer at Greenlight Guru, discusses the return on investment (ROI) of implementing a purpose-built electronic Quality Management System (eQMS) for medical device companies. She highlights findings from a third-party study by Hobson & CO, which revealed significant reductions in setup time, full-time employee requirements, and audit preparation time. Cruz explains how Greenlight Guru’s tools, including the ROI Calculator, Guru Assist, and GG Academy, help customers of varying stages—from early-stage startups to established enterprises—demonstrate value to executives and achieve faster time to market. The conversation emphasizes the importance of quantifying efficiency gains to justify software investments in a tight economic climate.

Most relevant to

early-stage companies, companies scaling up and large enterprises

Topics

Mentioned

Companies
Greenlight Guru, Hobson & CO
Products
Guru Assist, GG Academy
Also
ISO 13485, ISO 14971, FDA, 510 K

Related episodes from other shows

Other shows on the same ground, closest first.

  • 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

  • Let's Combinate · 35m

    205 - Why Less Than 20% of Companies Have Started Quality 4.0

    Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap that prioritizes people, process, and technology to move beyond compliance. Mager argues that legacy Electronic Quality Management Systems (EQMS) fail because they are pre-programmed, whereas modern solutions use 'digital twins' to model workflows and ensure digital continuity. He emphasizes that successful implementation requires a strategic roadmap, cultural change, and management control rather than just installing software.

    Quality & yieldFactory operations & automation
    6 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

  • Let's Combinate · 13m

    215 - Why Aren’t Technical People Leading Drug-Device Audits?

    Subhi Saadeh, Founder of Let’s Combinate BioWorks, explains why engineers in pharma and medical devices should become auditors, arguing that technical expertise combined with audit methodology creates the most effective auditors. He details how auditing provides a system-level perspective, revealing how design decisions ripple through Quality Management Systems (QMS) and identifying systemic root causes that isolated engineering work often misses. Saadeh addresses common misconceptions, such as the view that auditing is merely bureaucratic paperwork, and reframes it as a critical tool for building regulatory fluency and career versatility across industries like aerospace and medical devices. He concludes with practical steps for engineers to enter the field, including shadowing internal audits, learning audit frameworks like ISO 13485, and seeking mentorship from experienced professionals.

    Quality & yieldCareers & education
    1 chapters

  • Let's Combinate · 9m

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 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.