#434: ICYMI (In Case You Missed It!) Project Management In Medtech

Global Medical Device Podcast · 24 Nov 2025 · 1h 02m · Episode 434

What this episode covers

Perry Parendo, founder of Perry Solutions, discusses project management challenges in MedTech, drawing on his background in defense and automotive industries. He advocates for using Monte Carlo simulations to manage technical, schedule, and cost risks, arguing that companies often fail by focusing solely on compliance rather than project execution. Parendo emphasizes that successful development requires balancing agile and traditional methodologies, managing team motivation, and making data-driven decisions to avoid 'gold plating' and delays.

Other shows on the same ground, closest first.

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    184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

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  • Let's Combinate · 35m

    126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd

    Mat Stratton, Founder of Coalition Ltd, discusses his 20-year career in MedTech and combination products, highlighting his early work with Intel CEO Andy Grove on deep brain stimulation and drug delivery systems. He explains how the high-speed culture of Intel, driven by Grove's Parkinson's disease advocacy, contrasted with the slow 4-10 year cycles of medical device development. Stratton identifies 'multifunctional collaboration' and employee turnover as key bottlenecks, proposing solutions like 'two-pizza teams' and regulatory stewardship to accelerate progress in highly regulated industries.

  • Let's Combinate · 32m

    202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin

    Joey Frechin, a Senior Technical Program Manager in med tech consulting, explains the complexities of aligning risk assessments for combination products, noting that while drug and device teams are starting to integrate their processes, significant methodological gaps remain. He details the P1/P2 probability scoring methodology used in ISO 14971 to distinguish between device failure and patient harm, and shares his career strategy of becoming an expert in 'unwanted' but high-value tasks like DFMEA and PFMEA to bridge engineering and quality teams. Frechin also discusses current industry trends, where companies often pivot from complex bespoke designs to simplified or off-the-shelf subsystems to meet clinical trial timelines, highlighting the critical importance of early sterilization and accelerated aging testing to avoid late-stage failures.

  • Being an Engineer · 48m

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    Chris McKenzie, a mechanical engineer with a career in medical devices including roles at Richard Allen Medical and Eli Lilly, discusses leading engineering teams and managing product development. He contrasts early automotive manufacturing with modern medical device rigor, highlighting the transition from 2D drawings to 3D modeling using Pro/ENGINEER and SolidWorks. McKenzie emphasizes the importance of critical thinking, PMP-structured project management, and mentoring engineers through questions like 'What do you think?' to foster engagement and solve complex electromechanical challenges.

  • Let's Combinate · 1h 12m

    024 - "Operating Under Constraints "with Naveen Agarwal

    Naveen Agarwal, a PhD polymer scientist and quality management consultant at Creative Analytics Solutions, discusses operating under constraints, drawing parallels between his 1,500-mile running challenge and risk management in medical devices. He explains the distinction between post-market vigilance and surveillance, advocating for a customer-experience-focused approach to quality improvement that goes beyond regulatory compliance. Agarwal introduces the SNIP framework (Strength, New, Importance, Preventable) for data-based decision-making in post-market surveillance and argues that safety performance should drive innovation and reimbursement rather than just meeting baseline safety standards.

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