#359: Project Management in MedTech

Global Medical Device Podcast · 4 Apr 2024 · 1h 02m · Episode 359

What this episode covers

Perry Parendo, founder of Perry Solutions, discusses project management strategies for MedTech, drawing on his background in defense and automotive industries. He advocates for blending methodologies like Agile, Waterfall, and Toyota’s set-based design rather than adhering to rigid frameworks. Parendo emphasizes the critical use of Monte Carlo simulations to manage technical, schedule, and cost risks, arguing that MedTech companies often neglect project risk in favor of compliance. He also highlights the importance of leadership, understanding team motivations, and focusing on incremental improvements to drive successful product development.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: Greenlight Guru, Perry Solutions, General Motors, Boeing, Toyota
Tools: Minitab, Crystal Ball, Microsoft Project
Also: ISO 14971, FDA, Design News

Other shows on the same ground, closest first.

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Being an Engineer6 Feb 2026 · 42m
S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA
Bob Hankins, Director of Engineered Component Development at TE Connectivity, discusses leading global engineering teams in the regulated medical device space, focusing on complex components like catheters and structural heart devices. He shares lessons from his early career at a startup ventilator company, where recalls and FDA interactions taught him the critical value of PFMEA, DFMEA, and rigorous risk-based design processes. Hankins emphasizes the importance of balancing innovation with manufacturing rigor, advocating for a leadership style that empowers engineers through clear guardrails while maintaining strict compliance with ISO 13485 and FDA requirements.
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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.

#359: Project Management in MedTech

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

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

S2E31 How to Lead Engineers & Engineering Managers – Chris McKenzie

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

111 - 7 Books to level up for MedTech, BioTech and Combination Product Professionals with Subhi Saadeh

S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA