Project Management in MedTech

April 4, 2024


This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector.

Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.

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Key Timestamps

  • 00:00:15 - Introduction of Perry Parendo and the episode's focus
  • 00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles
  • 00:12:20 - Agile methodologies vs. traditional project management in MedTech
  • 00:22:35 - The importance of risk management and Monte Carlo simulation in project planning
  • 00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities
  • 00:45:55 - Strategies for efficient and effective product development processes

Key Takeaways

  1. The convergence of agile and traditional methodologies tailored to MedTech's unique demands.
  2. The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.
  3. A call for innovation that transcends regulatory compliance to genuinely benefit patient care.


Memorable quotes:

  • "We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo
  • "There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry Parendo

Practical Tips for Listeners:

  1. Adopt a flexible approach to project management by integrating various methodologies based on project needs.
  2. Prioritize risk management early in the development process to foresee and mitigate potential challenges.
  3. Always align product development objectives with the ultimate goal of improving patient outcomes.


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at


This episode is brought to you by Greenlight Guru, the only quality management system (QMS) and electronic data capture (EDC) software designed specifically for the medical device industry. Make your product development process smoother, faster, and compliant with Greenlight Guru. Discover the difference at

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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