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#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech

·17 min·1 clip

Ashkan Rasooli reveals his manifesto to take the BS out of medical device quality management systems.

The episode features an interview with Ashkan Rasooli at the LSI conference in California, focusing on practical QMS strategies for medtech. Rasooli begins by stating his manifesto to remove burdensome aspects from QMS, framing it as a powerful project management tool. He describes a phased product development process: phase zero (feasibility), phase one (planning), phase two (design execution), phase three (verification), phase four (validation), phase five (design transfer and regulatory clearance), and phase six (post-market). Rasooli argues that QMS should be implemented one phase ahead to support upcoming needs, not retroactively. The host interjects with an analogy comparing protocols to simple instructions, making QMS concepts more relatable. Rasooli explains that early feasibility phases benefit least from formal QMS controls due to rapid iteration, suggesting instead to build a quality culture focused on patient safety. He details that QMS becomes more formal in planning phases, where companies should define quality policies and manuals. Rasooli identifies two enforcement points driving QMS adoption: regulatory bodies like the FDA and investor due diligence, noting that startups often postpone QMS, leading to inefficient retrofitting. He advises preparing procedures for each subsequent phase, such as risk management for design or clinical procedures for validation. The episode concludes with Rasooli recommending startups start small with QMS to avoid it becoming a burdensome milestone, emphasizing gradual integration over time.

As heard by us

Why quality controls make more sense as objectives firm up, and why small monthly upkeep matters before it becomes a major milestone.

Quality management does not have to mean following procedures for their own sake. Ashkan Rasooli draws a useful line between compliance and understanding what each process is meant to achieve.

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Why you'd press play

You want a QMS that adds useful structure without treating every stage of device development the same.

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