lean

Adding Lean Product Development to Your Medical Devices


Client Issue: “Our product development process is very sequential. We don’t run things in parallel, so projects take forever. We know software is allowed to use Agile methods, and we would like to use lean techniques for our non-software products, but the regulations and guidance documents from the FDA describe waterfall methods.”

Solution: The FDA does NOT expect you to use a waterfall approach. In the guidance document, “Design Control Guidance for Medical Device Manufacturers”, the FDA clearly indicates it uses waterfall because it is simpler to explain, but understands product development is iterative and concurrent development is normal.

We work with your team to implement lean product development processes by first identifying areas of waste in the process, designing and implementing lean solutions. Many of these ideas can be introduced without affecting your design control process.

Post: 7 Steps to Integrate Medical Device and Lean Product Development

Post: Regulatory Requirements Do Not Prevent Integration of Lean and Agile Methods into Medical Device Product Development

Webinar: Lean and Agile in Medical Device Product Development

Course: Lean Product Development

For more information, contact
Mary Drotar, Partner
Strategy 2 Market, Inc.
[email protected]
312-212-3144
or complete this contact form
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