Thoughts on Agile in Healthcare


As noted in my previous blog post, I attended and presented at the INCOSE Conference on Agile in Healthcare last month. Here is my presentation. It was great to hear perspectives on being agile in healthcare product development, and discussing best practices with many thought leaders from major medical device manufacturers. I picked up two ideas that I’d like to investigate further and integrate into CMD’s processes as it makes sense.

First was the concept of agile practices in hardware development. While I don’t think a full-on scrum methodology makes sense for hardware (though it can be done with modified sprint cycles), I do appreciate the simplicity of a kanban-style backlog and project management process. In addition to kanban, I received some great insight on how to better integrate software and hardware development into sprint cycles.

Second, I’d like to investigate the SAFe agile framework further (P.S.: not an endorsement of SAFe). SAFe extends agile methodologies to the project and enterprise levels. A couple of medical device manufacturers with highly mature product development processes are using SAFe (or customized versions of it). It requires a good bit of tailoring to fit within a Quality Management System, but if done well, I think it has great potential for developing and maintaining a streamlined portfolio of safe and effective products.

Agile Product Development Presentation

Many medical device manufacturers and developers (including us) use agile principles to develop medical devices. Done properly, medical devices can be developed more efficiently while still meeting guidance, standards, and regulations. Unfortunately, many companies don’t do enough to ensure design controls are appropriately implemented when using agile during product development… whether it’s just for software, or the entire product development process. At the INCOSE Conference on Agile Systems in Healthcare on May 23 and 24, we’ll be presenting our direct experience with the FDA and medical device manufacturers. What does an inspector think of agile? How have medical device companies done it right (and wrong)? We’ll answer questions like this and have an open discussion on efficient, real-world implementation of agile in healthcare. Join us!