Recent stories of Agile application in the regulated medical industry show how first principles (from Agile, from Lean, and from systems thinking) led to solutions that served the individual company exquisitely well, and were compliant with regulatory needs (whether in Europe, the U.S., or elsewhere in the world).

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What is the hardest part of applying Agile methods to Medical development?

Brian and I were asked this question in connection with our new book “Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies”. I give two answers to that question…
 
There are “twin” hardest problems - first the misconception that Agile must be taking unacceptable shortcuts to be so effective. Second, once they’ve decided that’s not the case there is a strong misconception that Agile can be ‘installed’ by tick-box actions like buying a tool or a methodology. That second misconception is what our new book addresses, and will be the topic of our talk at Agile India 2021.

We wrote the book to help more people see positive, creative, successful implementations of Agile principles in the demanding environment of medical device development. Why successes and not failures? Attractors are stronger than repellers. People naturally want to emulate what they see working well for others, especially when those others are in similar roles to their own. 
 
But emulate is not the same as “copy” especially where complexity is involved. “In complexity you don’t copy an outcome, you replicate the starting conditions.” said Dave Snowden in a recent blog post https://www.cognitive-edge.com/siphonophorae-not-hybrid-2-of-2/   This point needs some explanation - and that is what our new book attempts to do. People in our case studies worked from their understanding of the key principles underlying Agile, Lean and systems thinking to take a fresh look at their situation. By starting from first principles and their own deep knowledge of their products, people, and markets they achieved results any consultant would be proud to match.
 
Did you know that if your software is designed and built without using a Quality Management System correctly, then the regulators can refuse to give permission to market it? That happened to one company and they ended up having an Agile company re-develop their software.
 
Did you know that your SOPs (standard operating procedures) should not be overly prescriptive. If they are they impede the flexibility that your Agile teams need. There is a sweet spot that you can achieve using BDD!
 
Did you know that an Agile company can move into doing medical device work without first getting certifications such as IEC62304 and ISO13485? It’s true. Simply by having a well-disciplined Agile Quality Management System, they attracted contracts to develop software for large medical device companies.
 
Want to know more? Come to our session!