United States 
Nancy Van will be presenting the following session
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keyboard_arrow_downNancy Van Schooenderwoert / Brian Shoemaker - Agile Successes in Regulated Medical Development
Nancy Van SchooenderwoertPresidentLean-Agile Partners.com
Brian ShoemakerPrincipal ConsultantShoeBar Associatesschedule 1 year ago
45 Mins
Case Study
Executive
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! -
1. What got you started/interested in modern software development methods?
I started my electronics & software engineering career in the 1980's and saw directly the many problems of the waterfall process. Within a few years I was using shorter feedback loops where I could but without the Agile vocabulary around it. The Navy halted our flight simulator contract and asked that we focus solely on driving down the alarming number of defects (they'd keep paying the contract). I was put on the cross-functional team that did root cause analysis on the giant pile of bugs. Best education in systems thinking that anyone could ever get!! By mid 1990's I was in a small company that was actively attempting to create an alternative development process as we built embedded systems for hire. What we created had many similarities to Extreme Programming.
2. What do you think is the biggest challenge faced by the software product engineering community today?
The belief that the business structures of yesterday can solve the problems of today and the future. Rewards based on individual performance and heroics completely undermine teams. Even skilled Agile teams.
3. What do you think are the most exciting developments in software product engineering today?
There are many more products now that are "software as a medical device" - they help people manage their medical issues in an individualized way. This kind of product opens the way for usability experts to access data they need, and for engineers to act on very short feedback cycles.
4. Why did you choose the topic(s) you will be speaking about at the conference?
I've always found that truth is stranger than fiction, and when it comes to Agile teams - more inspiring. I co-authored a book that shows case studies of real teams in real companies right now. They worked from first principles of Agile and Lean and Systems Thinking, and achieved surprising benefits. Of course there are setbacks too - and how those were handled is something to learn from also. My co-author Brian Shoemaker and I will share some stories from a couple of our case studies. More info about the case studies is here.
5. What are some of the key takeaways from your session(s) at Agile India?
- Understand how Agile can fit into a strict regulated environment
- A more disciplined approach to Agile methods works with the spirit of Agile and with regulatory needs
- In each case study solutions were figured out within the group which fit superbly to their own needs
- Any company can do this by applying first principles from Agile / Lean / Systems thinking
6. Which sessions are you particularly looking forward to attending at Agile India this year?
Quite a few sessions look very interesting to me!
Dr. Denis Bauer - Digital Disruption in health and medical research
Matthew Hodgson / Mia Horrigan - Measuring agility: Data analytics from psychology to grow your teams agility at scale
Ward Cunningham - Creativity Before and After Agile
Deepa Bachu / Kavitha Appaya - Empathetically Define and Rigorously Measure the Customer Value you Deliver
Scott Ambler - Data Technical Debt: Looking Beyond Code
Ryan Singer - Shaping the Work: Assigning Whole Projects, not Tasks
Pramod Varma - Building for a Billion: Aadhaar and India Stack Experience
Ellen Grove - Drawing Together (even when we're apart): Visual thinking for distributed teams
7. Any personal remarks/message you want to share with the software community?
I'm excited to participate in Agile India this year! Looking forward to the exchange of ideas. I want to say thanks to all the volunteers who've built the website, recruited sessions, and made us all feel welcome. It's a lot of work and you've done a beautiful job.
