Brian will be presenting the following session
  • Nancy Van Schooenderwoert

    Nancy Van Schooenderwoert / Brian Shoemaker - Agile Successes in Regulated Medical Development

    45 Mins
    Case Study

    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   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?

My experience in testing embedded instrument software for clinical diagnostics convinced me that there had to be a better way.

2. What do you think is the biggest challenge faced by the software product engineering community today?

The constant push to do more with fewer people, along with expectations of higher product quality.

3. What do you think are the most exciting developments in software product engineering today?

The advent of sophisticated tools for requirements management, traceability, and test definition.

4. Why did you choose the topic(s) you will be speaking about at the conference?

My colleague and I spent time collecting examples in which companies successfully employ Agile methods for regulated medical work - and we wanted to share some of our observations.

5. What are some of the key takeaways from your session(s) at Agile India?

Successful Agile implementation must involve BOTH clear understanding of underlying principles (from Agile, Lean, and systems thinking) and in-depth comprehension of the company's own situation.

6. Which sessions are you particularly looking forward to attending at Agile India this year?

Dr. Denis Bauer - Digital Disruption in health and medical research
Aino Corry - Team Meetings That Don't Suck - Avoid Retrospectives Antipatterns
Ellen Grove - Drawing Together (even when we're apart): Visual thinking for distributed teams
Alberta Soranzo / Martina Hodges-Schell - The remote leader – distant but not removed
Dave Dame - Product Innovation is on the Edge

7. Any personal remarks/message you want to share with the software community?

Please remember that risk management can be a live-or-die consideration - not just a concern for whether a project succeeds. Medical devices and aviation / transportation give us the clearest reasons to approach risk management this way!