SXSW Panel Picker slide show for Agile Development and the FDA Developing software for the healthcare sector is difficult enough, but doing so under the scrutiny of the FDA can seem impossible. However, if you want to have an impact at the point of patient care the FDA is going to be a factor in your development. We will look at ways to marry the seemingly contradictory philosophies of Agile development, with its high efficiency, low documentation process, with the FDA regulated requirements of complete audibility and seemingly endless piles of paperwork. Through a real-life case study we will looks at modern software development practices through the lens of the FDA.

1. 2015
© Decisio Health, Inc. 2015

2. © Decisio Health, Inc. 2015
Actionable Information for
Improved Outcomes SM

3. Decisio Health featured at FDA workshop May 10, 2015
© Decisio Health, Inc. 2015
“Your FDA clearance was
featured as the paving path in
regulation of clinical decision
support tools in the U.S. The
[FDA] regulatory attorney who
was presenting on this topic
explained that your clearance
reflects FDA’s thinking
regarding the regulation for
these software tools.”
-- Anna Libman
Manager Regulatory Affairs
Experien Group

4. Value Statement
Decisio Health provides an FDA cleared class II medical device that displays
real-time actionable information with the goal of increasing clinical guideline
adherence, which has been shown to improve clinical outcomes and reduce
hospital costs.
© Decisio Health, Inc. 2015

5. © Decisio Health, Inc. 2015
Case study for Agile development of FDA regulated software
• In January 2015 Decisio Health became the first 100% Web-native software
to receive FDA clearance
• There is still little guidance from the FDA in terms of what software
requires FDA clearance/approval
• Our software was developed over several years utilizing Agile development
practices while also maintaining FDA required quality controls and
documentation
• Despite seemingly contradictory requirements, Agile practices can be
utilized while creating FDA regulated software

6. Running in the ED
© Decisio Health, Inc. 2015

7. Running in a patient room
© Decisio Health, Inc. 2015

8. © Decisio Health, Inc. 2015
Clinical decision support customized to the facility’s protocols

9. © Decisio Health, Inc. 2015
Deliver clinical information across all hardware platforms
iPhone™, Android™ Android Tablet™, iPad™
PC/Nursing Station
Wall mount at Bedside

10. © Decisio Health, Inc. 2015
Actionable Information for
Improved Outcomes SM