It’s been 10 years since AAMI published TIR:45 2012, “Guidance On The Use Of AGILE Practices In The Development Of Medical Device Software.” Over the last decade, Orthogonal and its colleagues have taken part in the broad Agile transformation of medical device software, particularly related to the development of Software as a Medical Device (SaMD) and connected medical devices.
Our industry has learned a tremendous amount about the best (and worst) practices for accelerating the development of medical device software using Agile, Lean and other iterative product and software development methods. Now we’re ready to innovate with these methods even further – to move faster while breaking nothing.
Orthogonal is marking the 10th anniversary of TIR:45 by hosting a series of events and conversations. In the second half of 2022, we will bring together industry leaders to share cutting-edge insights, so collectively we can improve patient outcomes and drive business results.
Please join us virtually on June 22nd from 12:00 to 12:40 PM EDT for a short but insight-packed kick-off conversation with two of the most sophisticated practitioners of Agile SaMD development:
Michael Iglesias, who has worked on SaMD at a number of world-class MedTech firms (J&J, Eli Lilly, Novo Nordisk, and Philips) before joining Roche as a Global Advisor on Digital Health Quality & Compliance. Prior to working in SaMD, Michael was on the team at Apple developing the very first iPhone.
Larkin Lowery, who most recently worked at Tandem Diabetes Care as a Senior Director for Software Engineering. He implements Agile best practices learned over 20+ years from building high-performance software engineering teams and products for two other critical infrastructure industries: telecommunications and automotive.