Community Roundtable: SaMD, The Cloud & TINY GVS

Randy Horton

Published on: July 28th, 2022

The cloud is an incredibly powerful tool that can further our goal as Software as a Medical Device (SaMD) developers to improve patient outcomes faster. But it can be a scary place to host medical device software. When we give up control to third-party cloud providers, they can make changes to optimize the environment that they provide to us that could unintentionally compromise parts of our medical device systems.

Orthogonal’s VP of Solutions and Partnerships, Randy Horton, has helped draft the first industry guidance for the responsible hosting of SaMD on the cloud, and coined the concept of “This Is Not Your Grandmother’s Validated State” – aka TINY GVS – which challenges us to redefine the nature of software validation in an increasingly interconnected world.

Randy will be joined by fellow SaMD experts as part of a community roundtable event on Wednesday, August 10th, from 1:00-2:00 PM CDT, hosted by Greenlight Guru. Tune into the discussion on a new set of architectural approaches, best practices, and systems thinking that embrace a more modern approach to device safety and the meaning of the validated state.

You’ll be able to ask questions about:

The current state of cloud computing and the big three providers – Amazon Web Services, Google Cloud and Microsoft Azure.
How those public cloud service providers can be leveraged in the operation of connected medical device systems, SaMD and Digital Therapeutics (DTx).
The six key recommendations of AAMI CR510:2021 and how to implement them to ensure responsible and compliant use of the cloud for SaMD.
How you can use TINY GVS to modernize your approach to the concept of the validated state.
What’s coming in the following AAMI Technical Information Report (TIR) that will continue the work started with AAMI CR510:2021.

This will be an interactive discussion featuring multiple experts in MedTech, SaMD and cloud computing. Expect a lot of learning interspersed with friendly banter and a few pop culture references.