Medical Devices on the Cloud and Beyond: Talk

The annual AAMI/FDA/BSI International Conference on Medical Device Standards met in person, for the first time since lockdown, on October 18th–19th at AAMI’s Arlington, VA headquarters. The global medical device standards community gathered for a dynamic review of the recent changes in the regulatory landscape as well as lessons learned from the pandemic.

Orthogonal’s Randy Horton, Chief Solutions Officer, and Philip’s Pat Baird, Regulatory Head of Global Software Standards, presented during a breakout session at the conference. Randy and Pat detailed their first-hand experience working on the 2021 AAMI Consensus Report #510 and in-progress Technical Information Report #115, which both address how to safely and effectively use the cloud in the operation of a medical device. They looked at the broader issue of using 3rd party computing services that we don’t control – including the cloud, smartphones, FHIR, etc. – in the operation of a medical device, and how “TINY GVS” helps medical device developers tackle the challenges of utilizing distributed computing within and across a medical device, as well as in other external components that the device depends upon.

Afterwards, Randy and Pat were invited to the AAMI Studio for a conversation with Robert Burroughs, Chief Learning and Development Officer, and Joseph Lewelling, Senior Advisor, Strategy and Content, where they delved deeper into the topics discussed in their conference session. You can watch the recording of their conversation in the following video:

Want more info on cloud computing for SaMD? Read our series of articles on AAMI CR510:2021, the validated state and TINY GVS with the links below:

• The Validated State: MedTech’s Standard of Trust
• Cloud Computing and Validation: 6 Key Recommendations
• TINY GVS: Reimagining the Validated State