Medical Devices on the Cloud and Beyond: Talk

Randy Horton

Published on: October 3rd, 2022

2026 Update: The work discussed in this 2022 presentation ultimately contributed to AAMI TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions, published in 2026. TIR115 supersedes AAMI CR510:2021 and expands the guidance around managing public cloud computing in medical devices.

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 Philips’ Pat Baird, Regulatory Head of Global Software Standards, presented during a breakout session at the conference. Randy and Pat shared their first-hand experience working on the AAMI CR510:2021 and what was then the in-progress Technical Information Report #115.That work ultimately led to the publication of AAMI TIR115:2026, which provides guidance on the appropriate use of public cloud computing to enable medical device functions.

They also looked beyond the cloud at the broader challenge of medical devices relying on technologies manufacturers do not directly control, including cloud services, smartphones, FHIR-based integrations and other forms of distributed computing., 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 to learn more about cloud computing for medical devices? Start with our latest TIR115 resources, then explore the earlier articles that helped shape Orthogonal’s thinking on cloud computing and the validated state.