Talk

Medical Devices in Cloud Webinar: Sneak Preview of a New Expert Report

Ke Li Yew

Published on: December 14th, 2020

2026 Update: This 2020 webinar offered an early look at the industry work that became AAMI CR510:2021 and ultimately AAMI TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions. TIR115 now supersedes CR510 and provides expanded guidance for medical devices that rely on public cloud computing. Read our TIR115 announcement.

On December 16, 2020, Orthogonal’s Bernhard Kappe and Randy Horton joined a group of industry experts for a MedTech Intelligence webinar exploring the opportunities and challenges of operating medical device software in public cloud environments. The discussion offered an early preview of the work underway within AAMI to develop industry guidance for the safe, effective, and compliant use of public cloud computing in medical devices.

Event Title

Connected Medical Devices, Software as a Medical Device (SaMD) & the Cloud: Delivering Validated States, Safety & Compliance on Continually-Evolving 3rd Party Platforms

Original Event Description

The tremendous growth of public cloud computing platforms such as Amazon Web Services (AWS), Microsoft Azure, Salesforce Platform and Google Cloud has been driven by a wide variety of benefits related to reliability, performance, scalability, security, convenience, cost, and functionality. Seeking to capture these benefits, more and more medical device companies are placing key components of medical device software and functionality on public cloud computing platforms.

While the cloud offers high value for medical device manufacturers and device users, it also creates new challenges. Use of the cloud entails a tradeoff between realizing the benefits and losing some degree of control over the underlying technology. Although regular cloud component updates from Amazon, Microsoft, Salesforce, Google, and others can help keep their platforms safe and reliable, constantly changing computing environments pose a new class of challenge to traditional approaches to the idea of a validated state that ensure safety and compliance.

In this webinar, a group of industry leaders and pioneers in the use of medical devices in the cloud will outline these challenges in more detail, and share an emerging set of best practices that address these challenges so that medical devices can harness the full benefits of cloud computing. They will be sharing insights from their experiences in developing and launching cloud-based medical device functionality, as well as interviews they have conducted with professionals with experience in this area.

At the time of the webinar, the working group was developing what would become AAMI CR510:2021, one of the first industry consensus documents focused on the appropriate use of public cloud computing for medical devices and quality systems. That work continued over the following years and ultimately led to the publication of AAMI TIR115:2026.

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Event Speakers and Panelists

Working group members who participated in the webinar included:

Clay Anselmo, Principal Quality & Regulatory Consultant
Shriner & Associates
Mike Attili, President, Amaxo
Pat Baird, Head of Global Software Standards, Philips
Randy Horton, VP Solutions & Partnerships, Orthogonal
Bernhard Kappe, CEO, Orthogonal
Artiom Kisselev, Master’s student, UC Berkeley/UCSF Program in Translational Medicine
Joe Lewelling, VP of Emerging Technologies & Health IT, AAMI
Josh Schulman, SVP of Clinical Innovation, MaxQ AI
Nicola Zaccheddu, Sr. Software Quality Engineer, Philips Healthcare

The event will be moderated by Thomas Maeder from MedTech Intelligence.

Who the Webinar Was Designed For

The program is designed to inspire discussion among cross-functional teams across your organization, taking time to debrief and compare notes after the webinar. This includes:

R&D, Product Development, and Engineering teams – Hear software integration and product development case studies for cloud application
IT/IS, Software and Data teams – See successful software development, security, and data strategy implementations
QA, RA teams – Discover strategies navigate compliance, safety, and security concerns
Executive Leadership, Market Access, Digital Health, and Connected Device Product teams – Learn from the success of others already succeeding with Cloud Strategies.

From an Early Preview to TIR115
The issues discussed in this 2020 webinar became the foundation for several years of industry work on public cloud computing in medical devices.

That work first resulted in AAMI CR510:2021 and later AAMI TIR115:2026, which provides further guidance for designing, deploying, maintaining, and managing medical devices that rely on public cloud computing.

Get AAMI TIR115