Emerging AAMI Cloud Change Control Guidance: Webinar

Randy Horton

Published on: October 26th, 2023

2026 Update: When this webinar was recorded in 2023, AAMI TIR115 was still under development. In 2026, AAMI published . The final TIR supersedes AAMI CR510:2021 and provides guidance for designing, deploying, maintaining, and managing medical devices that rely on public cloud computing. Read our TIR115 announcement.

Emerging AAMI Cloud Change Control Guidance Webinar Banner

Public cloud computing offers significant benefits for medical devices, but it also introduces a different control model. Medical device manufacturers may depend on computing infrastructure operated and changed by a cloud service provider, sometimes without direct control over when those changes occur.

In this 2023 webinar, experts from Orthogonal, AWS and BioT discussed the change-control challenges created by cloud-powered medical devices and shared emerging best practices from the AAMI Cloud Computing Working Group while TIR115 was still under development.

The final guidance, published in 2026 as AAMI TIR115:2026, develops many of these concepts further, including supplier-controlled cloud resources, risk management, architecture, testing, change management, and postmarket monitoring.

Watch the original 2023 discussion for an early look at the concepts that helped shape the final TIR115 guidance.

Watch Webinar Recording

Speakers

Ian Sutcliffe, Principal Technology Strategist, AWS & AAMI Contributing Member, Amazon Web Services

Ian Sutcliffe is a Principal Technology Strategist at AWS with nearly 30 years of experience in IT, primarily in the Life Sciences industry. A thought leader in the area of regulated cloud computing, and intent on helping customers become Regulated Cloud Natives. Ian is also a Contributing Member of AAMI’s Cloud Computing Working Group

Randy Horton, Chief Solutions Officer, Orthogonal

Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech.

Horton served as Co-Chair of the AAMI Cloud Computing Working Group that developed AAMI CR510:2021 and AAMI TIR115:2026, both addressing the safe and effective use of public cloud computing for medical devices. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).

Guy Vinograd, Co-Founder & CTO of BioT & AAMI Cloud Computing Working Group contributor, BioT Medical

Guy Vinograd specializes in the Internet of Medical Things (IoMT) and cloud-powered medical devices with multiple patents. With over 25 years of experience, he’s a pioneer in cloud-medical-device regulation and has developed IoT systems for hundreds of thousands of devices. BioT, which he co-founded, offers MedTech firms a platform for smart medical devices with various capabilities. Guy also contributed to AAMI’s work on guidance for the use of public cloud computing in medical devices.

Moderator

John Miller, Vice President, Americas, BioT Medical

John leads BioT Medical’s go-to-market efforts with clients and partners. He brings to the role extensive experience helping life science clients create platforms and solutions from a diverse set of technologies: app dev, analytics, data and cloud. Most recently, John led US client management for the medical device and semiconductor industries at Mendix (acquired by Siemens). Clients leveraged Lowcode Application Development to build and deploy custom, cloud-based applications for Digital Thread, Supply Chain, Regulatory and Connected Customers use cases.

Prior, he ran go-to-market in the eastern and central US at an Israel-based startup Elastifile (acquired by Google). The first US clients leveraged Elastifile and GCP to run high-performance genomics and drug discovery workloads on the cloud. In addition, John has worked in both the US and UK in global sales and product management roles for EMC and NCR and in management at a privately-held marketing firm. John holds a Bachelor of Arts in Economics from Columbia University, and lives in Charlotte, NC.

TIR115 Is Now Published

The emerging guidance discussed in this 2023 webinar ultimately became AAMI TIR115:2026, Guidance for the appropriate use of public cloud computing to enable medical device functions.

Learn what changed, what manufacturers should know, and how the final guidance addresses public cloud risk, supplier management, MDS/MDDE boundaries, and continuous change.

Read Our TIR115 Announcement

Get AAMI TIR115