AAMI, an ANSI-accredited standards organization focused on the medical device industry, has guidance under development (TIR115) to extend current guidance for building safe and effective medical devices when device functions now operate on public clouds.
There are certainly benefits for medical devices and public cloud services. However, new risks can be introduced when responsibility and lack of direct control for computing infrastructure shifts from the device manufacturer to a cloud services provider.
This introduces the need for new and modified approaches to change control for cloud-powered medical devices. These approaches must address the ongoing needs of the many stakeholders associated with a medical device: Product/R&D, QA/RA, Enterprise Architecture, DevSecOps, Postmarket Surveillance & Support, etc.
This one-hour webinar serves as an introduction to the in-development AAMI guidance (TIR115) and shares emerging best practice insights for stakeholder groups.
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 serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. 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 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. Additionally, Guy contributes to the AAMI group shaping FDA standards for cloud usage in medical devices.
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.