Published on December 14, 2020
Orthogonal’s Bernhard Kappe and Randy Horton are looking forward to participating in a webinar taking place this Wednesday (December 16, 2020) from 1-2:30 PM EST that’s hosted by our partners at MedTech Intelligence. You can register for free here to attend this event:
Connected Medical Devices, Software as a Medical Device (SaMD) & the Cloud: Delivering Validated States, Safety & Compliance on Continually-Evolving 3rd Party Platforms
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.
The content they will present is a “sneak preview” of recommendations they are in the process of creating the first-ever written industry guidance on this important topic. This working group has been approved by the Association for the Advancement of Medical Instrumentation® (AAMI) to create and (after AAMI provides a detailed review and ultimately approval) publish the final guidance as AAMI CR510, A Consensus Report on the Compliant Use of Cloud Computing for Quality Systems and Medical Devices.
Event Speakers and Panelists
The working group for this Consensus Report who will be presenting at this event are:
- 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
Who Should Attend
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.
Please register for free here to attend this webinar. We hope to see you this Wednesday (December 16, 2020) from 1-2:30 PM EST.
Bonus Options (i.e., the lagniappes)
You are also welcome to:
- Provide input to the Consensus Report’s Working Group by completing this survey.
- Request to be updated with news about this Consensus Report and related efforts such as a forthcoming journal article in Biomedical Instrumentation & Technology (BI&T) by sending an email to Cloud.Consensus@orthogonal.io.
- Watch and share the online video recording of this event, provided after Wednesday by MedTech Intelligence.