Cloud-Native Medical Devices - This is Not Your Grandma’s Medical Device
Details
MedTech is eagerly incorporating cloud computing technologies to connect and enhance the core functions of regulated medical devices. The tangible fruits of these efforts include the rapidly growing domains of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems.
Join us for a mind-opening meetup about emerging software architectures and regulations to cope with the new cloud-native era. The meetup is lead by Randy Horton, Co-Chair of AAMI (Association for the Advancement of Medical Instrumentation) Cloud Working Group and Chief Solutions Officer, Orthogonal, Josh Schulman, Chief Science Officer at Joy Ventures, and Guy Vinograd, Co-Founder CTO, BioT.
The meetup is intended for product and architecture role owners in medical device companies.
Agenda:
18:00 - Gathering and Food (but not Pizzas)
18:15 - 5 min welcome and opening
18:20 – 18:50 - Cloud-native Medical Devices: A Game-Changing Architecture for Medical Devices
Speaker: Guy Vinograd, Co-Founder & CTO, BioT
Abstract:
An emerging generation of medical devices is upon us. They are for patient use but unexpectedly perform functions traditionally done by point of care and even lab devices that are much bigger and cost tenfold. Examples include blood-in-stool diagnostics using a camera installed in the toilet, virus diagnostics using a compact home spectrometer, and more. Being small and affordable for home use, these devices enable a new level of care because instead of just reactive diagnostics they are becoming proactive monitoring devices.
The 'secret' of these devices is a new architecture. Their hardware is composed of just sensors where the rest of their functionality, i.e the data processing part (of images, waveforms and other raw sensor data), is executed on the cloud.
We call this new architecture a “cloud-native medical device”. Let’s explore its details.
18:50 - Plank Break & Mondial balls for winners
19:00 – 19:25 - From a Fortress to a Container Ship: Evolving Change Control to the Era of Cloud SaMD
Speaker: Randy Horton, Co-Chair of AAMI (Association for the Advancement of Medical Instrumentation) Cloud Working Group and Chief Solutions Officer, Orthogonal.
Abstract:
Two years ago, a group of industry professionals convened to create the first-ever official guidance on how to manage change control for medical devices running in the cloud, when going to cloud means giving up some level of change control to the Amazons, Microsofts and Googles of the cloud world. What they realized along the way was that the cloud is just the beginning of the emerging story of giving up some control over a medical device, in return for gaining exceptional amounts of value and functionality. In this talk, we’ll review a new framework for thinking about using distributed computing in the operation of medical devices, and look at how we can take advantage of the huge potential of distributed computing to improve patient outcomes, while still keeping tight control on risk and safety.
19:30 – 19:55 - Panel: Cloud SaMD - Lessons Learned
In the third and final part of the meetup, we’ll have an open discussion about what we can learn from the shift to the cloud, and paint an exciting (also also intimidating) picture of what’s next for our individual companies and our industry as a whole.
Moderator: Josh Schulman
Panelists:
Guy Vinograd - CTO & Co-Founder, BioT Medical
Randy Horton - Chief Solutions Officer, Orthogonal
Dina Sifri - CEO and Founder, MedDev Soft
Ari Katzin - Lead Assessor, BSI
Cloud-Native Medical Devices - This is Not Your Grandma’s Medical Device