Cloud Computing in Medical Devices: Safe, Compliant, Effective. How?

Randy Horton
Randy Horton

The cloud is eating the world, including medical devices.

As of early 2020, worldwide cloud infrastructure service revenue was over $96 billion, with the combined market share of the three largest vendors, Amazon, Microsoft, and Google, at approximately 60%.  Cloud revenues of these three vendors have grown by over 50% per year since 2013.

Part of the growth in cloud computing can be attributed to how it complements other technology trends by serving as the backbone of a more connected world that as of 2019 comprised over 26 billion iOT devices, 4.4 billion internet users, and 3.2 billion smartphone users.

As with the rest of society and the economy, cloud infrastructure is becoming a greater part of healthcare and life sciences, including the medical device ecosystem. Countless medical device makers are already using cloud computing today in the operation of medical devices, and this trend is only going to accelerate in coming years.

Cloud computing in medical devices needs to be safe, compliant, and effective. But how do we get there?

To date, there have not been any regulatory or standards organizations that have provided guidance specifically focused on the new opportunities, risks, and challenges created by the introduction of cloud computing into medical devices.

To help address this crucial gap, we have formed a working group to develop guidance to address the safe, effective, and compliant use of the cloud as a component of medical devices.  Specifically, we are working with the Association for the Advancement of Medical Instrumentation (AAMI) to create and publish this guidance as an AAMI Consensus Report. (The official Consensus Report status has not yet been formally approved by AAMI.)

Help us help you. Take our survey and tell us what you need!

Literally everyone we’ve spoken to about this project agrees that there is an urgent need for actionable guidance on how medical device makers (not to mention regulators, patients, providers, and payers) can be confident that they are responsibly introducing cloud technology into their medical devices.

To produce something that has the right mix of forest and trees (i.e., theory and practice), we need to hear from you!  Essentially, we are treating this guidance document as a product and we want to make sure that our product is practical and useful to you!

So we are inviting you to take this brief survey to share your thoughts and experiences on this topic. Any information you can provide will be incredibly useful and result in an essential document that we hope you will constantly refer to, as opposed to yet another report that you only glance at once and put aside.

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The Working Group team and this blog’s authors are Bernhard Kappe (Orthogonal), Clay Anselmo (Shriner and Associates), Josh Schulman (MaxQ AI), Michael Attili (Amaxo), Pat Baird (Phillips)Randy Horton (Orthogonal), and Wil Vargas (AAMI).

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