FDA Issues Draft Guidance on Interoperable Medical Devices

In late January, the Food and Drug Administration (FDA) issued draft recommendations for designing interoperable medical devices. For people with diabetes, this means ensuring devices like blood glucose meters, insulin pumps, and CGMs can easily communicate with each other and other devices and programs (especially if they are from different companies).

The comment period for this draft guidance, called “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices,” is open until March 26, 2016. The FDA will take into account all the comments it receives before it finalizes the guidance. See below for our take on the guidance and for a preview of the feedback we will be submitting.

What is Device Interoperability?

Greater interoperability in diabetes could ensure that devices – regardless of who made them – can “talk” to each other and a wide array of software applications. Interoperable diabetes devices could reduce patient and provider frustration, save time and hassle, expand patient choice, enable new products and apps that leverage different sources of data, and even help patients achieve better glucose levels. Making devices interoperable starts with manufacturers’ design choices, and this guidance could influence those choices. At an FDA workshop on device interoperability in 2014, Tidepool’s Howard Look gave this depiction of device interoperability for diabetes as explained with the history of digital cameras:

In the early days, Canon, Olympus, and Kodak each had their own exclusive software for reading pictures off of their camera. Fortunately, the manufacturers settled .jpeg as a standard image format. Can you imagine if they also had a proprietary image format? Fast-forward to today, and everyone can read, view and share pictures despite using a wide range of different cameras, software, computers, and smartphones. In contrast, diabetes devices force users to use a company’s own software to both access the data and to view the data. This reduced choice increases the burden of managing diabetes.

Here’s another example: imagine if your iPhone or Android only worked with an Apple or Samsung-designed headphone? It would not be very useful! Unfortunately, this is often the state of affairs in diabetes, where a device from one company only works with products and software from that same company.

Our Take on the Draft Guidance

While the guidance is general and does not specifically mention diabetes, it has been expected ever since the November 2014 FDA Workshop on diabetes bolus calculators and interoperability.

In reading the guidance, we were glad to see the FDA recognize the value of interoperability for “innovation,” “new models of healthcare delivery,” and “lower cost” care. However, some of the language isn’t as strong as it could be to make a difference. The FDA only “encourages” the use of accepted communication standards – it does not mandate interoperable communication. Companies can continue to use whatever form of device communication they want, including their own non-interoperable (proprietary) standards, in which case the guidance isn’t really doing much to make a difference.

This document will be key for all diabetes devices and their associated communications (e.g., pump talking to a phone, CGM and pump talking to each other, meter sending data to a computer and electronic medical record), and we’ll be interested to see how patients, clinicians, and industry respond. Again, the comment period closes March 26, and FDA does take the comments it receives seriously. Please find the draft guidance here, and comment here if you have thoughts on the document!