If it takes a village to raise a child, what does it take to start a revolution? How about a bunch of really smart, driven, and dedicated people drawn from every corner of the realm? Because that's what we had at this year's DiabetesMine Innovation Summit, held Nov. 21 at Stanford School of Medicine. And as in previous years, we asked participants to break up in small groups and discuss ways to effect change.
Each of our speakers from the day's presentations -- touching on various approaches to innovation -- was stationed at a discussion table during the hour-long session dubbed "Insight to Action — Brainstorming Innovation Paths."
Each group was provided a worksheet to record their thoughts on Opportunities, Challenges, Big Ideas, and ideally a Call to Action on the topic at hand.
And talk they did!
Not surprisingly, the best-attended table fit the hottest theme of the year: Interoperability. Close seconds were the table on FDA Regulatory Paths and a pair of tables focusing on Best Practices for Engaging Patient Input on Tools and Care. Here's how we gauged those conversations, according to our ear and written responses from each table:
Interoperability - Speed Bumps?
This group focused on the very timely issue of data freedom, the general consensus being that once data can freely move from devices to the cloud, an "app ecosystem" will develop leading to widespread innovation of apps that are actually useful for patients' real-life needs.
Echoing Joe Cafazzo's talk on industry standards, I heard parallels to the medical digital imaging revolution of the last two decades where third-party vendors now make software apps that fuel imaging analysis that was undreamed-of just a few short years ago, while increasing the value of the gear that creates the data (in this case images). In diabetes, challenges remain in the regulatory world, and also the fear of liability on the part of the device makers who worry that if they open up data repositories they could be liable if a third-party app leads to an adverse event. Of course patient privacy concerns loomed large as well. One of the big ideas this group had on the privacy front is to ensure digital health data is treated like digital financial data: locked and secure. They also felt that Apple's new HealthKit software may provide a great opportunity that can benefit the growth of interoperability. Unfortunately, this group got so engaged in their discussion of opportunities, challenges, and ideas they ran out of time before crafting a call to action. (Some revolutions start more easily than others.)
Somewhat surprisingly, the table focusing on FDA pathways seemed to go straight into action points, with one idea being a call for studies that would allow the agency to approve insulin dosing straight off CGM data. Yes, this is a common practice in the trenches that's "off label" right now. I've done it myself for years and I'm sure many PWDs do the same (but putting on my clinical educator hat: for those new to CGM, my advice is to wait until you've learned when you can trust the device and when you can't). The idea of establishing this as approved practice far-fetched at all, as Dexcom is already preparing to ask for an insulin dosing designation on its new advanced CGM algorithm before long. Should that happen, it would be the FDA endorsing CGM as accurate and reliable enough to be used in place of fingersticks.
We're not there yet though, and even with that dosing approval we'd still be a long way from a useable Artificial Pancreas. In fact, this discussion group also recorded a call to action for the FDA to take point on pushing the AP Project(s) forward. A key challenge they identified centered on resources, or a lack thereof. While most patients want more CGM integration and AP-level tech, the agency spends most of its time now focusing on the flood of glucometers -- including the new post-market surveillance work. The FDA has stated that it would like to see internal diagnostics built into glucometers to make it easier for the agency to investigate performance both in routine use in the field and in investigations of possible adverse events. Hey, commercial airplanes have had black boxes for decades, why not my glucometer?
Meanwhile, another discussion point was the FDA seeing a big opportunity for device makers to design studies that don't simply rely on A1C as the endpoint, but would instead put more emphasis on everyday outcome practicalities like Time in Range (or TIR) in addition to A1C. (Note: FDA has already signaled its call for this via its final guidance on AP devices released in November 2012, recognizing TIR as a potential endpoint.)
Also discussed was the FDA's renewed call for device makers to come to the agency very early in the development process of new devices and work together with regulators to create the kinds of studies needed for smooth device approval. That's a theme we heard a lot of during the Summit, with companies like Asante Solutions, Tandem Diabetes, and Dexcom getting praise for those active dialogues in recent years.
About Patient Engagement...
The emerging theme from this pair of tables was, bluntly put: Diabetes sucks and if you want patients more engaged in their care you need to make it easier. To do that, you need to ask us what we need -- early on, before you create tools and tech that we're supposed to want, according to some doctors or engineeers. Opportunities identified by the groups included leveraging social communities and building out partnerships with our primary advocacy organizations, such as JDRF and ADA. Challenges include the lack of unity between the type 1 community and the type 2 community, and the fact that there are too many uncoordinated voices. The group members felt that patients are asked for input too late in the design process (which our Summit has been emphasizing since at least 2011).
The call to action rang clearly: Device makers and Pharma need patient advisory boards representative of the target audience. And these boards should be involved in the earliest phases of design. Some members felt the device companies tend to surround themselves with "friendly" users whereas they might learn more from PWDs who don't use their gear or have stopped using their products for various reasons.
The Power of Brainstorms
There was a lot great conversation and feedback being provided, not to mention many new relationships established -- as we heard so many people say they'll be keeping in touch and continue to work on these issues once they got back home. And yes, some of the calls to action are already in the works or not far from it.
I can tell you from first-hand experience that the last call to action, seeking and listening to our patient input early on, is already happening with some companies. For example, after giving the Accu-Chek Expert meter a less-than-enthusiastic review recently, I got an email from their product development team asking if I'd be willing to have a phone conference with them to provide my views in greater detail. They especially wanted to know what I'd do to make the next generation product better. I was also recently invited by the small pump maker Asante to be on their (unpaid) PWD advisory board. Asante chose a mix of PWDs of both genders of various ages and mixed backgrounds who use their product with those who don't. The top management and the Snap pump's chief architect met in person with this patient advisory board and brainstormed both the current product and possible future products. And of course let's not forget that Tandem Diabetes interviewed several thousand PWDs during the development of the t:slim pump.
So while there's room for growth, and not all the companies are embracing PWD design input, it's clear that this revolution is underway. I'd bet the device makers who drag their feet at giving PWDs a seat at their tables will suffer because the devices co-designed by us will be superior for our needs and will sell better than the ones developed in "silos."
Or as a note left behind on the of the tables at the end of the day said: "People with diabetes make a product cool!!"