Patient Engagement

Opening Up to Patient Innovation

Article · July 12, 2018

If you were on a plane about to make an emergency water landing, and you had the knowledge to MacGyver life jackets for everyone else with materials readily available, you might feel obligated to do everything you could to quickly share your insights with everyone in need. It would feel immoral not to.

That might seem like a straightforward scenario: You have information and the ability to help teach other people how to help themselves. What could be the problem with that?

In the current health care landscape, there are quite a few objections to that, particularly when you begin thinking of specific examples of do-it-yourself health tools and technologies. I know these objections well, hearing them weekly when I share publicly how I helped create the world’s first open source, do-it-yourself automated insulin delivery system (commonly known as an artificial pancreas). This self-built system uses off-the-shelf hardware interfaces with an existing insulin pump and continuous glucose monitor (CGM), allowing a computer to read and process the data and determine what changes in insulin delivery are needed. And it’s all made by people with diabetes and their loved ones.

Regulation: The Means vs. the Ends

To understand all the objections that arise, you also have to be aware of the way medical devices and systems are typically made available to the public. For new technologies to reach the market, devices or new tools are developed, put through clinical trials, and then brought to the regulatory bodies for review and approval.

Most people assume that patients who are building (or DIYing) their own devices are getting away with ignoring or flouting the laws and regulations around medical devices. But if you look carefully at the jurisdiction of the regulatory authorities, you’ll find that many such laws and regulations don’t apply to individuals, even if they’re also freely sharing knowledge about what they’re doing so that others can do the same.

The U.S. FDA’s regulatory authority comes from the medical device amendments to the Food and Drug Act, which authorizes the FDA to regulate the marketing and sale of medical devices. That authority in turn derives from the Commerce Clause of the Constitution, which gives the federal government the ability to regulate interstate commerce. Simply building a medical device for personal use does not fall within the FDA’s jurisdiction, so the structures in place for regulating commercial activities do not (currently) apply. And, when patients freely share information with one another on how to use commodity hardware, they are engaging in non-commercial speech, which is strongly protected under the First Amendment.

Legality aside, many take the default assumption that these activities should be regulated: If the companies have to be regulated, so too should everyone else. But this confuses the means with the ends: The goal of medical device regulation is to ensure safety and efficacy. The means by which safety and efficacy have traditionally been demonstrated involve years (if not decades) for a company to adopt an idea, test it, trial it, and get it all the way through regulatory approval without it getting dropped along the way.

Some health care providers (HCPs) object because patients self-building or self-selecting technology is different than the way things have been done in the past. Some may have specific and valid concerns about individual patients and their ability to manage such technology. But others have treated regulatory approval as a rubber stamp, and refuse to discuss anything that is not approved (conveniently ignoring other times when they have discussed things that would be considered off-label usage). Instead of outright disavowing new technology that they are less or unfamiliar with, HCPs could instead see the relatively small population of DIYers as an opportunity to get ahead of the learning curve of what technology will be coming for the broader patient population.

OpenAPS and Other Efforts Have Emerged to Meet Real-World Patient Needs

In some aspects of drug development and device development, the traditional pathway through traditional regulatory bodies may still make sense. But as incredible technology, computing power, and knowledge have become more readily available to the average person, there is now a new frontier. Patients like me now have the ability to create devices, tools, or systems for ourselves that outpace the abilities of what is in the traditional pathway for development. In some cases, self-built technology is half a decade ahead of what may be commercially available.

In automated insulin delivery, the technology involved is fairly straightforward, and the next steps have been obvious for more than a decade to those in commercial, academic, and non-profit organizations, and to patients as well. More recently, the availability of better consumer-grade technology, and the ability to collaborate via social media, has allowed patients to switch from being passive consumers and having to wait, to having the ability to actively engage and develop solutions that are personalized and work well for each individual. That’s how things like the open source artificial pancreas came into existence.

Like someone who has the ability to teach someone else to create their own personal floatation device in a time of need, we all felt obligated to share our work in DIY automated insulin delivery technology with as many others as possible. In our case, this meant making it open source. We knew, given the impact this technology had on improving life with diabetes, that this would help many other people with type 1 diabetes. We also knew, given the world we live in, that we cannot (nor would we want to) “distribute” medical devices.

And so, OpenAPS is currently a movement around making artificial pancreas technology more widely available than it is currently. Despite the fact that in the U.S. there is now (3 years after OpenAPS was created) one commercial system available, there remains strong demand for open-source DIY solutions. First-generation commercial “hybrid closed loop” technology is limited, by design, testing, and regulatory constraints, to being a one-size-fits-all device. Because it cannot be sufficiently customized, some users find themselves frustrated by their inability to get the commercial system to work the way they want it to. There are also questions of affordability and access, particularly given that the commercial version is not yet approved outside the U.S. and available to people with diabetes around the world.

And perhaps most important, open-source solutions are an additional research path complementing traditional research labs and medical device companies. The open source solutions have already demonstrated capabilities and real-world outcomes that most people thought were impossible with insulin-only (single-hormone) systems. So even as multiple commercial systems become available, they are not likely to make patient-driven innovation irrelevant; rather, they continue to make this technology more widely available, while DIY patient innovators continue to innovate at the leading edge of what is possible.

All Roles in the Health Care Ecosystem Must Adapt and Evolve

Patient-driven innovation is here to stay, and it will spread. OpenAPS may be a commonly cited example, but it’s not the only one out there.

And while some patient-designed innovation will end up inside a company and traditional regulatory frameworks, it doesn’t necessarily make sense to follow that path in all cases. Instead, regulatory frameworks need to be updated to deal with new communities of innovators. Not all innovation happens inside an organization. Not all innovation will be brought to market and distributed by a company. And, therefore, it is time to determine whether regulatory bodies should continue to exercise “enforcement discretion” as more communities share tools and technologies open source via free speech, or how new regulatory frameworks can promote a symbiotic relationship to better accelerate innovation and support a new class of innovators who are working to help those around them live better lives.

Clinicians will also need to learn to adapt to and evaluate technologies that patients bring into their clinics, rather than relying on regulatory stamps of approvals. We all need to learn to better evaluate the risk of harm from inaction versus the potential risks of taking actions to help people. When our bureaucracies and institutions focus too much on the risk of action without sufficiently considering the risk of inaction, such innovative approaches are left to patients who are able to assess the risk of using the technology, and who can choose to use those solutions if they assess a net risk reduction overall.

Patients continue to innovate in this way because their true needs are not being met by the way things work right now. Part of that is due to slow speeds of manufacturing and companies’ innovation processes. Part of that is due to the lack of patient-centered design. But even as companies learn to build faster and better technology, there will always be unmet needs in the patient community. There will always be people who deeply understand the problems we face as patients, and who are willing to spend time and energy to build and share solutions. While not all of us can build these solutions, we can all do our part to further the efforts of those working to improve the health of themselves, their families, and all of our communities.

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