FDA stifling innovation due to costs of the regulatory process


Pioneer Founding member
Developing a Do-It-Yourself-Pancreas
Charles Settles, Product Analyst, TechnologyAdvice

Diabetes, the seventh leading cause of death in the U.S., receives the 37th-most research funding, according to the NIH. Seeing little progress, some diabetics are taking matters into their own hands.

Health IT is one of the fastest growing segments of the U.S. economy. A seemingly endless number of vendors are developing various consumer and provider-facing apps, devices, and other tools to help deliver better care, improve overall population health, and reduce healthcare costs. Disruptive technology companies want to ‘hack’ healthcare, but some areas — like diabetes care — are so heavily regulated that innovation can be stymied.

The issue lies in language from section 201(h) of the Federal Food, Drug, and Cosmetic Act; new technologies like wearable trackers and medical apps can be considered medical devices — and regulated accordingly — if they are “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Furthermore, a medical app or device requires FDA approval if it is “intended to affect the structure or any function of the body.” While these limitations seem reasonable, diabetes and other chronic diseases are frequently ‘treated’ and/or ‘mitigated’ through regular testing — such as blood glucose testing.

An app that simply logs and analyzes blood glucose data, manually or via glucometers, requires regulatory approval. According to the most recent data from the CDC, nearly six million diabetics in the United States manage their condition with insulin. Not only do they need to test their blood glucose regularly, they must calculate and administer insulin to maintain the proper blood glucose levels — compensating for diet and insulin sensitivity. These calculations can be a matter of life-and-death. Anything that makes calculating them easier and more accurate would be an improvement over current methods, but for many reasons, including those we’ve outlined above, solutions are slow-coming.

Many have written on the FDA approval process and its effect on innovation. A 2010 report from AdvaMed found that nearly 80 percent of new medical device development costs can be attributed directly to regulatory processes. The report found the average cost of bringing a low-to-midrange concept 510(k) device to market is $31 million, meaning ~$24 million of that was spent solely on the FDA approval process. It’s no surprise that these costs can impede development. David Cassak, managing director at Windhover Information (a company that provided data for the AdvaMed report), sums up the thought process of many investors, who say “This new technology could be meaningful and could be helpful to patients, but we just can’t even take a chance on it.”

Despite this hesitation from larger medical software and device vendors, one uniquely motivated group of researchers is already in the game. Not satisfied with simple logging and analytics, Dana Lewis and Scott Leibrand have created what they’re calling the “Do-It-Yourself-Pancreas-System” (DIYPS). There’s no Silicon Valley office, marketing or sales budget, or even any employees. It’s just Lewis, Leibrand, and some hashtags: #DIYPS, #OpenAPS, and #WeAreNotWaiting.

In a Feb. 2015 interview with Ernesto Ramirez at Quantified Self, a global user-driven research and discussion community centered on self-tracking, Lewis revealed she’s personally battled Type 1 diabetes for 12 years. As a tech-savvy diabetic, Lewis manages her condition with both an insulin pump and a continuous glucose meter (CGM). While CGMs offer myriad advantages to manually testing and logging blood glucose levels, they are only half the solution needed. According to Lewis, since her CGM and insulin pump couldn’t talk to each other, Lewis needed to monitor her CGM and then make “about 300 decisions per day” concerning her insulin dosage.

Calling the constant decision-making “really fatiguing,” Lewis and Leibrand decided they were tired of waiting for medical software developers. They created an app that combined her carbohydrate intake, blood glucose data, and historical insulin dosages in order to predict her future blood sugar and send push notifications — with dosage suggestions — to her phone or smart watch. As if that wasn’t enough functionality, the pair recently ‘closed the loop’ between the CGM and her insulin pump, allowing the app to constantly monitor her blood glucose levels and automatically adjust her insulin dosage as needed.

Though Lewis and Leibrand have cobbled together an innovative solution that works for them, they can’t make the code available to others out of fear of potential FDA action. Does simply publishing the code for others to adapt and adopt make Lewis and Leibrand 510(k) device manufacturers? No one can say with certainty — the FDA approvals process simply wasn’t designed with current Health IT reality in mind. While Lewis says they “very much want to continue [their] conversations with regulators”, there’s a long road ahead for their DIYPS and greater movement, the Open Artificial Pancreas System (OpenAPS) Lewis describes the system as “an open and transparent effort to make safe and effective basic Artificial Pancreas System technology more widely available [in order] to more quickly improve and save as many lives as possible and reduce the burden of Type 1 diabetes.”

It’s obvious that there’s a need for a system like the DIYPS — but that’s just one small segment of the greater potential consumer medical technology marketplace. According to Lewis, “there’s not a lot of awareness of how many diseases — including diabetes — could have their care revolutionized just by having better access to data.” At MDT — and my organization, TechnologyAdvice — it’s our job to raise awareness and offer opinions and analysis. You can help out by letting us know about your own current projects and thoughts in the comments below.