Patient-innovators fill gaps that industry hasn’t addressed — or can’t

Here’s a long-held assumption that’s ripe for a challenge: Valuable improvements in health and patient care should come from experts in the pharmaceutical, medical device, and related industries.

There’s no question that such professionals are essential for innovation. But our research shows that patient-innovators also have important roles to play and will fill significant gaps that industry hasn’t addressed — or can’t.

Take Lisa Crite as an example. Like all women who have a mastectomy for breast cancer, she was advised not to shower for seven to ten days after the operation to avoid contaminating the wound and surgical drains. Since that’s a long time to go without showering, many women resort to wrapping their upper bodies with plastic wrap or trash bags to cover the healing surgical wound during a shower. Not satisfied with that approach and unable to find a suitable commercial product, Crite developed the Shower Shirt. Not only does it keep the area dry, it also has internal pockets for the the wound’s drains.

Dana Lewis, a health communications professional in her 20s with type 1 diabetes, is another example. She teamed up with a software engineer and others with diabetes to develop what the medical device industry had been promising to deliver for decades: a do-it-yourself artificial pancreas. Sean Ahrens is another. Living with Crohn’s disease, this computer science and business graduate from the University of California, Berkeley was frustrated with the lack of information about what he could do to prevent flare-ups of the disease. So he created Crohnology, which now has more than 10,000 registered users.

To understand what drives patient-innovators like these and the challenges they face, we worked with colleagues around the world to conduct nationally representative surveys in six countries. We also had face-to-face discussions with groups of collaborating patient-innovators.

One of the big surprises from this work was how many people have embarked on journeys of medical innovation: as many as one million people in the six countries surveyed reported having developed medically related products for personal use.

What drives most patient-innovators is the realization that something they want or need isn’t commercially available. While that’s often the same motivation for industrial developers, patient-innovators differ in three key ways, as we reported in the MIT Sloan Management Review:

• They invest their own time and money to develop a product or solution.
• They make it freely available instead of protecting it from imitators.
• They let others test and improve the initial design and make new versions freely available.

In addition to fulfilling a personal need, patient-innovators are also attracted by the learning they gain from the process and from sharing their innovations with people with similar needs. In short, it is a highly self-rewarding endeavor.

Two issues for patient-innovators: the law and safety

Anyone who wants to create a medical innovation for his or her own use is free to do so. This activity is protected by the right to privacy in the Fourth Amendment of the U.S. Constitution — even if others deem the innovation to be risky or downright unsafe. And this activity is beyond the reach of federal agencies like the FDA, which cannot regulate noncommercial activity.

That said, safety is important — and not guaranteed. A coding error in an artificial pancreas could lead to dangerous miscalculations of an individual’s insulin dose. But we don’t believe that concerns about safety should be a reason for governments to limit patient innovation. On the contrary, we believe that governments should encourage it.

It’s important to evaluate the dangers of patient-innovation the right way: by comparing its risks against the harm caused by the absence of such innovation. Once various do-it-yourselfers built an artificial pancreas, it became hard to overlook the fact that the lack of an FDA-approved commercially available version contributed to deaths from hypoglycemia of thousands of people with diabetes and a worsened quality of life for thousands more living with the disease.

When patients innovate to tackle medical problems that have not be addressed by commercial solutions, their efforts may well provide a net gain in safety and quality of life for the population of affected patients. We expect safety will improve further as low-cost clinical trial methods are developed to allow patient communities to test their innovations using similar ethical standards to those used by hospitals and universities for clinical research.

As the patient innovation system evolves, we expect to see greater complementarity between it and commercial medical innovation systems. Commercial producers and medical service providers will never be able to deliver everything that patients need. Innovative patients can fill many of the gaps if they are properly supported. A richer set of medical innovation options will benefit patients, commercial medical caregivers, producers, and society at large.

Harold DeMonaco is a visiting scientist at MIT’s Sloan School of Management. Eric von Hippel is professor of management and technological innovation at the Sloan School.