Patient Engagement

Patients and Caregivers as ‘User Entrepreneurs’

No one knows better than patients and their caregivers which solutions work best for their particular needs. Often highly circumstantial, those needs can be difficult for commercial companies to anticipate or fully understand. Some patients and caregivers take matters into their own hands and innovate to solve real problems in real time by developing, for example, a process for medication management, an aid for mobility or an app for self-care—whatever works.

Some make those solutions available to others with similar needs, perhaps informally at first and eventually as marketable products. Turns out, there’s a name for that: user entrepreneurs.

“User entrepreneurs for social innovation: The case of patients and caregivers as developers of tangible medical devices,” is a working paper written by researchers affiliated with university programs in technology and innovation management, medicine, and business and economics in Germany, Portugal and Denmark. They define user entrepreneurs as “persons who develop and market medical devices according to their own and/or their relatives needs.”

The paper analyzes 14 user entrepreneurs who have successfully brought their products to market. Although the case studies are not presented directly — which left me craving more detail — the paper is full of revealing quotations from the inventors:

My aunt, who was my grandfather’s primary caregiver, was very stressed when she took take care of him (…) Once, I sat night watch for my grandfather. When I saw him stepping off the bed. The moment his foot touched the floor, I came up with the idea… (Caregiver 3) (p15)

My neighbor helped me. I paid her a consulting fee and she helped me develop the prototype. (Patient 8) (p16)

It makes no sense to me that I’m the only one in the world with a solution to this problem. Thousands of people have the same problem. (Patient 5) (p16)

One night I was at my drawing board and I came up with the idea how to lift the wheelchair’s casters off the ground. Well, I filed for the patent the next day. (Patient 4) (p17)

I showed it to physiotherapists I knew, and they told me on the spot that if there was a machine like this, every physiotherapy department would buy one. (Patient 2) (p18)

Social good motivates these inventors

The paper examines patients and caregivers as user entrepreneurs with an altruistic, social purpose, thus the term “social innovation” in the title. In general, user entrepreneurs have been found to be motivated by “enjoyment during the development and commercialization process” (p3). In cases of social innovation, they also enjoy the natural transition from solving a problem and enhancing their own experience to wanting to share it with others. The product developers studied for the paper were not motivated by profit. They were more interested in filling a need by offering their products to others with similar health challenges. “…users such as patients and caregivers go beyond their own problem space and address the needs of many others.”(p25) Even or especially if the health problem is rare, connecting with others who face similar challenges provides a community experience.

The researchers explore in detail how patients and caregivers, many of whom lack relevant technical training or advanced education, manage to navigate the complex demands of product development, patent application, financing, manufacturing and marketing, not to mention the requirements of the medical device approval process. Of the 14 cases studied, four were not classified as medical devices, but 10 were: five as class I, four as class II, and one as class III.

The kinds of medical devices created, which are mentioned only briefly, belie both the challenges and creativity of the inventors, as well as the wide range of what it can mean to be an engaged patient or caregiver. One of the devices is a waterproof T-shirt that allows post-surgical patients to take showers and another enables wheelchairs to be driven through snow. One is an insulin pen capable of recordkeeping and another is an inhalation device for use by children with pulmonary disease. It connects to a computerized game, adding an element of fun to treatment.

Hat tip: I learned of this paper through an online discussion forum of the Society for Participatory Medicine. e-Patient Dave deBronkart brought this paper to the group’s attention, as well as a related article in the MIT Sloan Management Review.

The MIT article shares one author with the working paper and covers similar territory, with an emphasis on the relationship between “free consumer innovation” or user entrepreneurs and commercial producers. The article discusses a patient-developed artificial pancreas as an example of an advanced solution to a real problem that was technologically possible but not offered by medical device companies. The article reports that the patient and her developer partners offer the device for free online and use open source software, which has allowed a community to develop around the solution:

This was the start of the Open Artificial Pancreas System (OpenAPS) movement.2 Today, multiple communities participate in this movement, multiple noncommercial DIY artificial pancreas designs are being shared, and thousands of individuals with diabetes use these DIY systems daily to monitor, manage, and improve their health.

Safety is a legitimate question. The authors explain that patient-developed devices, including the artificial pancreas, are exempt from regulation as long as they are not sold commercially:

Approvals for high-risk devices — such as an artificial pancreas — could take four to five years and cost $75 million.11 As demonstrated by the history of the patient-developed artificial pancreas, patient innovators (whose noncommercial activities are exempt from FDA regulation) may be able to develop and produce something in a matter of weeks or months, at very little cost.

Regardless of whether the device is a waterproof T-shirt or artificial pancreas, these user entrepreneurs are charting new territory in patient engagement with their creativity and resourcefulness.


Susan Carr Susan Carr is a medical editor and writer specializing in patient safety and engagement. In addition to curating the EngagingPatients blog, she produces publications for the Betsy Lehman Center in Boston and the Society to Improve Diagnosis in Medicine. Susan lives and works in Lunenburg, Massachusetts.

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