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MDI Professor Shares Experience Bringing Medical Device Concept to Market | Technological Leadership Institute

Posted on
April 20, 2017
Two photos of Walkasins - one of the device and one being worn by a woman

Every other day we read about a new wearable coming to market, not to mention (often frivolous) research reports about the expected incredible market growth of wearables. Technology is constantly becoming better, faster, smaller, cheaper and simpler. Improved battery technology, the emergence of MicroElectroMechanical Systems (known as MEMS sensors), faster low-power microprocessors, 3D printers and other new tools are helping designers come up with new exciting technologies.

With regards to wearables, I make an important distinction between “consumer market wearables” (which is what we have mostly seen to date) and the emerging category of “medical grade wearables.”

Both of these categories may fit under the broader rubric of “digital health” or “m-health”. However, medical grade wearables would be considered medical devices regulated by the FDA, and which are therefore subjected to higher standards of scrutiny; much higher, in fact, when it comes to manufacturing, safety and efficacy.

Consumer market wearables are typically “easier” to bring to market quickly. Don’t get me wrong — bringing any product to market is hard, but bringing a medical device to market is even harder, a lot more expensive and more time consuming. I predict we will be seeing a lot more about “medical grade wearables” going forward as these technologies have the potential to change healthcare as we know it and for the better.

One such medical grade wearable is a prosthesis, namely a sensory prosthesis I have been working on for patients who experience balance problems due to peripheral neuropathy. This is a condition that affects millions of patients with diabetes as well as patients who have undergone chemotherapy that often leads to peripheral neuropathy. It started about 15 years ago as a research project with a grad student of mine in my former lab, the Injury Analysis and Prevention Lab at the NeuroMuscular Research Center at Boston University. (We were working on wearables back then before it was even considered a category!).

Initially, we demonstrated the concept of this technology with a desktop PC, a force platform and motor vibrators. The first wearable prototype we built was enclosed in a foot-long Tupperware box, programmed in assembly language and not very user-friendly. What we conceived and built for use in a research lab setting could not at the time be manufactured as a user-friendly practical wearable device.

A focused effort to commercialize this technology began in 2010 when I co-founded RxFunction Inc., a Minnesota-based medical device start-up company funded by a Minnesota angel investor, an SBIR grant from the National Institutes of Health (NIH) and a LOT of sweat equity. Years after our initial invention and first proof-of-concept prototype at BU, we have designed the wearable sensory prosthesis known as Walkasins, and I am both President and co-founder of the company.

Walkasins are designed to replace lost foot pressure sensation in patients with peripheral neuropathy. The wearable consists of a thin consumable shoe-sole insert that measures pressure under the foot, reflecting the person’s state of balance. Sensory information in the form of gentle vibrations is delivered to the skin through a strap worn just above the ankle. The user quickly learns to interpret the vibration signals to control balance, resulting in a “revived” sense of balance. The device produces near immediate and continued long-term improvement of gait and balance function, providing a unique solution to promote safe patient mobility and reduce the risk of falls and injuries. Patient comments such as, “I felt like I knew where my feet were,” “Walkasins were “soothing and relaxing,” ”Gave me more confidence. I felt stronger,” and “Felt less like a drunken sailor,” are common and very gratifying to hear!

Thanks to the incredibly rich medical technology ecosystem in Minnesota, we have been able to put together a team of experts helping move the device to market. Walkasins is a Class II 510(k) EXEMPT device meaning that FDA premarket notification is not required. Manufacturing, however, must occur under a quality system, the device must be correctly packaged, labeled and be listed with the FDA. Once registered with the FDA, Walkasins will first become available on a prescription basis.

Minnesota is one of the best places in the world for bringing a medical device to market and the M.S. in Medical Device Innovation program at the Technological Leadership Institute is a wonderful “short-cut” to learning what entrepreneurs may have learned over a lifetime!

Success, however, still requires plenty of passion, patience and perseverance combined with networking, outreach, great teamwork, a good deal of luck and a chunk of guts — as well as some level of knowledge, experience and expertise. Knowing what you know and what you don’t know, as well as knowing where to find what you need to know, is crucial. It is an exciting, frustrating, humbling, scary, happy, sad and rewarding journey all at the same time! But if it helps patients, it’s all worth it. And just maybe, it will also pay off financially.

Photo credit: RxFunction, Inc.

About the Author

Photo of Lars Oddsson

Lars Oddsson, PhD

TLI Faculty

Minnesota is one of the best places in the world for bringing a medical device to market and the M.S. in Medical Device Innovation program at the Technological Leadership Institute is a wonderful “short-cut” to learning what entrepreneurs may have learned over a lifetime!

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