By Dr. Lars I.E. Oddsson, PhD.
In a previous blog post I wrote about a Low-Tech solution to improve balance function. Today is about a High-Tech Solution. Every other day we read about a new wearable coming to market, not to mention bullish research reports about the expected market growth of wearables. These are interesting times indeed! Technology is constantly becoming better, faster, smaller, cheaper and simpler. Improved battery technology, the emergence of MEMS sensors, faster low-power microprocessors, 3D printers and other new tools are helping designers come up with new exciting technologies. And I know there is even more to come!
Meet “Medical Grade Wearables”
With regards to Wearables, I want to 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”. So what are the differences between Medical and Consumer Grade Wearables? Both of these categories may fit under the broader rubric of “Digital Health”. BUT, Medical Grade Wearables would be considered medical devices which are regulated by the FDA, and therefore subjected to higher standards of scrutiny – (MUCH higher) for manufacturing, safety and efficacy. Consumer Market Wearables are typically (all else being equal) “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 harder, a lot more expensive and takes a longer time. I predict we will be seeing a lot more about “Medical Grade Wearables” going forward and I think these technologies have the potential to change healthcare as we know it and for the (MUCH) better.
Early Wearables Development
Let me tell you a about a Medical Grade Wearable that I am involved with that should soon enter the market on prescription basis! Going back to the beginning nearly 15 years ago, this was purely a research project in my lab, the Injury Analysis and Prevention Lab at the NeuroMuscular Research Center at Boston University. Yes, 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. This was not wearable but it worked! The first wearable prototype we built was enclosed in a foot-long Tupperware box and programmed in assembly language. NOT user friendly but still a proof of concept. However, 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. Today, technology is sufficiently advanced for this to occur.
“Walkasins” – A Wearable Sensory Prosthesis
Walkasins are a wearable sensory prosthesis to replace lost foot pressure sensation in patients with peripheral neuropathy who have balance problems. Walkasins are developed by RxFunction Inc., a Minnesota-based start-up company funded by a grant from NIH. I am President, co-founder of the company and co-inventor of the technology. We have put together a GREAT team of experts from the rich Minnesota medtech ecosystem helping to move Walkasins to market. Walkasins consist of a thin shoe-sole insert that measures pressure under the foot reflecting the person’s state of balance. Sensory information in the form of gentle vibrations are delivered to the skin through a strap worn around just above the ankle. The user learns to interpret the vibration signals to control balance, it becomes a “new” balance sense. A subgroup of patients with peripheral neuropathy who experience balance problems and have sufficient sensation just above the ankle will benefit from using the device. Once registered with the FDA, Walkasins should become available on a prescription basis.