Suzanne Malinowski developed foot drop in her left foot in 2008 at the age of 36 as a result of degenerative disc disease and spinal stenosis. Although back surgery relieved the compression, the foot drop was permanent. She founded the New England Foot Drop Center and, in April 2016, was accepted into TREAT’s Commercialization Assistance Program.
Q: Tell us about the assistive technology device you are developing.
The MyQuest soft AFO (ankle foot orthosis) is a soft brace that provides walking assistance for foot drop. Foot drop is a condition characterized by the difficulty or inability to lift the front portion of one or both feet during walking due to nerve damage, muscle disorders or neurological conditions causing weakening or paralysis of the muscles in the lower leg. With limited or no ability to raise the front of the foot or the toes, foot drop is compensated for by lifting the foot higher than normally necessary when walking to avoid tripping over the toes. Some type of AFO brace is recommended for walking to keep the foot/ankle at a 90 degree angle during swing phase of the step. Without wearing any type of brace, mobility is greatly decreased, tripping/falling hazards are present and, over time, compensatory walking patterns can cause back, hip, knee, ankle, and foot issues and injuries.
There are many reasons people don’t like wearing braces. Over the course of five years, several orthotists provided me with different in-shoe brace solutions. For me, I experienced pain after a couple of hours of walking, had braces break and experienced increased muscle spasms. With these braces, it was necessary to wear a shoe that is one full size larger than normal and 2E wide. Since I have foot drop in my left foot only, my options were either to purchase two different size shoes or wear the larger size on both feet, so I went with the latter. While it may not seem like a big deal to have limited footwear options, when you have to dress up for work every day or go to events and these are your only shoe options, your desire to go diminishes. Your desire to do any of the things you used to or try anything new diminishes and affects your overall quality of life.
I was never a big shoe person; however, it was unacceptable that these were going to be my shoe options for the rest of my life. I tried out soft brace designs not covered by insurance only to find that none of them worked well enough for me. And so, the challenge began to make a brace that worked for my needs.
Q: What types of assistance did you receive from TREAT? Was there anything unexpected or surprising in what TREAT advisors recommended?
There are many facets to commercializing a medical device and TREAT advised me on the steps necessary to achieve my goals. This included developing a business model, strategic business goals and objectives, validating the desire/need for this type of product and making the product as user friendly as possible. They also discussed industry literature, FDA registration, insurance, reviewed financial projections, etc.
The TREAT organization asks the questions necessary to make sure you, as a product developer and business owner, have thought through why you have made the decisions you have.
Q: Having been immersed in the commercialization process for a while now, what advice would you give someone with an assistive or rehab technology device idea who is just starting out?
For those who have an assistive or rehab technology device idea, my advice would be to keep an open mind. We all get attached to our vision and sometimes struggle with accepting new ideas; however, remember that any changes recommended by TREAT are in the best interest for your product’s success. For me, I found the recommended changes were positive. I felt as though I had partners that took a vested interest in the product’s and business’ success. With TREAT’s assistance, I am more confident than ever that I have done all that I can to make this a great product. This experience has been invaluable.
I have been testing/wearing the MyQuest soft AFO brace full time for three years now. I couldn’t be more satisfied with the end result and now have a closet full of fabulous shoes. I am excited to bring this new brace to market. The MyQuest soft AFO will be available for sale in 2017. Please visit www.nefootdropcenter.com for more information.