Getting a Leg Up in Orthopedic Device Development

Recognizing the need for a better technology to help strengthen the foot and ankle muscles, Scott Rogoff, PT, DPT, OCS, a physical therapist at St. Jude Medical Center in Fullerton, Calif., decided to develop his own solution to the problem. As someone who suffered from his own injuries in that region, he was quite attuned to the lack of offerings for that specific area of the body. Orthopedic Design & Technology spoke with Rogoff about his invention, how it compares to other offerings in the sector, and the development process with his manufacturing partner.
 
Sean Fenske: Why did you develop a new rehab device for ankle injuries? What was your inspiration?
Scott Rogoff: I developed my Dynamic Ankle Rehabilitation Training (DART) device to make it more convenient and accurate for patients of all kinds to strengthen their weaker, complex ankle muscles in the clinic or at home. Performing accurate and effective global ankle strengthening (especially at home) has been a long standing rehab issue for those who have had ankle/foot injuries; I have personally had to deal with this type of problem. My inspiration was simple—to make it better for patients and their clinicians to have more success with the rehabilitation process regarding ankle strength and functional deficits.
 
Fenske: What are the issues with current offerings?
Rogoff: The issues with current devices that I have seen is that few are in clinics, and even fewer are in people’s homes because they are either too expensive, put the patient in poor positions, don’t allow for consistent accuracy of movement, and simply are not as effective as needed in isolating the specific anterior, medial, and lateral muscles of the lower leg. Strengthening of the gastrocnemius muscle (generically referred to as the calf muscle) is by far and away the easiest to treat, so it is not the primary concern of DART. DART can also be used for assisting in range of motion and proprioceptive concerns, as needed.
 
Fenske: How does your device stand apart from what’s already available?
Rogoff: DART stands apart from other devices because it positions patients more comfortably to perform these exercises, stabilizes the lower extremity more effectively to reduce compensatory motions, provides accurate angles of resistance, is user friendly for clinic or at home, and is cost effective.
 
Fenske: Could your device be altered to be used for other joints?
Rogoff: In some ways, yes, DART can be altered to support rehabilitation of other joints. Some ideas are already in the works. But the foot-ankle complex is unique in its movements and thus tends to stand alone (no pun intended).
 
Fenske: How did you find out about The Innovation Institute?
Rogoff: I found out about the Innovation Institute after speaking with St. Jude Medical Center CEO and President, Lee Penrose. I personally spoke with him while at an awards ceremony in early 2013 and informed him of my idea that I was working on. I asked if he knew of anyone or any companies who could help me bring my idea along to higher ground, and he immediately mentioned the Innovation Institute. He personally emailed Joe Randolph, Larry Stofko, and myself, and we were then able to schedule a meeting and gradually move forward since then.
 
Fenske: How did they help you with the development of your device?
Rogoff: The Innovation Institute’s Innovation Lab has been extremely professional and supportive throughout the process, including evaluation of the clinical and market opportunity and evolution of the concept and design. They have helped provide strong feedback and engineering support to help design different versions of DART to create a market-ready product based on feedback received from the medical community. They have also managed patent prosecution throughout the product development process and will begin marketing the product to industry partners as the design is soon to be finalized.
 
Fenske: What has been your overall impression of the development of a medical device?
Rogoff: My overall impression of the development has been great. We have made tremendous strides in the prototype’s specifications and continue to do so. The process simply takes time, consideration of global feedback, effective assessment, and evidence supported testing.
 
Fenske: What challenges have you encountered?
Rogoff: We have had a few challenges with design as well as patent considerations, but it is not uncommon to have these types of challenges and it will not prevent us from achieving our outcomes and goals. We have continued to address specificity with angular resistance setup based on biofeedback muscle testing to ensure ideal isolation of muscles during movements. We are very clear in our direction and are close to our ideal prototype design.
 
Fenske: Where do you currently stand with the technology and what’s your next step?
Rogoff: Our technology is simple at the moment—to keep this product cost-effective—but this device could have blossoming technology that could be added to it in the future.
 
Fenske: Where is this headed? Do you foresee a market launch?
Rogoff: Our hope is to see a market launch in the upcoming year, but it is still dependent on certain outcomes with our prototype testing and IP considerations.
 
Fenske: Care to make a final comment on your project?
Rogoff: I am simply excited to see this device come to market and be used in the rehab and medical community, as I know it can be a very beneficial and convenient tool for millions of people.
 
Get more information about Rogoff’s project via the following video.