StepAhead

An affordable, at-home therapy device to relieve diabetic neuropathy-related pain and slow down nerve degeneration to prevent amputation 

Diabetic peripheral neuropathy (DPN) is a condition resulting from damage to the peripheral nervous system due to poor blood circulation in diabetic patients, causing extreme pain in the extremities. According to the CDC, around 11.3% of the US population (37.5 million people) experience diabetes, among which 11.25 million  experience DPN and 130 thousand people undergo lower-extremity amputation. Existing treatments are predominantly over-the-counter and prescribed oral pain medication, but do not address chronic pain and often fail to alleviate acute pain due to poor blood circulation from high blood sugar. Moreover, the nerve degeneration can cause desensitization in the feet and potentially unnoticed cuts, infections, or amputation. As peripheral neuropathy is often chronic due to sustained nerve damage, rehabilitation devices must be focused on preventing further nervous decay and long-term pain management. A variety of therapies, such as electrical stimulation (E-stim) and infrared light (IR), have shown promising results in these aspects, but access to these therapies is currently limited due to the high cost and inconvenience of visiting a physical therapist. We have developed a device that detects early onset of diabetic neuropathy, using customizable novel physical therapy techniques that can be used outside a clinical setting. 

Our solution is a wearable device that utilizes electrical stimulation (E-stim) and Infrared (IR) light to reduce nerve pain while stimulating nerves to prevent further deterioration and amputation. Therapies can be programmed by their therapists with an app, laddering in both the intensity and location of therapies for optimal at-home pain-point targeting. We anticipate that individuals with DPN will use this wearable to alleviate pain and make sustainable rehabilitative progress.

Specifically, the device is a slipper-like wearable that patients can put their feet in for about 10-15 minutes a day to receive IR therapy from above the feet and E-stim at customized intensity, frequency, and location at the bottom of the feet. Both therapies have been scientifically proven to reduce nerve pain and nerve damage. IR therapy is based on a sheet of IR lights, while E-stim is based on an array of electrodes in the sole that can send small and safe amounts of electrical pulses to the feet. 

In addition, since diabetic neuropathy patients often have trouble carrying out intricate actions around their feet like tying shoe laces due to sensitivity in the feet, the slipper shape of the device makes it very easy to use the device since the user only needs to sit down and slip their feet inside. This, combined with the app that can control the device, will optimize user experience and improve compliance.

Our solution was designed as a preventative measure for diabetics to stay updated on their physical condition. The device elements, from the user-friendly mobile app to an ergonomic slipper, were developed for intuitive use for anyone with experience using a smartphone. Most diabetics are underserved due to high medical costs using insulin regulators and pumps and frequent visits to providers.   

Our team consists of five seniors in Bioengineering at the University of Pennsylvania- Rowan, Nadia, Helen, Mikey, and Dante. All of us have technical experience in circuitry, mechanical design/CAD, programming, and other engineering skills through our coursework. Many of us have been working together for multiple years now, and we function as an organized, driven, and communicative team. Each of us has different experiences and interests outside of bioengineering - including coding, data science analysis, mechanical engineering, and consulting - that have shaped our solution, and allowed for an interdisciplinary perspective. For example, we have leveraged the additional business background and connection to the M&T program and resources to conduct analysis on the appropriate price and expected returns of our solution. The decision to target diabetic peripheral neuropathy was one close to home, as members of the group have family members and loved ones with diabetes. Witnessing the constant pain and frustration with lack of appropriate treatments and care inspired our product’s design.

We have researched specific problems and needs of our target population (DPN patients), novel and effective treatments, and the optimal physical design of the final product by exploring the existing literature. Our most impactful research, however, has been in our conversations with healthcare providers and current patients. To the best of our ability, we have worked to ground our solution in the recommendations and needs of those who interact with DPN on a daily basis. Nurses and physical therapists have offered insight into innovative therapies that are perhaps not as popular on the current market. As we continue to develop and prototype, we will maintain our user-centric attitude by pitching a series of looks-like and feels-like prototypes to target groups. Their feedback and attitudes towards our product will determine the final form. 

Our solution provides a significantly improved treatment option for diabetic neuropathy over current treatments. 

Current solutions to diabetic neuropathy include three classes of treatments. The first class is to continue to monitor and control the progression of diabetes and take oral pain medications as needed. However, with the inherent nature of diabetes to limit a patient's blood flow, the ability for medications to reach the feet is often hindered. This creates results in delivery issues and ultimately, a lack of efficacy. Instead, our product use light therapy and electrical stimulation to offer pain relief, which can be achieved significantly faster and is less dependent on patients’ blood flow.

The second class is through physical therapy, where a variety of techniques including heating, E-stim, IR, and tactile therapy, are carried out at physical therapy locations. Accessing physical therapy can be challenging for patients for reasons such as distance, time, and money. There do exist separate E-stim and IR devices that individuals can purchase, but these lack localization or specificity to diabetic neuropathy. Our solution offers at-home customizable E-stim and IR at a low cost to overcome the issues of compliance and cost of traditional physical therapy.

The last class of treatments includes spinal cord stimulation. While spinal cord stimulation is currently the most effective pain mitigation method, it is highly invasive and involves implanting a device in the spine that blocks pain signals from reaching the brain. Not only is this expensive, but there is the additional potential for adverse complications such as infection, pain at the implantation site, and loss of therapy efficacy over time. Therefore, we did not pursue this therapy.

In summary, our solution is a non-invasive, affordable, and easy-to-use at-home device that can provide some of these effectiveness therapies traditionally only accessible through clinics in a convenient and customizable way. These features will improve compliance and accessibility, thereby improving the quality of life and prognosis of diabetic neuropathy patients. The programmability of the therapies through the app can also bridge physical therapists with patients and reduce the amount of healthcare burden in society. 

Our impact goal for this year is to optimize the ergonomic mechanical design and circuitry of our product in 1 month and start testing the device on a healthy population and those with DPN. The product will be easily reproducible, allowing us to send samples to healthcare professionals and discuss with them ways to start testing the product on patients to evaluate its effectiveness. The non-invasiveness of the therapies and proven safeness will ensure that risk of harming users is minimal.

The core technology that powers our solution is simple and low-cost, as described in the accessibility design specifications of our product. The app component is designed using Flutter and Bluetooth connection, and will be accessible via the Apple App Store. The therapies provided use simple circuitry- for IR therapy, a diode board and for TENS therapy, a driver board emitting low-voltage square waves. These are powered by a rechargable USB, which holds enough power for a week of use. Fabric electrodes exist at an interface with a rubbery, comfortable, and hygenic sole design. 

We have not yet launched our product, but in this coming year we plan to make at least 200 copies of the device to give to physical therapists for distribution to patients and follow up with these therapists or the patients directly to get their feedback and evaluate the effectiveness of our product. 

In order to bring our device to a completed form, two main barriers need to be overcome. Firstly, in order to avoid typically high abandonment rates of rehabilitative devices, many rounds of prototyping with intensive user input must be performed. This requires financial support for purchasing of various high-quality and sustainable materials for the user interface. Secondly, we need to reach more users. This also poses a financial challenge, as we would need to begin to reach networks that are further away, posing transportation costs. In order to create a truly accessible design, we need to ensure we are interviewing patients across many demographics. This can pose a cultural barrier, as we need to create a sense of trust with members of communities we don't necessarily belong to. 

University of Pennsylvania Stephenson Lab 

For our business model, we plan to keep the development of our mobile application in-house as well as the design of future iterations for our wearable hardware. When ready for scaling, we plan to partner with a manufacturer when it comes to mass production of our hardware. They will be a key partner for us given that they have an already established manufacturing pipeline. We plan to target patients both directly and through their physicians, this means developing a strong relationship with physicians is essential. We believe we can do this by sharing sample products with them and incorporating their feedback into the designs of our device. Overall our device provides patients with access to novel DPN pain mitigating techniques outside of the clinical setting. We plan to use a complex revenue model where the device can be prescribed by a physician and covered by an insurance provider or purchased directly on its own by a patient.

Currently we are applying for different grants and competitions and using these funds to move our project forward. As we progress forward, we plan to seek out dilutive funding from potential angel and VC investors. After we have a product launch on the market, we will see revenue returns on the products we sell.