The Journal of mHealth Vol 2 Issue 4 (August) | Page 34

Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers... Continued from page 31 crosses the line into regulated territory. Conclusion There are many general purpose IT technologies that are extremely useful in healthcare. There is nothing wrong with technology companies selling to physicians, and there is nothing wrong with physicians choosing technology to use that may require their own assessment and validation. So long as the tech company doesn’t cross the line and specifically suggest a medical device type use, FDA compliance is not required. Healthcare is finally entering the digital age. Fortunately, the law is unlikely to stand in the way of doctors and the tech companies trying to help them, so long as these guidelines are observed. About the author BRADLEY MERRILL THOMPSON is a Member of the Firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. He has served as regulatory counsel for Continua Health Alliance; as counsel to AdvaMed for payment issues; as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, and the CDS Coalition(focusing on clinical decision support software). He has been recognised by his peers for inclusion in The Best Lawyers in America© (2015) in the field of FDA Law and was recommended in the Life Sciences category by The Legal 500 United States (2014). n Innovative Sensor is a Vital Tool in the Prevention of Diabetic Foot Ulcers and Pressure Sores Diabetic foot ulcers are a major complication for patients suffering from diabetes. Through the condition they often lose sensation and feeling in the extremities, meaning that they are more prone to problems such as minor cuts, bruises or blisters. The inability to identify pain from the foot also means that these small wounds are often left unprotected or untreated, and overtime these can quickly worsen and develop into ulcers. The cost of treating diabetic foot ulcers and amputations is significant. The NHS in England spent an estimated £639 million–£662 million in 2010-2011, which accounted for approximately £1 in every £150 spent by the NHS during that period. 6,000 people with diabetes have leg, foot or toe amputations each year in England, many of which could be avoided, and around 61,000 people with diabetes are thought to have foot ulcers at any given time. These ulceration and amputation substantially reduce quality of life, and are associated with high mortality. The scale of the problem is significant and up until now there have been few options for diabetics to easily monitor their feet. Now, a new sensor technology developed by Scottish company HCi Viocare is hoping to improve the way in which diabetic foot ulcers are monitored with the development of connected wearable diabetic insoles that are designed to help diabetic patients monitor their feet and prevent diabetic foot ulcers. Low cost, ‘smart’ insole The technology, which can be incorporated directly into footwear or simply implemented using insertable insoles, uses a network of 21 inexpensive sensors incorporated into the insole to process pressure and shear data and then analyse that data in real time. The self-contained device can then connect to the wearer’s smartphone and alert them when it detects events 32 August 2015 that are of concern. The information can also be downloaded and used by doctors to track patterns of risk or remind wearers to regularly check their feet. Dr. Christos Kapatos, CTO and co-founder of HCi Viocare has led the development of the technology over many years of research and development. He describes the benefits of the innovation, “By monitoring the pressure and shear experiences of their feet in real-time, we can alert them [patients] about risky behaviour or bad footwear and if recommended thresholds of pressure, over time, are exceeded. Clinical studies have shown that as long as patients are focused on their feet and have a good management regime, they can prevent ulcers without any other intervention. We want to provide that focus. The insole is also a handy tool for blood glucose monitoring needs: it can record your activity better than with worn devices, tell you your weight and give you a much more accurate estimation of calories expended.” The company’s shear sensor measures the ‘squashing’, rather