‘Made in India’ Medical Device to Prevent Global Problem of Diabetic Foot Amputation

According to the World Health Organization (WHO), India had 69.2 million people living with diabetes in 2015. By 2030 it is expected to touch 100 million. Known as a silent killer, diabetes is a chronic metabolic disease caused by reduced insulin produced by the body. People with poor control over their blood sugar risk disease or damage to eyes, heart, kidney and other organs.

A lesser monitored yet widely prevalent complication of chronic diabetes is nerve damage or neuropathy, which affects the feet. The person does not feel; hence does not notice an injury. The injury does not heal, turning into an ulcer. If untreated, this leads to gangrene, and requires amputation, ranging from toe to entire leg. This creates disability, deteriorates functional independence and further aggravates the diabetic condition.

There is a diabetic foot amputation in India every few minutes, as per some estimates. These can be prevented by holistic examination of the feet, diagnosing the condition early, and taking proper care. The examination includes checking the perception of touch, vibration and temperature stimuli applied to the foot sole of patients. These tests are subjective – relying on the perceived response of patients, and hence need to be repeated.

Dr. Rajani Mullerpatan, Director of the Centre for Human Movement Science (MGMCHMS) at the MGM Institute of Health Sciences, Navi Mumbai noticed that the foot sole of diabetic patients is stiffer compared to normal patients. She hypothesized that a single device for objective testing of foot sole stiffness will replace several existing tests and help in mass screening and monitoring the foot complication.  She approached the Biomedical Engineering and Technology incubation Centre (BETiC) in IIT Bombay with a concept design to develop a novel device early detection of diabetic neuropathy. The team developed several versions with clinical input from MGMCHMS Team.

Nishant Kathpal, an IITB student who developed the latest version of the portable diabetic foot screener, declined an offer from blue chip company Intel to commercialise the product. He incubated a company called Ayati Devices in SINE, the business incubator of IIT Bombay. His team won the coveted Biotechnology Ignition Grant of Rs. 5 million from BIRAC, New Delhi. The funds are being put to good use, for pilot batch production, as well as clinical trials in MGM and other hospitals. The latest version of the product was launched on 2nd October 2019.

Nishant explains “Our device has a short plunger that presses the foot sole and measures the reaction force, to obtain the stiffness value. The device is fully automatic and can be connected to a mobile phone to visualize the results. These are categorized as green (safe), orange (borderline) and red (diabetic foot condition). The screening takes less than two minutes, compared to over 15 minutes by other products in the market. Early detection of diabetic foot neuropathy condition will enable more effective treatment, preventing millions of such foot amputations worldwide.”

The device is slated for testing on a large number of patients with diabetic neuropathy to generate objective data to create the three categories, which will be mapped against normative values from healthy people with diabetes

According to Dr. Rupesh Ghyar, Senior Executive Officer of BETiC, the device has successfully passed mechanical and electrical safety tests carried out in accredited regional test labs, in accordance with prevailing international standards. It has also received a no objection certificate from CDSCO, New Delhi, which regulates the manufacturing and marketing of pharmaceutical drugs and medical devices in India.

The team recently won the best IoT Healthcare Innovation award at the IOT Congress 2019, in Bangalore. They are also showcasing the device at Go Global India Program at London on 1st December. In February 2020, the device will be presented at Swissnex Academia Industry Training Workshop in Switzerland and Advanced Technologies & Treatments for Diabetes Conference in Spain. This is yet another ‘Made in India’ medical device that has potential to become a global success story.