Medtronic Develops DIY Artificial Pancreas and Files IPO for Its Diabetes Business

In recent years, the term “DIY Healthcare” has frequently appeared in major industry journals and newspapers both domestically and internationally. So, what exactly is DIY Healthcare? In the internet era, it can be understood as users employing wearable devices or medical apps to manage their own conditions via smart devices, or sharing self-collected medical data with healthcare professionals. According to a report by The Wall Street Journal in early May, Medtronic has enabled DIY capabilities for its medical treatment devices.

Medtronic, a Dublin-headquartered medical device company, has designed an artificial pancreas using OpenAPS (the Open Artificial Pancreas System). This artificial pancreas comprises an insulin pump, a computer motherboard, and a battery pack. The insulin pump is connected to a small radio communication stick that continuously monitors glucose levels. (The insulin pump is a pager-sized computer that delivers precise doses of hormones through small tubes inserted under the skin.) The DIY artificial pancreas automatically administers specific doses of insulin based on the patient’s blood glucose levels, thereby lowering their blood sugar. Furthermore, its size can be varied to facilitate portability for patients.

Medtronic is the world’s largest independent medical technology development company. In 2015, when Medtronic acquired Covidien, its market valuation reached $100 billion. Currently, Medtronic operates in more than 140 countries worldwide, employs over 86,000 people, and holds 53,000 patents.

As early as 2014, the chairman of Medtronic proposed prioritizing the development of the artificial pancreas. In March this year, the company completed device testing and planned to initiate clinical trials in June. In fact, Medtronic has been continuously developing Automated Pancreas Systems (APS), and the U.S. Food and Drug Administration (FDA) has supported the prioritized development of such technologies. Currently, several companies are developing APS technology; however, regulatory agencies have delayed the approval process, resulting in a relatively slow pace of APS technological advancement.

Currently, more than 50 patients have begun using DIY artificial pancreas systems based on this design. For instance, Dana Lewis, a patient with type 1 diabetes, built her own device in October 2014. Since then, her blood glucose levels have remained within the safe range, and she no longer needs to wake up at night to check them.

However, some experts have questioned its legality. To date, the U.S. Food and Drug Administration (FDA) has not authorized any physician or institution to use DIY artificial pancreas systems. Fortunately, however, the FDA lacks the authority to prohibit such practices as long as individuals do not sell these DIY artificial pancreas devices.

According to the Chief Medical Officer of Medtronic’s Diabetes Division, the company still has a long way to go before obtaining FDA authorization, with DIY artificial pancreas systems expected to become available in 2017.