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Delay in Commercialization of Artificial Pancreas Compels Patients to Build their Own Devices

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Published on : May 09, 2016

Necessity is the mother of invention. Medical device manufacturing companies and regulatory authorities have failed so far in introducing a robotic or artificial pancreas in the market. As a result, patients are following instruction online to create home-built devices to monitor glucose levels on real-time basis. These closed loop systems have been long known as devices to automatically dose the hormone insulin according to the blood sugar levels in type I diabetes patients. However, no medical device company has been able to introduce the device in the market as it has not been approved by regulators even though the Food and Drug Administration (FDA) has made it a priority to approve such devices. 

Medtronic Expects to Get Approval for Artificial Pancreas by 2017

Rather than waiting for commercial development and long approval process of robotic pancreas over a prolonged duration, many of the tech savvy patients are taking it as a do-it-yourself project. The FDA too cannot have a say in the development of these closed loop systems by patients as long as they do not sell or distribute them. In America, over 1 million patients are suffering from type I diabetes which is an autoimmune condition with the pancreas stopping the production of insulin. In artificial pancreas, an algorithm can optimize insulin dosage by processing the blood sugar data generated in a span of every five minutes by a sensor placed in the subcutaneous layer of the skin. Medtronic has completed a trial regarding the device and has submitted it for regulatory approval. Johnson & Johnson is working on a clinical trial regarding the efficacy of the device developed by the company. Medtronic hopes that its device will get approved by the next year. For home-built robotic pancreas, users have to assemble the system on their own and that includes expertise on software programming. Hence, it would be easier for patients if medical device companies get faster approval from the regulatory authorities to commercialize the device.