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Contracting co-development of a novel diabetes device
March 6, 2013
By: Mak Jawadekar
Contributing Editor
I recently returned from a trip to India where I had a chance to attend the BioAsia 2013 Conference in Hyderabad. Dr. Freda Lewis Hall, chief medical officer at Pfizer, gave a keynote address about Disruptive Innovations at work globally and how the emerging markets are tapping into these innovations and participating in applications of these innovations to garner benefits to the local patient population. While in India, I also had a chance to meet with the country’s president, Pranab Mukherjee, in Pune, where I briefly talked to him about a groundbreaking all-in-one insulin injector, glucose monitor and wireless communications system, known as 1Clik. The device was developed by Rana Arefieg of Global Innovations, based in Connecticut. President Pranab Mukherjee, along with the governor of the Indian state of Tripura, Dr. D.Y. Patil, praised the diabetes device at a private event held for inauguration of D.Y. Patil Knowledge City. The President reaffirmed the importance of innovation in his speech at the event, noting, “There is a real need for such innovative medical devices to be made available to the Indian population at affordable prices.” The 1Clik auto injector delivery system combines blood glucose tester, insulin calculator, insulin injector, and secure wireless reporting to the cloud in one easy-to-use device, keeping patients, doctors and family members informed. Key features of 1Clik include seamlessly integrating glucose monitoring, insulin injections, emergency monitoring and realtime patient information data, integrating with electronic medical records, and reducing complications from too high or too low blood sugar levels, among other factors. According to the developer’s literature: The patented 1Click is the next-generation mobile medical device initially used in diabetes management. It is intuitive and easy to use. It combines a blood glucose tester, insulin calculator, insulin injector, and secure wireless reporting to the cloud in one easy-to-use, fully automated device. Compliance sensors track successful administration. Dose lock key minimizes medication and administration errors. Emergency providers are notified when blood glucose levels are dangerously high or too low. Sensors sense the patient’s finger and automatically activate the device. All supplies are contained in one unit. The device tracks all data points and communicates with health records through cloud technology. Treatment protocols are embedded in software to deliver best in class treatments to anyone, anywhere. 1Click gives voice; visual or written instructions to assist patients avoid emergencies. Emergency notification services provide patients and care givers assurance that complications from diabetes can be safely managed. It has two measurements systems on board that must agree or the injection is aborted. One of these is an encoder built into the injection motor that feeds back the actual movement of the motor as it injects. The secondary backup is an infrared (IR) detector that visibly looks at the plunger location and verifies that the encoder reading is consistent with the IR reading. If the BG measurement results in a dosage that is less than the typical dosage for the patient by a settable percentage (can be set by the Physician and locked), 1Click will stop and give the user a warning. The user can override this if allowed (software settable) and continue. Or, if not allowed, the standard dosage will be used. Governor Patil, who is an educator, spoke directly to me about the immense potential to save lives with 1Clik and reduce the overall cost of diabetes on society, which is an estimated $100 billion per year. I had a chance to present the device during the keynote address I gave at the Pune branch of the Diabetic Association of India (DAI) conference, which was attended by hundreds of diabetes subject matter experts and key opinion leaders in both medical and technology fields. The device was very well received by the experts and is expected to change the face of diabetes management for generations to come. Some of the India-based CROs showed interest in co-development of the device for the local market, which seems quite lucrative. Also, some of the Mumbai-based CMOs showed interest in getting involved in the manufacture of the device, knowing that there is a huge diabetic population and it will really help the patients in need!
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