EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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newstrendsanalysis 8 | Summer 2015 European Medical Device Technology emdt.co.uk How Apple's ResearchKit Could Support Device Makers in Conducting Clinical Trials ResearchKit is used with Apple's iPhone for real-time access to an individual's health data, such as weight, blood pres- sure, glucose levels, and asthma inhaler use. ResearchKit can also access the iPhone's accelerometer, microphone, gyroscope, and GPS sensors to gain insight into a patient's gait, motor impairment, fitness, speech, and memory to test and monitor diseases such as Parkinson's. "It is already happening to a large degree," Greg Caressi, senior vice president, healthcare and life sciences, for Frost & Sullivan, told European Medical Device Technology. "Device makers are creating products that can be used by con- sumers in their homes to support remote- monitoring applications." The main feature of ResearchKit, how- ever, is to support companies carrying out clinical trials and healthcare professionals collecting information from individuals on a much larger and more efficient scale on a daily basis than they could in the past, according to Caressi. "Rather than fill- ing out paper forms or showing up at the research center once a week, month, etc., individuals that are part of the subject pool for a trial can report information electroni- cally via their own device," he said. "This will enable collection of more frequent (and theoretically more accurate) data to support research by pharma and medi- cal device companies, as well as academic medical centers. Remote-monitoring devices that might be used to check a patient's biometrics can automatically be uploaded and transmitted to researchers, which creates better data than patient- entered logs often used in trials, or less frequent readings taken in clinical settings when patients come in."Apple is just begin- ning to form partnerships with research organizations, which already include the American Heart Association, ULCL Jons- son Cancer Center, Weill Cornell Medical College in conjunction with to Mount Sinai in NY, and other academic medical centers, while numerous other research partners and private firms will likely use Research- Kit in the future, Caressi said. However, there is a potential disadvan- tage: The pool of several-hundred-million iPhone users who could potentially use ResearchKit do not necessarily form a sufficiently diverse demographic group for research purposes. "Drawbacks are the requirement to use an Apple smart phone or tablet, which limits the patient pool," Caressi said. "However, the possibility of skewing results to a less diverse set of users is offset by the wider pool of subjects you can now draw on, however. Eventually, these tools could be used to both recruit individuals into trials more rapidly and to expand the reach of trials to those outside of limited geographic areas where patients are near research centers (big hurdles and costs in running trials), as well as in collect- ing better data and more frequent data that will help understand trial results sooner and with more accuracy." Apple is obviously betting that Research- Kit could help boost its iPhone and other device sales. "Apple would like to see this drive device sales, as researchers could even purchase devices to send to patients in a kit with other remote-monitoring tools as part of the trial," Caressi said. Other device makers will likely follow Apple's lead. Already, Qualcomm Life and Novartis have formed a similar partnership. More medical device makers will almost inevitably seek more opportunities to design devices that "communicate wire- lessly to a smart phone, which acts as a transmission hub to relay information back to clinicians or remote patient-monitoring services providers," Caressi said. Research- ers in the United States have already announced ResearchKit projects. —Bruce Gain

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