MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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30 | JUNE 2014 Agents of Change in Medtech No. 11: The Wyss Institute at Harvard University The Wyss Institute for Biologically Inspired Engineering at Harvard University is working on a wide array of mindboggling projects that could transform life on the planet from a medical and environmen- tal perspective. The institute, which has offices in Boston and Cam- bridge, MA, is a collaboration of researchers at Harvard, the univer- sity's affiliated hospitals, Boston University, Tufts University, and the University of Massachusetts Medical School. One project involves 3-D printed artificial cardiac tissue called MeTro hydrogels that could someday be im- planted in patients who have suffered a major heart attack instead of sub- jecting them to a heart transplant. Another project is the Biospleen, a blood-cleansing device that can radically alter the way sepsis is treated globally. The device mimics the human spleen and could be used as an extracorporeal therapeutic device that flows blood in a closed system similar to a dialysis machine. Magnetic nanobeads coated with a specially engineered immune system pro- tein are introduced into the blood to capture and bind bacterial, viral, or fungal pathogens. The magnet pulls the particles bound to the con- taminating microbes from the flowing blood, and the cleansed blood is then returned to the patient. A physician doesn't need to know the cuase of the blood infection to administer the therapy. A third initiative is exploring infant sleep apnea and hypoxia, or insufficient oxygen supply to tissue in babies that are premature. Researchers at the Wyss Institute and the University of Massachusetts Medical School have developed an infant sleep apnea mattress that can provide gentle stimulation to a baby's body, which regulates respiration without disturbing the sleeping infant. The technology also incorporates sensors and computer processors to predict when an apneic or hypoxia event might occur. No. 12: Shared Clarity No. 10: Hackers As more and more connected devices hit the market, device mak- ers, hospitals, and consumers alike are overlooking one important fact: Any device connected to a network is vulnerable to attack. And when you're talking about medical technology, cybersecurity literally becomes a matter of life and death. By now most device makers should be well aware of Jay Radcliffe's 2010 hack of an insu- lin pump, in which he triggered it to re- motely release lethal doses of insulin. But more recent events like the widespread HeartBleed bug, one of the biggest threats ever to Internet security, should be a wake-up call. Online data is vulnerable, and medical data is some of the most valuable data of all. Even if the Radcliffe scenario seems far-fetched, think of how much personal and sensitive patient information is stored in electronic health records and connected medical devices. FDA has issued a draft guidance calling for device makers to be more cognizant of cybersecurity issues and to conduct more secu- rity testing before devices hit the market. A report release in April by SANS-Norse called the overall state of cybersecurity "alarming" and said that current legislations such as HIPPA and the HITECH Act are insufficient in terms of informing healthcare organizations on how to secure themselves. Medtech is lagging behind other industries in its cybersecurity efforts, and the industry as a whole seems to be deemphasizing pri- vacy and security issues. It won't be long until every device is con- nected in some way and the only way to ensure a device is truly safe and effective is to make sure it is also truly secure. Image courtesy of (right top and bottom) POGONICI/KYKYPY3HUK/iSTOCKPHOTO.COM, (left bottom) WYSS INSTITUTE, HARVARD UNIVERSITY Two major issues have belatedly emerged in the medtech world: cost and comparative effectiveness of medical devices. But no one has definitively answered the question of which devices work best in any given clinical category and, therefore, are the ones hospitals should use and payers should reimburse. Until now. SharedClarity, a Phoenix-based startup backed by insurance behemoth UnitedHeath, is trying to disrupt the hospital purchas- ing business while helping providers and payers identify products that work. Current members of the startup are Dignity Health; Advocate Healthcare; Baylor, Scott & White Health; and McLaren Health Care. Physicians from these member health systems review clini- cal literature on medical devices and respond to surveys about those devices, all with the goal of selecting clinically better prod- ucts among similar devices. The data is then passed on to Optum Labs, UnitedHealthcare's research and innovation division, for review. If a consensus is reached, then the SharedClarity sourcing group helps members strike purchasing agreements with manu- facturers of the products that came out on top in the clinical re- view. If not, a more customized comparative effectiveness study is done that harnesses UnitedHealth's claims data as well as device data before a final conclusion can be reached. In March, SharedClarity announced that it was doling out the first contracts in the drug-eluting and bare-metal stents space to Abbott and Medtronic. Boston Scientific's stents didn't make the cut. The Biospleen, developed at the Wyss Institute, could revolutionize treatment of sepsis. ES451729_MD1406_030.pgs 06.05.2014 03:19 UBM black yellow magenta cyan

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