MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY JUNE 2014 | 33 www.donatellemedical.com We make vital devices that sustain – and save – lives. We manufacture the complex medical devices others simply can't. We tackle tough tolerances. We meet deadlines. The FDA isn't into sort-of compliance. And neither are the patients who count on us. So our team doesn't tolerate risk. We can't. And neither can yours. In the medical devices we help design, manufacture and deliver, we strive to keep our 100% track record of meeting product development dates. So, no, we don't make yo-yos. We make your medical device promise a reality. 7JTJUVTJO#PPUIBUUIF.%.&BTU4IPX +BWJUT$FOUFSo/FX:PSL$JUZ+VOF We don't make yo-yos for kids. No. 6: WellDoc You can lead patients to treatment, but you can't make them adhere to it. While mHealth and digital health promise to give patients greater-than-ever control over their health, these solutions rely on the premise that patients will actually use them. Baltimore-based WellDoc believes mHealth's greatest opportunity lies in promoting positive behavior change in patients, and it intends to prove it by attacking the Godzilla of all chronic diseases: diabetes. The company's BlueStar program uses a patient's smartphone, tab- let, or personal computer to moni- tor blood sugar and medication adherence. It also uses education and tailored coaching to encour- age diabetics to keep their glucose levels in check. Patients can track their blood sugar as well as receive recommendations on meals, physi- cal activity, and medication dosage. An FDA-approved product that provides clinical decision support, BlueStar can be prescribed to a patient just like a drug and is reim- bursed by insurers. Fortune 500 companies like Ford Motors have pledged to make BlueStar available to their employees, and WellDoc is currently working to build awareness among physicians in antici- pation of BlueStar's release to the market later this year. No. 5: Organovo Organovo has the regenerative medicine and pharmaceuti- cal worlds really excited. The San Diego company uses its 3-D bioprinter to place human cells in a particular environ- ment so that the cells begin to interact with one another and the end result is functional human tissue. Instead of relying on 2-D cell cultures or animal studies, drug companies can now use these bioprinted human cells to run clinical trials much earlier in the drug- development process to see how the human body will react. In 2013, Organovo published data on a 3-D bioprinted liver model and found that the liver tissue lasts much longer than 2-D cell cul- tures. But perhaps more importantly, the tissue began to function like normal liver tissue. It produced liver-specific proteins, such as albumin and transferrin, and biosynthesized cholesterol. As of late April, the company was signing research service contracts with pharma companies that want to use the 3-D human liver tissue technology in their preclinical drug-discovery programs. But Organovo wants to do more than just help drugmakers. The company aims to create functional human tissue that can be used to repair or replace damaged or diseased tissue, which will require it to seek FDA approval as a medical device. Image courtesy of (left) WELLDOC, (right) ORGANOVO Organovo's 3-D bioprinter could be a boon for drug discovery. WellDoc's BlueStar program aims to spur positive behavior change in diabetes patients. ES451734_MD1406_033.pgs 06.05.2014 03:19 UBM black yellow magenta cyan

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