MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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6 | JULY 2016 mddionline.com XX Contents Cover Story 20 | What's Behind Medtech's Recall Epidemic? Medical device recalls hit an all-time high in 2014, and nearly a third of manufacturers experience multiple recalls for similar reasons. JOSHUA R. DIX, SURAJ RAMACHANDRAN, AND DARIN S. OPPENHEIMER Features 24 | Regulatory Developments from the First Half of 2016 FDA and other global regulatory bodies have been busy so far in 2016. MARIE THIBAULT 26 | Transitioning to a New ISO Standard Here's what you need to know about the ISO 13485:2016 update. BART REITTER 28 | It's Time to Rethink Your Cybersecurity Strategy Healthcare enterprise systems can be especially hard to secure against cyberattacks. ADAM HESSE 30 | Medtech Takes on Zika As fears about the mosquito-borne disease rise, the industry is responding with new diagnostics. CHRIS NEWMARKER Up Front 7 | From the Editor 10 | NewsAnalysis Heavyweight partners race to develop next-gen CGMs. Details on Medtronic's robotics platform. Columns 14 | Washington Wrap Up Physicians are identifying flaws in regulatory oversight of medical devices and publicizing their findings. JIM DICKINSON 16 | Product Development Insight An industrial designer's new concept for opioid overdose treatment. MARIE THIBAULT 18 | First Person These experts see bundled payments in orthopedics as an opportunity. MICHAEL ABRAMS AND GORDON PHILLIPS 38 | Inside Look Procyrion envisions its Aortix device as a less invasive approach that would keep heart failure patients ambulatory. MARIE THIBAULT Resource Planning Center 32 | Eye on Suppliers Connectors adapt to calls for smaller sizes and greater density. FRANK VINLUAN 34 | Products and Services The latest in components, equipment, services, and supplies, with a focus on motors and motion control. 37 | Advertisers Index 37 | Marketplace 24 14 July 2016 Volume 38, Number 7 These Threats Can Take Down a Device Company Defaults at medical device companies are relatively rare but have been occurring with more frequency in recent years. What can device companies learn from history? mddionline.com On the Cover: Design by John & Sundaresan Images courtesy of ANDREI TSALKO TARIKVISION/ iSTOCKPHOTO.COM 18

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