MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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6 | JULY 2016 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? On the Cover: Design by John & Sundaresan Images courtesy of ANDREI TSALKO TARIKVISION/ iSTOCKPHOTO.COM 18

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