MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, November/December 2015

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M e d i c a l P r o d u c t M a n u f a c t u r i n g n e w s q m e d . c o m / m p m n 4 n o v e M b e r / d e c e M b e r 2 0 1 5 6 need to Know it turns out manmade silk that is stronger than steel is closer than we think. 8 BIomedevice San Jose the december conference will bring together industry luminaries to share their knowledge on a wide range of topics. 10 Special Feature: Software some blame design failure—in particular, software design failure—for a rise in medical device recalls. 14 Special Feature: Top products & Services discover the medical device products and services that caught our eye the most this year. 20 Spotlight tubing 21 Special Feature: Software linux is gaining ground in the medtech sector. Here are six reasons why. 22 Special Feature: Sensors the cardioinsight ecvue vest has sensors integrated throughout, probing the heart through a patient's chest and back. 24 engineering Insight: Which U.S. State Is Best for medtech? what's the truth when it comes to the united states' three major medical device hubs? and are other states catching up? 4 editor's column 26 classifeds 26 advertisers index 20 14 You hold in your hands what is the last print issue of MPMn. we would like to thank you for your readership and for your commitment to helping make the world a better place through medical technology. the editors of this magazine, however, are not leaving. we will be redoubling our efforts to cover the medical device industry and relevant technological breakthroughs online. if you haven't already, we encourage you to regularly check out the editorial content on and to also sign up to get the Qmed daily newsletter at, where you can read such features such as: ■ 5 ways to Kill innovation in Your company innovation-your-company ■ which u.s. state is best for Medical device companies? best-medical-device-companies ■ How a doctor saved a child with a Macgyver Medical device doctor-saved-child-macgyver-medical-device ■ 10 antique Medical devices to Make You Happy it's 2015 medical-devices-make-you-happy-its-2015 medtech pulse, a blog written by the editors of MPMn, addresses emerging technologies, industry reports, supplier news, and research developments in the medical device industry, enabling you to stay abreast of developments as they happen. go to connect with us on LinkedIn and on twitter at and! in tHis ISSUe "we want to get new technology to patients as quickly as possible. first in the world is a good measure for that," says cdrH director Jeffrey shuren, Md. speaking in october at the transcatheter cardiovascular therapeutics conference in san francisco. shuren stressed that the agency still has the same standards for ensuring the safety and effcacy of medical devices, but that it is working hard on improving its medical device ecosystem. "this is not a competition. we are not in a race with europe or anywhere else," he said. "but if there is good technology, we do want to have it come out frst." that may seem like an especially ambitious goal given the agency's regulatory standards, which are some of the strictest in the world. this often translates into a need for device sponsors to generate considerable evidence in order to get a device approved. that in turn leads to high costs and and years of work on the part device companies. a signifcant number of medical device developers have either fed the united states or have decided to not consider the u.s. as part of their initial product launch strategy. "so for us the solution is: can we suffciently reduce the time and cost to bring product to the market such that innovators view our market favorably without compromising our standard of reasonable safety and effcacy?" shuren said. shuren stated that the agency has already made signifcant progress in 2014 and 2015, when it identifed signifcant regulatory cost and time drivers, and worked to address them. for instance, cdrH has worked with industry to make clinical trials less expensive and more effcient, shifting some data collection from pre-market to post- market, and providing "excellent customer service." if the agency can better understand the needs of industry, they are more likely be able to make better regulatory decisions and, quite possibly, help them identify a more streamlined pathway to market. in addition, cdrH is looking to reduce the regulatory burden for many device classes. in the agency's review of medical device types thus far, approximately 30% of device types reviewed were eligible for shift to down classifcation, which shuren says translates into less burden for the device sponsor. shuren also touted the agency's expedited access Pathway Program for breakthrough medical devices. the agency has received 19 requests for this program so far. one of the agency's next initiatives is to have greater engagement with its customers— both with industry and with patients— especially the latter. "our vision starts with patients. they are truly the focus of what we do. our basic mission is basically improving the health and the quality of life of patients," shuren says. in his summary, shuren called for industry to be more involved in collaborating with cdrH. "we have great partners, but we need more people to be engaged. ultimately, we rise or fall together." fda wants to be first 6 editor's coLUmn on tHe WeB voluMe 31 nuMber 6 EditoR-in-chiEf

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