MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, March/April 2015

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Q M E D . C O M / M P M N 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 M A R C H / A P R I L 2 0 1 5 2 1 1997 The FDA Modernization Act of 1997 is signed into law to Improve the eff ciency of the 510(k) process. 1998 The f rst robot assisted heart bypass operation takes place, under the guidance of Ralph Damiano, MD. 1999 Bluetooth debuts, which is now a commonly used wire- less protocol in the medtech space. Other Lithium-ion batteries catch on in medtech. Application-specif c integrated circuits (ASICs) gain a foothold in the med device industry. Nanotechnology gains steam as researchers begin to investigate the notion of manipulating matter at the molecular and atomic scales. The use of robotics gains momentum in medtech. A modif ed Tecan lab robot proved successful at perform- ing tasks such as culturing and harvesting bone mar- row and other tissues. Robots also f nds extensive use in prosthetics and rehabilitation. Luer alternatives debut in the mid-1990s. 2000s It certainly was not viewed as a medical device when it first hit the scene in 2007, but Apple's iPhone is arguably proving to be a significant medtech milestone for the 21st century. "Docs use iPhones (far, far more so than any other brand) for everything from healthcare apps to sending texts, and even for making phone calls, iPads for viewing medical images and probably medical records, and so forth. This has decentralized the workflow, as docs can now be anywhere rather than in front of a dedicated workstation," says Steve Axelrod, CEO of G-Tech Medical, which is developing a wireless "EKG for the gut" patch. Smartphones are proving to be a powerful interface, Axelrod says. "Apps can be used for lightweight things like calorie or step counting; for general, canned medical advice from an app or website; for connections to doctors ... rather than going into an office (including using the camera on the phone to send the doc an image); and for interfacing with the sensing hardware in real medical devices, like we're building." Micromolding medical device parts, which started in the mid-1990s, became all the rage in the early 2000s, according to Czuba."The growth followed (or led – depending on your perspective) the movement in the device industry to make things smaller, less intrusive and 'minimally invasive.' The industry combined good new materials, processed in reliable molding operations that produced parts that could be assembled with such precision that even small items and instruments were both safe and effective." Apple even recently unveiled its ResearchKit for medical and health research apps. Czuba notes that the early 2000s also saw the growth in popularity of cardiac catheterization. "We started with infusion catheters that could be threaded to the heart, then balloon catheters, then stenting catheters, and now a whole host of functional mechanical catheters that can perform all sorts of procedures, including the latest: heart valve replacement on beating hearts!" Other milestones in the new millenium include: 2000 Craig Venter and Francis Collins of the National In- stitutes of Health announced the mapping of the f rst human genome. FDA clears Intuitive Surgical's da Vinci robot for some procedures. 2002 The Medical Device User Fee and Modernization Act of 2002 passes, enabling FDA to collect user fees to support its review activities. 2003 After the f rst drug-eluting stent, the sirolimus-eluting Cypher stent debuted in Europe in 2002, the f rst drug- eluting stent was approved by FDA in 2003. 2004 Graphene, everyone's favorite wonder material, was discovered by Andre Geim and Konstantin Novoselov. The f rst adaptive artif cial knee debuts. Known as the Rheo knee, the plastic artif cial knee adapts to a patient's walking style and changes in terrain. It was developed by Össur Corp. 2006 Stem cell technology advances after two research groups develop a liver grown from stem cells and learn how to convert human skin into stem cells. FDA ends ban on silicone breast implants. 2007 It would have been hard to know in 2007 that the iPhone, which launched that year, would have much to do with the medtech industry. But the f rst FDA- cleared apps would follow several years later, and it wouldn't be long before the term mHealth (mobile health) would become a buzzword. MIT physicists demonstrate a highly resonant wire- less power transfer. Since then, medical device de- signers have turned to the technology to potentially recharge LVADs, pacemakers and other devices through the skin. 2008 Demand for antimicrobial materials begins to grow following CMS's announcement that they would no longer reimburse hospital-acquired infections, like MRSA. 2010 Barack Obama signs Patient Protection and Afford- able Care Act, better known as "Obamacare," into law. 2011 First transcatheter valve (Edwards' Sapien) approved. 2012 FDA clears AliveCor's iPhone-based ECG—part of a steady stream of smartphone-powered health technolo- gies. Shown above is the Android-based version. 2013 Microf uidics advances start to make their way into diagnostics. Theranos (Palo Alto, CA) opens its f rst in-store sample-collection location at a Walgreens pharmacy near its headquarters. The company says it can perform a "full range" of lab tests on a single drop of blood. 2015 FDA approves f rst system of mobile medical apps for continuous glucose monitoring. 1994 1996 2011 2012

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