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Medical Product Manufacturing News, March/April 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 2 0 M A R C H / A P R I L 2 0 1 5 SPECIAL FEATURE: LOOKING BACK T o commemorate MPMN's 30th year anniversary, we are providing a summary of milestones relevant to the industry from 1985 to the present. Included in the list are engineering-related items as well as noteworthy medical devices. 1980s The 1980s were the decade when microprocessors broke into the implantable medical device field, fueled by the development of the Intel MCS-51 (commonly referred to as the 8051) in 1980. All of a sudden, it was possible to run algorithms, perform updates, and much more, recalls Bill Saltzstein, president of Code Blue Consulting (Seattle). Back then, Saltzstein worked on cardiographs at Hewlett Packard, where microprocessors allowed the devices to "do more than just put out squiggles." There was a bit of a Wild West feel back then; schools weren't producing many computer science engineers yet. "I'd say the microprocessor has been key to the last 30 years of medical devices, at least electronic," Saltzstein says. Other milestones from the decade include: 1985 A robot called the Unimation Puma 200 placed a needle for a brain biopsy under CT guidance—one of the early milestones for robot-assisted surgery. The Nucleus Mini22, the f rst cochlear implant, was approved by FDA. 1986 Debut of the Tripartite Biocompatibility Guidance for Medical Devices, a groundbreaking document that would ultimately be replaced by ISO 10993. FDA approves a rate-responsive pacemaker known as Activitrax from Medtronic. FDA releases the Blue Book Memorandum, Premarket Notif cation Review Program. Casually referred to as the "Mohan Memorandum," the document helped establish the criteria for substantial equivalence behind the 510(k) regulatory pathway. 1987 Deep-brain electrical stimulation system debuts after Alim-Louis Benabid of the University of Grenoble im- plants a deep-brain electrical stimulation system into a Parkinson's patient. 1988 FDA becomes an agency of the Department of Health and Human Services thanks to the Food and Drug Administration Act of 1988. 1989 Point of care ultrasound debuted in the ICU. Microf uidics takes off after lab-on-a-chip research accelerates thanks the efforts of European research- ers who develop micropumps and f ow sensors, and lay the groundwork for integrated microf uidic treatment systems. Nitinol gains a foothold in the industry after FDA ap- proves nitinol-based Mitek Surgical Products' Mitek anchor. Other Endoscopy takes off, with the U.S. market for endo- scopic products hitting $533 million by 1988. 3-D printing makes inroads after the f rst 3-D printed solid models were made in the early '80s and the ste- reolithography received patent protection in 1984. MRI and CT technology become more common in hospitals, eventually reaching widespread adoption by the 2000s. Rapid prototyping makes inroads in the industry. Laser direct writing processes take off. 1990s The 1990s saw the arrival of stents, LASIK, and nanotechnology. Researchers raced to map the human genome. Important U.S. laws related to FDA were passed. And by the end of the decade, Bluetooth had arrived. PEEK manufacture gained steam in the 1990s, enabling the material be used for a growing number of medical implant procedures—especially in orthopedics (think spinal cages) and trauma applications. The uptick in PEEK manufacturing, and the rise of other promising medical device materials such as ultra- high-molecular-weight polyethylene, were partly able to take place because of Congress' passage of the Biomaterials Access Assurance Act in 1998, says Len Czuba, president of design firm Czuba Enterprises (Lombard, IL). This law was important because it protected bulk suppliers of medical device materials from lawsuits. "What that did ultimately was open up the door for the materials suppliers to begin to do their research on implantables, and expanded the materials that are available for use," Czuba says. Additional milestones for the decade include: 1991 The f rst patient with a battery-powered, implanted left-ventricular assist device leaves the hospital. Ther- mo Cardiosystems Inc. and the Texas Heart Institute developed and tested the device. 1992 The Medical Device Amendments of 1992 in the United States establish a single reporting standard for user medical device facilities, manufacturers, and distributors. 1994 First stents, launched by Cordis, hit the market in 1994 in the United States and become commonplace clinically soon thereafter. European Union's regulatory system for medical devices debuts. 1995 MEMS technology becomes prevalent in the med device f eld. FDA cleared the way for the f rst use of an excimer la- ser for photorefractive keratectomy in 1995. By 1999, FDA had formally approved LASIK eye surgery. Today, it is the world's most popular elective procedure, with more than 28 million LASIK procedures performed worldwide, according to the American Academy of Ophthalmology. ISO 10993 debuts, establishing well-known guidelines for biocompatibility. 1996 FDA approves anterior interbody spinal cages. Most cages are used for anterior lumbar interbody fusion (ALIF). MPMN has seen plenty of amazing developments over its 30 years of existence. Everything from PEEK to the smartphone has helped spark medtech innovation. Chris Newmarker and Brian Buntz of Milestones That Mattered for Medtech 1989 1980

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