MPMN surveyed suppliers to the medical device industry as to what they thought was the most significant breakthrough of the past 25 years within their area of expertise. Read MPMN editors' picks at qmed.com/mpmn/25years.
“The most influential thing in laser technology is happening right now: laser bonding of dissimilar materials. This provides better functionality with fewer parts. You can join polymers to metals and silicone to glass without adhesives or extra materials. This is still in the research stage.” —Henrikki Pantsar, senior engineer, micromachining, Fraunhofer USA Center for Laser Technology (Plymouth, MI).
“Stent crimping using a radiocompression mechanism made crimping even and repeatable. Previous approaches were manual and labor intensive, as well as subject to operator error.” —Ed Goff, founder of Blockwise Engineering (Phoenix).
“Miniaturization has had a tremendous impact over the past 25 years, enabling smaller features. Also, the emergence and rise of shape-memory alloys has been significant.” —Herb Bellucci, president and CEO, Pulse Systems (Concord, CA).
“The release of QSR led the industry down the path to safer and more-effective devices. It was FDA’s first attempt at design controls.”—Michael Guzzo, site engineering manager, Ethox International Inc. (Buffalo, NY).
“The ability to laser-cut nitinol tubing was a pretty big deal. This allowed design flexibility and facilitated a better fit in the anatomy.” —Alan Pelton, chief technical officer, NDC (Fremont, CA).
“Higher-end magnets allow for smaller and more-efficient motors to be used.” —Paul McGrath, regional sales manager, Maxon Precision Motors (Fall River, MA).
“ISO 13485 quality management system certification for suppliers opened the door for the transfer of OEM manufacturing/outsourcing.” —Vincent R. Pope, CEO and president, Taurus Engineering & Manufacturing Inc. (Faribault, MN).
“Polymeric synthetic fibers and the structures made with textile processing capabilities have been—and prove to be—an incredible advancement within the life sciences arena.” —Todd Blair, national sales manager, Biomedical Structures (Warwick, RI).
“The power of rapid prototyping and how it can reduce major development costs and improve design flaws. The 3-D laser scanning technologies help with the modifications of ergonomic medical device efforts.” —John Frangella, business manager, Proto3000-3D Engineering (Vaughan, ON, Canada).
“Radiofrequency technology in combination with closed-loop temperature control was a breakthrough for catheter manufacturing by providing control, higher accuracy, precision, truly validated products, and the ability to quantify all inputs.” —David Joyce, sales engineer, Vante (Tucson, AZ)
“Micromolding had an immense impact on the medical device industry.” —Cindy Dupay, marketing specialist, Donatelle (New Brighton, MN)
“Miniaturization allowed for breakthroughs in power supplies in terms of more wattage per cubic inch and allowing for smaller products.” —Peter Hines, sales representative, GlobTek Inc. (Northvale, NJ)
“The most significant advance in the medical product manufacturing industry of the past 25 years has been the availability of affordable but powerful computers. Computers have revolutionized part design and complex mold machining, increased productivity through manufacturing automation, and improved quality with finished part testing and SPC analysis.” —Dean Langadas marketing director, Quality America Inc. (Tucson, AZ)
“We have made a giant leap in the design and manufacture of energy-efficient power supplies. Twenty years ago, we didn't think much about efficiency. A system could be running at 30% to 70%, and today 85% is average and more than 90% is becoming the standard.” —Don Nasca, business development manager, Delta Products Corp. (Beaverton, OR)
“The most significant shift in focus was to disposable devices in the early 1990s and ironically now the shift back to reprocessing reusable instruments in 2010. The dichotomy between the manufacturing and design of these two types of devices is remarkable. Infection prevention and general convenience fuel the disposable device market, which tends to have a smaller profit margin, while the reusable market tends to have a higher profit margin. The differences in the manufacture and design of a low versus high profit margin item are consequently dramatic as they are at opposites of the manufacturing and design strategy spectrum.” —Cheryl L. Box, president, Mark Two Engineering Inc. (Medley, FL)
Published in MPMN, November/December, Volume 26, No. 9
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