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30 Years of Milestones That Mattered for Medtech

  • 1985

    • Michel Mirowski (right) and Morton Mower (left) show off an early automatic defibrillator prototype.
       
    • 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 first cochlear implant, was approved by FDA.
  • 1986

    • Introduction 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 Notification Review Program. Casually referred to as the “Mohan Memorandum,” the document helped establish the criteria for substantial equivalence behind the 510(k) regulatory pathway.

    Shown above are promotional materials for the Activitrax

  • 1987

    • Deep-brain electrical stimulation system debuts after Alim-Louis Benabid (pictured) of the University of Grenoble implants a deep-brain electrical stimulation system into a Parkinson’s patient.
  • 1989

    • Point of care ultrasound debuted in the ICU by Daniel Lichtenstein.
       
    • Microfluidics takes off after lab-on-a-chip research accelerates thanks the efforts of European researchers who develop micropumps, flow sensors, and lay the groundwork for integrated microfluidic treatment systems.
       
    • Nitinol gains a foothold in the industry after FDA approves nitinol-based Mitek Surgical Products’ Mitek anchor. (Nitinol image from Lenore Edman.)
  • Other 1980s Milestones

    • Endoscopy takes off, with the U.S. market for endoscopic products hitting $533 million by 1988.
       
    • 3-D printing makes inroads after the first 3-D printed solid models were made in the early '80s and the stereolithography received patent protection in 1984.
       
    • MRI and CT technology become more common in hospitals, eventually reaching widespread adoption by the 2000s. (Shown above is the team who worked on the first whole-body MRI scans. Image courtesy of Sir Peter Mansfield.)
       
    • Rapid prototyping makes inroads in the industry.
       
    • Laser direct writing processes take off.
       
  • 1994

    • First stents debuted in 1994 in the United States and become commonplace soon thereafter. Shown here is an early Cordis stent.
       
    • Debut of European Union’s regulatory system for medical devices
       
  • 1995

    • MEMS technology becomes prevalent in the med device field.
       
    • FDA clears the way for the first use an excimer laser for photorefractive keratectomy. By 1999, FDA had formally approved LASIK eye surgery. Above is the excimer laser used in the first LASIK surgeries. 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

  • 1998

    • The first robot assisted heart bypass operation takes place, under the guidance of Ralph Damiano, MD.
       
    • PEEK manufacture gained steam in the 1990s, enabling the material be used for a growing number of medical implant procedures—especially in orthopedics 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.
  • 1999

    • Bluetooth debuts, which later became a commonly used wireless protocol used in the medtech and consumer industries.
  • Other 1990s Breakthroughs

    • Lithium-ion batteries catch on in medtech.
       
    • Application-specific 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 modified Tecan lab robot proved successful at performing tasks such as culturing and harvesting bone marrow and other tissues. Robots also finds extensive use in prosthetics and rehabilitation.
       
    • Luer alternatives debut in the mid-1990s. The image of a traditional luer fitting and a luer alternative provided by Value Plastics.
  • 2000

    • Craig Venter and Francis Collins of the National Institutes of Health announced the mapping of the first human genome.
       
    • FDA clears Intuitive Surgical’s da Vinci robot for some procedures. Shown here is the Si model of the da Vinci robot.
       
    • 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.”  
       
    • The early 2000s also saw cardiac catheterization’s growth in popularity. “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!” Czuba says.
  • 2003

    • After the first drug-eluting stent, the sirolimus-eluting Cypher stent debuted in Europe in 2002, the first drug-eluting stent was approved by FDA in 2003. The stent was enabled by a durable drug delivery polymer matrix coating from SurModics (Eden Prairie, MN).
  • 2004

    • Medtronic launches world’s first digital pacemakers, according to trade group LifeScience Alley in Minnesota. Founder Earl Bakken developed the first external battery-operated wearable pacemaker in 1957.
       
    • Graphene, everyone’s favorite wonder material, was discovered by Andre Geim and Konstantin Novoselov.
       
    • The first adaptive artificial knee debuts. Known as the Rheo knee, the plastic artificial knee adapts to a patient’s walking style and changes in terrain. It was developed by Össur Corp.
  • 2007

    • 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. Stem cell treatment image courtesy of Wikipedia.
       
    • FDA ends ban on silicone breast implants.
       
    • MIT physicists demonstrate a highly resonant wireless power transfer. It was able to send 60 W over a distance of 2 m at high efficiency. Since then, medical device designers have turned to the technology to potentially recharge LVADs, pacemakers, and other devices through the skin.

       
  • 2000s Milestones

    It certainly didn’t seem to have much to do with medical devices when it first hit the scene in 2007, but Apple’s iPhone is arguably one of the most significant medtech milestones in the first decade of the 21st century. 

    The first FDA-cleared apps would follow several years later (the AgaMatrix iBGStar was one such product), and it wouldn’t be long before the term mHealth (mobile health) would become a buzzword, as a steady stream of smartphone-powered health technologies were developed.

    “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 for personalized medical device 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.”  

    Read on to find out about more milestones in the new millenium.

  • 2008

    • Demand for antimicrobial materials begins to grow following CMS’s announcement that they would no longer reimburse hospital-acquired infections, like MRSA (pictured here).
  • 2011

    • First transcatheter valve (Edwards’ Sapien) approved.
       
    • First bioabsorbable stent is approved in Europe.
  • 2015

    • FDA approves first system of mobile medical apps for continuous glucose monitoring. Shown here is DexCom's G4 Platinum continuous glucose monitoring system.
  • Greatest Medical Devices of All Time

    Qmed surveyed its audience about their thoughts on what are the most important medical devices ever developed. We've compiled a slideshow of the top 12 items here, including recent innovations as well as those with roots stretching back hundreds of years.

    We also ask, out of these 12 finalists, which do you find the most important?

    Continue >>

  • 1980s Milestones

    The 1980s were the decade when microprocessors broke into the implantable medical device field, fueled by the arrival 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.

    Curiously enough, one device that did not have a microprocessor right away was the first implantable cardioverter defibrillator, developed in the early 1980s by a team that included Michel Mirowski, Mir Imran, Stephen Heilman, Alois Langer, Jack Lattuca, and Morton Mower. Imran who is presently founder, CEO, and chairman of San Jose, CA–based InCube Labs, told Qmed last year that FDA at the time had never approved a software-operated implantable device.

    “They thought it would be dangerous. They thought there would be no way to test the reliability of the code,” Imran said. The first-generation implant, then, was engineered to be almost completely analog. “We had a very simple, analog telemetry system.”

    Read on to find out about more milestones from the decade. 

    Image of Intel 8051 from CPU collection Konstantin Lazet, posted on Wikimedia Commons 

  • 1990s Milestones

    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.

    In 1991, the first patient with a battery-powered, implanted left-ventricular assist device (shown above) leaves the hospital. Thermo Cardiosystems Inc. and the Texas Heart Institute developed and tested the device.

    Read on to find out about more milestones from the decade. 

  • 1988

    • The FDA becomes an agency of the Department of Health and Human Services thanks to the Food and Drug Administration Act of 1988.
  • 2013

    Microfluidics advances start to make their way into diagnostics. Theranos (Palo Alto, CA) opens its first 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, and do it faster and cheaper than a standard lab.

  • 2010

    • GE launches the Vscan, a pocket-sized ultrasound system.
       
    • Barack Obama signs Patient Protection and Affordable Care Act, better known as “Obamacare,” into law. (Image from Flickr).
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