Year In Review: The Top Medtech Storylines Of 2013

By Jim Pomager, Executive Editor

As we close the books on 2013, it’s time to reflect on the year that was in the medical device industry — partly just to reminisce, but also to see if there are any lessons to learn as we prepare to enter 2014. I took some time to review the most popular content from Med Device Online over the last year, as well as my notes and recollections from industry events, conversations, etc., and boiled it all down to 8 key storylines/trends. Here’s what I came up with (including plenty of links for further reading):

1. 3D printing frenzy. Easily the year’s most talked-about technology in the medical device industry (and many others), 3D printing promises to facilitate customization, foster innovation, and enable the fast and inexpensive fabrication of everything from prosthetics to living tissue and organs. As I pointed out in my article 4 Reasons Why 3D Printing Will Revolutionize The Medical Device Industry, it seems like not a week goes without a report of some new medical miracle being accomplished through 3D printing. While the technology is certainly overhyped to some degree, and may never replace traditional manufacturing in the production of certain medical devices, it’s a natural fit for other biomedical applications, which market researcher Atin Angrish reviewed in a recent guest column for MDO.

2. Building better organs. One of the most exciting applications for 3D printing is in the fields of biomaterials and regenerative medicine. In 2013, researchers reported meaningful advances in the 3D-printing of things like human liver tissue, skin, and miniature kidneys; replacement bone materials; bioartificial cartilage; and riboflavin-based implant materials. Even without the help of 3D printing, regenerative medicine yielded lab-grown lung cells, intestinal cells, a miniature pancreas, and even beating human heart tissue during the year. No less interesting and important were advances made by artificial organs, including FDA approval of Second Sight Medical’s bionic eye and Medtronic’s artificial pancreas, and continuing progress on the first bioprosthetic heart, among other breakthroughs.

3. Cybersecurity of networked medical devices. The proliferation of networked medical devices and mobile health (mHealth) technologies over the last several years has given rise to a new challenge for device makers — keeping their products (and patients and caregivers) safe from hackers, malware, and other unauthorized access. I wrote about the particular set of headaches associated with protecting wireless implantables, though the risk extends well beyond pacemakers and insulin pumps. The FDA is taking the issue so seriously that in June it issued a cybersecurity safety alert to medical device manufacturers and hospital networks, along with draft guidance on addressing cybersecurity issues in premarket submissions. The agency also has final cybersecurity guidance near the top of its list of priorities for 2014.

4. FDA releases final UDI guidance (among others). Speaking of final guidance, the FDA finally published its final rule for the national unique device identification (UDI) system in September. The rule will require most medical devices to carry a unique identifier on their label and packaging, and in some cases on the devices themselves, by next year at the earliest (Class III devices) and 2018 at the latest (Class I devices). Read FDA's New UDI Rule: What Device Makers Need To Know for more on the rule’s requirements, and what you need to do to prepare. CDRH issued other guidance related to more niche topics in 2013, including mobile medical applications, radio frequency wireless technology, investigational device exemptions (IDEs), and others. (Here’s a preview of the guidance docs the FDA plans to publish next year.)

5. That pesky medical device tax. Much to the dismay of medical device manufacturers and advocacy groups alike, it looks like the medical device excise tax provision of the Affordable Care Act will survive its first year of existence. House Republicans tried to get the tax repealed as part of federal budget negotiations back in September, but the tax emerged unscathed. However, there is bipartisan support for repeal of the 2.3 percent tax, which is expected to generate nearly $30 billion in revenue for the government — or cost medtech companies $30 billion in revenue, depending on how you look at it — over the next decade. More reason for optimism: The most recent budget deal, which passed the House and is close in the Senate (at the time of this writing), re-opens the door to a possible repeal.

6. Medical robots — the good and the bad. Robotic surgery giant Intuitive Surgical found itself on the defensive for a good portion of 2013, in the wake of bad press and regulatory scrutiny. The company had to endure: a journal article questioning robotic surgery’s value relative to cost for hysterectomies, an FDA investigation into surgeons’ experiences with its da Vinci system (indicating mixed reviews), and a Class II recall label for da Vinci’s instrument arm. Yet, hospitals persisted in implementing and using robotic platforms — for surgery, telepresence, and other applications — and researchers in developing them, in several cases based on International Space Station technology. (Related, Stryker made headlines in September when it announced it was purchasing MAKO Surgical for $1.65 billion.)

7. Quest to create the next great non-invasive diagnostic device.  There were a ton of developments in the field of non-invasive diagnostics in 2013. One of our most most-read news stories of the year was about a group of German researchers who devised a spectroscopic technique for measuring blood sugar in skin cells with light. Another popular story was about a pair of glasses that will enable doctors and nurses to see a patient’s veins beneath the skin, using multispectral imaging. There were also two types of “electronic skin” designed to continuously monitor pulse and temperature (by Stanford and University of Illinois researchers, respectively). And who could forget about Qualcomm’s $10 million Tricorder XPRIZE competition, whose official roster of teams was announced last month?

8. BRAIN takes center stage. In April, President Obama announced the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, a public/private collaboration aimed at mapping the activity of every neuron in the human brain. The research project’s goal is to devise technologies that will advance our understanding of the brain, and ultimately lead to treatments for Alzheimer’s, Parkinson’s, autism, and other neurological disorders. Meanwhile, progress continued in the development of novel devices and techniques for addressing such conditions, with several neurostimulators (from Medtronic, St. Jude, NeuroPace, and others) nearing or reaching the market in 2013, and with continual strides being made in the area of optogenetics (using light to modify brain activity).

That’s my list. Do you agree or disagree with my selections? What would be on your list? What can we learn from these storylines and trends as we enter 2014? Please post your feedback in the Comments section below.