From GlaxoSmithKline’s big bet on bioelectronic medicine and the rise of precision medicine to the FDA approval of the world’s first “artificial pancreas,” med tech has had quite the year. But one company has captivated the public’s—and our readers’—consciousness for better or worse: blood-testing startup Theranos, helmed by black-turtlenecked college dropout Elizabeth Holmes.
The Silicon Valley upstart burst onto the scene with a star-studded advisory board and the big promise that it could perform all sorts of diagnostic tests on just a few drops of blood. Early on, the company achieved a valuation as high as $9 billion and inked a partnership with Walgreens that served as an early validation of its tech. But the house of cards came tumbling down this year, after a Wall Street Journal report highlighted problems with the company’s proprietary blood-testing tech last fall and federal agencies started investigating.
Three of 2016’s most-read stories center on Theranos. The Centers for Medicare & Medicaid Services handed down sanctions, including a ban on Holmes owning or operating the Newark, CA, lab for two years. At Theranos’ first—and much anticipated—presentation at a scientific conference, Holmes unveiled a totally new tabletop blood-testing device instead of detailing the technology behind the company’s existing product. And finally, a San Francisco-based hedge fund, one of the company’s major backers, sued Theranos for securities fraud.
While the Theranos saga was like a manual for how not to launch and run a med tech company, Holmes did manage to spot where the diagnostics industry wanted to go: decentralizing tests and reducing the amount of blood needed.
Yet, despite the uproar surrounding Theranos and the murky science behind its flagship product, our most popular story this year was a cartilage-based implant that could potentially replace metal and plastic hip implants.
The tech, cultivated at Washington University in St. Louis and Cytex Therapeutics, bridges biotech and med tech: It involves growing new cartilage using a patient’s own stem cells on a biodegradable scaffold molded into the shape of the patient’s joint. It is then implanted onto the surface of an arthritic hip, potentially delaying or eliminating the need for hip replacement surgery.
Another top story surrounded bioelectronic medicine, which uses electrical impulses to induce the body to heal itself from illness. Researchers seek to eventually use bioelectronic implants alongside drugs, or to replace them altogether. GlaxoSmithKline has been leading the charge, having established a bioelectronics division in 2012, and betting big on a $715 million joint venture with Verily to develop the nascent technology. But while there’s a lot of buzz around the tech, the Big Pharma doesn’t plan to test third-party devices until next year and won’t debut its own bioelectronic device until 2019.
2016 was a big year for diabetes, with devicemakers inking deals to integrate patient-generated data, help patients better manage their condition and apply cognitive computing to diabetes data in the hopes of improving treatment. But the pinnacle of diabetes innovation this year came when the FDA approved Medtronic’s hybrid closed-loop system, the first “artificial pancreas" to be approved anywhere.
The system, which continuously measures blood glucose beneath the skin, automatically regulates background insulin via an infusion patch. While the device is the first of its kind to receive approval, Medtronic counts it as another step toward its ultimate goal of a fully automated closed-loop system.
Readers had been awaiting the “artificial pancreas” approval with bated breath. While the Sept. 28 approval story came in at No. 6, the June 30 story announcing Medtronic’s PMA submission of the device was almost as popular, taking the No. 10 spot. Dexcom sneaked into the No. 9 spot on the news that an FDA panel was leaning toward a positive opinion on using data from its G5 continuous glucose monitor to administer insulin without confirmatory fingersticks. While FDA approval for this indication is still pending, Health Canada gave Dexcom the go-ahead earlier this month.
M&A rumblings round out the rest of the reader-selected news. While a number of top devicemakers have been active on the M&A front--Stryker, Medtronic and Becton Dickinson come to mind—the two stories that made it into the top 10 were Thermo Fisher’s rumored $30 billion bid for Illumina, which was our second most-read story this year, while Abbott mulling the divestiture of its medical device business to Terumo for $1.5 billion took the third-place spot.
As you may have noticed, FierceMedicalDevices underwent a makeover this year, folding into the FierceBiotech umbrella and adopting a new schedule. But whatever the changes, our mission is still to deliver the most pertinent med tech news to you, our readers. Did your favorite story make it into this year’s top 10? Let us know! 2016 has been an exciting year. Let’s make 2017 even better.