10 medical device industry stories you need to know (Medical Design & Outsourcing)


10. Changes at the top

Omar Ishrak Medtronic Miles White Abbott

Medtronic CEO Omar Ishrak (left) and Abbott CEO Miles White (right) are both exiting the corner office at their respective companies next year. [Images courtesy of Medtronic and Abbott]Omar Ishrak is preparing to retire from Medtronic’s corner office next year. Geoff Martha, already promoted to company president this year, will become the new CEO. Read how Ishrak transformed Medtronic into the world’s largest medtech operation.

Meanwhile, Miles White will step down from the CEO position at Abbott (NYSE:ABT) on March 31 after 21 years at the helm, but will remain with the company as executive chairman. Robert Ford, currently Abbott’s president and COO, will become the company’s 13th CEO. Medical Design & Outsourcing will have an article about White’s legacy posting in early January.


9. A robot revolution in the ortho surgery space

Stryker Mako robot-assisted surgery orthopedic device ortho devices medical device

[Mako knee robot image courtesy of Stryker]Stryker’s success with its Mako robot-assisted surgery platform has other orthopedic device companies hastening to enter the space. Stryker’s big competitors — Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet and Smith & Nephew — have either launched or are preparing to launch their own robots. And Medtronic has big plans for robot-assisted spine surgery.


8. Leadership changes at FDA

Dr. Stephen Hahn

The U.S. Senate recently confirmed Dr. Stephen Hahn — previously CMO at Houston’s M.D. Anderson Cancer Center — as the new commissioner of the FDA. He’s the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April.

The FDA continues to look at ways to reform the medical device regulation process amid heightened media scrutiny, including including the International Consortium of Investigative Journalists’ “Implant Files” articles and the Netflix documentary “Bleeding Edge.” The agency, for example, has released draft guidances for the first four types of devices it will evaluate under its expedited Safety and Performance-Based Pathway to 510(k) clearance.


7. Lack of preparation for MDR/IVDR

Europe E.U. MDR

[Image courtesy of Google Satellite]With only months to go before the EU’s new Medical Device Regulation takes effect, many medical device companies are struggling to meet the deadline, and Europe’s medtech trade association is accusing government authorities of dragging their feet.

Biotronik, meanwhile, announced in September that it was the first medtech manufacturer to receive MDR certification for a Class III (highest risk) medical device.


6. The U.S.-China trade war

U.S. China trade war medical device industry suppliers

[Image by art director Matt Claney]Under President Donald Trump, tariffs have become a go-to negotiating tactic with other countries, including close U.S. allies such as Canada and the European Union. In late May, Trump threatened to levy them against Mexico over illegal immigration; had he followed through, it could have been a serious situation for the U.S. medtech industry as many companies increasingly manufacture south of the border.

No trade dispute, however, appeared to be as deep and long-lasting as the confrontation between the world’s two largest economies. If the tariffs actually make a country great again, it might be Malaysia, Vietnam or Costa Rica, global medical device industry suppliers told Medical Design & Outsourcing over the summer.


5. Federal court prepares for trial of former Theranos CEO Elizabeth Holmes

A federal judge has ordered the FDA and the Centers for Medicare & Medicaid Services to produce documents pertinent to the government’s criminal case against former Theranos CEO Elizabeth Holmes and president Sunny Balwani, which is expected to go to trial in 2020.

Holmes and Theranos were once Silicon Valley darlings, with Holmes claiming that her company was set to revolutionize blood testing with technology that could analyze tiny amounts of blood. Investigative reporting, though, soon dismantled the claims Holmes was making about Theranos’ technology, raising questions about whether she and others had misled investors. The downward spiral culminated in the 2018 shutdown of the company, with the SEC criminally charging Holmes and Balwani over what it described as a “massive fraud.” Theranos has become so infamous in the public imagination that other companies seeking to innovate in the blood testing space now have a higher bar when it comes to proving their technology.


4. Just 18% of executive roles held by women

Less than a fifth of the executives at the 100 largest medical device companies are women, according to an analysis of Medical Design & Outsourcing’s annual Big 100.

And only three companies on the list have a female CEO: B. Braun Melsungen, Insulet and Paul Hartmann.


3. Permanent repeal of the medical device tax

President Trump on Dec. 20 signed off on spending bills that included a permanent repeal of the 2.3% medical device excise tax. providing the medical device industry a win that it has sought for nearly a decade. The tax was part of the Affordable Care Act of 2010 and was one of a number of funding mechanisms meant to help pay for the health reform. But the medtech industry argued that the tax limited jobs and innovation

Device companies over the years achieved temporary suspensions of the tax through Congress — but never an outright repeal, until now.


2. EPA moves closer to stricter regulation of medtech ethylene oxide sterilization

Ethylene oxide

The EPA is requesting comment on available control technologies for reducing EtO emissions and on developments in practices, measurement, monitoring, processes and control technologies for the sterilant. With EtO currently the major method for sterilizing plastic medical device parts — and implementation of alternatives potentially years away — medical device companies could potentially face major extra costs going forward. Communities across the country have become alarmed over local sterilization plants using carcinogenic EtO.


1. Competition heats up in the robot-assisted surgery space

Medtronic robot-assisted surgery system

Medtronic’s investigational robot-assisted surgery system includes a tower, surgeon console, surgical end effectors, and robotic arm carts [Image courtesy of Medtronic]Medtronic (NYSE:MDT) this year unveiled its much-awaited Hugo RAS system, which the world’s largest medical device company touts as more flexible and cost-effective than systems presently on the market. Medtronic’s goal is to achieve U.S. 510(k) clearance in roughly two years.

Johnson & Johnson (NYSE:JNJ), meanwhile, announced that it was purchasing the remaining stake in Verb Surgical — following what J&J described as a successful strategic collaboration with the Alphabet (NSDQ:GOOGL) life sciences unit Verily. J&J’s Ethicon subsidiary in February inked a $3.4 billion deal to pick up surgical robotics pioneer Dr. Fred Moll’s newest robotic surgical play, Auris Health, and its FDA-cleared Monarch platform.

Meanwhile, the dominant player in the soft tissue robotic surgery space — Intuitive Surgical (NSDQ:ISRG) — isn’t resting on its laurels. Its da Vinci SP robot for single-port surgery has a tube that is about an inch wide and delivers fully articulating instruments: three that can manipulate things and one that’s a steerable endoscope. The robot is in the process of launching in the United States.