From leading OEMs spinning off, to international trade wars and long-anticipated safety reports from the FDA, 2018 was full of big shake-ups for the imaging industry.
Presented in no particular order, here are the overall top five stories of the year.
FDA issues long awaited report on third-party service
Two years after opening a docket that stirred debate in the medical equipment industry, the FDA published its highly-anticipated third-party service report entitled, "FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices."
In a conversation framed around the definition of certain terms pertaining to equipment service, the FDA had set out to better understand how non-OEM entities were engaging with medical equipment, and whether or not that activity was compromising patient safety.
The comprehensive, 28-page document began with a recap of the FDA's authority and regulatory history, followed by a summary of the docket and the responses it received, as well as a recap of the public workshop from Fall 2016.
The takeaway was unmistakable: The FDA does not recommend additional regulation of servicers of medical equipment.
For many third-party service providers and in-house HTMs, the report was a testament to the quality work they perform. For other organizations, including MITA, which represents imaging equipment manufacturers, the report merely proved that there wasn't enough evidence being collected on adverse events pertaining to third-parties.
As the year wound down, the debate entered new territory. In December, the FDA hosted a workshop examining the distinction between "servicing" and "remanufacturing" – indicating that the definitions of these two terms need clarifying. We will continue to cover that ongoing discussion throughout the new year.
GE to spin-off healthcare unit
General Electric had a pretty wild ride in 2018. Its stock value plummeted and the multinational conglomerate was dropped from the Dow Jones Industrial Average. In order to right the ship, the company announced plans to spin off its healthcare division as a separate enterprise and focus its attention on its power, aviation and renewable energy businesses.
The decision marked the final piece in a string of spinoffs the company had undertaken to cut debt, simplify its structure, and raise cash, including the spinoff of its train manufacturing business and the $3.3 billion sale of its distributed power division. It also will sell off shares of its ownership in oil services company Baker Hughes over the next two to three years.
“Today marks an important milestone in GE’s history,” CEO John Flannery said at the time. “We are aggressively driving forward as an aviation, power and renewable energy company – three highly complementary businesses poised for future growth. We will continue to improve our operations and balance sheet as we make GE simpler and stronger.”
In December, insiders told Bloomberg News that GE filed confidentially
for a healthcare IPO.
A public filing is likely next spring, the sources said.
RSNA and the year of AI (part 2)
Anyone who still says 2017 was the year of AI at RSNA probably wasn't at RSNA 2018. Smart algorithms and deep learning continued to take over the industry with a vast range of applications and tools in various stages of development.
Skeptics would be correct to pause and point out that the actual real-world benefit of these systems is still being determined, but the industry seems committed to the idea that AI is a game-changer and radiology will never be the same.
At RSNA, a panel of three physician experts in developing AI imaging platforms and one manufacturing CEO shared their insight in a lively discussion entitled "Medical Imaging Analytics & AI: Technologies and Solutions for Better Healthcare Today and in the Future,"
Patients and radiologists alike want to reduce dose and gadolinium exposure. According to Dr. Greg Zaharchuk, professor of Radiology at Stanford University and founder of Subtle Medical, AI can do that. He added that those are the first places where successful AI solutions will emerge.
Gene Saragnese, CEO MaxQ and past CEO of Philips Imaging, said that apps that work on both low-end and high-end systems will be the most desirable and therefore the first to penetrate the market.
A killer AI app would be one that counts lung nodules under low-dose CT, said Dr. Eliot Seigel, chief of Radiation Oncology for the VA Maryland Healthcare System, citing the process as "tedious" and requiring a lot of work to submit the report to a registry for reimbursement. Ushering AI into that element of workflow would reduce cost and make the procedure more widely available, he said.
Machines can see a tumor earlier, with more accuracy than humans – we know that, said Dr. Lei Xing, professor and director of Medical Physics at Stanford. However, he added, the best AI app will take that info and combine it with other patient data from other clinical sources to fundamentally change value. It might predict, for example, which patients will respond to certain treatments based, in part, on genomic information coupled with the image analysis.
Siemens spins off Healthineers with Frankfurt Exchange IPO
Setting a positive example for what can happen when an industrial giant spins off its healthcare unit, Siemens Healthineers shares roared up after being launched on the Frankfurt stock exchange on March 15.
The price at the IPO was in the lower half of its guidance range of 26 to 31 euros.
Siemens raised 4.2 billion euros ($5.2 billion) from the offering – Germany's second largest IPO in almost 20 years.
Buyers snapped up 150 million shares, representing 15 percent of Healthineers. Siemens stated that it intended to continue as a majority shareholder for the long haul.
Calling the Healthineers “a truly global innovator with unique scale,” Bernd Montag, CEO of Siemens Healthineers, stressed that given its positioning and global footprint, the organization will be “one of the main long-term beneficiaries of the significant structural growth inherent in our markets.”
China trade tariffs target imaging equipment
Citing the trade deficit and the need to protect the intellectual property of U.S. businesses, the Trump Administration introduced a series of tariffs on Chinese goods this year. In response, China issued tariffs of its own and a trade war was underway.
Among the products poised to be hit by the tariffs were medical devices, such as MR magnets and CT scanners. By late September, nearly $5 billion worth of U.S. medical devices had fallen under the wrath of China’s retaliatory tariffs.
That round of Chinese-imposed tariffs added $3.5 billion in impacted medical devices, affecting “almost all remaining U.S. MedTech exports to China in 2017,” said AdvaMed in a presentation at the annual MedTech Conference in Philadelphia, reported Forbes.
“If the trade war continues and escalating continues to grow, there will be more impact,” AdvaMed CEO Scott Whitaker told attendees at the conference.
On December 24, Varian Medical Systems announced it received notification from the United States Trade Representative (USTR) that its exclusion request for Halcyon radiotherapy systems for cancer treatment, which are manufactured in China, had been granted.