Looking back at 2017 there was no shortage of high impact headlines for the medical imaging industry.
Over the last week or so we have highlighted some of the
top news in MR, as well as
breast imaging and
company mergers — three topics which saw particularly consequential shake-ups over the last 12 months. Now, we take a few big steps back and turn our attention toward the overall top five stories of the year.
These were the stories our readers read and shared more than any others. These are the stories that altered the landscape of an entire industry and promise to set the stage for 2018, (and although artificial intelligence — as a concept — didn't make the cut, it deserves an honorable mention for the way it
completely took over RSNA).
Canon picks up Toshiba Medical, setting the stage for bigger imaging footprint
The winning bid was announced in March of 2016, but
a lot of dust cleared in 2017 regarding the details of how Toshiba Medical would look under the umbrella of Canon, which acquired the imaging giant in a $5.9 billion deal.
The transaction itself was not without controversy, and what followed was a lengthy regulatory approval process to complete the integration of the unit, necessitated by the global nature of the company that demanded it follow a variety of national or regional laws covering both pharmaceuticals and medical devices.
At RSNA 2017, Toshiba and Canon exhibited side-by-side
The two are slated to completely merge under the Canon brand on January 4, (today) and an even bigger investment into the health care sector is expected from the combined entity in the years to come.
Regulatory drama unfolds between OEMs and the ISOs who work on their machines
Ever since the FDA opened its docket investigating the safety impact third-party stakeholders have on medical equipment in early 2016, the debate has roiled people with a range of different viewpoints.
At its core, the argument boils down to OEMs believing that third-parties lack adequate oversight and thus, put patient safety in jeopardy, while third-parties assert that there is no evidence of a safety issue and that if there
were any issues could be attributed to the unwillingness of OEMs to share necessary manuals and passwords with them.
The third-party service debate
continued throughout 2017
The debate is likely to continue well into 2018 with the FDA expected to issue a report in the coming months highlighting findings from its own investigation into these matters. Meanwhile, MITA is seeking feedback on its own “Requirements for Servicing of Medical Imaging Equipment” standard, which it hopes to have approved as a national standard, but has so far been
unable to gain support from the non-OEM community — a tug of war that has been highlighted by editorials from Robert J. Kerwin, general counsel for IAMERS, in a number of contributions published on our site.
For all involved, patient safety is the top priority — achieving that without unnecessarily hurting market competition is where things get complicated.
Expect to hear some resolution on this front in the coming year.
GE makes big investment in repair operations... and Wisconsin
In March, GE Healthcare celebrated the grand opening of its new Repair Operations Center in Oak Creek, Wisconsin — a massive equipment repair headquarters and the company's latest investment in the Badger State.
The 280,000 square foot facility, known as the ROC, is a hub for equipment repairs and testing, built on lean manufacturing principles. Formerly a Staples warehouse, the building brings together disparate GE repair facilities under one roof.
The ROC is GE's new repair headquarters in Oak Creek, WI
The space is only partially filled, and more of the company's repair locations are slated to be incorporated — including the entirety of its GoldSeal refurbishing operations for imaging equipment and the Unisyn ultrasound probe repair subsidiary.
A large portion of the facility will be dedicated to GE's 20-year-old GoldSeal refurbishing business, including a 50,000 square foot imaging equipment storage facility that will be added to the warehouse.
The investment in its ability to efficiently repair imaging equipment shows that GE is betting on a business model where capital equipment upgrades may not always be the best option for providers, and getting older model solutions back in working order makes more sense.
For equipment that is beyond repair, the ROC has an area dedicated to harvesting parts. A deconstructed CT scanner was on site, which an employee said would be stripped for approximately 30 reusable parts — which would be tested, packaged and deployed to the supply chain — before the remaining shell would be recycled.
Children not at increased risk for cancer from routine imaging tests: study
In a pronouncement sure to add kindling to a long-burning debate, a group of researchers maintain that normal CT and nuclear medicine imaging do not put kids — or adults — at higher risk for cancer. Furthermore, they assert the premise for such concerns is based on misinterpretation of a foundational study dating back 70 years.
Have radiation concerns
missed the mark?
The original studies giving rise to LNT, published by a Nobel Laureate and others, concluded that all radiation was harmful, regardless of the dose and dose rate, down to zero dose. However, the
Journal of Nuclear Medicine article asserts the studies were not done at low doses, so the conclusions were inaccurate.
Jeffry Siegel, Ph.D., president and CEO of Nuclear Physics maintains that the resulting current drive for minimal doses as low as reasonably achievable (ALARA) is based on a misinterpretation of these original studies. Also, the study asserts that Japanese survivors of the atomic bomb blasts in World War II — the gold standard in dose-response population according to the article — illustrate the faulty assumptions of LNT and ALARA for both pediatric and adult populations.
The notion that the public perception of radiation is misguided has been floated several times over the last few years by several different research groups, but in 2017 we got the first glimpse of a future where the war against dose might not be the top order of business when it comes to imaging exams. Unless evidence to the contrary emerges, it would indicate a sea change from the mindset that has driven the last decade of innovation.
Which brings us to the last item on our list...
Siemens to IPO Healthineers
All year, new details leaked out regarding the upcoming IPO of Siemens Healthineers. Now the IPO is entering its final lap, and should be finalized by the end of March 2018.
Siemens Healthineers
preps for IPO
The IPO has been an ongoing story, highlighted by an August announcement that it would happen during 2018. Estimates for the worth of the unit would be at or about $47 billion.
"Our preparations for the public listing are completely on schedule,” Siemens Chief Financial Officer Ralf P. Thomas said in a statement in November, following the decision to list the IPO on the Frankfurt Stock Exchange Regulated Market.
The decision to split Siemens and to make Healthineers a public listing ties in with CEO Joe Kaeser’s Vision 2020 plan, which began in 2014, to spin off divisions into what he calls a “fleet of ships” model to narrow the core of Siemens.
How that split will impact the imaging marketplace is unclear, but it's something we will be continue to report on throughout the coming year — and beyond.