No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders.
(Image by Markus Winkler on Unsplash)
It’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen.
President Donald Trump’s administration streamlined some FDA processes. The medical device excise tax, enacted during the Obama-Biden administration, was permanently repealed.
But any normal state of affairs in the industry was upended by the coronavirus pandemic. COVID-19 disrupted supply chains, brought elective surgeries to a halt and attracted all sorts of businesses to jump into an industry that they knew nothing about.
The pandemic also brought about unprecedented cooperation within medtech and between medtech and companies in other industries, such as automotive.
Now medtech has to balance which presidential candidate would be best for the industry going forward. We asked a few observers how they foresee the effects of another Trump administration versus a Biden presidency. Here’s what they said:
Shaye Mandle, president & CEO of the Medical Alley Association, the trade group for Minnesota’s medtech hub, said the industry has been fairly satisfied with changes at the FDA that began under President Obama and continued under Trump. But, he said, the pandemic may have changed the regulatory landscape for good.
The FDA has been aggressively working to bring products to market to help COVID patients and those who care for them and CMS has extended Medicare coverage for more devices.
“The expectation in particular on the part of the American public and patients, to see the federal government being more focused on innovation and getting products to market because of COVID-19, I think is something that would be difficult to walk back on for either president if they wanted to,” Mandle said.
He termed Trump’s support of business tax reform as “strong” but declined to speculate on whether a President Biden would push Congress to enact a new medical device tax. As far as tariffs are concerned, the industry has not been pleased with all of Trump’s decisions. Mandle found it difficult to predict what Biden would do about tariffs, but noted that the tariff situation was different under Obama than it has been with Trump.
“The key for us is going to be seeing how the next administration works with industry to accomplish those goals that are in the national interest but also in the industry’s interest,” Mandle said.
Patient safety activist Madris Tomes worries about the political and practical issues brought on by the pandemic.
“Companies that have never produced medical devices before now are creating them. You have to monitor and do postmarket surveillance on those devices,” she said.
Those companies may not know how to follow such guidelines for products that the FDA authorized them to sell during the public health emergency. “I haven’t seen anything put out by the CDC or the FDA to guide any of these newer vendors in this space,” added Tomes, CEO of Device Events and a former FDA public health analyst.
She believes that the Trump administration is putting political pressure on the FDA not only to grant emergency use authorizations — which don’t require the usual amount of agency screening for safety and efficacy — but to speed a COVID-19 vaccine to market. If the agency approves an ineffective COVID-19 vaccine, it could fuel the anti-vaccine movement and lead to more cases of other diseases such as measles, Tomes said.
The agency had many issues that needed fixing before Trump’s election in 2016, including a need for more money from Congress to increase postmarket surveillance of medical devices, she added, noting that more than 1 million medical device adverse events were reported to the agency in 2019. Whether a Biden administration would push for such funding would depend on the level of advocacy for it, Tomes said.
“It’s not an outrageous ask; it’s a very practical ask,” Tomes said. “They’d only need 10 scientists. It could save a lot of lives.”
Brian Johnson, president of the Massachusetts Medical Device Industry Council (MassMEDIC), said the outlook for the FDA will depend on who’s in charge. Trump appointee Dr. Stephen Hahn is still in his first year heading the agency, he noted. If Biden wins, FDA leadership will likely change.
“We believe strongly that the FDA is a critical agency to the safety of the American people and believe that, no matter which party is in charge, the FDA should be given the resources necessary to keep America safe,” Johnson said. “In a time of great uncertainty, with the COVID-19 pandemic still a major threat to our country’s health, the FDA should not be used as a political football.”
National medtech industry trade group AdvaMed remains apolitical, according to CEO Scott Whitaker, who declined to comment on the election’s outcome. But speaking as CEO of Stryker, AdvaMed chairman Kevin Lobo said in a September 11 news conference that both campaigns’ promises to “reshore” medical device production to the U.S. due to pandemic-induced supply chain problems must be reconciled with the complexity of medical devices themselves.
“We operate a global supply chain, as do many other medtech companies,” Lobo said. “There are products that we export, there are products that we import, there’s components that we import and components that we export.
“Medical devices are complex, they’re not sort of singular items, and so any kind of challenges that are presented by any nationalistic policies, whether they’re in the United States or whether they’re in China or whether it’s other countries are things that we will work through, and we’ve been able to do that throughout this pandemic to keep our supply chains operating very very well,” Lobo added. “That’s kind of how we operate and we expect to continue to be able to operate in the future. The key is to be able to make sure that devices are available. That’s why the (national) stockpile is so very important an initiative to make sure that the right products are available through the pandemic. We’re optimistic at being able to continue to operate the way we do today with global supply chains.”
This article was updated September 11, 2020 with comments from Stryker CEO Kevin Lobo.
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