Thousands of medical device professionals gathered last week at The Medtech Conference in Toronto to discuss upcoming policies, new technologies and medtech trends.

The event, Advamed’s largest to date, brought 4,350 attendees from 48 countries, and featured comments from Michelle Tarver, who was recently named acting director of the Food and Drug Administration’s device center. Other FDA leaders also spoke last week, as did regulators from Canada, Europe and Japan.

Discussions about artificial intelligence and machine learning, upcoming deadlines for the FDA’s laboratory developed test rule, diversity and patient representation, and the impact of the upcoming U.S. election led the agenda. Here are five highlights from the event.

1. Don’t be a ‘poster child’ for LDT non-compliance

Legal and testing experts discussed the future of a controversial new rule on laboratory developed tests (LDTs) that is currently the subject of a lawsuit by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology. 

The final rule, issued in May, would require tests made and used by labs to meet medical device reporting and quality system regulations, while the FDA had previously taken an “enforcement discretion” approach with these types of tests. The first stage of the new rule goes into effect on May 6, 2025.

Between the lawsuit and an upcoming U.S. presidential election, it’s difficult to predict what will come next. However, experts said laboratories should prepare now for the new regulations. 

“My advice to anybody who has a company … is absolutely understand the final rule and be in compliance all the time. It's going to be around for a while, maybe longer than we otherwise would think, and you don't want to become a poster child for what happens when you ignore something like this final rule,” Scott Garrett, operating partner at private equity firm Water Street Healthcare, said during a panel. 

Neither plaintiff in the lawsuit has yet sought a preliminary injunction, and there is no deadline for the court to rule, said Nathan Brown, a partner at Washington D.C.-based law firm Akin Gump. 

Brown outlined two possible scenarios: one where the FDA rule is upheld, and another where the court finds that LDTs are not medical devices. The latter could limit developers of LDTs from seeking FDA clearance or approval, which can be helpful with reimbursement, Brown said. 

The upcoming election adds another curveball. Advamed CEO Scott Whitaker said the approach to the LDT rule could depend on who is secretary of the Department of Health and Human Services, who is FDA commissioner, and who are the agency’s legal advisers.

“We kind of have to wait and see who’s there to understand that,” Whitaker said. 

If the White House changes hands, it’s possible that a Trump administration could freeze the rule, said Carly McWilliams, Roche’s head of regulatory policy for North America. 

Congress could also reintroduce bipartisan legislation bringing lab-developed tests and in-vitro diagnostics under one regulatory framework. Efforts to do this have been ongoing since 2014. Whitaker said that one of Advamed’s goals for next year is to get a more expansive regulatory reform initiative that aligns the two types of tests into the next Congress. 

“The status quo is gone,” McWilliams said. “The rule is there. The litigation is pending, and it's the rule and/or mystery court ‘choose your own adventure’ situation, or Congress can pick up the ball that has been snowballing for a decade.”

2. Medtech M&A is still down

Mergers and acquisitions remained slow in the first half of 2024, offset by a handful of high-priced purchases. 

The number of M&A deals between July 2023 and June 2024 was 99, compared with 170 deals in the year-ago period, according to EY’s Pulse of the Industry report, released ahead of the conference. However, the average deal size, $583 million, was the highest in several years. 

The number was inflated by a few large deals, including Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical, BD’s $4.2 billion purchase of Edwards Lifesciences’ critical care unit, and Boston Scientific’s $1.18 billion buy of Silk Road Medical. 

Boston Scientific is also still waiting for its $3.7 billion acquisition of Axonics to close after the Federal Trade Commission requested more information.

“You have a handful of acquirers,” John Babitt, EY’s life sciences partner, said in an interview. “It’s Stryker, it’s Boston, it’s J&J that really continue to innovate and reshape their portfolio, and so they definitely have been more aggressive.” 

One way that this year is different from last year is that more private equity firms are getting involved, Babitt said, listing Baxter’s sale of its kidney care unit to Carlyle Group and a separate sale of its biopharma solutions business to Warburg Pincus and Advent International. Babitt attributed the shift to lower valuations and a more favorable interest rate climate.

3. Prepare clinical trial diversity plans

The FDA published a draft guidance in June on diversity action plans for clinical trials, intended to increase enrollment of underrepresented groups of patients in drug and device trials. Companies will need to submit plans as part of their Investigational Device Exemption application detailing their enrollment goals disaggregated by race, ethnicity, sex and age group, and plans to meet those goals. 

CDRH’s Tarver said the guidance is not fully implemented yet, but “now is the time to start trying to put together some of these diversity plans and get feedback, so that you can get some insights into what it might look like.” 

Tarver said the agency has already received diversity action plans in the double digits. 

Tarver also emphasized the importance of patient feedback, highlighting the FDA’s 2022 final guidance on patient engagement in the design and conduct of clinical trials. The results so far have included companies changing their trials based on patient feedback and providers looking to better communicate with patients to increase participation, Tarver said. 

“I would encourage people to think about, how do we improve adherence, how do we improve utilization, and how do we make this so that it's not another hurdle that a group has to get over in order to participate in a clinical trial?” Tarver added. 

4. AI questions abound

Questions about medical devices that use AI and how they are regulated dominated last week’s conference. Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, fielded questions about generative AI during a CDRH town hall panel. 

So far, the FDA has not received any applications for medical devices that use generative AI, a technology that uses certain machine learning models to generate images or text, but the agency is thinking through how to regulate these products in the future. 

“Generative AI is a completely different type of product that we are having to think through,” Tazbaz said. 

CDRH is working on a draft guidance around lifecycle management in AI-enabled devices, a concept that Tazbaz outlined in a blog post in July. This approach, which includes monitoring how models perform after they’re pushed into the market, will also apply to generative AI, Tazbaz said. 

“The reality is that from our evaluation point of view, we have to start thinking about the postmarket elements of generative AI, given the fact that it adapts,” Tazbaz added. 

The FDA is also trying to address the challenge of ensuring models are safe and effective after being pushed out into different environments.

The FDA plans to host a Digital Health Advisory Committee meeting on generative AI on Nov. 20 and 21. Separately, the agency is also working on a final guidance about pre-determined change control plans, where medical device developers describe in pre-market applications certain modifications they plan to make to a device, allowing them to make those changes without filing another application with the FDA. 

Company executives also shared their aspirations for new technologies at the conference. Peter Arduini, CEO of GE Healthcare and chair of Advamed’s board of directors, hopes to see AI improve patient outcomes at lower costs. Arduini also expects generative AI to change how work gets done. 

“We have a great opportunity to shape, ultimately, policies, standards and the safe and effective use of the tools,” Arduini said during a keynote presentation. “Particularly with AI, we want to be able to have a profound effect on our broader industry, and I think that's going to be an incredibly important discussion for us as an organization.”

5. Acting device director emphasizes focus on patients

Tarver emphasized the importance of listening to patients at this year’s conference. Tarver has participated in FDA panels hosted at the event in years past, but took to the podium for the first time last week.

“Everything starts and ends with patients,” Tarver said, also emphasizing timely access to devices. 

Tarver, who has worked for CDRH for 15 years, helped create the FDA’s first patient engagement advisory committee and served as chief transformation officer. 

The acting director highlighted a new effort by CDRH to consider people’s living environments in device development and clinical trials. Called Home as a Health Care Hub, the program will first focus on diabetes, and designing solutions that work in the homes of people with the fewest resources. 

CDRH has not named a permanent director yet. Jeff Shuren, who stepped down this summer, said Tarver “will make an excellent center director, and quite frankly, the best is yet to come.”