AdvaMed Plans Industry Cybersecurity Standards, Eyes Tariffs and FDA Staffing

AdvaMed, one of the medical technology industry's most prominent lobbying groups, plans to develop industry standards on cybersecurity, privacy and interoperability, its board chair Mick Farrell said at a press event during The MedTech Conference in Boston on October 19, MedTech Dive reported.

Farrell, who is also chief executive of sleep and respiratory device maker ResMed, compared the effort to drawing up a code of ethics for the industry. "What we want to do is raise the bar of the whole industry throughout cybersecurity," he said, according to MedTech Dive. "Those headline-grabbing episodes send a message that anybody can be impacted at any time."

A year of attacks

Stryker and Boston Scientific both faced cyber incidents this year that disrupted their operations, and Intuitive, Medtronic and Abbott also reported cyberattacks, MedTech Dive noted. Farrell said smaller companies with less security infrastructure may also be vulnerable, and that the trade group sees an opportunity to support them.

Farrell said connected devices carry value as well as obligations: ResMed's respiratory machines connect to the cloud, giving patients access to their own data, but that requires the company to invest in security, he said.

Kirsten Tullia, AdvaMed's executive director of digital health tech, said the group has been building forums for chief information security officers and other learning opportunities aimed at preventing attacks across the industry, according to the report.

Tariffs and the BD model

AdvaMed president and CEO Scott Whitaker said the group is also watching tariffs and FDA staffing levels. No tariffs specific to medical technology have been imposed under the Section 232 investigation the Trump administration opened into the sector, but the threat hangs over the industry, MedTech Dive reported.

Earlier this month BD reached an agreement with the administration under which it committed to invest $19 billion in the US over several years in exchange for relief from future Section 232 tariffs, subject to agreed milestones. Whitaker said AdvaMed played no role in those negotiations but was paying attention to them.

"I think what we learned from the BD negotiation is there's a model that the administration seems to like," Whitaker said. He argued the industry should get credit for manufacturing 70% of the medical devices sold in the US. "Can we get to zero [tariffs]? I hope so," he said. "If they're consistent, we will. But you know, policymakers aren't always consistent."

FDA staffing

Whitaker said a key concern is keeping staffing levels up and retaining high-quality reviewers at the Food and Drug Administration. Staffing was a central issue in this year's medical device user fee negotiations after the administration cut FDA staff in 2025, MedTech Dive reported.

"Working with [the FDA] to make sure they hit their hiring targets and maintain quality employees, I think, is very very important," Whitaker said.

AdvaMed's annual meeting is being held at the Thomas M. Menino Convention and Exhibition Center in Boston, according to MedTech Dive.