The Filutowski Law Firm, PLLC

WOBURN — Fielding complaints about poor communication and delays in reviewing and approving new products, the top US medical device regulator yesterday said his agency will overhaul its procedures to speed innovation while protecting patient safety.“We have not been clear about our expectations and we need to be,’’ Dr. Jeffrey E. Shuren said during a visit to the Boston area. Shuren, who took over as director of the Food and Drug Administration’s Center for Devices and Radiological Health in January, said regulators are committed to making “midcourse corrections,’’ including seeking more clinical data before devices win clearance.

Hosting a “town meeting’’ for more than 400 medical device executives and other industry professionals at the Hilton Boston/Woburn hotel, Shuren heard plenty of criticism from leaders of start-up companies who said FDA delays, mixed signals, and lack of predictability were causing confusion and threatening their businesses.

“To the investors in my company, it has become increasingly clear that prestated and prenegotiated rules of the game can now be capriciously and arbitrarily changed, and that good science no longer suffices for FDA clear ance,’’ Eric Bornstein, chief science officer at Nomir Medical Technologies in Brookline, told Shuren.

While the company and the agency had agreed on the structure, size, and measures of clinical studies for its specialized laser that kills bacteria in toenail fungus, company officials said, the FDA later changed the rules in a way that would require additional capital from its more than 100 angel investors.

Peter Steiger, chief executive of Optasia Medical Inc., a British company with US offices in Sudbury, said medical device makers believe a “wall of silence’’ has been erected at the FDA. Calls and e-mails to regulators often have not been returned, he said.

“Some of us have experienced unbelievable delay,’’ said Steiger, whose venture-backed company is awaiting approval for software that runs on radiology workstations used to document vertebral fractures in patients with osteoporosis. “A process that is expected to take 90 days has taken 22 months in our case and we still have no decision.’’

Shuren, a neurologist who completed his medical internship at Beth Israel Hospital and his residency at Tufts New England Medical Center, didn’t address the complaints of specific companies. But in an interview after the session, his second of three town meetings scheduled across the country, he said the devices center has been working to improve its standards, training, and decision-making.

An initial report on revamping the FDA’s approval process for medical devices, including changes in the development of clinical trials, is expected to be released for public comment in the coming weeks. New procedures could take effect later this year in what is known in the industry as the 510(k) medical device approval process.

About complaints over communication, Shuren said, “There’s much the center can do to be consistent with industry. We have cases where the manufacturer is right that we can do better.’’ In other situations, he said, device makers simply don’t like the feedback they receive from regulators.

Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council, a Boston trade group, said many device makers have complained that communications with FDA regulators have deteriorated over the past 18 months.

In a letter to Shuren last week, members of the Massachusetts congressional delegation urged the agency “to avoid unnecessary regulatory barriers that will needlessly lengthen the review and approval process,’’ especially for small companies trying to bring new technologies to market. The letter didn’t specify which barriers the lawmakers were objecting to.