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Medtronic’s Hawkins: 510(k) changes to be ‘neutral to slightly negative’

Outgoing Medtronic Chief Executive Bill Hawkins is predicting only mild pain when the federal government unveils changes to the 510(k) rules governing approval for most medical devices.

Outgoing Medtronic Chief Executive Bill Hawkins is predicting only mild pain when the federal government unveils changes to the 510(k) rules governing approval for most medical devices.

Hawkins told attendees at the JP Morgan Healthcare Conference this week in San Francisco that updates to 510(k) “will be neutral to slightly negative” for those trying to create new innovative medical devices, according to EE Times.

Changes to the 510(k) program are weeks away. There was initial and serious consternation over 510(k) changes, and concerns still remain over issues such as the treatment of Class II devices and the treatment of company trade secrets. Recently, though, there’s been increasing pressure by U.S. Food and Drug Administration Officials and several U.S. senators to adopt a more deliberate, cautious approach to new rules, as opposed to wholesale restructuring that medical device firms are fearing.

“I am optimistic about this year because people can’t wait forever to get their back repaired or deal with heart failure and we expect gradual positive changes at the FDA which is really getting the feedback they need to get the balance right here,” Hawkins told the group.

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Some major medical device executives think additional regulation would be a greater advantage to them. However, Hawkins, who has helped lead some of the lobbying efforts for 510(k) changes, wants lower barriers so the smaller med-tech companies Medtronic acquires would continue to innovate.

“There’s an ecosystem in our industry that requires different levels of players, and in our whole country overall less barriers [to innovation are] needed,” he said, according to EE Times. “I’d rather have [regulatory] barriers lower and have more innovation occurring that could help [smaller] companies we could integrate.

“I am reassured there’s a good dialogue, and hopefully we will not see dramatic changes,” he added.

Hawkins highlighted many of the setbacks in areas such as diabetic, cardiac and neural devices as evidence of federal regulation requiring “more and more” being required to get into the marketplace.