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Compliance Corner: Follow These 4 Tips From FDA's Maisel For A Better Pre-Market Experience l Pharma Intelligence


When it comes to getting novel medical devices to market, Bill Maisel knows that time is money.

Maisel, director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health, says he routinely discusses the "importance of time" with ODE reviewers.

"It used to be forbidden at the FDA to talk about the cost for a company [to launch a product]. After all, why should the FDA care about how much it costs a company to develop a product?" said Maisel, who is also acting head of CDRH's Office of Compliance, as well as the device center's chief medical officer.

"Well, we think it’s really important that we think about that now because a really great idea may never see the light of day if we’re not thinking about the cost it’s going to take to get that product to market," he said.


"As much as you can communicate and have an organized submission, and help us understand how you got where you got, is by far the most critical part of a successful review process," FDA's Bill Maisel says.


Maisel pointed out that for a smaller, 30-employee company, an additional eight weeks for a clinical trial can cost $2m, while the price tag for an extra year for a hundred-patient study can be as much as $24m.

That's why it's important, he said, that FDA and manufacturers are on the same page to ensure there are no delays when a product is being reviewed.

"Whether it’s through nonclinical testing, animal studies or clinical trials, we always want to be thinking about what we can do to shorten the time to get these products to our patients," Maisel said.

In that spirit, Maisel offered four tips to device-makers to ensure a smooth pre-market experience. His comments came at MedCon 2018 in Cincinnati.

1. Tell a full story: "You know your product so well that the story about how you got to where you got to gets lost [in submissions] – for example, why you did the testing you did, and why this one anomalous test result wasn’t something to worry about because you did these four other tests," Maisel said.

"If we don’t understand that story, then it’s hard for us to get to the same place that you’ve gotten to. So, our review staff homes in on that one anomalous test, but there’s no explanation of what you did when you saw that. And so, as much as you can communicate and have an organized submission, and help us understand how you got where you got, is by far the most critical part of a successful review process."

2. Communicate: "Communication is a two-way street, and we’re working hard to train our staff to be that way," Maisel said. "And I would encourage you to be that way as well. Some companies are better at it than others.


"Be available, be communicative," Maisel says.


"It’s always easier when our staff can talk to the people who are knowledgeable about the testing, and when companies are responsive and respond quickly to an email," he said.

"Consider for a moment that you're [an ODE] reviewer and you have a few files on your desk, and a company doesn’t get back to you for a few days. Well, you’re going to move on to the next file, and by the time you come back to it, maybe you’ve forgotten where you were and it will take you time to get back up to speed. So, be available, be communicative."

3. Invest in regulatory expertise: "Some small companies tend to think of regulatory expertise as an extra add-on, as opposed to a critical component of their success, just like they’d have a chief medical officer or a chief financial officer," Maisel said. "And it’s really critical, and we definitely see the difference in companies that don’t invest in and value regulatory expertise."

4. Loop in ODE management if necessary: "Some companies don’t like to involve [ODE] management because they’re concerned they’re going to offend a reviewer. They want to develop a long-term relationship with that staff," Maisel said.

But sometimes it's important to "keep management in the loop. Maybe it’s as simple as just emailing the reviewer and CC’ing the branch chief on your emails. It’s very hard to fix something when there’s three days left on the clock. It’s much easier to fix it when you early on recognize there’s a problem and you try to resolve it," he said. "And our staff should expect this; they're told that when someone wants to involve a supervisor because they've tried and they're just not seeing things the same way, that’s fine. We have scientific disagreements all the time.

"I would encourage you to fold in the managers as soon as you sort of recognize you’re stuck."

From the editors of The Gray Sheet

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