A NOTE FROM THE EDITOR
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When the National Standards Authority of Ireland (NSAI) announced that it was going to make Ireland a medical device hub and develop a global centre of excellence for the med-tech sector, I can’t say that my jaw dropped. My initial reaction was
a) Isn’t Ireland already a med-tech hub?
b) What exactly does the second part of that sentence mean? Global centre of excellence sounds impressive, but it’s a fairly vacuous phrase standing on its own.
So, I decided to check in with NSAI’s European manager John O’Dwyer, MD, and get some context. One thing I found out is that excellence doesn’t come cheap—the standards association is investing millions of euros to achieve that goal, O’Dwyer told me. Much of that money is being spent on shoring up the company’s in-house knowledge base.
“Our staff includes PhDs with many years of industry experience,” explains O’Dwyer. “They have expertise in microbiology, biomedical science and engineering, clinical medicine, biochemistry, and so forth.” Assembling a regulatory dream team is only part of the equation, however. You also need a primo playbook. Providing timely regulatory guidance is all about knowing in advance what needs to be done, says O’Dwyer, and then doing it.
“We performed a root-cause analysis of what ultimately determines [CE marking] timelines,” explains O’Dwyer. “The findings brought to our attention the importance of presubmission meetings and conference calls.”
Meeting with the customer beforehand and going over the milestones in detail pays huge dividends, according to O’Dwyer. “We gain a thorough understanding of our customer’s technology, competence, and ability to prepare the technical file. We can then determine the type and volume of data that will be needed to satisfy the demands of the directive. Based on that information, we can provide a realistic timeline for gaining CE mark approvals,” he says.
The best laid plans, however, can fall apart if deadlines are not met. NSAI likes to know in advance when the client intends to have the technical file completed. “We can then schedule review time and assign a staff member,” says O’Dwyer. “The file won’t be arriving cold, so to speak. Because we have already communicated with the client in some depth and are familiar with the technology, we can complete the initial review and send it back to the customer within the week. High-risk devices may take longer, but no more than two weeks,” adds O’Dwyer.
“Since we have been holding presubmission meetings, we have consistently reduced the number of questions and shortened timelines,” says O’Dwyer. “It has allowed us to reduce our certification times by more than 50%. We intend to further reduce the time to market and give our customers that extra competitive edge,” he adds.
NSAI’s long-term goal, according to O’Dwyer, is to further consolidate its knowledge base and provide quality regulatory services for high-tech implantable and combination products. “We have a well-established relationship with some of the leading companies and competent authorities in the drug-device arena,” he says. Getting products to market ahead of the competition is vitally important when you are dealing with high-tech devices, adds O’Dwyer. “Whoever gets to market first will have an advantage.”
If you want to learn more about NSAI’s initiatives, go to the company’s Web site at www.nsai.ie. Even better, if you are attending MEDTEC Ireland in Galway this month, you can ask O’Dwyer in person. He will be one of the speakers at a session on regulatory matters on 24 September.
