Profits on approval

Ireland’s medical-technology sector is in good health at the moment, helped by the fact that approval for selling medical devices can be obtained more quickly here than in the US

DESPITE THE NATION’S economic woes, Ireland’s medical-technology sector has been doing well recently. According to the Irish Medical Devices Association, in 2009 we exported equipment to the value of €6.8 billion, up 9.2 per cent on the figure for 2008. We are the second-biggest exporter of medical devices in Europe, after Germany, and the sector here encompasses more than 150 companies and provides around 24,000 jobs.

In general, Europe has traditionally been attractive for companies looking to commercialise their new medical devices, partly because, in the case of some products, they can get regulatory approval faster here than in the US. A 2010 study in the US, supported by the Medical Device Manufacturers Association and the National Venture Capital Association, surveyed 204 companies about their experiences of getting medical devices approved and on to the market. “Respondents reported that their devices were available to US citizens an average of two full years later than patients in other countries,” it states.

This state of affairs has altered somewhat recently, with new medical-device directives in Europe and a process of change taking place in the US Food and Drug Administration (FDA). But while the result can vary according to the product, Europe still looks to be the faster route to regulatory approval.

So what’s involved in getting to market on either side of the Atlantic? Why the time lag on the US side? And what does that difference mean to countries like Ireland?

If a company wants to start selling a medical device in Europe, it needs to get a CE mark. Of course, the term “medical device” covers a multitude, from tongue depressors to MRI machines, so devices are often classified according to their potential risk factors and other concerns, such as how invasive they are.

If a device is low-risk, its manufacturer may simply be required to declare that the product meets the requirements set down by European directive. For a higher-risk device a notified body, such as the National Standards Authority of Ireland (NSAI), has to verify that the product conforms to standards and the company has to provide clinical trial data to back up those claims.

Once the product gets a CE mark it can be sold across Europe, explains Pat O’Mahony, chief executive of the Irish Medicines Board (IMB), which is the competent authority for medical devices in Ireland. “Individual states cannot place extra barriers or restrictions on sale of devices in their territory unless they have a major safety concern about that specific device," he says.

In the US the set-up is slightly different. While the main focus in Europe is on safety, in the US there's an increased focus on efficacy as well before a product gets regulatory approval, according to John O'Dea, chief executive of Crospon, a medical-device company headquartered in Galway but with an office in the US also.

Traditionally the main route in the US for a new or altered low-risk product has been to submit a pre-market notification, or "510(k)", showing that a product is substantially equivalent to a device that is already on the market. This may eliminate the need to conduct clinical trials on a product prior to FDA approval. Meanwhile, higher-risk products require more stringent pre-market approvals (PMAs), which require clinical evidence to prove that the product works and operates safely. Then there's the middle ground, where a low-risk product might need clinical data for approval. In the industry, this is sometimes referred to as a "510(k) with clinicals" and, according to O'Dea, it's the route companies are having to take more often.

"It's becoming more commonplace with the FDA that they want to see some sort of a trial done," he says.

This middle ground is where Crospon found itself when bringing its EndoFLIP imaging catheter technology to market recently. The company secured market clearance on both sides of the Atlantic, but while in the US the process took around 21 months, in Europe it only took around four months.

Because of the sometimes substantial time-frame differences for getting approval, many companies look to sell medical devices here first, so that they can generate revenue and gather post-marketing data. They then apply to the FDA to get the product on to the US market.

Given Ireland's English-speaking population and our track record in medical devices, could this trend throw up even more opportunities to attract investors here when they are looking to get CE approval?

"I have seen a lot more potential start-ups looking to set up a company in Ireland on the basis of the regulatory process and getting to market quickly," says Derek Young, head of the Centre for Innovation in Surgical Technology at the Colles Institute in the Royal College of Surgeons in Ireland. "About 10 to 15 companies have come in to me in the last six months asking can we help them set up the clinical work here in Ireland, and in other European countries as well."

The differences in regulatory approval open a window of opportunity for Europe, according to Young, but he believes that the FDA will eventually catch up and streamline itself.

"This has been creeping up for a number of years and now it is coming to a critical point for them [the Americans]," he says. "And they know they have to deal with it and they are dealing with it, but it is going to take time."

So what does Ireland need to do to make sure we remain attractive to medical-device companies looking to commercialise in Europe?

"Ireland is still catching up, but we are driving forward to make our system more uniform in terms of doing clinical trials," says Young. "And we also need the resources behind us. By that, I mean the clinicians, the surgeons, the doctors - free up some of their time to let them take part in clinical trials."

Getting ethical approval for clinical studies can also be a time-consuming step in Ireland, according to Young. "The factor most companies don't have is the time to go in and get these trials up and running, and if we don't it other countries will snap them up, particularly Holland."

But changes are afoot. In 2010, to speed matters up, the IMB established a process whereby the authority can review device research applications at the same time as hospital research ethics committee reviews are being carried out.

"It is hoped that this approach will allow for more timely access for Irish patients to novel medical-device therapies and will afford time savings in the research programme of the device industry," says IMB chief executive Pat O'Mahony.

He notes also that we are likely to see the regulatory approach to medical devices undergoing significant changes in Europe and the US over the coming years, with a push towards greater harmonisation.

In such a global market though, what is to stop companies moving beyond Ireland and Europe and going to less tightly regulated regions for approval to market their medical devices? This might look like a handy loophole on paper, but the reality is about effective marketing, and about company reputations too, according to Derek Young.

"There is some evidence of that happening, but the fact is that it's very hard to sell your product in other countries with that seal of approval," he says. "Clinicians will not end up using your device on the basis of what you have done [if you rely on less regulated approval]. So it's not just about regulatory approval, it's marketing as well. And the bottom line is that there can't be a compromise on patient safety."