Keeping a Pace with Changes in Clinical Evaluations for Medical Devices

Helen Winsor

Danielle Giroud, Founder of the World Medical Device Organisation, joins Pharma IQ to discuss regulatory changes in the medical devices market. To listen to the podcast now go to What's Next for the Medical Devices Market? Regulatory Changes.

Pharma IQ: Welcome to the show, Danielle; how are you today?

D Giroud: I’m fine, thank you; thank you for inviting me.

Pharma IQ:
It’s a pleasure. Now the first question that I’d like to ask you is, with the increasing evidence-based medicine politics, where do you feel the medical device market is moving towards?

D Giroud: Well, definitely, the medical device market is not spared in terms of providing evidence for its products; and evidence is more and more needed on safety and also performance. It means that companies, or medical device companies will need to deliver significantly more data to get their products to the market; but, definitely, to get their products reimbursed by the different national systems, and that’s really a worldwide tendency.

So what I see is that it might take time, and it will definitely cost a little bit more money to produce that data and get the products efficiently to the market; not just on the market, but efficiently selling them to the market.

Pharma IQ: That’s an important point. And do you think the regulations within the EU are moving towards being as strict as those in the US; and, if so, do you think that we will eventually have a unified regulation for medical devices on a global scale?

D Giroud: Well, let me break down this question, because, in my view, the regulations in the EU, they have a different approach, but they’re not less strict than anywhere else in the world.

Now, the enforcement of these regulations in the EU may not have been as strict as in the past because of the different systems and the different variety of interpretation among the different countries involved, and certainly the different notified bodies involved in the EU who actually are the gatekeepers of enforcing the regulations in Europe.

This is changing actually, and with the new Medical Device Directive, and also the new efforts of the competent authorities enforcing the regulations throughout Europe. So if we want to speak about moving towards a unified system, or unified regulatory system in the world, I guess, we still have some steps to make in Europe to get a unified approach of the European system. And then, I think, we can align better also with regulations in the rest of the world; so, for me, it’s first an effort that needs to be made in Europe to get a unified approach still in Europe, but we’re getting there.

Pharma IQ: Yes, sure. And with the recent updates to the Medical Devices Directive, how do you feel this has, and will, impact on the medical devices industry going forward?

D Giroud: Well, it relates a little bit to the previous question as well; there were updates in the Medical Devices Directive, but most of those updates are just like reinforcing and clarifying things that were already there. So what I mainly see with the updates of the Medical Devices Directive is that companies have less and less room for interpretation, and will have to comply with all the points of the Directive. So I really see the updates of the Directive as more enforcing of points or regulator requirements that were already there. And so, in my view, there is not a major economic factor in the updates of the new Directive for the medical device industry, but more like, there’s less way out of complying with it.

Pharma IQ: Yes, and what do you think medical device professionals need to do to remain compliant?

D Giroud: Very interesting question there. Definitely, I mean, the way I see it is, well, medical device professionals will have to do continuous training, continuous education to be able to be compliant. And, I think, one point that is very necessary among the professionals from the different specialities is that cross-functional training and understanding of each other’s responsibilities will definitely improve compliance and improve efficiency of how medical devices come to the market. So, for me, it’s really the professionals from the different specialities, regulatory quality, clinical and so on, they need to understand a minimum of each other’s speciality so that they can work better together and improve their compliance.

Pharma IQ: Absolutely. And I understand that big changes are being made to safety reporting requirements; what difficulties will the industry be facing there?

D Giroud: Yes, well, they are facing the difficulties actually because the changes are there. We are still waiting for a new draft guidance and that will also be one of my presentations at the conference. The guidance document is still in draft, let’s say by the European Commission, but several drafts of these have been published; there are some new definitions and some new reporting requirements coming on.

Competent authorities will look at the reporting requirements for safety during clinical investigations much more stringently as well; they’ll have a higher demand. I can’t say that we’re looking at a uniform system yet; France will still have these requirements, and Germany is now developing some additional requirements for reporting. So the difficulties the industry will be facing over the next month while this system is coming into place is a lot of logistics; finding out who wants what reported, in what language and what form.

I think the guidance document is there too as an attempt to homogenise the reporting systems throughout Europe; but, definitely, yes, with the revision of the Medical Devices Directive, Europe has gone to a more complex reporting system rather than simplified. So it’s not going to be easy for the industry to find out who wants what over the next months until all this is settling down into a more homogenised system unfortunately. But, let’s hope that by the time we get to the conference we get some clear in-view; and certainly I’m following this up very carefully, so I’ll be able to inform the industry about what’s needed.

Pharma IQ: Yes, and I understand that there are also new updates with ISO 14155, what do you feel ISO’s role is within the medical devices industry, moving forwards?

D Giroud: Yes, there are some significant updates on the ISO 14155 coming on. I’m the convenor of the ISO 14155 Working Group, so I’m following this very closely. We’d like to get this ISO final draft out as quickly as possible, but it’s somewhere stuck at the ISO administration. Right now there’s a lot of work in translation and editing and things like that to do; so also by the time the conference that document will be at least published for voting and so on, we hope that will be done in September.

Duly, with ISO 14155, not only in Europe, because there it is accepted and it is really the reference document for conducting medical device trials; but for worldwide, we’re looking at a much better acceptance of the new guidance document. So let’s hope that the ISO 14155, over the next few years, can become a global document for conducting clinical investigations with medical devices.

Pharma IQ: Thank you. Now, Danielle, you’ll be chairing our Clinical Evaluations and Investigations for Medical Devices Conference, which will be running from 18th - 20th October 2010 in Berlin. Now, for anyone interested in attending, what key learning point might they expect to take away from your presentation?

D Giroud: From my presentation, and also from the whole of the conference, I think a lot has been changing with regard to the clinical evaluation. I think, there are still quite a number of companies or professionals struggling with all the information coming on to us - of what is it now, what’s going to happen, when are things going to be implemented?

Certainly, from my perspective, from my presentation’s perspective with the ISO and the safety guidance, attendees will get an up-to-date view on what is really needed, and some kind of, also, interpretation. Because even though these documents are published, what are we doing, how do we practically work with these documents?

So I will definitely try and give a practical view on how to move forward and how to use all this information. I truly hope that in that conference we will have a very efficient and a very open and practical exchange among the people attending and among the speakers, so that we can work on that famous cross-functional learning aspect between the different parties. So I truly hope that people from different specialities will be attending, so we can clarify all the grey areas on clinical evaluation for medical devices.

Pharma IQ: Yes, thank you, Danielle. Well, we really do look forward to hearing more from you at the event, and we hope this will provide a valuable forum for discussion. Thanks so much for your time today; it’s been a real pleasure talking to you.

D Giroud: Well, any time. And absolutely, I’m looking forward to it.

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