Alex Denoon, lawyer at Lawford Davies Denoon in London, says that regulations for device companies are getting stronger every year due to the incoming additional requirements. "The area is extremely complicated to navigate. There is nothing really wrong with the legal framework, but there is a lot of conservatism amongst regulators," he says. This has resulted in a loss of agility in the medical devices sector.
However, he does not think things will change any time soon. Scandals in Europe have lead regulators to reinforce and adopt a more stringent approach for all products and therapies, as well as additional scrutiny, care and need for data. Considering this scenario, CTA asked Alex Denoon what device companies need to do to comply.
CTA: What could be done to help device companies comply with stronger regulations?
AD: I do not think it is a matter of trying to convince the regulators to take a less rigorous approach. I think it is a matter of preparing, preparing and preparing so that the documents you take to regulators or to an ethics committee are thought through as much possible and they answer questions that might not have been even thought of yet. This is because if you are halfway through an application process and a regulator says 'I'd like to understand how this would work in children' or something like that, then you can be stalled for longer time trying to provide this information – so preparation, preparation, preparation is key!
CTA: Are device companies actually preparing themselves for this?
AD: The good ones are. The well-established pharmaceutical and med tech companies are doing a competent job at preparing and handling some of these complexities. I would say most people are scaling up and putting more resources towards it. I think the regulations will simply slow down access to therapies, but not prevent access to therapies. It used to be the case that with a relatively high-end medical device you could come out with two or three revisions over the year and now it is much more likely to be one a year at most, more likely one every two years, simply because of the additional regulatory burden and requirements. That is not a necessarily bad thing, but it is an inexorable thing that a lot of the agility is slowly being lost in the medical devices sector.
CTA: How would you suggest device companies best prepare for regulations?
AD: Unless they are big, device companies rarely have the in-house competence to do it all themselves. Therefore, they should regularly speak and engage with powerful consultants. Also, they should develop a detailed regulatory strategy that includes what to do if things go wrong. Most people have a regulatory strategy but assume everything is going to go well rather than prepare for when things inevitably turn out to be messy, complicated or challenging.
CTA: What could happen if device companies do not prepare themselves and do not comply with the regulations?
AD: Anyone who thinks they can take a shortcut is likely to get a nasty surprise. The regulators are being very, very conservative at the moment and I do not see that diminishing. The regulators were pretty savagely criticized for not being able to identify the PIP breast implant issue and as a result they toughened up their own behaviour even before the law changed. So the regulators in Europe collectively got together and said 'Let's just raise the bar a bit and make sure we are getting a tougher level of scrutiny.'
The consequences of not complying would be catastrophic. This often occurs when companies hope to have a launch in X months time and you take your dossier for the final approval and at this stage they say they would like to see more data on something, or that they are not satisfied with something (for example, that you only had 60 people in the clinical study and they would like to see 1000, and thus have to do the study again). If you are a start-up you will not have enough time to do that and you will be delayed for an indefinite period.
As a result, companies could suffer an enormous drop in value on the stock market. If you try to take a shortcut, you can have your product removed from the market, which is extremely unpleasant. It is not a matter of financial penalties; it is that the regulators will not give you the certificate needed. The reputation of the company is at stake.
