An expert opinion on medical device regulation

17 Feb 2012 2min read

Team Consulting

Company update

There has been a lot of discussion in the media over the last few months regarding PIP breast implants and this conversation has now moved on to medical devices in general and how they are regulated. As one of the world’s leading medical device developers we have 20 years’ experience in this area and an opinion on this issue:

The following quote is from Jerry Turner, CEO:

The process of designing and developing a medical device is a long one, far longer than consumer product development. At every stage of the process, which can take up to seven years to develop, test and achieve regulatory approval, user and patient safety is paramount. By users we mean the wide range of healthcare professionals (doctors, nurses, surgeons, midwives, etc).

Throughout the process we ask: Can a user use this medical device correctly and without injury through misuse? What are the risks? Are the components, materials and even colours approved for medical purposes? How can we reduce the chance of misuse or errors? How can we improve patient compliance – as it isn’t just about reducing risk.

The issue with the PIP breast implants is not, according to the UK’s MHRA, regarding the rate of rupturing, which is apparently in line with the failure rate of other leading implants. The issue is that the manufacturer apparently used an unapproved silicone, which was brought to the regulators’ attention during the saga. This is not a widespread problem from what we see. All of our clients, which include many of the world’s leading pharma companies, follow regulatory guidelines carefully – as we do for them when designing devices. They want commercially successful drugs and devices and they do this by playing by the regulatory rules and enhancing, and saving, the lives of patients.

It is not in the interests of companies with integrity to try and trick the regulators or bypass the process. They do get found out and they suffer the legal and financial consequences.

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