MDR a Blessing or a curse?

Medical Device Regulation 2017/745/EU (MDR) a Blessing or a curse?

At the centre of a Medical Device Company three things contribute greatly to the design of our DNA: Regulation, Usability and Standards. These things seek to deliver harmonisation of care, safety in medical device use, and compatibility with other medical devices placed on the market. This short piece is focussed on Medical Device Regulations which is going through major changes in Europe.

At the centre of Medical Device Regulation at least in theory, the thought has been that the intended use of the device and therefore the patient safety is key. But even with the Medical Device Directive 93/42/EEC (MDD) being transposed into law during the early 1990's, we have seen major failures in breast implants, replacement hips and more recently surgical mesh.

How did these things ever get to market in the first place? If the patient, the ultimate customer was at the centre of our world, how did we allow non-medical grade materials to be included in medical devices?

During the COVID-19 pandemic the mayor of New York City Andrew Cuomo asked the question, ‘What value would you put on a life?’, and he concluded 'life is priceless'. So how do we get to the point that as an industry we failed so badly?

Now my opinion, is that it is because we are instinctively focused on revenue and margin. Before you all stone me, businesses exist to make money, and that’s a given. However, for me the greatest privilege about working in medical devices is, that everything we produce helps in the treatment or protection of a human being at their lowest point in life, i.e. when ‘they are sick'. As leaders we continue to kick the subjects of regulation, usability and standards down the road, because we see them as a matter of compliance.

However, think about it; it is those very things that make us Medical Device manufacturers and not producers of cars. For Medical Devices to have the greatest clinical and social impact in the 21st century, these codes must be at the centre of our 'strategy'. These functions must have a strong voice at the board table and their guidance be regarded as beneficial and essential to the present and future of the business.

So, is the transition from the Medical Device Directive 93/42/EEC (MDD) to the Medical Device Regulation 2017/745/EU (MDR) a blessing or a curse? Today most MedTech leaders would regard it as a curse, because in the present everyone is incurring cost to comply with Regulation 2017/745/EU (MDR). It may be regarded as a margin eater and to what gain? I would argue 'harmonisation'. The biggest weakness in my opinion of the Medical Device Directive, is that member states had a choice in how it was transposed into local national law. Even though there was one European law, each member state could tweak it to create local and subtle barriers to trade.

So, is the Medical Device Regulation the answer to all of these issues? No! Not on its own, but if Medical Device Leaders embrace the change and use it to focus on patient outcomes, which is what the Regulations, Usability and ISO Standard guide us to do, patients and governments will be better served. The Medical Device Regulation create an opportunity for the best in class to serve patients, and our communities, with products, technologies, services and procedures that raise the standard of care.

We have all shown glimpses of what we can do during the COVID-19 pandemic, so let’s take hold of this change in our industry and turn it into a ‘blessing and not a curse’.

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