Why sustainability and EU MDR were hot topics at MD&M West

Our editor Laura Hughes discusses what everyone was talking about at MD&M West earlier this year.

MD&M West claims to be the largest medical design and manufacturing event in the world, and this year the event celebrated its 35^th year.

After visiting the United States in 2019, I had heard from several companies how important a show MD&M West was for them, and an event they eagerly looked forward to. So, I wasn’t surprised when I arrived on the first day of the show, to see the picturesque venue in the LA sunshine surrounded by thousands of attendees. With the exhibition floor, talks and workshops constantly providing a range of topical offerings, I had to force myself outside to get some quick fresh food from the food trucks at lunch time.

There was, however, two key subjects I noticed during talks, workshops, panel discussions, and meetings which were constantly being mentioned. These were sustainability and EU MDR.

Sustainability

Excessive and non-recyclable packaging is something that has recently been scrutinized in the media, with big supermarket chains taking action such as the removal of packaging around multipacks. The medical sector is no different, with manufacturers and consumers both taking an interest in the material within medical devices.

During MD&M West, I was able to attend a panel discussion on sustainable packaging. Here, it was highlighted how many factors there are to consider when aiming for sustainable packaging. These include but are not limited to:

• How much water was used to create this packaging?
• How many greenhouse gases and toxic chemicals were involved in the process?
• Can this material be repurposed?
• What parts can be recycled and where?

However, a manufacturer’s number one priority will probably always be to ensure the medical device fulfils its purpose and meets the required regulatory standards, before looking to ensure it is sustainable.

It is also important to bear in mind how sustainability means different things for different people. For some people it is using less material, whereas for others it is using material that can be recycled.

Steve Duckworth, global head of segment medical and pharmaceutical, Clariant, said for him, “it is more about using less material, rather than making everything recyclable.” He explained how the company’s number one priority is to ensure that the device does not compromise patient safety. Duckworth also highlighted how once medical devices are recycled, these devices cannot then be re-used in the medical field. He explained there can be issues around the responsibility of these devices following recycling, if a single use medical device is recycled and reused and an incident occurs.

Additionally, awareness is also a really important factor to think about. Education is needed so that both users of medical devices and the manufacturers know which parts can be recycled and where. For instance, everyone knows aluminium can be recycled, but more information is often needed as to which plastics can be recycled and where.

Solvay, a materials and chemicals company, explained how there was a real focus currently on replacing single use metal with plastic. However, I was informed that the plastic currently used is not recyclable. Rose Catherin, sales development manager, Solvay, explained this is because of a supply chain issue. Catherin said how there was not a system in place to collect the devices from the hospital and take them to a relevant location in order for recycling to take place.

It is clear to me more actions are needed both by consumers and manufacturers to ensure we are acting in an optimal way for our environment. Although, I do think we have come a long way, and by talking about the topic at big industry events we are only going to make advancements more rapidly.

EU MDR

The European Medical Device Regulation (EU MDR) was planned to take effect on 26^th May 2020. However, following the coronavirus pandemic, the European Commission has stated this deadline will be delayed.

This regulation applies to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety.

The subject is a real hot topic amongst the manufacturers of medical devices. During MD&M West there was multiple talks on the subject, and it was brought up in my meetings with various organizations.

Additionally, our latest North American magazine which was distributed at the show featured a two page article on EU MDR and a survey we had conducted with our readers. This was regularly highlighted during our meetings as an article that organizations had found particularly interesting.

How ready are companies for the implementation of EU MDR? Well, if the audience of the EU MDR talk I attended during the show are anything to go by - not very. Isabelle Lang-Zwosta, a global regulatory affairs and business development director – medical (MD) from Knoell Germany, delivered a talk on how to overcome the hurdles of MDR and provided manufacturers with a last minute checklist during the show. At the start of her talk she asked people in the audience to raise their hands if they were ready for EU MDR, and not a single person raised their hand.

Lang-Zwosta highlighted how if you had begun preparations in 2017, you would be prepared, however, this is not the case for many companies. Companies who are attempting to prepare for EU MDR are facing multiple barriers as part of the process, such as the need to recruit someone who is responsible for the process within each organization, the Eudamed database failing to be up-to-date, and queues of 6,000 for notified bodies!

An important point Lang-Zwosta raised was that organizations really need to look at the sales around their medical devices. This is because it is expensive to get a device to comply with EU MDR, and so companies need to be sure the process is worth it before beginning.

Despite the postponement, the EU MDR deadline is still rapidly approaching, and companies will need to work hard to ensure they are as prepared as they can be for the deadline. However, with an out-of-date Eudamed database, a huge queue for notified bodies and the disruption caused by the coronavirus pandemic, I think multiple companies will struggle to comply with the deadline.