To celebrate our 9^th Birthday on 6^th June 2021, we got the whole team together for the first time in over a year, at our offices in Bloxham. Our specialist consultants largely work remotely or on site with clients (when it’s safe to do so), so getting together to exchange ideas and keep up to date with regulations, technology and key client issues is vital; particularly since it hasn’t really been possible for a while.

It was the first team meeting for a number of new staff members; Kate Bandy, RA Consultant, who joined IMed in April, Rebecca Munro Stearn, our new Project and Ops Manager AND our newest recruit, Ana Quinn – IMed’s Clinical & RA Consultant, who joined us from NAMSA and was attending the meeting on her first day with the company!

Members of the team presented Leeanne, IMed’s Founder and MD, with a delicious red velvet birthday cake, at our company’s Strategy Day, complete with 9 candles for her to blow out. I asked her about the birthday and the last 9 years at IMed;

‘It was great to see that everyone was as excited by our 9-year achievement as I was and who doesn’t love receiving cake?’

How has the regulatory landscape changed in the last 9 years?

‘Where do I start? MDR, IVDR, Brexit, UKCA, UKRP to name but a few of course. But I can remember when a number of countries didn’t even have any regulations or standards and since IMed started, they’ve gone on to introduce them.  There are changes every week in global standards or definitions or emphasis and we’ve had to become much more agile at interpreting and incorporating the most up to date rules into every job. Clients are relying on us to stay on top of any developing regulatory changes, sometimes reacting on a day-to-day basis – or even on what’s anticipated by the market, so as not to delay manufacturer projects and timelines – and to make sure they are poised for any emerging new responsibilities’

Can you give some examples?

‘Absolutely. First of all, clinical evidence; the amount and quality of evidence which it’s necessary to provide currently – both pre and post market – has significantly increased. Clinical Evaluation Reports are now substantial documents which include more studies, more data and more evidence, presented in a more thorough and cohesive manner than was required historically. Risk management and analysis requirements are also now more in depth and post market surveillance is more rigorous, with greater expectations of recording, reacting and providing solutions to events of failure.

The truth is that, as the regulations develop, there is more and more onus being piled on to the manufacturers and we need to be certain that they are aware of this and make provision for any necessary changes to their processes and recording those changes. It’s a big responsibility for the manufacturer and also for our experts, who continue to be trained up and to absorb all changes to regulatory and safety standards into every project.

More recently of course, with the COVID-19 pandemic, we’ve also seen our regulators draw up temporary approvals to speed up the release of critical devices without compromising patient safety. This has been particularly prevalent with diagnostic products, face coverings and PPE. So, there is a raft of further regulatory work for us all to do, as we migrate devices to CE Marking and UKCA too. But IMed is ready for that, as well as the IVDR transitions, increasing demand for more substantial clinical evidence and representing our overseas clients as their UKRP. We are also working hard on a number of other new services to release to clients over the next year, so we can make life even easier for them going forward. Watch this space!’

Have clients become more regulatorily savvy, since IMed launched in 2012?

Oh yes, definitely. It could be very frustrating in the past, trying to explain to product designers, inventors and start-ups, that they have to follow certain procedures and rules to keep patients safe. Back in the day, manufacturers top management used to sometimes call the QA/RA team ‘the sales prevention department’! But things have moved on now thankfully!

We specialists have got better at explaining why the regulations exist and how they ultimately protect the manufacturers themselves, as much as the patients/users. Also – products teams have more understanding and empathy with what we are trying to achieve for all parties. So, we’ve developed easier, more collaborative working practices, like sharing files electronically and holding regular cross-discipline meetings, to ensure everyone’s key issues and necessities are considered contemporaneously. All sides seem to now have a mutual respect for one another’s position in the product life cycle and this is why I like to employ my team from industry; so that IMed’s people genuinely understand the manufacturers position, then can empathise and enable.

IMed started off with just myself consulting to a handful of clients, but we are now regularly involved with a large selection of clients with a wide range of diverse medical devices and IVDs and have registered products in many global markets. So, we’ve changed quite a bit too. In fact, I’d say that over 9 years, IMed have become exceptional at managing change on multiple fronts; in the market, in the regulations themselves and in the technologies that we use to assist our clients.

So – what’s been the secret of our longevity and continuing expansion?

I’m keen to acknowledge IMed’s staff’s efforts, which have undoubtedly contributed to our growth; in particular in building up our ever-important bank of strong client relationships – which remain key to IMed’s working methodology and focus.

‘IMed recruits people who are well qualified in QA/RA, but also have demonstrable skills in industry, communication and cementing relationships with clients. IMed’s client retention has remained extremely high throughout all our 9 years in business and I have a wonderful team to thank for ensuring that fulfilling our clients’ needs comes high up the list of objectives for success, along with giving good, up to date advice and prioritising patient safety.

And what’s next?

Software, software, cybersecurity and more software! Seriously, the medical device market is moving very much toward software and active devices, so we are making sure that the team have the right knowledge and risk appreciation to face the next wave of innovations. Roll on our 10^th year and perhaps we’ll have a real party on 6^th June 2022!’