Jonathan Ripley joins the team at IMed

We are delighted to introduce IMed’s latest key hire, Jonathan Ripley, who joined the IMed management team on Monday, as Head of our growing IVD department. Al Mills gave him the usual day-one grilling, so read on to find out more about Jonathan and his views on QA/RA, IVDR and bicycles……

Where are you originally from?

I was born and raised in Enfield, North London. I start to sound like I’m from London again whenever I go back there to visit friends and family.

What did you want to be when you grew up?

I wanted to fly fighter jets in the RAF. I love planes, the power and the roar of a jet fighter!

How did you find your way into RA/QA and IVDs?

After studying Microbiology at University my first proper job was in a GMP pharmaceutical manufacturing plant. The Quality culture and team were a big influence on the way the site ran and so, when a job came up, I decided to go for it. I helped a company build their first diagnostic IVD CE marked kits and had to get to grips with RA pretty quickly, throughout the implementation process. This took me on a path that saw me working first in Quality Assurance in pharma, followed by Defence and then transferring to IVDs. Regulatory Affairs was just a natural progression and the next milestone.

Why does QA/RA interest you?

QA/RA is central to the workings of a regulated company. There aren’t many roles that have the breadth and scope of QA/RA. It makes work interesting and thought-provoking and allows you the opportunity to work with each team in a company. When things go well, you can really see where you have contributed and helped the team and when there are obstacles, it’s really time to roll the sleeves up and get stuck in. Now, with IMed, I’ll be working with many teams and more devices, so my sleeves will likely be up permanently!

And what about your most recent work?

I recently worked for a company bringing a SARS-CoV-2 lateral flow test to market. The Covid19 IVD regulatory landscape is tough. It’s constantly changing and adapting to help get kits that work to market.

What appealed to you about this role and IMed?

I have worked in consultancy before and find it a real test of knowledge and skills within our profession. Being able to react to specific questions on products you have only just been introduced to is a true test and it helps grow your experience and mental agility fast. I was keen to get back to this and am super excited to be involved in further growing IMed’s thriving IVD department.

What do you have to say about IVDR and UKCA?

Overall though the changes, brought about by IVDR, are significant, but I think the move to safer products for patients and users is always a good thing. The IVD Directive is outdated and out of step with most current global regulatory frameworks, so it needed to change. When IVDR was published in 2017 manufacturers were glad to see the 5-year transition deadline; I know that, because I worked for one! The 5 year timeline was due to the scale of the changes that were being imposed by the new legislation. However, it’s clear that it has been a huge battle for both the industry and the EU, to be able to put the foundations in place. Now we are just 7 months away from the transition date of 26 May 2022, lots of people in the industry still believe that IVDR transition will be delayed, similar to the MDR transition. As a manufacturer I wouldn’t want to rely on this though and would be some way down the line to transition by now. But we shall see.

UKCA is a result of the UKs decision to leave the EU. The UK’s regulatory framework for Medical Devices is based on the old EU directives. The recent consultation released by the MHRA on the future of regulation of medical devices is suggesting a greater alignment with the EU IVDR and MDR with a suggested transition date of July 2023. There is a lot to be done by manufacturers, regulators and notified bodies to achieve this too. It’s going to be a big challenge for industry on the back of the Regulation changes in Europe.

What would you say is the key thing for IVD companies to focus on currently?

Clearly many companies have been focussed on the Covid19 pandemic and assisting in getting kits and testing solutions to market. This has been seen as both a huge task and as an opportunity by manufacturers, who have utilised the emergency measures to get to market quickly, to assist the global effort. Now that a lot of the testing capability across the world is in place, companies need to consolidate, by making sure they can continue to access the markets by having a sound regulatory strategy and capability. Emergency pathways won’t be open forever and planning for future regulatory submissions should be an absolute priority.

And when you’re not delving into regulatory detail, where can we find you?

Either hooked up to my bass guitar or tinkering on my bike. I have built a few bikes from scratch now and absolutely love the mechanics of it. Love music too, though I’m still working on my guitar skills……

Well, we are glad to have you on board Jonathan, irrespective of your guitar prowess – it’s great to have you on the IMed team!

If you want to pick Jonathan’s brains about your next IVD quality or regulatory decision, then please get in touch on 01295 724286 or send us an email to hello@imedconsultancy.com