Richard Holborow on ‘one of the most important Conversations that Matter sessions in the history of RAPS Convergence’

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Richard Holborow, head of clinical compliance at BSI.

You are the head of clinical compliance at BSI. What does your role entail?

I'm responsible for the clinical evaluation assessments that we perform as a notified body. I also manage the 15 internal clinicians we have at BSI, who range from neurosurgeons to cardiothoracic surgeons, and they help evaluate the clinical data that manufacturers present as part of their conformity assessment. It's my role to make sure our internal procedures and policies meet the requirements of the EU MDR. It's also to make sure for our clients that we are applying the letter of the law, but that we are doing so in a pragmatic way.

Under the old system with the Medical Device Directive, internal clinicians were not required at a notified body. It’s the MDR that's driven this, and that’s how my role came to be. I'm also responsible for postmarket surveillance activities, so when manufacturers present their PMS plans and periodic safety update reports, my team and I ensure we are applying consistency in our assessments.

What led you to this role?

Nobody grows up saying, “I want to be a regulatory affairs professional.” That's the reality. You naturally fall into regulatory affairs, and you either love it or you hate it. I worked in the NHS here in the UK as a cardiac physiologist for 16 years. When I was working in surgery, people would hand me a CE-marked device that would say it was fit for purpose in Europe. But the reality was that I had no idea how that CE mark got there.

When I was looking for a career change to spend more time at home, I literally searched the words “implantable defibrillator,” which is an area that I practiced in, into Google, and it came back with two jobs. Bizarrely, one was lifeguard. I was not the greatest swimmer. You wouldn't want me trying to save you, so that one was out. The second was with BSI, who was looking for a clinical evaluation specialist. I applied and I've loved it ever since. As a clinician who had not previously known about what went into the whole regulatory process, it’s been incredible to see how a device gets to market. It's been a huge eye opener.

I think a lot of clinicians, if you ask them today, “What is the regulatory process behind a medical device getting to market?” They would assume somebody is sitting with a rubber stamp, some old gentlemen of 89 years of age, just stamping things and moving it forward. The reality is far, far beyond that. It's actually reassuring to see what goes on behind the scenes in order to get a device to market. It's that trust and safety that goes into that assessment, which sadly not a lot of clinicians realize, which would be great for them to be aware of.

You’re speaking at a Conversations That Matter session. These are always in-demand sessions at RAPS Convergence. For those who have not attended this type of session before, can you explain what people can expect?

I'm honored that RAPS has asked me to speak at this particular session. It's a really important session because the barriers are down and the manufacturers and regulators in the room are all having open conversations about the challenges that we're all facing. So often, we perceive challenges as affecting one particular stakeholder. But ultimately, so many of these challenges affect our community as a whole.

I would say that this is probably going to be one of the most important sessions of the history of RAPS for Conversations that Matter, because there is so much change that is happening globally, but especially in the EU. Through my involvement with the European Commission, with various meetings and task forces, I'm hoping to be able to bring some insight to help manufacturers plan and consider what they need to think about for the future. But I am also there to take feedback. That honest and sometimes critical feedback that we receive as people who certify devices is so important.

You’re also speaking at a session on clinical data transferability. What excites you about that topic?

One of the frustrations we often hear from manufacturers is that they don't want to repeat clinical investigations or clinical data collection activities. One of the things I always try to get across is that the clinical evaluation process is really a scientific process. It shouldn't be dependent on regulatory requirements. If your evidence is sufficient to demonstrate safety and performance of a device from a clinical investigation with the right patients and the right patient populations, it shouldn't be then a gamble as to whether or not that's suitable data for Japan, the EU or the US.

Evidence is evidence and that's how scientists should look at it. That's something that we try to get across. I’ll also emphasize that putting in good effort and getting good quality, sufficient clinical data should not be then a barrier to any regulatory aspect.

What have your previous experiences at RAPS Convergence been like?

After first attending in Phoenix in 2022, I’ve been each of the last few years in Long Beach, Montreal, and Pittsburgh.

These conferences are fantastic opportunities to connect. I think what I've loved is when you go to these conferences, everyone is very much in the attitude of,“ I want to know what you do, I want to know who you are, and I want you to teach me something new."

And as an organization, we get to see some of our clients and we get to meet new clients.  People drop by and say, “I heard you were going to be here. I wanted to come and say hello. And we had a great experience with our application.” Or they might want to talk about something about some potential future business with us. It is a huge, huge opportunity for us as an organization.

What has the conference offered you from an educational perspective?

When you go into the actual sessions from an educational perspective, you really see people connect in the room. Even when the session is finished, you’ve learned something, and you suddenly find yourself migrating to people who raised questions during the session You might say, "You had a really good question there. And I've had this experience.” And suddenly there's this exchange of experience that occurs. And before you know it, you've got a LinkedIn plus-one saying to you, “Can I join your network? We spoke at RAPS.”  And that helps you build that connection. I've built some fantastic friendships as well as actual working relationships with people from RAPS, and it's great that it brings a real community feel.

Particularly for RAPS Convergence, it's great to be able to hear what's happening from FDA or about manufacturers in the US, the challenges that they're seeing and trying to bring that alignment across regions. The same way that when we see, for example, “How to get your product to market in China,” which have been absolutely fantastic to really understand the systems and processes that exist globally.

This conference gives you opportunities to think about your career as well. The regulatory community is one of passion and it's one of interconnection, and it’s great to see, as someone who's moved around in different roles across it, how many opportunities there are.