The Regulatory Expert Targeting Sunnier Uplands For The Medtech Industry

The role and purpose of medical device regulation is now better understood than at any time in its history, and regulators are no longer seen as gatekeepers preventing business from happening. In Vivo Rising Leader 2022 Graeme Tunbridge, formerly at the MHRA and now a senior VP at BSI, is a champion of the climate of inclusivity.

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Challenge, transparency, honesty, unapologetic. These words are sprinkled liberally throughout the conversation I am having with BSI’s Graeme Tunbridge as we talk about how the two-time Medicines and Health care products Regulatory Agency (MHRA) executive came to be one of the pivotal players in UK medical devices regulation, and a leader in the wider industry.

I work out one of the reasons for myself. Today is 26 May 2022 – “IVDR Day” ̶  a moment of great significance in the EU medtech calendar. It has been many years in arriving – “too many,” in Tunbridge’s view. As of now, every new in vitro diagnostic device entering the EU market must comply with the much more stringent IVD Regulation that has superseded the former directive.

That makes this a seriously busy day for device companies and technical file auditors, as the senior VP of global medical device regulation at the world’s largest conformity assessment body (CAB) is all too aware. But in Tunbridge’s range of values, clear communication and explanation, sticking to the plan and being a reliable interlocutor are, evidently, equally important. I, too, feel valued.

Tunbridge not long ago left the role of devices director at the MHRA to join BSI and its 1,000 regulatory staff, after a career spent entirely serving the UK public sector, in central government and the MHRA – chalking up two stints at each. His career began at the Department of Health in 2004.

In January 2022, with the MHRA in mid-transition, he left the agency, having been devices director since 2019. It happened that BSI was also losing a long-standing senior leader, and Tunbridge considered a move into the CAB sector to be a compelling alternative to navigating a period of uncertainty at the MHRA.

The agency was in a state of flux, having decided under new chairman Stephen Lightfoot and chief executive June Raine to reorganize internally and refocus its methods of working. It was also seeking a new place for itself in the post-Brexit global devices world.

New Global Remit

Graeme Tunbridge

As SVP of global regulatory and quality, Tunbridge sees opportunities to expand BSI’s business in foreign markets. This will contrast with the many years he spent focusing on the UK alone in the wake of the Brexit vote in 2016. Building the standalone UKCA marking-based system has latterly been Tunbridge’s main focus at the MHRA.

At BSI, Tunbridge has oversight of all global conformity and accreditation schemes that the company covers in medical devices, including ISO 13485 compliance.

He also has the new EU regulations to deal with on behalf of clients. “It’s good to get back to being involved in the EU MDR and IVDR,” he said. “I oversee the teams that ensure that the work we do as a global conformity assessment body (CAB) is compliant. For example, every time that guidance from the European Commission’s MDCG comes out that affects the operations of the notified body, we need to make sure that we have taken this into account across all of our activities.”

This is an era of enhanced global harmonization and partnership approaches to device regulation, including the Medical Device Single Audit Program (MDSAP); potentially the Medical Device Single Regulatory Program (MDSRP), championed by the US CDRH’s director Jeff Shuren; and regional programs that leverage elements of harmonization, like the ASEAN Common Submission Dossier Template (CSDT).

As Tunbridge sees it, the sharing of the job of devices regulation is being recognized more and more for the benefits it can bring to health care delivery in the wider sense.

The Step To BSI

Against this backdrop, joining BSI is “the next step for me and a great challenge,” he said. The challenge for CABs is huge and growing, but there is clearly a major opportunity ahead for them. For Tunbridge, notified bodies and CABs are the nexus in the medtech regulatory universe: “Manufacturers come to us, and we go to regulators.”

As such, CABs occupy a unique middle ground, in which everything else orbits around them. “Global CABs are what global medical device regulation needs to be shaped around,” he said.

Now a few months into the role, he is fully focused on helping BSI’s regulatory services, headed by group director Manuela Gazzard, expand in the global market. The company already operates schemes in a dozen jurisdictions, its program including the Japan, Singapore, and Malaysia systems, among others.

“We trade on our reputation,” Tunbridge said. “BSI services are not cheap compared to those of some other providers, but we have very highly trained people who do a thorough job, and I am very unapologetic about that.” For example, BSI will not simply rubber stamp products approved in other jurisdictions for entry into the UK market. “We need to do pre-market assessment and surveillance,” he said.

In terms of staff numbers, it may come as a surprise to learn that BSI is the second biggest medical device regulatory body globally, after the US Food and Drug Administration. Tunbridge said: “We have a global footprint and an enormous responsibility that goes with it. I am very alive to that. BSI has dedicated people driven by doing the right thing, and being seen to be an exemplar.”

The Long Shadow Of The MHRA

This involvement in big global schemes enables BSI to continue to feed into the MHRA. “Here’s how a global CAB system can support the MHRA in the future,” Tunbridge said, showing an empathy with the hard task his former colleagues have before them.

The UKCA marking consultation in late 2021 was impressive in its scope; the tough part – implementation – comes next, he said. “That will be beyond everything that has gone before.”

Nevertheless, Tunbridge feels he still has a valuable important role to play here. “I think I can really help the UK government and the MHRA shape the future UK legislation, based on my understanding of the challenges for the regulator and what I’ve learned over the past four of so months working with BSI. I can also help the UK understand how it can fit into the bigger picture and draw on the expertise within BSI.”

While at the MHRA, Tunbridge pressed for greater inclusivity, advocating closer relationships between the MHRA and the approved bodies/CABs in the UK. He believed there needed to be more ongoing discussion between the two and a more dynamic relationship leading to shared priorities.

A major issue has always been how the UK should support and attract innovation to the market. “No one has been able to stitch that whole pathway together” in the last 30 or 40 years, he said. Ongoing discussions at MedTech Europe have recently homed in on such a need. (Also see "Bernasconi: Europe Needs A Better Strategic Rudder For Medtech Innovation Policy" - In Vivo, 9 May, 2022.)

Understandably, those years spent at the MHRA will not easily be forgotten and moving away from the agency was evidently not without some sadness on his part.

The change, in the end, was decided quickly. A move out of the MHRA was still not on Tunbridge’s radar as 2020 turned, but the agency’s proposed reorientation of its regulatory approach was becoming more apparent as time went on. When in summer 2021 the agency communicated its proposed new structure and its refocus on life-cycle stage-based regulation, Tunbridge saw his time there coming to an end.

The MHRA wants all its regulatory activity (pharma and devices) to fit into three buckets: pre-market innovation, and approvals and safety. This vision has no place for a medical devices leadership role at the agency. “My job was disappearing,” Tunbridge said.

It is a wholesale change in how the MHRA operates. The director of devices used to have a voice at the table and sat on the executive committee. Devices is a smaller MHRA activity than pharma, and the fear among many UK device stakeholders is that the agency’s agenda will be driven by pharma, “even though pharma and device regulation need be considered differently.”

One unwanted outcome of the transition is that the associated job role changes prompted many devices staff, including experienced executives, to simply leave the agency. Tunbridge regrets that a lot of expertise was lost precisely at the time that their skills and knowledge of device regulation and its history, and the UK’s interaction with Europe and international relationships were critically needed.

The knock-on effects for the industry, UK market and National Health Service device users are yet to be manifested. Meanwhile, the UK is having to get to grips with the fact that, in comparison with the EU, it is a small player and cannot operate in the same way as it did before. With the MDR and IVDR to comply with, will companies bother with going through UK-only legislation? Tunbridge wonders.

For devices staff at the MHRA trying to assimilate the organization changes, there was precious little light visible at the end of a long tunnel they were being asked to go through.

The COVID-19 outbreak had also called on devices staff to show resilience, but to also be highly resourceful in the knowledge that helping to end the suffering caused by the pandemic was a challenge the MHRA could and should rise to. “The COVID episode was exhausting, but invigorating,” he said. “It’s what you want to do  ̶  to rise to these challenges.”

Tunbridge admits that his final year at the MHRA was as tough as any in his career. But now outside the organization, he still thinks about the agency and how it should interact with device innovators. That will probably always be the case for someone who spent over nine years in key roles at the MHRA.

His first spell there, as head of medical devices for EU policy, began in 2011 and lasted over four years, whereafter he returned to central government. But medtech regulation was under his skin, so when the then MHRA devices director John Wilkinson offered Tunbridge a role back at the agency in 2017, he did not hesitate.

Tunbridge credits his former boss with providing a solid grounding and being very supportive. Wilkinson was not inhibited by expectations, Tunbridge observed, and always sought to bring a broad perspective to the role. Tunbridge has included these qualities in the blueprint for his own career.

Find out who else made the list for 2022's top 30 Rising Leaders.

Getting The PIP

Early in his MHRA career, an event occurred that was the catalyst for the major EU regulatory change now underway.

Tunbridge had been at the agency for six months when the French government announced in late 2011 that it had detected problems with silicone breast implants manufactured by Poly Implant Prothèse (PIP), a French company. The implants containing substandard materials had been cleared by a local notified body. The collective wrongdoing emerged when some implants began to leak.

Tunbridge disagreed with the assertion made in some circles that this was simply a case of fraud from which there was nothing to learn. On the contrary: “PIP highlighted areas where the system wasn’t quite up to scratch.”

For example, a decade ago the EU system relied on 80 notified bodies that were all working to varying standards in clearing products for market launch. Already in hand at the European Commission was the early work to recast the original directives, as amended in 2007. “But PIP showed we needed more than just a ‘technical’ recast,” Tunbridge said.

Having held its notified bodies to high standards, the MHRA took a position very early on that substantial regulatory change was needed. Almost overnight, what had been intended as a few tweaks to EU legislation became a fundamental change in how things were to be done at EU regulatory level.

“People saw the UK government as very effective at shaping the MDR and IVDR.”

For its part, the MHRA pushed for the voluntary joint assessments of notified bodies, and then helped shape the EU regulations as a pragmatic and objective contributor.

Taking A UK And EU Leadership Role

Tunbridge was instrumental in the changes happening at EU level. His MHRA role meant he would lead the UK negotiations at the European Commission, which involved wearing a policy hat, interacting with the UK central government and parliament, and going to Brussels. The UK brought its pragmatic best to the debating table.

“I have always been pleased about the way people saw the UK government as very effective at shaping the MDR and IVDR, and in the negotiations,” he said. “We got direct operational input from people who had been involved in the system for many years. They understood both how it worked and its failings.”

He continued: “We were able to put it all in a broader political context, and decided that whatever we did, it had to make sense on a practical operational level and also be politically acceptable.”

It is Tunbridge’s view that good decisions often come from disagreements, debate, and discussion. “The MDR and IVDR are not perfect, but I am very proud of what we have achieved, and once we get the teething issues out of the way and have built Eudamed, Europe will have the leading medical device framework in the world,” he said.

“The MDR and IVDR negotiations were enjoyable and challenging, but I also thought that we should not have taken five years to get from Commission proposal to adoption in 2017. It should have taken two years at the most.”

“The IVDR and MDR are essentially good – we just haven’t been honest about what they will entail.”

In 2022 there remain some issues, but nothing insurmountable. “We must avoid throwing the baby out with the bathwater. I am very confident that there are sunnier uplands coming up ahead for EU regulation.”

Telling It As It Is

For the moment, implementation issues remain for the MDR and IVDR. The trick, said Tunbridge, is not to pretend that they are not there.

“The IVDR and MDR are essentially good; we just haven’t been honest about what they will entail,” he said. “Transparency and honesty are valuable tools – they are real leadership values that I hold very close to my heart. I see transparency is the best way forward across a lot of things. To its credit, the UK was totally transparent during the MDR negotiations.”

It is still the case that people need to be more honest about the MDR, he said. It will cause slightly slower access to market and will stop some products from reaching the market. “But that was sort of the point; it was inevitable.”

As to the IVDR, he says: “I don’t think there is a full appreciation that the IVDR is a bigger step up for manufacturers than the MDR, for companies as well as notified bodies.”

For any transformational change to succeed, it needs to be started early, Tunbridge recommends, “and then you bring people along with you.” That was not the case in the UK’s Brexit negotiations, where many feel honesty and transparency were not always on display during the political debates ahead of the vote.

Looking at counterparts, he has often mulled what is it about their leadership style that is effective and to be admired. He said: “I’m unapologetically a bit of a magpie when it comes to using techniques and ideas that other leaders have found to work well for them.”

Tunbridge values authenticity. “People get what they see, and see what they get. I am being myself all the time.” He added: “I don’t have fixed views in a lot of areas and I like to think I can be won over by a good argument – and vice versa.”

On the other hand, he also values humility, and the ability to admit when something has not worked out. “You’ve got to be able to do that, if not, you go down a path that will lead nowhere.” And he avoids surrounding himself with people who will only nod agreement.

Upgrading The Image Of  The Regulator

Along with the leadership traits, Tunbridge owns up to being a details person. “I like understanding things from first principles, looking at legislation and seeing how it translates into action.”

 

Tunbridge has done much to dispel the default image of regulators as staid and devoid of drive and imagination.

 

Most of what he and his staff did at the MHRA was focused on post-market safety, “but our interventions were effective and meant products were better in the future.” He says that people go into a career in device regulation because they want to get good products to patients. In that way the MHRA and BSI are alike.

“People feel passionately about it. It’s a vocation.” Moreover, Tunbridge has done much to dispel the default image of regulators as staid and devoid of drive and imagination. On the contrary, during his career, especially as head of devices at the agency, he had done a lot to upgrade and transform the reputation of the role, bringing enthusiasm and energy to the task. “I’d like to think I’ve done that.”

Defending, But Listening Too

There are times too when he has been on the back foot, as in 2018 when the UK investigative TV program, Panorama, came knocking as part of the Implant Files’ intended exposé of supposedly ineffective devices regulation and insufficient patient safety.

Tunbridge, not yet devices director, suddenly found himself at the end of the TV camera. “It was very challenging, but their reporting was sensationalized. However, legitimate concerns were being raised too, and what was hard to justify was the lack of transparency around the system.”

Similarly, he identifies issues of transparency and communication as being at the heart of the point raised in the 2020 Cumberlege review of patient safety. Tunbridge said the problems (with pelvic mesh – one focus of the Independent Medicines and Medical Devices Safety Review) were flagged early by the MHRA, but the messaging was not having the impact needed.

“In all such cases, you need to be able to say: ‘We should address this’,” he said.

“One of the great things about the MDR is that it has flipped [lack of transparency] on its head, and if anything, there will be too much information out there. One of the big challenges will be sifting the wheat from the chaff. But doing that is a real positive outcome from it.”

Leadership Traits And Values

I glean during our hour-long talk that Tunbridge has a strong code of leadership values, which filter down to his staff. But he happily jokes that the world “would be a very boring place if everyone was in the same mold as me.” He values diversity and, as Gazzard does, likes to surround himself with people who complement him.

Open communication, joint problem solving, no finger pointing are other favored traits. “You want to be a good person to be around when times are tough.” As it happens, he is also good at explaining things in the way people will understand. “It comes from having to understand it myself,” he says.

He also takes nothing for granted. He said: “Rarely a day goes past where I don’t get inspired by working in the medtech sector. Having a leadership position in this world is a privilege.”