By Parminder Kalle, Chief Commercial Officer at IMed Group
The ABHI conference this year had a clear tone. Diagnostics is under strain, regulation in the UK is shifting gear and the role of the Regulatory Affairs (RA) leader is expanding faster than most companies are ready for. The day felt less like a technical update and more like a moment of collective honesty about where the system stands and what needs to happen next.
Diagnostics: the pressure point that now sets the pace
“Diagnostics has become the silent bottleneck of the NHS. Demand is rising faster than capacity and digital systems still lag behind what modern care requires.”
Chris Sleight, Greater Manchester Diagnostics Network
Chris Sleight’s session cut through the noise. He painted a picture that anyone working in UK healthcare recognises instantly: demand keeps rising, the workforce keeps shrinking and digital maturity still lags behind what you would expect from a modern system. Manchester alone has poured huge capital into scanners and CDCs, yet the bottleneck remains people, processes and data that cannot travel from A to B without friction.
The issue is national. Access varies wildly across regions, waiting times remain stubborn and the capability for large scale digital diagnostics still feels underpowered. AI is discussed with enthusiasm, yet adoption moves slowly because the foundations are not ready.
The message was simple: diagnostics is now central to everything from cancer to elective recovery, so its weaknesses impact the whole NHS. The solution cannot be more isolated investment, it has to be collaboration, digital infrastructure and workforce models that look beyond the traditional approach to clinical capacity.
For RA leaders this reality matters. Regulation will only become more data driven and more focused on real world performance and evidence expectations around diagnostics, connected systems and AI will rise not fall. PMS will continue to expand as regulators rely on live data to offset faster access routes.
MHRA: a regulator that now wants to set the pace not follow it
“The MHRA is moving from a cautious regulator to a proactive partner. Regulation has to keep pace with innovation, not stand in its way.”
Lawrence Tallon, Chief Executive, MHRA
Lawrence Tallon and Rob Reid were clear that the agency is no longer content with a defensive posture. The commitment to indefinite CE recognition removes the uncertainty that has hung over the sector for years and it frees up the UK to reposition UKCA as a genuine first to market route for innovators. This was a subtle point but an important one, stressing that UKCA is no longer about duplication, it is about speed.
The agency is also putting real weight behind AI. Not as a marketing line but through investment in expertise, new advisory structures and the Airlock sandbox. The direction is towards iterative regulation where adaptive technologies are monitored continuously rather than approved once and frozen in time. That shift alone will reshape how RA teams think about documentation, design control and PMS.
International alignment was another strong thread and the partnership with the FDA, the UK joining the Health AI network and the focus on reliance routes all point to a more outward looking model. For companies this means smarter regulatory strategies that reuse evidence and reduce friction across jurisdictions.
“International alignment isn’t optional anymore. Our collaboration with the FDA and global networks is about creating faster, more predictable pathways for innovation.”
Dr Rob Reid, Deputy Director for Innovative Devices, MHRA
Regulation as a growth enabler not a barrier
The panel sessions added a wider lens. Rising costs for manufacturing, conflicting sustainability targets and increasing reporting obligations are squeezing margins at the same time as global competition for investment intensifies. The argument was that regulation cannot keep adding cost without considering competitiveness. It must support innovation and efficiency, not slow it down.
This is why PMS, clear standards and predictable pathways matter and the more streamlined and aligned the UK becomes, the more likely companies are to bring innovation to market here first.
What does it mean for RA and Quality leaders?
Across the day a few clear expectations emerged:
- RA teams will need stronger capability in digital and AI
- Risk files will need to reflect interconnected systems not isolated devices
- PMS will become the primary lever for regulatory trust
- International reliance will become the smart route to market
- Evidence will need to show performance and equity of access as diagnostics expands beyond hospitals.
This environment rewards organisations that can move quickly, plan strategically and build regulatory systems that keep pace with adaptive products.
Where outsourced expertise fits
Many companies will not have the internal bandwidth or the specialist skills to adapt at the pace MHRA expects. This is where external support adds real value. IMed already helps clients strengthen PMS, prepare for AI driven regulatory expectations and design global pathways that minimise duplication. The emerging landscape makes this type of flexible specialist resource essential rather than optional.
Closing reflection
The ABHI conference did not feel like another regulatory update but like the start of a new phase where diagnostics, digital health and AI set the direction for the entire sector.
“Regulation is not paperwork. It’s the difference between a child living with hundreds of seizures a day or having the chance to reclaim a future.”
Mark Grumbridge, Head of Clinical Investigations, MHRA (Oran’s DBS story)
The UK clearly wants to position itself as a leader in innovation and access. The challenge now is readiness: companies that act early will benefit, while those that wait will find the regulatory bar shifting beneath them.
At IMed we’re already supporting clients through this shift with PMS strengthening, AI/digital health readiness, regulatory strategy and hands-on support for UKCA and global pathways. If you want to discuss how these changes shape your own roadmap, contact us at hello@imedconsultancy.com!
