IMed Consultancy: supporting NHS-born innovation with University Hospital Southampton –

In his role of Head of Commercial Innovation at University Hospital Southampton NHS Trust, Martin Gossling has worked closely with the Academic Health Science Network and, more importantly, UHS own innovators, to support the NHS England agenda to accelerate the pace and scale of medical innovation.

Martin has supported internally-developed innovations and assisted SMEs with products from ideation and incubation, to managing access to the NHS for clinical needs assessment and execution of clinical testing protocols. However, the innovation pipeline within the NHS has, historically, struggled due a shortage of direct funding and a lack of resources for SMEs in terms of clinical product development. To respond to this need to commercialise innovation, in 2023 UHS is launching a new initiative, called the UHS IDC, in partnership with private sector funding and development partners. The objective of this clinical entrepreneurship project is to support homegrown, NHS innovation and help ground-breaking new devices, typically from Class I to Class IIb, be commercialised through the NHS and even abroad. It is thus critical that any trial requirements, potential conflicts and regulatory framework issues are addressed upfront.

  The new UHS IDC, requires up-to-date specialist advice from experienced consultants that move in the regulatory and compliance space daily. Rather than spending hours researching the latest regulatory updates and changes, Mr Gossling knows he can rely on a team that will be able to provide an accurate and immediate response to any regulatory conundrum.

“The NHS relies on sound clinical advice to support its effort for the development and promotion of internally developed medical devices. Up-to-date, accurate regulatory consultancy is critical to ensuring that new medical grade innovations can be safely and successfully commercialised,” explains Mr Gossling, “Some of the devices we will collaborate with the UHS IDC to develop have a truly revolutionary potential and it is a moral imperative to ensure that these are made available to patients and clinical staff in a timely and cost-effective manner .”

Regulatory framework is in flux as new technologies have aggressively thrown software-based and AI-driven medical devices into the fray, driving debate around how to regulate and handle metrics surrounding the performance of these products. “Trying to put a unique, world-first product into a regulatory framework that was not designed for it, and that up to a few years ago only contemplated the existence of physical devices, is a complex and painstaking task that can only be entrusted with confidence to specialists in the regulatory field. IMed Consultancy are just that: an experienced team that lives and breathes regulatory compliance. You could bounce these ideas around in your head for days, or simply call on the experts.”

Because of their first hand work in hospitals on a daily basis, Health Care Practitioners (HCPs) are the most likely to have brilliant ideas that truly improve processes, patient comfort and safety. At the moment the framework to support this type of innovation is scarce and inventors typically have to become fully fledged entrepreneurs to secure their own funding while also potentially committing an IPR violation. This is therefore an impractical route for most HCPs and results in innovation languishing. To combat this waste of brilliant ideas and give patients access to hundreds of potentially life-changing new devices, in 2023 University Hospital Southampton is launching the Innovation Development Centre that aims to commercialise NHS-grown innovations at a rate of 5-10 per year.

“While the development centre will focus on bench testing, prototyping, clinical trials and market launches, IMed Consultancy will provide support on regulatory compliance across the board and preparing technical files that satisfy all regulatory requirements including, for example, definition of how a product is controlled and proof that all checks and balances have been carried out,” notes Phil Rogers, COO of the new UHS IDC, “Within five years, we expect IMed Consultancy to be supporting us on over 25 Class II innovations, and, as the products begin to be commercialised abroad, in the US and Europe, we will be calling on IMed Consultancy to ensure that technical files meet and continue to meet FDA and EU standards too. As the IDC will be carrying the UHS name, we cannot afford to make any regulatory mistakes.”

IMed Consultancy will therefore be supporting the Innovation Development Centre to help ensure that products are fit for market so hospitals where innovation is nurtured can benefit from licensing fee income, HCPs will be rewarded for their efforts and the ideas of frontline professionals can seamlessly transition from concept to reality.

“We’re absolutely delighted to play such a key role driving both medical device innovation and supporting the NHS through University Hospital Southampton in its path to commercialising new products. We know that the fail-rate for medical device start-ups is staggeringly high, and all too often connected to poor regulatory advice in early stages of development; we’re here to ensure that our expertise ferries these products across to the market seamlessly. At a later stage, we also look forward to leveraging our experience supporting medical device and IVD manufacturers as they enter global markets will ensure that these new products make their way to different international markets where they will improve patient outcomes and working practices,” concludes Leeanne Baker, Founder of IMed Consultancy.