Act together

It is an exciting time for the industry. Fresh opportunities are increasing each day, driven by the needs of healthcare systems to improve patient diagnosis, treatment and experience. This has not only led to greater demand for innovative devices, but also the potential to work in a new, more collaborative way, breaking down the traditional silos between industry and academia, as well as interacting with healthcare professionals throughout the development process.

A model that has begun to be more heavily used in the UK is the partnering of industry with Academic Health Science Networks (AHSNs). These are UK organisations, first licensed in 2013, which are pioneering new ways of developing and implementing innovations for use within the UK’s NHS in the disease areas defined as being the highest priorities. AHSNs have established a medtech innovation national network to accelerate this process for medical devices, which includes physical devices and in vitro diagnostics. This remit therefore excludes software as a medical device and large devices, such as MRI scanners. The Eastern Academic Science Network (Eastern AHSN) has reported that the NHS currently spends ?6 billion a year on medical devices, highlighting the huge potential for manufacturers.

The medical device landscape is shifting and faces challenges in the form of new regulatory requirements, as well as the strong market forces demanding competitively priced products for a complex and diverse healthcare procurement environment. In their 2019 report, the Eastern AHSN proposed an innovation pathway aimed at manufacturers seeking to tap into this market, which aimed to ensure that the resulting products meet patients’ needs as well as being commercially successful. Throughout this process there are a number of areas for collaboration with academics and healthcare professionals.

“The health and science infrastructure in the UK is uniquely positioned to take advantage of the opportunities for economic growth and improved patient outcomes created by med-tech,” says Piers Ricketts, vice-chairman of the AHSN and CEO of the Eastern AHSN. “However, there is a risk of companies getting lost as they navigate the innovation maze.”

Take the stages

The first of the stages outlined in the report is ‘creation’. As the name suggests, this involves identifying the market value of the concept, the impact on health outcomes and identifying market access barriers. To assist in this stage, AHSNs offer Innovation Exchanges, funded by the UK’s Office for Life Sciences, where potential medical devices can be linked with existing local healthcare system challenges. This stage might also involve patient and public involvement, including direct interaction with NHS trusts, AHSNs and medical charities, as well as the National Institute for Health Research (NIHR)’s national advisory group, INVOLVE.

Development is the second stage, where the product is refined for regulatory assessment and clinical evaluation. The first step in this process is prototyping, in which there are a number of opportunities for collaboration. For example, through catapult centre, which are non-profits that facilitate UK businesses, scientists and engineers to work together on late-stage research and development. There are 11 of these centres in the UK, spanning a diverse range of areas, including cell and gene therapy, digital, high-value manufacturing and precision medicine. There is also the NHS Innovation Accelerator, an NHS England initiative delivered in partnership with AHSNs. It was launched in July 2015 to support delivery of the NHS ‘five year forward view’. It supports the uptake and spread of high-impact, evidence-based innovations across the NHS.

The second step in the development process is testing through clinical trials. This will, of course, vary significantly, depending on whether the device is in vitro or not, and its perceived level of risk. Collaboration in this stage may involve interaction with the newly formed NIHR med-tech and in vitro diagnostics co-operatives (MICs), which act as centres of expertise, bringing together patients, clinicians, researchers, commissioners, and industry to support the development and evaluation of medical devices within clinical settings. There are a number of MICs in the UK, each with a different theme and led by a specific NHS organisation.

It is also in this stage that contract research organisations might be used for the clinical testing of the product. With the increasing demand from regulators for real-world patient data, use of Health Data UK’s digital innovation hubs can be useful to obtain health-related data at scale for research and innovation. The HealthTech Connect horizon scanning database can also be valuable, as it provides a record of medical devices at all different stages of development. This aims to reduce duplication and provide a smoother route to market in the UK.

Regulation is the following stage, which is invariably complex with the huge amount of legislation to navigate. To help with this process, there are medtech innovation briefings, commissioned by NHS England, which provide evidence-based advice to those considering the implementation of new medical devices or diagnostics. These aim to be fast, flexible and responsive to the need for timely advice about novel technologies. The National Institute of Clinical Excellence (NICE) organises these to avoid local NHS organisations having to produce similar information for local use.

£6 billion
The amount spent each year by the NHS on medical devices.
Eastern Academic Science Network

NICE plays a large role in reviewing the evidence for a specific technology once it has received a CE mark. The NHIR, hosted by the University of Newcastle, undertakes horizon scanning to inform NICE of any products early in their development, to help ensure that guidance can be published as close as possible to the launch date.

Commissioning and adoption is the next stage. The NHS supply chain has a new operating model that aims to deliver improved procurement and logistics support to the NHS. This will be achieved in three ways: increasing uptake of products published via the national route to market, increasing the use of a standard range of products by the NHS, and using enhanced buying power to influence purchasing behaviours and ensure that the best products are provided in a cost-effective way to the NHS.

There are six main routes to market for companies interested in supplying their products to the NHS. These are direct to trusts or primary care organisations, through the NHS supply chain, through collaborative purchasing arrangements, national framework contracts, government tenders and contracts, as well as selling to companies that use the product to deliver their service in the NHS. AHSNs play a key role in supporting adoption of new devices into the NHS, which has been supported by a recent study by the King’s Fund. Findings highlighted the need for new technologies to be incorporated into a wider service redesign in order to positively impact health outcomes.

Relationships of convenience

Working more collaboratively with academia can also take the form of ‘clustering’, when companies concentrate efforts in a particular geographical location. The NIHR has designated 11 MICs to build expertise and capacity in the NHS to develop new medical technologies and provide evidence on commercially supplied diagnostics. These bring together patients, clinicians, researchers commissioners and industry.

There is growing interest in these clusters, with a current network of more than 100 science and technology parks in England. Although there is no single formula for a cluster, the Eastern AHSN has identified a number of key success factors.

The first of these is academic strengths, as facilities can provide world-leading expertise from researchers in physical sciences and engineering. The interdisciplinary way of working also allows areas of convergence to be capitalised upon. In addition, clusters facilitate access to leading research clinicians, patient populations and real-world data.

Effective business networking can also take place within these clusters, as they bring together small and large companies in a structured way. Regional sponsorship is another potential advantage. These environments are attractive in terms of schools, housing and transport. There are also opportunities for funding of relocation and supportive business rates. Furthermore, the ecosystem also includes legal advice, specialist design consultancy and manufacturing, and access to investors. The infrastructure not only provides specialist facilitates and equipment but also local capabilities such as advanced manufacturing.

“The potential of cutting-edge technologies to support preventative, predictive and personalised care is huge, and the UK has the chance to lead the world,” says Richard Phillips, director of healthcare policy at the Association of British HealthTech Industries, who co-authored the report. “We have the opportunity to build an ecosystem that continually creates the best technology that can be exported, alongside new methods and insights that can contribute to health outcomes globally.”

The AHSN’s work remains in an early stage but offers huge potential for OEMs to work in a more collaborative way – in manufacturing and the other aspects of the product development process. The AHSNs have outlined the next steps of their work. This includes rigorously assessing and prioritising technologies for national support in the UK, facilitating access to cutting-edge research and development, connecting companies to high-tech manufacturing advice, partnering with NHS providers seeking to adopt novel technologies and supporting OEMs in market access activities.

Case study: CMR Surgical

CMR Surgical, from Cambridge, has developed a next-generation surgical robotic system that aims to transform minimal access surgery (MAS) over the next few years. The system, named Versius, is designed to be more portable, versatile and costeffective than existing systems. The CMR vision is to make MAS universally accessible, thereby improving healthcare outcomes at lower cost. The Versius system is specifically designed to meet this vision. The medical robotic market is highly competitive, with an established global leader and emerging competition from several companies the backing of which includes the likes of Google and Johnson & Johnson. Global annual revenues for robot-assisted MAS are presently approximately $4 billion and anticipated to reach $20 billion by 2025. The Versius system takes up a smaller footprint, is portable and flexible, and is intended to come to market at a significantly lower cost. CMR recently attracted $100 million in the largest ever series B investment deal raised by a European medical device company.

“Typically, medical device development, from idea or design through to commercialisation, is normally a 10-year journey, and we will have done that in around five,” says ECO Martin Frost. “You can only do that by having clear focus on what you want to deliver and why, recruiting excellent people and creating a culture that facilitates creative, responsive thinking.

“We identified an unmet need – 95% of minimal access procedures are not yet done robotically,” he continues. “We then looked at why this was the case and what we could do to address that need. From the beginning, we had a plan of how we would get our product to market and our commercial advantage.”

Source: ‘The MedTech Landscape Review’ by the AHSN Office for Life Sciences and the NHS