The Department of Health and Social Care (DHSC) has published a medical technology strategy, setting out how they will ensure that the health and social care system can “reliably access safe, effective and innovative technologies.”
DHSC has worked with partners across the industry, the government and the healthcare system to identify four strategic priorities. These include ensuring resilience and continuity of supply of medtech products; supporting innovation and encouraging thriving, dynamic markets; developing and enabling infrastructure; and specific focuses on key issues and markets.
Vision for medtech
The strategy starts by highlighting how DHSC’s vision focuses on three central objectives: right product, right price, right place.
On right product, the strategy states: “We will ensure products are clinically safe and effective for all by developing best-in-class regulations and upholding safety standards. We will encourage innovative and sustainable product development to better meet patient needs, diagnosis and outcomes.”
With regards to the right price, it says: “We will create an environment that supports the understanding and delivery of value for money and affordability across the whole patient pathway, using high-quality data to ensure that prices are reasonable for both the health system and sustainable for suppliers.”
Finally, for right place, the strategy notes: “We will ensure the UK is positioned internationally and domestically to increase access, diversity and resilience in the supply market, to get technology to the patients and healthcare professional who need them.”
Resilience and continuity of supply
Continuity of supply for medical equipment, devices and consumables is “essential for the consistent delivery of safe, high-quality patient care.”
A variety of suppliers, supply channels and products has provided a level of systemic resilience, the strategy acknowledges, which has protected the healthcare system from short-term supply disruptions. However, increasing consolidation in the sector and globalisation of production and supply chains is said to have reduced some of that resilience, with factors such as the COVID-19 pandemic and war in Ukraine highlighting vulnerabilities in supply chains.
A shared responsibility for supply resilience
The strategy recognises that government has a role to play in securing continuity of supply, especially when faced with major incidents and events.
“However, supply resilience needs to be at the forefront of considerations for medtech business’ sourcing, production and supply chain models, particularly for the most critical medical technologies,” it states.
The document adds that strengthening contractual requirements could support this, whilst acknowledging the value that voluntary initiatives can bring in establishing best practice principles of supply resilience management across the sector.
UK medtech flexible manufacturing capacity and capability
A further vulnerability to supply is around the globally extended nature of supply chains, in line with limited UK based production capability and capacity.
The strategy urges more focus to be placed on maintaining basic capabilities to support production of a broad range of medical technologies, and notes that existing schemes such as the Life Sciences Innovation Manufacturing Fund are able to support growth in this area.
“Establishment of these capabilities and capacity also has a role to play in the realisation of our ambition to establish greater use of commercially viable and resilient circular economy models for medical technologies,” the strategy states, “where the supporting infrastructure for reuse, remanufacture and materials recovery will need to be located near to the point of use.”
Widespread use of equipment designed to work only with consumables from a single supplier is highlighted as a source of vulnerability. The strategy notes that this impact was “felt sharply in intensive and critical care areas at the height of the pandemic and placed undue pressure on already overstretched logistics systems through the need to carry products across duplicated ranges.”
The strategy acknowledges that sometimes designing bespoke consumables to work with specific equipment can help design in safety, but suggests that experiences in recent years have called for a fresh look at the way products are designed and to remove unnecessary instability.
Resource security and efficiency
On the topic of the pandemic, the strategy adds that the “high prevalence of single use devices supplied into the UK health and care system created additional pressure when responding to the rapid increases in patient demand created by COVID-19.”
Some of this pressure could have been alleviated if products and supply models were designed to facilitate greater decontamination, reuse or remanufacture of devices, it points out.
“Moving towards devices that are designed to be decontaminated and reused, or that can be remanufactured, would help to reduce our reliance on both raw material availability and the capacity of production and logistics.”
To achieve this, the strategy recommends that the medtech industry increasingly looks to design products in a way that reduces demand on virgin materials, makes better use of recycled materials and increases the extent to which the supply can shift to support higher levels of reuse, remanufacture and materials recovery.
Innovative and dynamic markets
The document describes how the UK medtech market “largely embodies the principles and approaches of a free and open market. While regulation exists to protect patients by ensuring minimum standards, choice and competition are the primary market mechanics.”
It notes the volume of products on the market as both challenging and beneficial in terms of offering choice, but adds that there are an estimated 500,000 different product types regularly used within the NHS which can be difficult for staff and patients to navigate.
The volume of products also contributes to an ‘adoption challenge’, in which products meet the market but can struggle to be procured and used in the NHS with multiple competing products – many of which claim similar innovations.
“The challenge for the UK health and care system is intelligently exercising choice across such a diverse range of products and innovations in a way that maximises value for money, where patient outcomes are a fundamental component of that value,” the strategy says. “To address this challenge, a common language and framework for discussing and communicating innovation is needed.”
Ultimately, it continues, contracting and pricing levers could tackle some of the adoption problem, but to address the root cause, “we need to create a coherent, end to end environment that provides increased clarity, alignment and a reasonable apportionment of risk for innovators, clinical and commercial professionals.”
Effectively exercising choice
The strategy acknowledges that meaningfully comparing product quality, performance and pathway cost can be difficult and resource intensive. In addition, assessments tend to rely on reports done by others but there are variations in specification and standards. This can create inefficiency and frustration for both the healthcare system and industry partners.
“The appropriate use of real-world evidence in support of a robust, class based, evaluation process is therefore essential to support effective decision making and choice,” the document states.
National clinical and technical product leadership
Whilst areas of “exceptionally strong clinical leadership” already exist, with products evaluated against best practice, patient experience and outcomes, the strategy notes that many products do not receive the same level of clinical focus and leadership. It adds that this is especially true if the products are not exclusive to individual specialisms.
“Expanding this clinically led national approach across all areas of medtech would significantly simplify the commercial landscape for both industry and the health and care system.”
Focusing innovation in the right places
Strategically, the healthcare system provides industry with an overall signal of future intent, and the medtech industry takes steps to understand demand.
However, “given the many diverse communities of patients, healthcare professionals and other professionals across the NHS, these signals can be divergent and disconnected from clinical and commercial processes. In the absence of a clear central signal across the breadth of products, it often ultimately falls to industry to drive the direction of product development.”
The strategy highlights how the pandemic showcased the industry’s ability to respond at speed to clear granular demand signals from the NHS, and encourages the NHS to learn from this experience.
“Ensuring delivery of the medtech vision will also require the further development of key enablers,” the document says. Whilst other comparable sectors such as medicines have clear systems, processes and data collections, the medtech sector has not yet developed enablers to the same level of maturity or scope.
It adds that the “ever-increasing complexity of the market, the pace of innovation and the challenges around major shocks such as the pandemic necessitate a new approach that will build a stronger infrastructure of enablers.”
The strategy focuses on three different areas:
- Existing data initiatives. Since January 2021, all medical devices must be registered with the MHRA before they can be placed onto the market in Great Britain, enabling a greater degree of information to be shared. The strategy points out that there is also a range of commercial data held by NHS organisations. “These initiatives (across safety, regulation, procurement and commercial areas) have tended to be independent of one another,” it notes, “resulting in pockets of very rich data but with gaps and difficulties in creating a more joined-up picture.”
- Improving data standards and linkages. “Data collection and management in medtech is currently purpose led rather than approached holistically for the sector – there are a range of registries, databases and survey collections maintained by different organisations on different topics and sub-sectors for different end purposes,” the strategy states. This decentralised nature means that there is no single data standard which makes it difficult to cross-reference data from different sources at a national scale. Lack of central oversight limits governance for data development; and the lack of standards results in lower data quality. “Having higher quality, joined-up, comprehensive data for medtech will make it easier to compare products, reducing search time and making it easier to make informed choices to select the right product, at the right price, in the right place.”
- Encouraging proactive data collection. Data collection in medtech is often driven by short-term needs and responses to incidents, the strategy says, but an important lesson from the pandemic was the need for a more systematic and proactive approach to data gathering on equipment. It raises a “clear need to gain insights to answer retrospective, real-time or future looking questions with sufficient accuracy, so that sound, timely decisions can be made routinely and flexibly.” DHSC seeks to build on this momentum and drive further improvement through the National Equipment Tracking Information System.
Relationship with industry
- Creating channels for industry and government to engage centrally. The strategy points out that there are many examples of strong partnerships between government and the medtech industry, focused around specific topics of events, which can provide illustrations of best practice. To progress joint priorities, it adds that industry and government must engage in a more open and collaborative manner with supporting infrastructure in place.
- Identifying priority areas for collaboration. The strategy points out a number of priority areas where a collaborative approach with industry can be impactful, including joint development of a circular economy approach to enable greater utilisation of reuse, remanufacture and material recovery within the medtech market; working together to drive improvements in data collection and sharing; and collaborating with industry to understand inflationary pressures with a view to developing a long-term policy position.
Specific market focuses
Whilst medtech represents an “exceptionally diverse” range of products, the strategy notes that the majority are designed, developed, selected and procured through “broadly comparable systems and predominantly face common challenges”. The overarching vision and priorities of the strategy have been developed with these in mind; however, it recognises that some segments of the market face particular challenges.
It states: “In these areas, we will work to apply the principles of the strategy at a more granular level. This may be in the form of tailoring the broader elements of the strategy to best fit the needs of a particular market, or through supporting the aims of the strategy through the addition of specific actions to tackle singular issues.”
Medtech in the community is one such area. The strategy acknowledges the variation in these appliances along with the fact that their opportunities and challenges need to be factored into a more focused strategy for medtech in the community. It is suggested that this strategy would focus on promoting meaningful choice, modernising administrative arrangements, and embracing new commercial and service models.
Another area requiring a more specific focus is diagnostics, with a need to move to a more patient-centric model of care and to better connect the life sciences sector with the NHS to transform elective diagnostics through technologies. Four diagnostic priorities are shared: to support the NHS to adopt more efficient models of care to tackle the elective backlog; to improve patient outcomes through early detection and diagnosis; to provide clear demand signalling to industry to support innovation in the UK diagnostics sector; and to use the legacy of investment during COVID-19 to ensure preparedness for any future pandemic.
The strategy points out several factors that will be critical to success: a joined-up approach with awareness of how different elements and priorities interact; clear, meaningful metrics with clear targets directly aligning to core priorities of the strategy; a framework for strong collaboration in the industry; supported and empowered leadership with senior leaders across the sector fully committed to the vision; support for the change process to ensure implementation capacity; ambitious but realistic timelines, with the vision set out as a long-term goal and an aim to work in stages.
The strategy is to deliver the following actions: the Medtech Directorate is to set up the appropriate governance structures to achieve the aims set out here; the DHSC Director for Medtech is to oversee the governance implementation and ongoing activities; DHSC will work with stakeholders to develop an implementation plan, to be published in early 2023, outlining the planned achievements for each priority.
To read the strategy in full, please click here.