22/02/2023
The Government have recently published the first Medical Technology Strategy setting out how it plans to drive the sector forward. This is the first time the Government has set out its vision for the sector and it is overwhelmingly clear just how important Medical Technology will be not only in improving the quality of healthcare outcomes, but in driving the economy.
The Strategy acknowledges that the increased use of technology in the health sector is irresistible and that continued investment is vital in the forthcoming years. All those working in the sector, whether as a provider or a purchaser will need to ensure that the uptake of digital is high on their agenda to take advantage of the opportunities.
We set out the key headlines from the Strategy and consider what the proposals mean for the sector going forward.
The need for a Strategy
The document acknowledges that due to the sheer scale and pace of movement in the sector, that a strategy is required to ensure that the developments are “safe, effective and innovative”. Battling the competing interests of driving commerce and introducing new technologies but in a way that is safe and collaborative is one of the key aims of the Strategy and it seeks to “set the direction” for travel across the UK health and care system. The Strategy aims to provide guidance on the three central objectives of “right product, right price and right place” and the desire to developed shared engagement.
Facts and Figures
- The sheer scale of the sector and the size of the opportunity is set out in detail in the Strategy which values the sector at over £26billion.
- Estimated £10billion spent on MedTech by the NHS in the last year.
- Provides 138,100 UK Jobs.
- 1 in 12 UK patent applications were in made in the MedTech sector.
- One third of the UK spend in the sector is on prosthesis and surgical equipment.
What is Medical Technology?
Whilst the Strategy acknowledges that the technology continues to evolve and new breakthroughs are made all the time, the focus of the Strategy is on four categories of medical device used for diagnosis or therapeutic purposes:
- General medical devices: such as syringes, dressings, heart valves, ECG monitors, CT scanners, surgical robots, and dialysis machines, including any software used to drive them.
- Active implantable medical devices (AIMDs): powered implants or partial implants that are left in the human body, such as implantable cardiac pacemakers, implantable nerve stimulators, cochlear implants, and implantable active monitoring devices.
- In vitro diagnostic medical devices (IVDs): equipment or systems intended for use in vitro to examine specimens including all instruments, software, reagents and calibrators, such as blood grouping reagents, pregnancy test kits and Hepatitis B test kits.
- Digital health and software: such as standalone software, decision support and mobile apps.
Four key targets
The Strategy highlights the following four priority areas for the sector together with the key considerations in making them happen:
- Ensuring resilience and continuity of supply of products
Robust supply lines to be able to guarantee the supply of products must be developed. These supply chains may be reliant on suppliers from across the globe and the Strategy calls for a clear need to set the direction of travel for the future in “a way that proactively addresses resilience”. Systems and products must be interoperable and comply with centrally set standards to incorporate safety elements. - Supporting innovation and encouraging dynamic markets
The variance in product use across the NHS does not always deliver the best value for money or provide what the system actually needs at the right time. The abundance of products results in some struggling to reach the market and the Strategy calls for increased clarity, alignment and a “reasonable apportionment of risk” for all participating in the development of products. A plan for additional coherence and co-ordination to get the best products to market quickly is required together with consistent national leadership. - Developing infrastructure
Better use of data to identify the current situation and emerging trends is required as a way of assessing what is needed by patients. The “unclear mechanisms” for engagement can impede collaboration and barriers need to be removed where possible to speed up and streamline the way in which products are identified and get to market. Broader strategic relationships and partnerships need to be forged between industry and government to engage in a collaborative manner. - Utilising the right product, at the right place and the right time.
The diversity of the sector provides huge opportunity but equally is incredibly complex. Identifying and tackling specific problems whilst “working towards an overall vision” is something the Strategy seeks to resolve both in relation to medtech in the community and in diagnostics. It concludes that R&D should be directed towards products that maximise impact and improves outcomes and this includes the use of more AI.
What comes next?
The Strategy acknowledges that Medical Technology is the future and that it will be vital to continue to invest in the sector over the forthcoming years. There is a clear acknowledgment of the strain currently on the NHS and the role that tech can play in driving improvements and efficiencies. The Strategy also acknowledges the impact of an aging population and the lost-lasting effect of COVID, and accepts that the Strategy is just one part of the bigger picture and there is a need for wider change.
Whilst the Strategy identifies clear opportunities to continue to drive change in the sector, it is not exactly clear how this will happen in practice but sets out a roadmap for the next 5 to 10 years. The Strategy identifies that the Medical Technologies Directorate with the Department of health will lead of identify and establish the long term strategy for the sector.
It is clear that the sector, whilst incredibly complex, provides a wealth of opportunism for providers and purchasers going forward. Being able and willing to pivot as the sector changes over the forthcoming years will clearly be vital if the aims and objectives of the Strategy are to be met.
How can Bevan Brittan help?
Our MedTech legal and regulatory team are experts in supporting clients in the delivery of new technology within health and social care.
We understand the need to work in partnerships across health and social care systems and are able to provide a one-stop, integrated service drawing upon expertise across the firm’s Corporate, Commercial, Employment, Regulatory, Information Law, and Clinical Risk teams using a multi-disciplinary team approach with our various subject matter experts and sector specialists working together to produce legal advice and solutions for you.
Our lawyers have the agility to look at problems from different perspectives and offer expert commercial, legal and regulatory support to help you succeed in your ventures.
