Getting your medical device into the NHS

Chris French discusses the importance of engaging with the NHS early in the device design process.

You’ve had a great idea for a medical innovation that would greatly benefit patients, clinicians, save cost and/or improve performance; you’ve secured (or in the process of securing) the investment for this and the investor milestones agreed and you understand the technology needed to develop this product. You have the design processes and team in place and you know your target market is the NHS. According to your business strategy the product would definitely benefit the NHS – so why wouldn’t they buy it?

There is a commercial programme that needs to run alongside your product development. If your primary market has been identified as the NHS then this could have a considerable influence on the requirements and specification for your product. Therefore, at the very beginning of the design process you need to already be engaging with key stakeholders and decision makers in the NHS rather than just focussing on the clinical requirements. Feeding these inputs into the design as early as possible will ensure the final product is commercially viable.

The NHS is the largest healthcare delivery organisation in the world and whereas this sounds like a single organisation, the reality is an immense collection of individual businesses and services which are run and managed by different providers and commissioners – all with very different agendas. The providers focus on patient access and outcomes, while the commissioners are responsible for financial balance, performance against operational targets, governance & regulation, and population health management and outcomes.

Other challenges to consider are the NHS is constantly changing depending on the political climate, budgets are fixed or are more restricted, and staff are under resourced. Understanding the heterogenous network of the NHS, how decisions are made and the problems they face will enable you to maximise on the efficiency and effectiveness of your long-term business strategy. A flexible approach is critical to ensure that your process changes as the NHS changes….it’s a long process!

You will also need to recognise that your product may have other elements that will influence the NHS’s decision to purchase. It may be a great idea but does it fit in with their existing strategy? Does it require integration with the IT system? Will it require considerable training to use the product and what is the impact of this on staff time, cost and resources? Does it prevent (or potentially cause) other health problems? What is the cost of this product versus other similar (but perhaps not as effective or beneficial) products that may already be heavily integrated in the hospitals and surgeries? Would the outcomes of this technology create bottlenecks in other departments or areas of the hospital? How can this product help them achieve the efficiencies that they require?

If you can answer these questions and demonstrate exactly how your product could reduce long term hospital costs, or improve patient outcomes, or save hospitals and health organisations time and resources (or maybe all of these) then you already have a strong business case for your product.

Being able to produce a business case that will satisfy all the stakeholder requirements will be essential.  The sooner you understand the complexity of the NHS and engage with identified key stakeholders, the sooner you will be able to create a viable strategy to sell your product into the NHS.

Click here for an overview of how the NHS is structured.