In many of the conversations we’re having this year, one of the top things people tell us that they struggle with is the challenge of getting their medical device into the NHS.

Perhaps that looks familiar, strikes a chord, feels like something you’d say? Then make sure you’ve a good cup of tea or coffee to hand and we’ll begin our tour of the things you’ll want to know about to give your device the best possible opportunity to be used by NHS Trusts.

Afterwards, you may want to think about how you’ll put what you learn into action.

To have any chance of selling your innovation into the UK health service, you’ll need a business case to justify the expenditure and quantify the benefits to the NHS. You need to be aware that an effective business case is owned by the NHS organisation you’re working with. You help them with your knowledge, expertise and so on. So it’s important to create something that they can pick up and use internally.

The business case does three things:

  1. captures knowledge about how the organisation will function with, and without the innovation
  2. Get resources, funding and approval to move forward
  3. provides consistency to the varied audiences you’ll need to get on side

To stand a realistic chance of being read, don’t make it a 56 page document.

Put your key messages in the first few paragraphs.

Things like what you’re doing, what you’re solving, what needs to be done.

Get these core messages across early on the the reader’s time with your document

 

Some things to bear in mind as you “help” create the business case:

  • You won’t be present in all the discussions about the business case. Ask “who else do I need to talk to, who else will need to sign it off?”
  • Decision makers have different agenda
  • It’s not just a clinical decision – there’s lots of information out there (e.g. CCG board meeting risk registers, Acute Care Trust meeting risk registers, meeting minutes) to find out what is keeping them awake, what keeps being flagged on their risk registers.
  • There are “no brainers”
  • Collaborate with the NHS teams involved
  • Address the burning issues of the customer
  • The decision making process is slower than you want it to be.

Don’t be tempted to do too many pilot studies at friendly NHS trusts. The reality is that, when projects are funded, people will use the product happily, but when the funding stops, it’s often a very different picture. Ask the question, will you buy the product, after the study?

So, what questions do the NHS reviewers need answering by this business case?

  • Is there a clear need?
  • Does it fit with the Trust’s objectives and plans?
  • Are benefits clearly stated?
  • Is it clear how the benefits will be realised?
  • Are demand and capacity income forecasts robust?
  • Is it clear why the preferred option has been selected?
  • Is it affordable?
  • Are risks and mitigation plans explicit?
  • Do main stakeholders support it?
  • Does the team have the capacity and capability to deliver it?

 

To do this, the “Five Case Model” will be used:

  1. Strategic: is the proposal needed, will it further the aims and objectives. “why change what we do today?”
  2. Economic: is it value for money, has a range of options been considered, is it the best balance of cost, benefits and risk. What’s the impact on wider health, e.g. waiting times, patient satisfaction, mortality rates. Does it save money in one area whilst increasing costs somewhere else
  3. Commercial: is it viable, is there a supplier who can meet our needs, can we secure a value for money deal
  4. Financial: is it affordable, are the costs realistic and affordable, is the required funding available and supported. What options are there to fund this, rental, staged payments, etc.
  5. Management: is it achievable, are we capable of delivering the project, do we have robust systems and processes in place. Include metrics and how you’ll measure “what good looks like”

It’s all about de-risking the project for the NHS, building pilot studies around KPIs that will support the subsequent business case.

 

As you watched this video, you’ll have started to think about how you can go about preparing the business case for your product, to put you in the strongest position for adoption. You may now want to get some guidance to turn your thoughts into concrete actions.

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