Working with innovators in health and care the question of evidence always arises. After all, we work in a world of “evidence-based care” so no one should be spending money on a product for patients where there is no evidence of benefit to the patient, staff, costs or preferably all three.
I must confess I am one of the many people who will ask entrepreneurs “what evidence do you have?”, because launching a product into the market without evidence is like pushing water uphill.
You would think then that when the answer I receive is “we are piloting it at X NHS trust” I would be pleased, thrilled even (as entrepreneurs often are). Don’t get me wrong, evidence from within the NHS is essential, but to coin a phrase I use frequently “The NHS has more pilots than British Airways” (before they were furloughed).
Pilots are very valuable, but you need to establish ground rules for all involved.
Planning and structure is essential
Before giving your very valuable time, and product to an NHS team you need to consider:
- Is a pilot what you need, or do you really need a clinical trial?
Pilots are intended to be short, generating evidence from a limited number of patients if you are looking for evidence for pharmaceuticals for example you would need a clinical trial.
- What is the purpose of the trial?
What are you seeking to prove – e.g. that it improves patient outcomes/saves money/improves staff satisfaction
Is this pilot to produce evidence specifically requested by the trust
- What are the commitments for those involved?
Your commitment in training and support
Staff commitments for training, interacting with patients, gathering evidence, writing-up outcomes
- What does a positive outcome look like?
Define what success would look like before starting the pilot. If this includes retrospective analysis with previous treatments (for example) – verify, ensure that there is an agreement for this to happen and who will be completing the work.
- What type of evidence will the pilot generate?
Peer-reviewed publication
Poster
Case Studies
- What will you get out of it?
Starting a pilot without a clear definition of what a positive outcome would achieve is a hiding to nothing. Budgets will always be restrictive in the NHS, so moving from free use of something to paying for it is a complex process requiring commitment from the staff involved. If you think that once you have proved that your product works in the way expected and produced required outcomes the NHS will buy it automatically you are very wrong.
- Ask before starting:
If the pilot is successful will the trust purchase the product?
Is the budget agreed for this?
Once the pilot is completed what process will we have to go through to receive a Purchase Order
Who is responsible for the budget and decision? – speak to them if possible before starting
You may feel that it is worthwhile conducting a pilot for evidence alone and that you are not expecting a purchase as an outcome, that is your business decision. Just remember if you are a small business, with a limited number of staff members, pilot work can take up a lot of time and energy that could be spent on other things (like sales), so when considering the cost versus the benefit do not undervalue your time.
Having said all of this, please don’t be put off from working with the NHS in this way. NHS evidence is recognised around the world, so it’s well worth the effort as long as the work is properly planned and structured.
We work with clients to help them to spend their time and money wisely, establishing the evidence base they need to sell their products, whether that’s through support to structure pilots, or working with our specialist associates to plan and deliver clinical trials.
This article was written by Medilink EM Member, Pym’s Consultancy.