November 01, 2020
Navigating the UK NHS (National Health Services) landscape for MedTech market entrants wishing to sell new products or services to the NHS, can be complex and time-consuming especially for start-ups and SME’s with limited resources and limited knowledge of the UK healthcare market.
A planned market access strategy will help accelerate the time to product evaluation and product adoption.
The NHS is a complex mix of organisations and as it moves forward implementing The NHS Long Term Plan1, supplier products and services need to meet the requirements of multiple
decision-maker and influencer stakeholders from a wide range of care providers, payers, clinical and patients’ organisations. Identifying the relevant stakeholders requires an
understanding of the current pathways of care where your product would be used, how the current care is provided, by who and how this is paid for.
It’s important to define what products are being used currently, what are the limitations of these products and what advantages does your new product offer the clinician, the payer, the healthcare system and the patient.
Define the purpose of your product, what patient group(s) or disease state(s) will the product benefit. What’s the annual number of patients who could benefit?
How does your product impact the healthcare system? Is it cheaper to purchase, does it offer greater benefits that will lead to over-all costs savings in the NHS? Be clear on the healthcare system benefits in relation to NHS improvement drivers and measures e.g. Reduced length of hospital-stay or early discharge, changes delivery of care from secondary care to primary care, reduces resource, takes less time to manage etc. Ensure you have the clinical and economic evidence to support your claims and position these to your target stakeholder groups. Each group will have differing needs to be addressed.
Regulatory Approval is critical to demonstrate the product is manufactured in accordance with the essential requirements as specified in the relevant Directive and that it is safe to use.
To sell in the UK, medical technologies must hold a CE-mark. Regulatory approval will be discussed in more detail in future Med2Mark articles.
Build your clinical and Health Economics evidence:
The British health care system is probably the one that uses the most systematically and the most extensively Health Economics as a resource-allocation decision-making framework, A Value Dossier using a range of models from expert testimonials (clinician, patient, academics) through to real-world evidence data collection and randomised controlled trials is a critical piece of your submission.
Finally, be clear what patient problem or healthcare system issue the product will address and how it does this to improve patient and healthcare system outcome.