The hurdle medical devices companies often face, particularly SME’s (small and medium sized enterprises), is the labyrinth that needs to be navigated prior to successful product uptake. A large number of requirements needs to be satisfied including CE registration, submission of evidence, and clinical evaluation, which also need to be fulfilled in the correct order. Identifying and gathering appropriate evidence that’s meaningful to the NHS (National Health Service) can be a challenge for companies without dedicated market access or health outcomes research personnel. The Medtech Early Technical Assessment (META) tool, developed in partnership with Greater Manchester Academic Heath Science Network, aims to help speed uptake of good, innovative devices by preparing companies for discussions with health technology assessment organisations and payers. Leeza Osipenko, head of NICE (National Institute for Health and Care Excellence) Scientific Advice stated ‘’We want to help healthcare systems get access to more products that meet such criteria and help companies develop these technologies and relevant evidence to demonstrate value to patients and payers.’’
Identifying the evidence gaps
The META tool is accurately described as a stepping stone to provide a framework in order to organise a company’s journey to successful uptake. META asks structured questions to identify any gaps in a product’s evidence and can then recommend how to fill such gaps, whether what’s missing is further regulatory support or a more robust clinical argument. At the launch of the META tool at the Royal Society of Obstetricians and Gynaecologists in London, those who had experienced using the tool remarked how ‘highlighting the gaps was key’ as well as the clear importance of ‘developing a sound value proposition’. It was also mentioned how a ‘quick no’ from NICE was just as valuable as a ‘quick yes’.
Another key feature is that META is intended to be a tool of ‘self-discovery’, not a product that simply gives you the answer. The tool is used to guide you to find an answer without directly telling you. NICE doesn’t tell companies to quit if the product hasn’t met the requirements, rather it guides the company towards the correct path in order to attain the evidence needed. This ‘tough love’ approach was found to be valuable to companies who piloted the tool, as by using META, people found they gained a better understanding of requirements and overall strategy rather than simply being told what to do before NICE will engage with their product. However, while some companies like the idea of cementing their understanding of market access and uptake, some others may prefer to have the submission work completed and the evidence gaps identified and filled to speed up the process further.
Bringing it together
NICE’s META tool hopes to provide SME Medtech companies in particular, with an improved understanding of the requirements for a successful product uptake. Here at DRG Abacus we understand the particular challenges Medtech face, especially regarding gaining successful uptake. We partner with our Medtech clients to provide strategic advice and support as well as create bespoke solutions required for market access including cost-effectiveness models, value proposition development and payer engagement tools. It will be interesting to see whether the META tool will become an integrated part of the journey to market access and uptake for medical devices; and whether consultancies will have to adapt to accommodate this tool within their service portfolio.
If you have any questions regarding ways to gain a successful uptake for medical devices or would like further information on any aspects of our insights on working with Medtech companies, please contact our in-house experts at firstname.lastname@example.org