The Challenge for MATCH
The medical device sector is not like the pharmaceutical market, where a few large companies bring innovations routinely to market using mature processes. Healthcare and medical devices are typically brought to market at high risk, often by small companies, and their value to users and service providers is often poorly established.
Further, medical devices are increasingly subject to the scrutiny of agencies (like NICE and similiar organisations around the world) that are assessing the clinical and cost effectiveness of new technologies. And yet the methodologies necessary to assess many of these technologies are not yet well established or sufficiently robust, and can vary dramatically from one jurisdiction to another. This situation presents some real difficulties.
In early development, for example:
- How do you pick winners 5-10 years out?
- How can you make them to cost and specification?
In late development:
- What is your best strategy to gain evidence?
At launch:
- What will be your most effective way of providing evidence of value for reimbursement assessment?
And for products already in the market:
- How can you best re-enter the regulatory cycle?
Inevitably, this uncertainty impacts upon many innovative products and technologies in some or all of the following ways:
- Longer time to market and to patient benefits
- Higher costs for both manufacturer and healthcare provider
- Greater commercial uncertainty and lower unit sales
- Increased rate of commercial failure and missed or delayed opportunity
What is needed is a shared concept of value across the board. Manufacturers and regulators could then endorse processes that are fit for purpose for medical devices. Users could share a common, robust, definition of value with regulators and be confident that the products reaching the market would provide them with real benefit. This is the challenge for MATCH.
