Let’s say your solution increases access to care, decreases the cost of care and improves outcomes…but can you prove it?
Let’s focus on the importance of evidence
Even if trials can be faster and less capital consuming for medical technologies than for drugs, they consume two to five years in the planning, execution and final communication. This interval of time is very comparable to the time it has taken for the U.S. market to prioritize cost and access attributes at the same level (if not higher) than outcomes (Figure 1). As a result, many medical technologies are now reaching the market with evidence that covers “only” clinical outcomes, and lack evidence on their “cost/ workflow” and “access” impact. Unless secondary outcomes related to cost, access and care delivery workflows were added during the trial as astute amendments, these products come to market with a competitive weakness.
Building evidence for cost, outcomes and access requires an urgent evolution in all MedTech companies, and this is an acute situation for the companies that are located outside the U.S. and do not benefit from the local ecosystem effect.
It also requires a greater “intimacy” with their end users, not only their clinical users, but all the stakeholder and workflow participants who are affected by their technology, which should result in potential staffing adjustments (for instance to increase the perspective of hospital workflows in the design and configuration of a product).
Companies that are in planning phases for a new product introduction (start-ups or companies working on their product portfolio) with a projected U.S. launch must consider the new pain points of the U.S. market as they design their new product concepts, or reach the first milestones of their product development cycles.
Simply said: if your product concept does not address outcomes, cost, and access attributes, and if such attributes cannot be proven with a well designed clinical trial (or “economic trial”), then pause, reassess your team and customer knowledge, and start again.