In conclusion to the Medtech series, to prepare for US Market Entry, early product concept documents, and most business plans for MedTech start-ups must include a clear-cut definition of the product “Intent of Use” and related FDA pathway, and CMS reimbursement pathways.
The selected intent of use and underlying technology platform must address all the new pain points of the U.S. Healthcare system:
- Reduce the cost of care
- Augment the quality and effectiveness of the care Workflows
- Enhance the access and related affordability of care.
Most important, during clinical and economic trials, product claims and cost-benefit must be proven in a way that will be tangible to the target user of the product.
Recommendations:
#1:Your Medical Device design must address the three pain points of the U.S. healthcare markets: Outcomes, Cost, and Access.
#2: Define the “Intent of Use” of your product very early in the product development stage.
#3: Design the“Intent of Use” of your product to optimize the FDA and the Reimbursement Coding (CMS) pathways.
#4: Design the technological characteristics of your product to optimize the FDA “Substantial Equivalence” criteria and the reimbursement payment values.
#5: Include and validate all the attributes (Outcomes, Cost, and Access) that you intend to claim in your validation plans and or clinical trials.
#6: In case you do not have the experience (e.g., FDA and CMS) and customer intimacy needed to make the relevant decision and trade-offs early in the product development cycle, allocate extra budgets early in the design process to insource or outsource that effort. Thus, providing you with a competitive edge when executing your U.S. market entry.