Objective: This conceptual framework sought to lay out the R&HE considerations for go/no go decision making in the new product development process. Key questions to address at each phase of the product development process are presented. Background: Full revenue potential or even viability depends on the ability to achieve coverage and reimbursement. Without demonstrating value, product will either fail or compete on price alone. To avoid these pitfalls, R&HE planning should be formally incorporated within the product development process. However, in many medical device/diagnostic companies, there are no set standards for R&HE requirements throughout the product development cycle. Framework: There is great risk and cost associated with delaying R&HE assessment of a product in development. At early stages of product development, the goal is not to stifle ideas but assess effort and risk. The framework recommends a preliminary assessment of effort and risk that associates with the following: unmet need, product novelty, payment type and stakeholders. The feasibility stage is the pivotal point between planning and production and the last opportunity to make low-cost changes. At this stage, a comprehensive understanding of the landscape and evidence requirements are needed to make an informed decision before moving to development, where change is costly. Detailed planning should include value analysis and stakeholder/payer testing, R&HE evidence plan and an expected reimbursement timeline by country and setting. At development, the goal should be execution of the R&HE plan, with necessary adjustments based on new data. Once the product is commercialized, companies should re-assess efforts and determine the need for real-world evidence. Conclusion: Identifying R&HE requirements at each phase of the development process will help companies identify opportunities and barriers early in product development, make informed clinical evidence strategies, and demonstrate stakeholder-relevant value.