Table 2:

Health Economic Analyses in the R&D Process of manufacturers and in the product life cycle.⁸²

Phase	Information based on HTA	Subsequent manufacturer's decisions
Early-State Development	Potential of a prosthesis/orthosis being cost-effective as part of manufacturer's investment decision prioritize between competing possibly cost-effective concepts or prostheses/orthoses; identify those parameters that have the largest impact on the likely cost-effectiveness of the prosthesis/orthosis in order to direct limited research funds.5	Design and management of prostheses and orthoses Regulatory and reimbursement strategy
Mid-state development	Feasibility check of cost-effectiveness based on first observational/small clinical studies Develop optimal clinical assumptions with clinical experts Develop a disease-specific model	Value proposition Health-economic study for payer review
Late-state development	Cost-effectiveness can be demonstrated Affordability is shown with a budget-impact analysis	Claims for reimbursement
Product life cycle	Re-calculate the health economic model with extended data Validate assumptions	Use to maintain or extend coverage