In order to ensure that new products entering healthcare markets are cost-effective over existing products Health Technology Assessment programs are implemented in health care systems. Whereas HTA agencies can screen out underperforming products it is equally important that manufacturers implement procedures to ensure that no underperforming products are developed and brought to market in the first place. By analogy, there are standards that companies need to comply with to ensure that their products are safe; similar standards or methods to ensure that new products are cost-effective could be developed. Based on 20 years experience of medical device innovation in industry, academia and consulting a conceptual model to ensure cost-effective innovation is proposed. The method divides the value assurance process into 3 stages: concept generation, concept validation and market entry strategy. During the concept generation phase solutions to a critical problem with an unmet clinical need and a related disease burden are generated and evaluated with the core group of clinicians and multiple stakeholders according to costs, risks and benefits. The most promising concepts are iteratively tested and validated according to freedom to operate, safety, efficacy, ease-of-use, invasiveness, procedure success rate and head-to-head comparative cost-effectiveness until a candidate product can be addressed to a target patient group and practitioners at a profitable price. Finally, markets with the best clinician community support, largest size, highest attainable prices and lowest barriers to entry are addressed. This may sound as commonsense, but there are some important evolutionary principles hidden: 1) downstream market selection criteria are translated into early upstream tests; 2) multiple concepts are generated to handle early uncertainty; and 3) iterative tests are performed until a satisfying concept is selected. This model should ensure a product will pass HTA cost-effectiveness evaluation if eventually exposed to it.