Alternative market entry strategies for medical device products. How to develop relevant data when clinical information is lacking

Abstract

The introduction of new products in the medical devices market is a critical activity. However, launches are not always accompanied by clinical or economic evidence to support the products' use, and, as a consequence, a company's commercial strategy is sometimes hampered. Using a real-life example, we propose a methodology that can generate relevant information with a goal of increasing product penetration. The product is an antiseptic suture that could reduce the rate of surgical infection. Although preclinical data for the product are positive, generating efficacy data through high-quality, prospective, randomized clinical trials is a technically difficult task. This results in a lack of evidence to support the claim of surgical site infection reduction at the time of product launch. To address this, we designed two animal models replicating orthopedic surgery (knee replacement) and, in parallel, we prepared an economic analysis. Our results could be used to support commercial activities and to accelerate the product's introduction in the market. This methodology could also be used for other indications, under appropriate conditions.