Bringing products to market based on supporting efficacy data

By Melinna Giannini

March 8, 2022

Most healthcare product developers rely on clinical trials to establish the safety of a new product. And, while clinical trials are required to prove patient safety for surgical products and new drugs, clinical trials are not required for many non-invasive products. These have FDA safety clearance letters to assure patient safety and include products like proprietary biologics (supplements) and far-infrared heat lamps.

Manufacturers could be collecting data from coded healthcare claims with the ability to identify the cost-effectiveness of their products when compared to the cost of using conventional therapies for treating the same diagnosis.

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