Beginning With The End In Mind: Using A Target Product Profile (TPP) To Guide Strategic Medical Device And Diagnostic Development

By Kimberly Hunsicker, MSN, CRNP, MBA, Vice President, Medical Device and Diagnostics, Premier Research

Medical device and diagnostic makers face myriad challenges when developing a new product, including working within resource and financial constraints, deciding which opportunities have the highest return on investment (ROI), determining differentiating claims and positioning within the market and, in some cases, aspiring to the possibility of attaining multiple indications across multiple therapeutic areas. Developing a multidisciplinary framework to address these challenges and inform the decision-making process can provide medical device and diagnostic organizations with a significant advantage in early product development, resulting in a higher probability of approval and successful product launch.

The Target Product Profile (TPP), a concept originally aimed at pharmaceutical drug development, is a multidisciplinary strategic development process tool that can be adapted by medical device and diagnostic programs for product development. Implementing a robust and disciplined TPP process can help to drive alignment in cross-functional strategies, leading to more effective and cohesive product development.