Steve Maylish led a panel discussion at the 2019 Larta NIH CAP Commercialization Training Workshop yesterday. His topic was "Integrating clinical research into the product development cycle, and working with pilot site. What needs to be communicated to ensure better and faster decision making, to improving organization's performance and productivity".
Product development is often seen as a waterfall process, due to management tools like Microsoft Project Plan. In reality, it’s an iterative process that evolves with the design effort. As discoveries are made and modifications incorporated, users need to be involved. The best products start with an unmet clinical need, marketing research and involve the customer throughout the development process. For many products, clinical trials are required for FDA approval. In today’s environment, value-based products may also need patient outcome data for industry acceptance. If possible, clinical trial data should incorporate feedback to the designers and feed into patient outcome analysis.