Foundations for Building an Innovation-Centric Product Development Framework for Medical Devices

Abstract

The medical device industry, governed by a tight regulatory landscape, often relies heavily on structured Product Development Processes (PDPs) to bring innovative solutions to market. These structured processes create significant challenges when integrating technological innovations that emerge in the later stages of the development cycle. This study explores the complexities of this "innovation paradox" within large United States-based medical device corporations, examining how the rigidity of traditional PDP models affects the incorporation of innovative changes to in-flight projects. Drawing upon insights from a comprehensive literature review and a quantitative analysis utilizing a Monte Carlo simulation, this research highlights the impact of integrating an innovative change on the overall project timeline and cost. The simulation results show that introducing innovative changes to the PDP typically extends project timelines and increases the total net present costs and are affected by the timing of the change and its technological maturity. Introducing changes in later project phases significantly increases both duration and cost compared to earlier phases. Changes with lower technological maturity led to greater duration and cost escalations, especially when introduced late in the development cycle. To balance regulatory requirements and PDP agility, large medical device companies can adopt hybrid PDP models, establish dedicated innovation assessment teams, create flexible product designs, and focus on value-driven innovations that meet patient and market needs.