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A Model-Based Framework for NPD in a Highly Regulated Environment
IIE Annual Conference (2011)
  • Lourdes A. Medina, University of Puerto Rico, Mayaguez
  • Gül E. Kremer, Iowa State University
  • Richard A. Wysk, Penn State University
The completeness of the New Product Development (NPD) process is a critical factor for the success of new
products. Empirical research demonstrates a significant correlation between the number of stages followed in the
development process and the success of new medical devices. At the same time, the experience of the development team impacts the time-to-market of new products, which correlates directly to success. Medical device development is a very complex area in NPD due to the complex nature of these products, multiple stakeholder groups, and the regulatory processes involved. While detailed descriptions of different components of the NPD process exist in literature, they in general lack in comprehensiveness. To fill this void, the proposed model in this paper provides a complete framework for inexperienced developers to follow in medical device development endeavors. Regulations play a significant role in the development, considering the regulatory pathways at early stages of the development and having to comply with design controls. The model is divided into five components: product definition, design, risk management, production planning, market introduction and post-launch and medical device records. The flow of the process is demonstrated using an example of total hip replacements.
  • New Product Development,
  • Medical Devices,
  • Conceptual Model
Publication Date
This is a proceeding published as Medina, Lourdes A., Gül E. Okudan Kremer, and Richard A. Wysk. "A Model-Based Framework for NPD in a Highly Regulated Environment." In IIE Annual Conference. Proceedings, p. 1. Institute of Industrial and Systems Engineers (IISE), 2011. Posted with permission.
Citation Information
Lourdes A. Medina, Gül E. Kremer and Richard A. Wysk. "A Model-Based Framework for NPD in a Highly Regulated Environment" IIE Annual Conference (2011)
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