ABSTRACT

Project Management in the pharmaceutical and medical device manufacturing industries follows a more technical/formal path, especially in the design stages of the products. Pharmacologists look at how drugs work, and computer scientists apply the power of their sophisticated machines to analyze and assess new chemicals. Each of these individuals plays a critical and necessary role in new drug development. The iterative development process eliminates the sequential aspect of the waterfall process and allows for more flexibility and interaction, particularly with the customer. A much more flexible product development environment embraced by Daniel R. Matlis and David Rubin is the Total Product Life Cycle approach developed by the United States. In 1991, there was an unprecedented case of stakeholders and a drug manufacturer signing a cooperative research and development agreement. Managing projects such as the development of medical devices or new drugs, whether traditional or “proactive,” has its own set of issues and procedures.