The rapidly changing biomedical device industry and the associated pace of the advancement of technology requires that biomedical device companies release products into the marketplace as fast as possible to recoup the investment made into them as well as to cope with fierce competition. An extensive literature review was performed to discuss the challenging areas in the product and process development of biomedical devices. These included the integration of advanced technologies, the integration of biomedical devices with the human body, government regulations, biomedical product liability issues, social and ethical issues, as well as sterilization methods. This research proposed that the use of computer simulation, in particular, SLAM II, can help biomanufacturing companies incorporate planned flexibility and strategic planning in product and process development, while addressing the challenges in the field of biomanufacturing.

Although a well-planned process development can ensure rapid time-to-market and a more solid proprietary position for biomanufacturers , no research was found that investigated the use of simulation as a project management tool to accelerate biomedical device product and process development and to estimate the risks involved in the decision-making process. Therefore, this thesis addressed two important objectives in biomedical device project planning: minimizing project completion time and the associated risks.

This research was concerned with the development of a methodology for creating product and process development plans using simulation technology. The Biomedical Operations Project Planning (BOPP) methodology was developed to aid project planners in the creation of biomedical device product and process development simulation models. The general biomedical device product and process development simulation model consists of 14 steps, from the development of the model to the analysis of the results. Several combinations of nodes and activities (subnetworks) within SLAM II were created to facilitate the use of simulation in the project planning of biomedical devices. This research also developed necessary data collection and general biomedical device simulation model templates, thereby providing project planners with the option of either modifying the templates to suit the needs of different medical devices or developing new simulation models using the instructions in the BOPP methodology.

Finally, a model of product and process development of an external insulin pump is provided as an example application of the BOPP methodology.