Integrated development process and requirements management approach to drive quality and reliability in medical product development

10 May 2019, 15:20-16:00

The transformation of Philips into a global health solutions company has fundamental impact on the organization and execution of innovation projects. In an increasingly complex and dynamic environment, speed of execution and providing first-time-right solutions to the market with high quality and reliability is key to success. The need to balance the interests of various stakeholders in Philips’ global organization to develop cross-business solutions results more and more in formation of global multidisciplinary development teams, in which the various skills and responsibilities have to be seamlessly integrated. Short lead times and cutting-edge technology challenges drive towards more iterative, adaptive and risk driven development processes, which are challenged by regulatory requirements.

The Philips Excellence Process Framework (PEPF) aims to standardize Philips internal processes. In particular, innovation to market processes front-load and de-risk development by driving a multidisciplinary, cross-functional collaboration as well as best systems engineering practices and compliance to quality standards. Besides the execution of predefined tasks, recording of objective evidence for the execution of these tasks in the form of documented deliverables is essential to deliver high quality while being robust against compliance audits.

This talk will outline the key principles of the development process framework and how it is founded on good system engineering practices. Attention will be given to requirements engineering along the process flow, and how tooling can be used to capture essential information elements. In particular, the embedding of design for quality and design for reliability practices will be explained, and challenges to be resolved will be addressed.