Medical device design within the ISO 13485 framework

The design and development of medical devices has become an increasing complex and regulated process. Little if any consideration is given to the regulatory requirements when developing medical devices in universities. This has resulted in an imposing barrier preventing academic innovation reaching clinical adoption. The scope of universities is not to become the legal manufacturer of medical devices. However, should the development of novel devices ever aim to benefit patient care and reach a clinical setting, design controls must be implemented throughout the project life cycle to demonstrate feasibility and safety. The aim of this thesis is to develop user-centred technologies which comply with industrial design control practices whilst helping to bolster and promote innovation within academia. Four projects relating to medical devices have been designed in response to well-defined and end-user-originated clinical needs. These devices can serve as the exemplar for the framework developed in this work with each reaching staggered phases of development within a controlled design process. Although unique, the devices have significant overlapping characteristics that lend the devices to parallel development, leveraging in-house know-how and ‘lessons learned’ into the process of innovation. This thesis focuses on the novelty and design of the aforementioned projects in a discrete structured approach and reflects on the development of each project within the context of a design control process which was developed as part of this work. It is the ultimate goal of this work to develop a flexible structured system compliant with the international requirements for product design and development which may be exported internationally. However, the full execution of this ambition was limited due physical, and financial limitations. This manuscript will describe the technical and commercial opportunity of devices and reflects on the success of developing same within a design control process developed as part of this work