Abstract
The current in vitro diagnostic design process is a combination of methods from engineering disciplines and from government regulatory agencies. The goal of design processes that have been developed is to ensure that a new product meets the user’s expectations and is safe and effective in providing its claimed benefits and proper functioning, otherwise known as the essential design outputs. In order to improve the ability of designers and auditors to ascertain the safety and efficacy of a product, the use of design controls has been adopted that specify a method of evaluating the design process at several key stages. The main objective of this research was to examine the resolution and architectural details necessary to build an adequate manufacturing control system to assure the EDO outputs in large IVD instruments in the company under study. The control system is the defined inspections and test processes to delineate between acceptable and unacceptable product before release for sale. The authors reviewed current design control regulatory requirements within the IVD industry, as well as design controls in other regulated industries. This research was completed to determine what opportunities could be transferred to large in-vitro IVD instruments using an IVD manufacturer as a case study. In conclusion, the research identified three areas where a properly configured EDO can add value within IVD instrument design and manufacture, namely: (1) development of a control system which is fit for purpose; (2) a mechanism to manage and proliferate key design knowledge within the organisation and thereby manage outsourced services; and (3) implementing a scaled engineering change process because changes impacting EDO naturally require extra regulatory and engineering oversight.