Abstract:
In the advent of great advancements in medicine and health technologies, medical device manufacturers are facing a revolution marked with both proliferation of market opportunities and stricter responsibilities imposed upon them. As part of the product commercialisation cycle, process validation requires that the company provides evidence of its ability to produce product per a predetermined quality and safety standard. However, several challenges burden manufacturers. From ambiguous regulatory guidelines to managing various business consideration including supportive infrastructures and competencies, companies are faced with a daunting prospect. This study thus sought to investigate the requirements for a validated manufacturing system, understand the challenges facing manufacturers, and examine optimal approaches to implementing and executing process validation. A combination of qualitative case study analyses and autoethnographic research constituted the principal interpretivist approach of this investigation. The research culminated in a thorough discussion regarding the key implications for companies to undertake process validation as well as the potential benefits of achieving a 'modular' validated state. From considerations into the timing of activities, the balance of cost to benefit, and the maintenance or reduction of risk to the product, this investigation details how these implications may be assessed relative to a manufacturer's current capabilities, concluding with a recommended integrated methodology for engaging in process validation. This proposed strategy seeks to offer an amenable approach for manufacturers that ensures regulatory compliance while optimising the identified considerations by gradually achieving a 'modular' validated system.