Design Management Group

Managing technology feasibility within the medical device industry

Researcher: Jon Johnson

Innovation is becoming a critical factor in ensuring commercial success within the area of medical diagnostic technology. Biotechnology and healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure which is inherently full of risks and uncertainty. In this context early technology assessment and proof of principle is often sporadic and unstructured. Existing design process models aimed at the medical healthcare industry are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval.

Currently there is a lack of technical guidance in the area of feasibility and as a result there needs to be a more consistent approach. This research provides a theoretical framework which offers practical guidance in improving development efficiency within the front-end phases of healthcare development. It also attempts to gain insight into the activities which occur when establishing confidence within the core science and technology, prior to substantial commercial investment. This qualitative research comprises of three provisional investigational studies analysing recent innovations within leading medical organisations. The findings of this empirical study have shown that front-end activities continue to lack both technical guidance, robust data, technically related regulatory consideration and underestimate the importance of preliminary technology assessment.

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