Stakeholder mapping for rapid diagnostics test development : the importance of early regulatory requirements assessment

Abstract

This thesis describes research and recommendations based on a stakeholder analysis for developing a rapid diagnostics device piloting and feasibility testing service hub for the Oulu region with a focus on acquiring permits for using human samples for device testing. The practical research was performed during the COVID-19 pandemic, which was a time of hurried development of rapid testing devices across the world with limited human resources and haste due to high disease mortality and morbidity.

Literature review was performed for stakeholder analysis models and medical diagnostic product development. Empirical research was performed to determine the specific needs of a selected group of Oulu area biotech companies and potential stakeholders via questionnaires, interviews, and workshops. Along with the local stakeholder analysis, a practical case study was performed for acquisition of human samples for testing of a rapid diagnostic device developed for detection of COVID-19 disease. The theoretical framework and results of questionnaires and interviews were analyzed and a general stakeholder analysis with focus was done based on synthesis of the theories along with the results of the empirical research for recommendations for what to focus on early during rapid diagnostic device development.

The key result from this study is that the Oulu region has expertise and facilities for all areas required for diagnostic device development, but a hub connecting all these different areas of expertise is lacking. Early regulatory assessment and planning for sample acquisition is imperative for the success of product development, with implications on the design of the device as well as on timelines for product testing and release.

The practical significance of the study is based on inquiries that show that many of the greater Oulu area biotech companies are interested in participating in such a service, and not-for-profit research institutes would also benefit from the establishment of services for generating revenue as well as for generation of publishable results from collaborations. While this thesis describes services that are already available, there is a clear need to develop a public and easily reachable hub, through which product and idea developers can quickly find tangible connections to support their medical diagnostic product development needs. Further analyses and research are ongoing for establishing a working, billable, and sustainable service hub.