Date of Award

August 2013

Degree Type

Dissertation

Degree Name

Doctor of Philosophy

Department

Health Sciences

First Advisor

Timothy B. Patrick

Committee Members

Janis Eells, Sanjoy Ghose, William D. Gregory, michael Lovell, Mary K. Madsen

Abstract

The processes for commercialization of medical devices in healthcare are complex and varied, and it has been difficult to define the ingredients of success. There exists a need to better understand evidence based best practices as there is lack of documented evidence based on best practices for commercialization of medical devices by startups. Commercialization of innovative medical devices in healthcare is in constant demand and the reasons are many fold. Most of the research based startups act as agents of economic development and therefore they need to function more efficiently and effectively. There exists a constant demand from end users to improve medical techniques, results patient experiences and cost effectiveness. However, a large number of strong and commercially viable innovations in healthcare fail to achieve commercialization.

The purpose of this paper is to build a theory. The study examines qualitatively commercialization practices of case study NovaScan LLC, a breast cancer detection device company. Through this single case study, various performances indicators of the commercialization steps followed by the company are identified and findings are presented in the form of theoretical propositions. Extensive literature review and analysis helped in better understanding of the process of commercialization from both healthcare and non-healthcare perspective. Data gathering, which focused on the above mentioned aim was carried on for nearly over four years, initially as an outsider participant and then in the latter part of study, as an insider participant. The data consisted of observations, informal conversations both via telephone and in-person, using an unstructured interview protocol, field notes, company archives and other historical data. Data collection participants were those institutional officials who were responsible both directly and indirectly for the innovation and commercialization activities at NovaScan LLC. All observations, conversations, field notes, documents and other records have been documented. The analysis for this study involves continuous back and forth linking of theory presented by literature findings and data obtained at NovaScan LLC. For the purpose of data analysis, the data is not coded sentence by sentence; rather it's focused on theme identification based on underlying meaning.

The results verify the impressions of many practitioners in the field of innovation and commercialization of medical devices in healthcare. The findings are presented in the form of seven propositions and also propose a framework of commercialization. These findings are recommended to be tested in future. Various activities related to commercialization process do not happen in isolation with product development in a startup firm like NovaScan LLC. Commercialization strategies are an integral part of development work and are well-aligned with the development process and all stages of development process overlap with each other.

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