Perceptions and Attitudes Regarding Medical Device Development in Canada Among Canadian Innovators: A Qualitative Study.

objectivesThe Canadian medical device industry presents unique challenges to innovators. However, little attention has been paid to exploring the distinct experience of Canadian medical device innovators in the literature. The objective of this study is to explore the experience of Canadian innovators in navigating this industry, with a focus on their perceptions and attitudes towards the use of health economic evaluation.

methodsSemi-structured interviews were conducted using virtual conferencing technology. All participants were C-level employees of small- and medium-sized enterprises (SMEs) with adequate knowledge of their company's overall strategy. Qualitative data were analyzed to reveal emerging themes.

resultsInterviews were performed with ten participants. Forty percent of participants rated themselves as having either minimal or basic knowledge of health economics. Thirty percent of participants had not pursued early economic evaluation of their device, while 90% rated health economics as being either "Quite important" or "Very important" to their company. The perception of increased barriers to successful device adoption in Canada relative to the USA was a prominent sentiment among participants, with 50% expressing discontentment with either the device approval process or health technology assessment process in Canada. Twenty percent stated that their primary target market involved the USA and/or other international jurisdictions.

conclusionCanadian medical device innovators appear to understand the importance of health economic evaluation in the innovation process. However, they report difficulty with device approval and adoption, with some innovators focusing their efforts outside of Canada altogether. Further research should be directed toward understanding how to better support SMEs, given that they are a tremendous source of growth for the Canadian medical device industry.