Competency gaps and institutional challenges for translational research in medical devices: insights from Brazilian researchers.

BACKGROUND

The translational research approach aims to accelerate the innovation process. In the healthcare sector, this process is highly regulated and requires a broad set of skills. This study with researchers from Brazilian institutions aimed to identify the knowledge, skills, and structures that permeate the process of translating research into medical devices and to what extent they are present in Brazilian research groups working in the area.

METHODS

A structured questionnaire was applied in which the characteristics of the participants and the level of mastery in each skill were analyzed. Fisher's exact test was performed to verify the association between the percentages of knowledge and importance. Pearson's Chi-square test was also performed to verify the association between the sum of knowledge, categorized by the median, and the characteristics of the questionnaire participants. Finally, an exploratory factor analysis (EFA) was performed to validate the questionnaire construct.

RESULTS

One hundred two researchers working in the area of health innovation in Brazil, especially in the medical devices segment, answered the questionnaire. These researchers come from different regions of the country and work in several areas of knowledge, such as engineers (28%), doctors (12%), information technology and connectivity professionals (11%), pharmacists (8%), nurses (7%), and other formations (34%). The research revealed that a small number of these researchers have a good level of knowledge in human factors engineering and usability (23%), in patent legislation and asset management (24%), in pre-clinical and clinical trials (29%), in business plans (30%) and in the requirements of the technology incorporation process in the SUS (31%). The results reveal significant learning gaps and institutional deficiencies in essential skills and structures for translational medical device research.

CONCLUSION

Understanding the necessary skills and gaps to be filled can contribute to the adoption of institutional strategies and the formulation of public policies capable of promoting more effective results for the Brazilian health system.