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This study investigates factors affecting the transformational leadership of small and medium medical device enterprises in Thailand, using quantitative research methods by collecting questionnaire data from 283 employees, Stratified sampling was used to identify subgroups of the population, then a simple random assignment was used without replacement. Descriptive statistical analysis, including frequency, percentage, means and standard deviations, was used to clarify personal factors such as type of personnel, gender, age, educational level, the period of business operation, and the number of employees, multiple regression was used for test for demographic characteristics and transformational leadership. The research found entrepreneurs that most of 65.5% were male; 83% were 41-50 years. For levels of education, 45.5% had master's degrees. For period business operation, 6-10 years comprised 47.2% of the sample. 57.4% worked in companies with 51-100 employees. For category of medical equipment business, medical materials were 39%. Age, educational level, and the period of business operation could explain the variation on transformational leadership; at 49% percent significance at the 0.05 level, these had the strongest relation with transformational leadership. This research was limited by the fact that not all the questionnaires could be returned. For future research we suggest that new variables may be added to reflect modern conditions such as digital leadership. [ABSTRACT FROM AUTHOR]