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Background  The demand for home healthcare devices arises; however, many home healthcare devices on the market are not designed to reflect the needs and features of the end-users. This study explored the user knowledge factors that hindered the design of new home healthcare devices and the interrelationships between the factors.    Methods  The abovementioned factors were identified from analysing the project documents of thirty-eight carefully selected home healthcare devices produced by five manufacturers; followed by interviewing the thirty stakeholders playing key roles in developing the devices.    Results  The design of the home healthcare devices was influenced by (1) the user insights utilised in formulating project strategies; (2) the sources of user information; (3) the execution of user research; and (4) the formulation of the manufacturers’ principal innovation processes.    Conclusions  The users’ characteristics and needs were not sufficiently reflected in developing new home healthcare devices. One root cause was that the end-users were not perceived by the manufacturers as a key success factor in most cases, given that most of the devices were initiated following the public sector’s requests. Actual or potential applications of this study include the facilitation of the appropriate application of human factors methods in developing new home healthcare devices and the improvement of the user performance of the end-devices.    Supplementary Information  The online version contains supplementary material available at 10.1186/s12911-021-01464-3.

User knowledge factors that hinder the design of new home healthcare devices: investigating thirty-eight devices and their manufacturers