Strategies for Medical Device Development: User and Stakeholder Perceptions

Table 2

Assessment structure of medical device development.

Dimension	Factor	Description	Literature	Interview
User action (UA)	User needs considerations	Plan product designs that meet target users’ needs with the intended use and service capabilities	A	●
	Training course	Education and training courses for users to avoid errors and failures in use	B	●
	Empirical cognitive ability	Users need to have basic knowledge and experience to avoid misuse of the product	C	●
	Physical and mental health	Product function design is based on the user’s physical health and mental state	D
Technical capability (TC)	User interface design	Planning the human-machine interface design to meet safety regulations and user requirements	E	●
	Competitive products	The design is based on the published information and “recall” reports of the comparison products	F	●
	Calibratable maintenance	Functional testing, calibration maintenance, and troubleshooting specifications for products	GH	●
	Label warning	According to the product’s attribute type and service function, design a clear label warning	IJ	●
Use environment (UE)	Intended location	Product placement is evaluated based on the intended environment and conditions of use	K	●
	Public safety protection	Planning protective measures according to formulate safety operation rules to prevent accidents	L	●
	Hygiene requirements	Develop clean and hygienic requirement standards for the use of the environment	MN
	Device usage time	Make reasonable operating procedures based on the length of usage time for the product	OP	●
Organizational characteristic (OC)	Management culture	Different organizational management models and cultures influence product design	Q	●
	Team communication	Communication within and outside of the organization affects the development of products	R	●
	Resource allocation	Planning for the allocation of resources to support all phases of product development	ST	●
	Regulatory assessment	Setting product design strategies to meet regulatory requirements of medical device quality control	U	●

Note: A: [14], B: [15], C: [16], D: [37], E: [38], F: [39], G: [8], H: [40], I: [41], J: [42], K: [17], L: [18], M: [43], N: [44], O: [19], P: [20], Q: [45], R: [46], S: [47], T: [21], U: [9].