General Considerations for the Development of Biomedical Devices

Investigation on Methods and Characteristics in Medical Device Development

“…Legal issues, which include the points just described, also cover ethical issues including beneficence, non-maleficence, justice, and respect for autonomy, which must be taken into account when developing medical devices (Santos et al, 2013). Lantada and Morgado (2013) further add technical and human issues. Technical issues refer to geometric and material details, which have certain characteristics due to the direct contact of the medical device with the human body.…”

“…These include aspects such as biocompatibility of materials or the cleanable and sterilizable design of the devices. Human issues include the coordination of different experts, who all have an interest in the medical device and can provide different inputs during development (Lantada and Morgado, 2013). The heterogeneity of the stakeholders is also emphasized by Santos et al (2013).…”

“…As safety issues are particularly important for medical devices, the application of design methods within the healthcare sector should be given appropriate importance. However, medical devices have special issues (Lantada and Morgado, 2013;Santos et al, 2013) that may need to be considered when applying design methods in the development process. The investigation on how these special issues and characteristics of medical devices influence the application of design methods is the subject of this paper.…”