End-users in the medical device design process
End-users might play an essential role in the process of medical device design. End-users act as a reference point for human factors that could be important in helping design medical devices that are best suited to serving user needs (Money et al., 2011). Studying the user’s characteristics gives medical device manufacturers a new insight into the field of engineering; the manufacturers are better suited to understanding what the user exactly needs and focus on developing a device that meets the exact needs or assists in meeting them. The drawback of not taking into account user needs is that the manufacturer might create a product that meets no need at all. Most manufacturers identify niches that are generalized, and failing to carry out a study that helps them understand the exact needs based on the generalization leads to creating an outdated product.
In the product design and development stages, research and analysis have to be carried out to know precisely what gap the newly developed product will fill. While developing medical devices, the validation and verification process requires that medical devices meet some set criteria, including carrying out a study to evaluate the effect of the device on the user. Not putting into consideration the therapeutic use of the equipment makes it not pass the validation process. The therapeutic area for device usage falls under the first step, which is evaluating user needs; it is the user who is to undergo therapy using the developed product (Borad, 2019). Nobody would want to create a product that is vague and has a broad scope of application.
References
Borad, A. (2019, December 11). Medical device design and development: A definitive guide. Retrieved July 15, 2020, from https://www.einfochips.com/medical-device-design-guide-for-medtech/
Money, A. G., Barnett, J., Kuljis, J., Craven, M. P., Martin, J. L., & Young, T. (2011, February 28). The role of the user within the medical device design and development process: medical device manufacturers’ perspectives. BMC Medical Informatics and Decision Making, 11(15). Retrieved from https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/1472-6947-11-15