Background: In the new forefront of healthcare at patients' homes, medical devices developed to use at home setting by lay users are essential. The adoption of home-use medical devices will benefit both patients and public healthcare services in terms of quality of life, enhanced outcomes, and reduced cost of care. Home use medical devices associated with Internet-Of-Things (IOT) technology assists patients in performing self-care as well as providing health information remotely to health care professionals. However, adopting technology requires understanding the nature of the medical device and medical device development (MDD). Existing studies concerning the new product development (NPD) processes or design processes were systematically reviewed to explore knowledge and expertise to provide a framework for IOT engineers or designers to adopt IOT technology to home use medical devices.Objective: This study aimed to review the published literature to explore the current studies in the field of the NPD process, design process, design methodology, and outcome of the device affecting user acceptance.Methods: A systematic review following PRISMA guidelines of the English language literature from four electronic databases and academic search engines published from 2007 to 2018 was conducted. The papers were screened and assessed following predefined inclusive and exclusive criteria. The results were analyzed according to the research questions.Results: The findings revealed state-of-the-art in the NPD process and design process (n=4), the design methodology (n=23), and the resultant outcomes of empirical or clinical research in the validation stage (n=14) of medical device development (MDD). The findings also delineated existing studies in NPD, design process, and design methodologies aimed to ensure that medical devices would be effective and safe. Human factor engineering (HFE), cognitive method, ethnographic, and other methodologies were proposed to understand users, uses and context of use. Barriers, constraints, and multidisciplinary communication were addressed. Tools, processes, and methodologies were proposed to overcome the barriers.Conclusion: As home-use medical device development (MDD) and the adoption of IOT technology is now at a crossroads. This study addresses the necessity for future academic studies related to IOT adoption to MDD, including unique risks, multidisciplinary problems, emerging from IOT technology. Finally, future studies aimed at fabricating the NPD process or design process for IOT home-use medical devices to gain user acceptance were outlined.
Medical devices are migrating from hospital use to home use along with health professional users to lay users. New technologies, including Internet-Of-Things, lead home use medical devices to a new generation of easy to use, smart, portable, and communicable from anywhere. IOT technology enables the home use medical devices to seamlessly detect and connect home patient health status and health activities allowing the patients to remotely connect and share their health data to friends, family, and healthcare staff. Thus, home use medical devices with IOT connectivity play an essential role in assisting home patients to continue their medical care at home and monitor health activities, reducing the risk associated with non-communicable diseases (NCDs) in the first place. The devices empower the home patients to actively manage their health treatment and activities by themselves, either without or with minimum training experience and support. The targeted users of such devices are not limited to patients with chronic diseases but consumers who want to prevent them from serious illness and maintain good health. Accordingly, the success of the IOT home use medical devices also depends on the acceptance and adherence of the users to use the device as a part of their everyday lives. Developing medical devices concerning human factors to be safe and effective is crucial. Many studies contribute to providing design processes and methodologies in this regard. Furthermore, in the case of the IOT home use medical device development, engineers or designers must also understand the acceptance and adherence of the users toward the use of the devices in their daily life routine. Several studies coined the term as consumer medical devices bringing the consumer product development concept to use in this home use medical device development. Though several studies revealed factors influencing user acceptance of the devices such as convenience, ease-of-use, or usefulness, it still is difficult for engineers or designers who do not have expertise or experience in human factor research to integrate the knowledge with existing device development processes. This study proposes a T-A-C-V-I-U model linking relationships from IOT functions to device attributes, consequence, personal values, attitude toward using, and behavioral intention. The model aimed to analyze how device attributes would affect user acceptance. It was constructed from literature reviews on IOT functions, wearable and IOT device attributes, and factors influencing personal value and user acceptance based on Technology Acceptance Model (TAM), Health Belief Model (HBM), and Hierarchical Value Map (HVM). The model would assist non-user research or less-experienced human factor designers to consider which IOT functions should be embedded on a home use medical device to gain user acceptance. Vice versa, it would help assess how determined IOT functions would influence targeted users' acceptance. Finally, the Design-for-user Acceptance of IOT Home use medical device (DfAIH), a design process dedicated for IOT home use medical device development, is proposed. The design process is constructed following the design-for-x framework. It provides a step-by-step design process to convey product development and validation using the T-A-C-V-I-U model to gain user acceptance.
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