Comparison of Medical Device Design Alternatives Using the Mechanical Properties of NiTi Alloys

Abstract Engaging stakeholders during medical device design processes, especially during front-end design activities, is a critical consideration for successful product design, which includes the safety and effectiveness of devices. The use of prototypes with stakeholders is encouraged by proponents of human-centered design, but guidelines for front-end stakeholder engagement with detailed descriptions of prototyping practices are lacking. One important question design practitioners must ask for each stakeholder engagement is how many prototypes to use. This study investigated reasons design practitioners chose to use one or more prototypes to engage stakeholders during front-end design activities within their design projects. Participants described using multiple prototypes, for example, to allow stakeholders to compare across different design alternatives, and to convey to stakeholders that multiple alternatives are being explored. Participants described using a single prototype, for instance, to probe for deep responses about a narrow topic and to refine a single concept through feedback. These results have the potential to inform design decisions and pedagogical approaches to prototyping use.

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Lessons Learned From Kinematics Research Applied to Medical Device Design

Journal of Biomechanical Engineering ◽

10.1115/1.4038764 ◽

2018 ◽

Vol 140 (2) ◽

Cited By ~ 1

Author(s):

Arthur Guy Erdman

Keyword(s):

Medical Device ◽

Lessons Learned ◽

Device Design ◽

Medical Device Design

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Designing for Safety and Usability: User-Centered Techniques in Medical Device Design Practice

Proceedings of the Human Factors and Ergonomics Society Annual Meeting ◽

10.1177/1071181311551164 ◽

2011 ◽

Vol 55 (1) ◽

pp. 793-797 ◽

Cited By ~ 9

Author(s):

C. Vincent ◽

A. Blandford

Keyword(s):

Medical Device ◽

Design Practice ◽

Device Design ◽

Medical Device Design ◽

User Centered

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Out-of-the-Box Medical Device Safety

Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care ◽

10.1177/2327857916051014 ◽

2016 ◽

Vol 5 (1) ◽

pp. 84-85

Author(s):

Shannon Clark ◽

Divya Natesan ◽

Morgan Walker ◽

Denise Forkey

Keyword(s):

Risk Analysis ◽

Medical Device ◽

Usability Study ◽

Device Design ◽

Medical Device Design ◽

Safety Risks ◽

Related Risk ◽

Medical Device Safety

Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced or eliminated by conducting a usability study related to the out-of-the-box experience.

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Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

Applied Sciences ◽

10.3390/app11209430 ◽

2021 ◽

Vol 11 (20) ◽

pp. 9430

Author(s):

Fabiola Cortes-Chavez ◽

Alberto Rossa-Sierra ◽

Elvia Luz Gonzalez-Muñoz

Keyword(s):

Medical Device ◽

Design Process ◽

User Satisfaction ◽

Engineering Students ◽

User Acceptance ◽

Development Stage ◽

Device Design ◽

Design Processes ◽

Medical Device Design ◽

User Hierarchy

The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.

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A User-Centered Medical Device Design Decision Making Approach Using Hybrid Rough Cooperative Game Model

10.1115/detc2021-71293 ◽

2021 ◽

Author(s):

Liting Jing ◽

Junfeng Ma

Keyword(s):

Decision Making ◽

Medical Device ◽

Set Theory ◽

Cooperative Game ◽

Rough Set ◽

Rough Set Theory ◽

Design Decision ◽

Device Design ◽

Medical Device Design ◽

User Centered

Abstract With the advancement of new technologies and diverse customer-centered design requirements, the medical device design decision making becomes challenge. Incorporating multiple stakeholders’ requirements into the medical device design will significantly affect the market competitiveness and performance. The classic design decision making approaches mainly focused on design criteria priority determination and conceptual schemes evaluation, which lack the capacity of reflecting the interdependence of interest among stakeholders and capturing the ambiguous influence on the overall design expectations, leading to the unreliable decision making results. In order to relax these constraints in the medical device design, this paper incorporates rough set theory with cooperative game theory model to develop a novel user-centered design decision making framework. The proposed approach is composed of three components: 1) end/professional user needs identification and classification, 2) evaluation criteria correlation diagram and scheme value matrix establishment using rough set theory; and 3) fuzzy coalition utility model development to obtain optimal desirability considering users’ conflict interests. We used a blood pressure meter case study to demonstrate and validate the proposed approach. Compared with the traditional Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) approach, the proposed approach is more robust.

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