Integrated Fuzzy-Based Modular Architecture for Medical Device Design and Development

2010 ◽  
Vol 4 (3) ◽  
Author(s):  
Celestine C. Aguwa ◽  
Leslie Monplaisir ◽  
Prasanth Achuthamenon Sylajakumari ◽  
Ram Kumar Muni
Keyword(s):  
Medical Device ◽  
Programming Model ◽  
Optimal Number ◽  
Product Cycle ◽  
Device Design ◽  
Modular Architecture ◽  
Design And Development ◽  
Medical Device Design ◽  
Goal Programming Model ◽  
Medical Device Manufacturers

In this paper, we present an integrated collaborative modular architecture method for medical device design and development. The methodology is focused on analyzing the input of stakeholder data from existing products and components to achieve an optimal number of modules. The methodology starts by defining a product’s functional and physical decompositions. Product parameters are selected such as quality, reliability, ease of development, and cost. These are prioritized using analytical hierarchy process (AHP) to determine the medical device manufacturers’ focus area. The parameters’ subsequent metrics are selected for performance requirements. Next, we evaluate the candidate modules by acquiring stakeholder data and converting them to crisp values by applying the Sugeno fuzzy-based method. Finally, we determine the subsequent optimal module values using a multi-optimization goal programming model. We present here a proof of concept using a typical glucometer. The implication of this work is the determination of the optimal number of product modules based on stakeholder constraints. Hence, an original equipment manufacturer (OEM) can work on fewer components per module without adversely affecting the integrity, quality, and reliability of the final product. Next is the improved quality of patient care by enabling cost reductions in product design and development, thereby improving patient safety. This methodology helps reduce product cycle time, thereby improving market competitiveness among other factors.

scholarly journals Effect of Rating Modification on a Fuzzy-Based Modular Architecture for Medical Device Design and Development

2012 ◽  
Vol 2012 ◽  
pp. 1-14 ◽  
Author(s):  
Celestine C. Aguwa ◽  
Leslie Monplaisir ◽  
Prasanth A. Sylajakumari
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Optimal Number ◽  
Device Design ◽  
Modular Architecture ◽  
Design And Development ◽  
Medical Device Design ◽  
Potential Failure ◽  
International Testing ◽  
The Impact

The goal of this research is to determine the effect of customer ratings on the optimal number of modules for medical device design. Medical devices have a 90% failure rate in their first prototype tests according to the international testing body, Intertek. To address this key issue of quality, we present an integrated, collaborative, modular architecture method for medical device design and development. A typical glucometer is used as proof of concept to demonstrate the methodology and analyze the impact of changing the customer ratings on the optimal number of modules and minimum deviation. The implication of this research is to generate scholarly work and to reduce the number of potential failure points in medical devices by determining the optimal number of modules.

Out-of-the-Box Medical Device Safety

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.

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

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.

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

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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