An Analysis of Complexity Measures for Product Design and Development

2012 ◽  
Author(s):  
Josue R. Crespo-Varela ◽  
Gül E. Okudan Kremer ◽  
Conrad S. Tucker ◽  
Lourdes A. Medina
Keyword(s):  
Product Design ◽  
Medical Device ◽  
Consumer Products ◽  
Product Complexity ◽  
Design And Development ◽  
Complexity Measures ◽  
Device Development ◽  
Complexity Metrics ◽  
Development Costs

Complexity metrics have been developed for multiple applications such as consumer products, software, trajectory selection and assembly systems. Although existing complexity metrics were developed to reduce product design and development costs, their lack of simplicity in formulation and robustness has limited their applicability. This paper proposes a standard methodology for comparing and evaluating these metrics and introduces dimensions of complexity that should be considered towards the goal of developing a generalizable product complexity measure. To this end, this paper introduces variables that integrate multiple facets of complexity into a single metric. A medical device case study is used to compare the efficiency and robustness of existing complexity measures. The medical device case study also serves as the motivation for the proposed complexity metric due to the complexity of the domain itself and the increasing importance of mitigating healthcare costs. Overall, product complexity metrics can aid medical device development by increasing the understanding about the design and its implications regarding development time and FDA approvals.

Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development

2013 ◽  
Author(s):  
Lourdes A. Medina ◽  
Marija Jankovic ◽  
Gül E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Decision Time ◽  
Product Complexity ◽  
Complexity Measures ◽  
Design Complexity ◽  
Regulatory Decision ◽  
Complexity Metrics ◽  
Relevant Variables ◽  
Or Organization ◽  
The Relationship

Product complexity has been studied as an important factor to decrease the cost and time of the development process. With this purpose, prior research has included the development of design complexity metrics as a method to assess and decrease complexity. Recent studies have also focused on the comparison of complexity metrics for the particular case of medical devices development (MDD). However, the major issue relevant to MDD has not been addressed; the relationship between FDA regulations and the device complexity is not clarified. Therefore, to increase MDD safety and decrease the time to market, we must understand the regulatory decision process and rules. In this paper, we investigate the relation between different complexity metrics and FDA’s decision time using a sample of 100 hip replacement devices. Bayesian network learning is used to explore in detail local relationships between different variables, both complexity measures and product variables. This relationship was found significant for the first two clusters of the analysis. However, for a third cluster it is speculated that FDA decision time does not depend solely upon the degree of medical device complexity. Company or organization relevant variables could be playing a greater role than just complexity. Additional questions are drawn based on the results that must be investigated.

scholarly journals A New Design and Development Framework for Better Aesthetic Appearance for Consumers Products

2021 ◽  
Vol 56 (3) ◽  
pp. 262-273
Author(s):  
Mohd Qadafie Ibrahim ◽  
Fairuz Izzuddin Romli ◽  
Hassan Alli ◽  
Eris Elianddy Supeni ◽  
Hambali Arep
Keyword(s):  
Product Design ◽  
Engineering Students ◽  
Consumer Products ◽  
Design And Development ◽  
Form And Function ◽  
Design Engineers ◽  
Development Framework ◽  
Aesthetic Appearance ◽  
Development Processes ◽  
The Aesthetic

One of the primary issues with many product design and development processes today is having a good balance between the elements of form and function. While all products must be able to perform their intended functions, considerations of aesthetic features are also necessary for them to be accepted as a good quality design. However, most available design and development processes of consumer products have been more focused on achieving the functional aspects and have tended to treat the aesthetic aspects as less crucial features. This approach has led to many failed functional products in the market, as their physical design lacks appealing factors to targeted users. To improve the situation, a new product design and development framework is proposed in this study to better facilitate designers or engineers in creating an all-rounded quality product design. This new method is developed based on the findings from a survey conducted among engineering students, who are future product design engineers, in order to identify and also resolve issues with the current methods that they typically apply for their design tasks. All in all, the new proposed method is fundamentally tailored to offer a structured guide for developing beautiful and useful products based on a semantic design approach.

Framing Sustainability in Human-Centered Product Design

2009 ◽  
Author(s):  
Lora A. Oehlberg ◽  
Alice M. Agogino ◽  
Sara L. Beckman
Keyword(s):  
Product Design ◽  
Mission Statement ◽  
Consumer Products ◽  
User Needs ◽  
User Research ◽  
Sustainable Solutions ◽  
Sustainable Products ◽  
Trade Offs ◽  
Minimal Environmental Impact

Engineers today have access to a myriad of tools for developing sustainable products that have minimal environmental impact. Although consumer interest in sustainability is increasing, it is still not foremost on the minds of many consumers. Engineers are thus faced with the dilemma of developing sustainable solutions for consumers who may not yet want or be able to articulate sustainability needs. We explore this issue by examining user research conducted by students in a graduate-level product design course. We present findings on how users define and describe sustainability, how sustainability needs interact with other user needs, and what tradeoffs people make and feelings people have when faced with sustainability trade-offs. We present a case study of one design team’s findings about sustainability, and how those findings affected the formulation of the team’s mission statement and product strategy. Based on these results, we propose recommendations for how to facilitate the design of innovative and sustainable consumer products.

scholarly journals A Case Study of Physician Interaction in the Medical Device Development Process

2010 ◽  
Vol 4 (2) ◽  
Author(s):  
Lauren Aquino Shluzas ◽  
John H. Linehan ◽  
Larry J. Leifer
Keyword(s):  
Medical Device ◽  
Risk Perceptions ◽  
User Interaction ◽  
Team Members ◽  
Medical Device Development ◽  
Device Development ◽  
Wide Range ◽  
Contextual Framework ◽  
Case Based

A multiphase empirical field study is being conducted at Stanford University to examine the process of physician interaction during medical device development. The initial component of this study involved creating an analytic framework for case-based research that provided a conceptual guide for the pilot case study documented in this paper. The pilot case study examined the process of engaging physicians in medical device development within the context of an entrepreneurial device company. The methods used in this study included a combination of interviews with cross-functional team members, a quantitative survey, and the collection of archival data. Data analysis first involved documenting physician-developer interaction practices that had been used within the company, from needs finding to post-market surveillance, across multiple product generations. Leading development factors involving physicians that had influenced the company’s clinical and financial outcomes were next identified. The case study illustrated the importance of working with and understanding the user experiences of a wide range of physicians when developing new products. The case also captured how physician interaction influences risk perceptions toward medical device performance for both surgeons and developers. The case likewise highlighted the benefits of a systems-based design approach, as opposed to designing products for a single technical end point. From a methodological perspective, the case study revealed the importance of examining user interaction within a contextual framework, as opposed to an isolated examination of input and output variables. The study presented in this paper has provided a foundation for future case-based analyses regarding the process of physician interaction in medical device development.

scholarly journals A user-centred approach to requirements elicitation in medical device development: A case study from an industry perspective

2012 ◽  
Vol 43 (1) ◽  
pp. 184-190 ◽  
Author(s):  
Jennifer L. Martin ◽  
Daniel J. Clark ◽  
Stephen P. Morgan ◽  
John A. Crowe ◽  
Elizabeth Murphy
Keyword(s):  
Medical Device ◽  
Requirements Elicitation ◽  
Medical Device Development ◽  
Device Development

Evaluation of success factors for medical device development using grey DEMATEL approach

2017 ◽  
Vol 12 (2) ◽  
pp. 204-223 ◽  
Author(s):  
Milind Shrikant Kirkire ◽  
Santosh B. Rane
Keyword(s):  
Sensitivity Analysis ◽  
Medical Device ◽  
Success Factors ◽  
Future Research ◽  
Content Type ◽  
Medical Device Development ◽  
Active Involvement ◽  
Device Development ◽  
Medical Device Manufacturers

Purpose Successful device development brings substantial revenues to medical device manufacturing industries. This paper aims to evaluate factors contributing to the success of medical device development (MDD) using grey DEMATEL (decision-making trial and evaluation laboratory) methodology through an empirical case study. Design/methodology/approach The factors are identified through literature review and industry experts’ opinions. Grey-based DEMATEL methodology is used to establish the cause-effect relationship among the factors and develop a structured model. Most significant factors contributing to the success of MDD are identified. An empirical case study of an MDD and manufacturing organisation is presented to demonstrate the use of the grey DEMATEL method. Sensitivity analysis is carried out to check robustness of results. Findings The results of applying the grey DEMATEL methodology to evaluate success factors of MDD show that availability of experts and their experience (SF4) is the most prominent cause factor, and active involvement of stakeholders during all stages of MDD (SF3) and complete elicitation of end-user requirements (SF1) are the most prominent effect factors for successful MDD. A sensitivity analysis confirms the reliability of the initial solution. Practical implications The findings will greatly help medical device manufacturers to understand the success factors and develop strategies to conduct successful MDD processes. Originality/value In the past, few success factors to MDD have been identified by some researchers, but complex inter-relationships among factors are not analysed. Finding direct and indirect effects of these factors on the success of MDD can be a good future research proposition.

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