This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when ...developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products' commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how.
Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand.
Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products.
•An optimal design procedure is developed for the damper devices in cable-stayed bridge.•The genetic algorithm is implemented in optimization based on parallel computation.•The optimal design ...parameters lead to significant reduction of overall repair cost.
The seismic vulnerability of cable-stayed bridges located in seismically active regions can be of great concern to the regional safety and resilience. A promising design practice for cable-stayed bridges lies in decoupling the deck from deck-pylon connection and incorporating energy dissipation devices to reduce the dynamic responses. In this study, the performance-based seismic design (PBSD) procedure is adapted to the optimal design of damper devices at the deck-pylon connections in a benchmark cable-stayed bridge. The benchmark cable-stayed bridge was modeled in the OpenSees platform, which was calibrated against the previous finite element models. Then it was seismically designed with viscous and metallic dampers in the longitudinal and transverse direction, respectively. The component-level fragility functions of the cable-stayed bridge were first derived based upon the multiple stripe analysis (MSA) method, and then the system-level repair cost ratio (RCR) surfaces were built under the PBSD framework. Finally, the genetic algorithm based on parallel computation was utilized to identify the optimal parameters of the damper devices. The analysis results illustrate that the optimal design parameters can be effectively obtained through the proposed method, and the damper devices with optimal parameters lead to a significant reduction of the overall repair cost. The study also demonstrates that if the device parameters are not selected appropriately, the dampers can have negative effects on bridge responses. The design framework and the findings could provide the guidance for the designing and retrofitting of cable-stayed bridges in practice.
Chair's Comment Emery, Andrew
Administrative & Regulatory Law News,
07/2022, Letnik:
47, Številka:
4
Trade Publication Article
Recenzirano
What I like the most about our conferences is bringing people together to discuss the complexity of the law and the complexity of governing. People love to put others in buckets, like the simplistic ...notion that our three branches, I, II, and III, do entirely distinct and separate tasks, rather than degrees, of A, B, and C. That is not the complex system our founders created to force us to work together and to check each other's work. Prior Chairs, like Linda Jellum, Renée Landers, Ron Levin, Jeff Rosen, Phil Harter, Jamie Conrad, Bill Funk, Michael Asimow, and Warren Belmar, among others, offered me advice and continued to support the Section in ways I am forever grateful.
The design of furniture products is influenced by increasing consumer interest in green products and sustainability values. However, although the demand for sustainable furniture products is high, ...the standardization of sustainability characteristics in furniture design has still not been achieved. A thorough literature review was conducted, which considered various sustainability characteristics that apply in industries that design furniture. This review paper aimed to identify common sustainability characteristics so that a new standard for furniture industries can be established. In this review, numerous themes were explored relating to design guidelines, design criteria, design preferences, design optimization, design evaluation and assessment, design decision making, strategic planning, design strategies, the integration of eco-design, and eco-design tools. A total of 137 articles were reviewed regarding their sustainability characteristics according to the triple bottom-line framework for a relevant product sector. Due to the limited reports on the sustainability characteristics of furniture design activities, this paper also tried to include common sustainability characteristics of non-furniture products that are available on the market. Through the review, 10 sustainability characteristics were identified for the environment, 17 for the economy, and 16 for the social dimension as being common among manufacturers when designing their products. A further in-depth analysis was conducted by mapping the characteristics to those that were significantly implemented in the design process, of which five (5) were environmental, two (2) were economic, and five (5) were social sustainability characteristics. This review is significant in helping furniture designers to use appropriate and effective sustainability standards in the design and manufacture of products that meet customers’ demands. Previous literature reviews have not clearly measured the triple bottom line. Furthermore, no definite characteristics were proposed in previous works regarding wooden furniture design, leaving a gap to be closed by future works.
To understand how organizations combine conflicting institutional logics strategically to create and pursue new market opportunities, we conducted an indepth longitudinal study of the multiple ...efforts of the Italian manufacturer of household goods Alessi to combine the logics of industrial manufacturing and cultural production. Over three decades, Alessi developed three different strategies to combine normative elements of the two logics, using each strategy to envision and pursue different market opportunities. By combining the logics of industrial manufacturing and cultural production, Alessi was able to envision new possibilities for value creation and to enact them through innovation in product design. The three strategies triggered a common set of mechanisms through which the purposeful combining of logics enabled the pursuit of opportunity, while each strategy structured the process differently. We develop a theoretical model linking the development of recombinant strategies to the dynamic restructuring of organizational agency and the related capacity to create and pursue new market opportunities. Our findings and theoretical insights advance understanding of the processes through which organizations challenge taken-for-granted beliefs and practices to create new market opportunities, use logics as resources to enable embedded agency, and design hybrid organizational arrangements.
The verification and validation of engineering designs are of primary importance as they directly influence production performance and ultimately define product functionality and customer perception. ...Research in aspects of verification and validation is widely spread ranging from tools employed during the digital design phase, to methods deployed for prototype verification and validation. This paper reviews the standard definitions of verification and validation in the context of engineering design and progresses to provide a coherent analysis and classification of these activities from preliminary design, to design in the digital domain and the physical verification and validation of products and processes. The scope of the paper includes aspects of system design and demonstrates how complex products are validated in the context of their lifecycle. Industrial requirements are highlighted and research trends and priorities identified.
Reading Graphic Design History uses a series of key artifacts from the history of print culture in light of their specific historical contexts. It encourages the reader to look carefully and ...critically at print advertising, illustration, posters, magazine art direction and typography, often addressing issues of class, race and gender. David Raizman's innovative approach intentionally challenges the canon of graphic design history and various traditional understandings of graphic design. He re-examines 'icons' of graphic design in light of their local contexts, avoiding generalisation to explore underlying attitudes about various social issues. He encourages new ways of reading graphic design that take into account a broader context for graphic design activity, rather than broad views that discourage the understanding of difference and the means by which graphic design communicates cultural values. With a foreword by Steven Heller.
Background
This study focuses on probing preservice technology teachers’ cognitive structures and how they construct engineering design in technology-learning activities and explores the effects of ...infusing an engineering design process into science, technology, engineering, and mathematics (STEM) project-based learning to develop preservice technology teachers’ cognitive structures for engineering design thinking.
Results
The study employed a quasi-experimental design, and twenty-eight preservice technology teachers participated in the teaching experiment. The flow-map method and metalistening technique were utilized to enable preservice technology teachers to create flow maps of engineering design, and a chi-square test was employed to analyze the data. The results suggest that (1) applying the engineering design process to STEM project-based learning is beneficial for developing preservice technology teachers’ schema of design thinking, especially with respect to clarifying the problem, generating ideas, modeling, and feasibility analysis, and (2) it is important to encourage teachers to further explore the systematic concepts of engineering design thinking and expand their abilities by merging the engineering design process into STEM project-based learning.
Conclusions
The findings of this study provide initial evidence on the effects of infusing the engineering design process into STEM project-based learning to develop preservice technology teachers’ engineering design thinking. However, further work should focus on exploring how to overcome the weaknesses of preservice technology teachers’ engineering design thinking by adding a few elements of engineering design thinking pedagogy, e.g., designing learning activities that are relevant to real life.
•The paper demonstrates the application of multi-mode (system) reliability analysis to the design of horizontal curves.•Two noncompliance modes were considered: insufficient sight distance and ...vehicle skidding.•The process is demonstrated by a case study of Sea-to-Sky Highway located between Vancouver and Whistler, in southern British Columbia, Canada.•The results show the importance of accounting for several noncompliance modes in the reliability model.•The proposed analysis could be used to calibrate the design of various geometric elements to achieve consistent safety levels based on all possible modes of noncompliance.
Recently, reliability analysis has been advocated as an effective approach to account for uncertainty in the geometric design process and to evaluate the risk associated with a particular design. In this approach, a risk measure (e.g. probability of noncompliance) is calculated to represent the probability that a specific design would not meet standard requirements. The majority of previous applications of reliability analysis in geometric design focused on evaluating the probability of noncompliance for only one mode of noncompliance such as insufficient sight distance. However, in many design situations, more than one mode of noncompliance may be present (e.g. insufficient sight distance and vehicle skidding at horizontal curves). In these situations, utilizing a multi-mode reliability approach that considers more than one failure (noncompliance) mode is required. The main objective of this paper is to demonstrate the application of multi-mode (system) reliability analysis to the design of horizontal curves. The process is demonstrated by a case study of Sea-to-Sky Highway located between Vancouver and Whistler, in southern British Columbia, Canada. Two noncompliance modes were considered: insufficient sight distance and vehicle skidding. The results show the importance of accounting for several noncompliance modes in the reliability model. The system reliability concept could be used in future studies to calibrate the design of various design elements in order to achieve consistent safety levels based on all possible modes of noncompliance.
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