Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.

Addressing the cognitive and social influence inhibitors during the ideation stages of technology roadmapping workshops

Technology roadmapping workshops are essentially a social mechanism for exploring, creating, shaping and implementing ideas. The front-end of a roadmapping session is based on brainstorming in order to tap into the group's diverse knowledge. The aim of this idea stimulation activity is to capture and share as many perspectives as possible across the full scope of the area of interest. The premise to such group brainstorming is that the sharing and exchange of ideas leads to cognitive stimulation resulting in a greater overall group idea generation performance in terms of the number, variety and originality of ideas. However, it must be recognized that the ideation stage in a roadmapping workshop is a complex psychosocial phenomenon with underlying cognitive and social processes. Thus, there are downsides to group interactions and these must be addressed in order to fully benefit from the power of a roadmapping workshop. This paper will highlight and discuss the key cognitive and social inhibitors involved. These include: production blocking, evaluation apprehension, free riding/social loafing, low norm setting/matching. Facilitation actions and process adjustments to counter such negative factors will be identified so as to provide a psychosocial basis for improving the running of roadmapping workshops. © 2009 PICMET.

Proceedings of an international workshop on the value of computer-based engineering tools, held in Cambridge in April 1997

There is increasing adoption of computer-based tools to support the product development process. Tolls include computer-aided design, computer-aided manufacture, systems engineering and product data management systems. The fact that companies choose to invest in tools might be regarded as evidence that tools, in aggregate, are perceived to possess business value through their application to engineering activities. Yet the ways in which value accrues from tool technology are poorly understood.

This report records the proceedings of an international workshop during which some novel approaches to improving our understanding of this problem of tool valuation were presented and debated. The value of methods and processes were also discussed. The workshop brought together British, Dutch, German and Italian researchers. The presenters included speakers from industry and academia (the University of Cambridge, the University of Magdeburg and the Politechnico de Torino)

The work presented showed great variety. Research methods include case studies, questionnaires, statistical analysis, semi-structured interviews, deduction, inductive reasoning, the recording of anecdotes and analogies. The presentations drew on financial investment theory, the industrial experience of workshop participants, discussions with students developing tools, modern economic theories and speculation on the effects of company capabilities.

Data fusion approaches and applications for construction engineering

Data fusion can be defined as the process of combining data or information for estimating the state of an entity. Data fusion is a multidisciplinary field that has several benefits, such as enhancing the confidence, improving reliability, and reducing ambiguity of measurements for estimating the state of entities in engineering systems. It can also enhance completeness of fused data that may be required for estimating the state of engineering systems. Data fusion has been applied to different fields, such as robotics, automation, and intelligent systems. This paper reviews some examples of recent applications of data fusion in civil engineering and presents some of the potential benefits of using data fusion in civil engineering.

Managing global network operations along the engineering value chain

Purpose: This paper aims to improve understanding of how to manage global network operations from an engineering perspective. Design/methodology/approach: This research adopted a theory building approach based on case studies. Grounded in the existing literature, the theoretical framework was refined and enriched through nine in-depth case studies in the industry sectors of aerospace, automotives, defence and electrics and electronics. Findings: This paper demonstrates the main value creation mechanisms of global network operations along the engineering value chain. Typical organisational features to support the value creation mechanisms are captured, and the key issues in engineering network design and operations are presented with an overall framework. Practical implications: Evidenced by a series of pilot applications, outputs of this research can help companies to improve the performance of their current engineering networks and design new engineering networks to better support their global businesses and customers in a systematic way. Originality/value: Issues about the design and operations of global engineering networks (GEN) are poorly understood in the existing literature in contrast to their apparent importance in value creation and realisation. To address this knowledge gap, this paper introduces the concept of engineering value chain to highlight the potential of a value chain approach to the exploration of engineering activities in a complex business context. At the same time, it develops an overall framework for managing GEN along the engineering value chain. This improves our understanding of engineering in industrial value chains and extends the theoretical understanding of GEN through integrating the engineering network theories and the value chain concepts. © Emerald Group Publishing Limited.

Buyer-supplier relationships in a servitized environment: An examination with Cannon and Perreault's framework

Purpose: The purpose of this study is to examine a buyer's adoption of servitization and the associated implications for the relationships with its suppliers. Design/methodology/approach: The authors use the case study approach to examine the tripartite relationship between a manufacturing company and two of its two suppliers. The paper explores the perspectives of employees on multiple organisational levels, and collects evidence on both sides of a relationship. The authors use template analysis utilising Cannon and Perreault's relationship connectors framework to analyse the data. Findings: There are overarching implications of servitization adoption for buyer-supplier relationships. The implications are notable in all five relationship connectors. Parties expected more open exchange of information, operational linkages were strengthened and changes in the structural arrangements of relationships were witnessed. Legal contracts are complemented by relational norms. The authors also observed a departure away from a win-lose mentality and increased levels of supplier adaptation to support the buyer's provision of integrated solutions. Research limitations/implications: The findings are confined to this tripartite relationship and to an extent are context specific. Practical implications: The study unveils buyer-supplier relationships in a servitized context and provides managers with a better understanding of some of the potential implications that the adoption of a servitization strategy may have for managing buyer-supplier relationships. Originality/value: This is the first empirical study that explores the implications of servitization on buyer-supplier relationships. It advances the understanding of the implications that the adoption of servitization has on the manner in which two parties interrelate and conduct commercial exchange. © Emerald Group Publishing Limited.

Band alignment between Ta2O5 and metals for resistive random access memory electrodes engineering

Band alignment of resistive random access memory (RRAM) switching material Ta2O5 and different metal electrode materials was examined using high-resolution X-ray photoelectron spectroscopy. Schottky and hole barrier heights at the interface between electrode and Ta2O 5 were obtained, where the electrodes consist of materials with low to high work function (Φ m, v a c from 4.06 to 5.93 eV). Effective metal work functions were extracted to study the Fermi level pinning effect and to discuss the dominant conduction mechanism. An accurate band alignment between electrodes and Ta2O5 is obtained and can be used for RRAM electrode engineering and conduction mechanism study. © 2013 American Institute of Physics.

Briefing: Re-Engineering the City 2020-2050 - Urban Foresight and Transition Management

Cities may be responsible for up to 70% of global carbon emissions and 75% of global energy consumption and by 2050 it is estimated that 70% of the world's population could live in cities. The critical challenge for contemporary urbanism, therefore, is to understand how to develop the knowledge, capacity and capability for public agencies, the private sector and multiple users in city regions systemically to re-engineer their built environment and urban infrastructure in response to climate change and resource constraints. Re-Engineering the City 2020-2050: Urban Foresight and Transition Management (Retrofit 2050) is a major new interdisciplinary project funded under the Engineering and Physical Science Research Council's (EPSRC) Sustainable Urban Environments Programme which seeks to address this challenge. This briefing describes the background and conceptual framing of Retrofit 2050 project, its aims and objectives and research approach.