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.

Developing a framework for mapping industrial emergence

The industrial landscape is becoming increasingly complex and dynamic, with innovative technologies stimulating the emergence of new industries and business models. This paper presents a preliminary framework for mapping industrial emergence, based on roadmapping principles, in order to understand the nature and characteristics of such phenomena. The focus at this stage is on historical examples of industrial emergence, with the preliminary framework based on observations from 20 'quick scan' maps, one of which is used to illustrate the framework. The learning from these historical cases, combined with further industrial consultation and literature review, will be used to develop practical methods for strategy and policy application. The paper concludes by summarising key learning points and further work needed to achieve these outcomes. © 2009 PICMET.

Architectural research and its enemies

Like the Research Assessment Exercise (RAE) that preceded it, the UK government's proposed Research Excellence Framework (REF) is a means of allocating funding in higher education to support research. As with any method for the competitive allocation of funds it creates winners and losers and inevitably generates a lot of emotion among those rewarded or penalised. More specifically, the 'winners' tend to approve of the method of allocation and the 'losers' denigrate it as biased against their activities and generally unfair. An extraordinary press campaign has been consistently waged against research assessment and its methods by those involved in architectural education, which I will track over a decade and a half. What follows will question whether this campaign demonstrates the sophistication and superior judgment of those who have gone into print, or conversely whether its mixture of misinformation and disinformation reveals not just disenchantment and prejudice, but a naivety and a depth of ignorance about the fundamentals of research that is deeply damaging to the credibility of architecture as a research-based discipline. With the recent consultation process towards a new cycle of research assessment, the REF, getting under way, I aim to draw attention to the risk of repeating past mistakes. Copyright © Cambridge University Press 2010.

Disentangling the Complexity of Early-Stage Technology Acquisitions

While tools have been developed to assist firms' decision making for bringing known products and components into the supply chain, fewer tools are available to guide the acquisition of earlier-stage technologies, which is a riskier proposition due to higher technological and market uncertainties. Through synthesis of literature in technology sourcing, open innovation, alliances, mergers and acquisitions, outsourcing, and technology and knowledge transfer and consultation with industry, this paper identifies critical issues that decision makers should consider before making an early-stage technology acquisition. Sixteen questions emerge to guide decision making, comprising internal, technology, and partner assessments. These questions allow a firm to disentangle the complexity of early-stage technology acquisitions and select the most appropriate targets.

Soil mix technology for integrated remediation and ground improvement: From laboratory work to field trials

Relatively new in the UK, soil mix technology applied to the in-situ remediation of contaminated land involves the use of mixing tools and additives to construct permeable reactive in-ground barriers and low-permeability containment walls and for hot-spot soil treatment by stabilisation/ solidification. It is a cost effective and versatile approach with numerous environmental advantages. Further commercial advantages can be realised by combining this with ground improvement through the development of a single integrated soil mix technology system which is the core objective of Project SMiRT (Soil Mix Remediation Technology). This is a large UK-based R&D project involving academia-industry collaboration with a number of tasks including equipment development, laboratory treatability studies, field trials, stakeholder consultation and dissemination activities. This paper presents aspects of project SMiRT relating to the laboratory treatability study work leading to the design of the field trials. © 2012 American Society of Civil Engineers.