5 resultados para Approval

em Cambridge University Engineering Department Publications Database


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Technological investment is an important driver of innovation and the evaluation of technology potential is becoming increasingly important in this context. Although there is a range of possible approaches and tools for understanding and communicating the value of technology to potential customers, not all are useful or accessible in practice, where the situation is often complex and constantly evolving. Although many companies have their own customised processes in place for securing approval for technology development, often combining several techniques, very few empirical studies have been performed to learn from these practices and provide an overall view of the process of ";selling"; technologies internally or externally. In this paper, the current literature and practice related to technology valuation is reviewed and summarised in a five step process for building a business case for technology investment that gives guidance on where and when to use specific valuation tools. The seller or proposer's perspective is taken and consultative sales techniques incorporated. This provides a flexible reference for R&D managers and adds to the body of literature on the selection and use of valuation tools. A user friendly guide has been published detailing the five step approach. © 2011 IEEE.

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The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

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The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

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Innovation is a critical factor in ensuring commercial success within the area of medical technology. Biotechnology and Healthcare developments require huge financial and resource investment, in-depth research and clinical trials. Consequently, these developments involve a complex multidisciplinary structure, which is inherently full of risks and uncertainty. In this context, early technology assessment and 'proof of concept' is often sporadic and unstructured. Existing methodologies for managing the feasibility stage of medical device development are predominantly suited to the later phases of development and favour detail in optimisation, validation and regulatory approval. During these early phases, feasibility studies are normally conducted to establish whether technology is potentially viable. However, it is not clear how this technology viability is currently measured. This paper aims to redress this gap through the development of a technology confidence scale, as appropriate explicitly to the feasibility phase of medical device design. These guidelines were developed from analysis of three recent innovation studies within the medical device industry.

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Strategic planning can be an arduous and complex task; and, once a plan has been devised, it is often quite a challenge to effectively communicate the principal missions and key priorities to the array of different stakeholders. The communication challenge can be addressed through the application of a clearly and concisely designed visualisation of the strategic plan - to that end, this paper proposes the use of a roadmapping framework to structure a visual canvas. The canvas provides a template in the form of a single composite visual output that essentially allows a 'plan-on-a-page' to be generated. Such a visual representation provides a high-level depiction of the future context, end-state capabilities and the system-wide transitions needed to realise the strategic vision. To demonstrate this approach, an illustrative case study based on the Australian Government's Defence White Paper and the Royal Australian Navy's fleet plan will be presented. The visual plan plots the in-service upgrades for addressing the capability shortfalls and gaps in the Navy's fleet as it transitions from its current configuration to its future end-state vision. It also provides a visualisation of project timings in terms of the decision gates (approval, service release) and specific phases (proposal, contract, delivery) together with how these projects are rated against the key performance indicators relating to the technology acquisition process and associated management activities. © 2013 Taylor & Francis.