Headroom approach to device development: Current and future directions

OBJECTIVES: The headroom approach to medical device development relies on the estimation of a value-based price ceiling at different stages of the development cycle. Such price-ceilings delineate the commercial opportunities for new products in many healthcare systems. We apply a simple model to obtain critical business information as the product proceeds along a development pathway, and indicate some future directions for the development of the approach. METHODS: Health economic modelling in the supply-side development cycle for new products. RESULTS: The headroom can be used: initially as a 'reality check' on the viability of the device in the healthcare market; to support product development decisions using a real options approach; and to contribute to a pricing policy which respects uncertainties in the reimbursement outlook. CONCLUSIONS: The headroom provides a unifying thread for business decisions along the development cycle for a new product. Over the course of the cycle attitudes to uncertainty will evolve, based on the timing and manner in which new information accrues. Within this framework the developmental value of new information can justify the costs of clinical trials and other evidence-gathering activities. Headroom can function as a simple shared tool to parties in commercial negotiations around individual products or groups of products. The development of similar approaches in other contexts holds promise for more rational planning of service provision

Expert Elicitation for Reliable System Design

This paper reviews the role of expert judgement to support reliability assessments within the systems engineering design process. Generic design processes are described to give the context and a discussion is given about the nature of the reliability assessments required in the different systems engineering phases. It is argued that, as far as meeting reliability requirements is concerned, the whole design process is more akin to a statistical control process than to a straightforward statistical problem of assessing an unknown distribution. This leads to features of the expert judgement problem in the design context which are substantially different from those seen, for example, in risk assessment. In particular, the role of experts in problem structuring and in developing failure mitigation options is much more prominent, and there is a need to take into account the reliability potential for future mitigation measures downstream in the system life cycle. An overview is given of the stakeholders typically involved in large scale systems engineering design projects, and this is used to argue the need for methods that expose potential judgemental biases in order to generate analyses that can be said to provide rational consensus about uncertainties. Finally, a number of key points are developed with the aim of moving toward a framework that provides a holistic method for tracking reliability assessment through the design process.Comment: This paper commented in: [arXiv:0708.0285], [arXiv:0708.0287], [arXiv:0708.0288]. Rejoinder in [arXiv:0708.0293]. Published at http://dx.doi.org/10.1214/088342306000000510 in the Statistical Science (http://www.imstat.org/sts/) by the Institute of Mathematical Statistics (http://www.imstat.org

Software reliability and dependability: a roadmap

Shifting the focus from software reliability to user-centred measures of dependability in complete software-based systems. Influencing design practice to facilitate dependability assessment. Propagating awareness of dependability issues and the use of existing, useful methods. Injecting some rigour in the use of process-related evidence for dependability assessment. Better understanding issues of diversity and variation as drivers of dependability. Bev Littlewood is founder-Director of the Centre for Software Reliability, and Professor of Software Engineering at City University, London. Prof Littlewood has worked for many years on problems associated with the modelling and evaluation of the dependability of software-based systems; he has published many papers in international journals and conference proceedings and has edited several books. Much of this work has been carried out in collaborative projects, including the successful EC-funded projects SHIP, PDCS, PDCS2, DeVa. He has been employed as a consultant t

Ways of Applying Artificial Intelligence in Software Engineering

As Artificial Intelligence (AI) techniques have become more powerful and easier to use they are increasingly deployed as key components of modern software systems. While this enables new functionality and often allows better adaptation to user needs it also creates additional problems for software engineers and exposes companies to new risks. Some work has been done to better understand the interaction between Software Engineering and AI but we lack methods to classify ways of applying AI in software systems and to analyse and understand the risks this poses. Only by doing so can we devise tools and solutions to help mitigate them. This paper presents the AI in SE Application Levels (AI-SEAL) taxonomy that categorises applications according to their point of AI application, the type of AI technology used and the automation level allowed. We show the usefulness of this taxonomy by classifying 15 papers from previous editions of the RAISE workshop. Results show that the taxonomy allows classification of distinct AI applications and provides insights concerning the risks associated with them. We argue that this will be important for companies in deciding how to apply AI in their software applications and to create strategies for its use

Improving the Economic Decision-Making Capability and Viability of Chinese Wool Textile Mills

The successful restructuring of Chinese industries is of immense importance not only for the continued development of China but also to the stability of the world economy. The transformation of the Chinese wool textile industry illustrates well the many problems and pressures currently facing most Chinese industries. The Chinese wool textile industry has undergone major upheaval and restructuring in its drive to modernize and take advantage of developments in world textile markets. Macro level ownership and administrative reforms are well advanced as is the uptake of new technology and equipment. However, the changing market and institutional environment also demands an increasing level of sophistication in mill management decisions including product selection, input procurement, product pricing, investment appraisal, cost analysis and proactive identification of new market and growth opportunities. This paper outlines a series of analyses that have been integrated into a decision-making model designed to assist mill managers with these decisions. Features of the model include a whole-of-mill approach, a design based on existing mill structures and information systems, and the capacity for the model to be tailored to individual mills. All of these features facilitate the adoption of the model by time and resource constrained managers seeking to maintain the viability of their enterprises in the face of extremely dynamic market conditions.China, wool textile mills, industry transition, decision-making models, Agribusiness, Livestock Production/Industries,

Knowledge-based support in Non-Destructive Testing for health monitoring of aircraft structures

Maintenance manuals include general methods and procedures for industrial maintenance and they contain information about principles of maintenance methods. Particularly, Non-Destructive Testing (NDT) methods are important for the detection of aeronautical defects and they can be used for various kinds of material and in different environments. Conventional non-destructive evaluation inspections are done at periodic maintenance checks. Usually, the list of tools used in a maintenance program is simply located in the introduction of manuals, without any precision as regards to their characteristics, except for a short description of the manufacturer and tasks in which they are employed. Improving the identification concepts of the maintenance tools is needed to manage the set of equipments and establish a system of equivalence: it is necessary to have a consistent maintenance conceptualization, flexible enough to fit all current equipment, but also all those likely to be added/used in the future. Our contribution is related to the formal specification of the system of functional equivalences that can facilitate the maintenance activities with means to determine whether a tool can be substituted for another by observing their key parameters in the identified characteristics. Reasoning mechanisms of conceptual graphs constitute the baseline elements to measure the fit or unfit between an equipment model and a maintenance activity model. Graph operations are used for processing answers to a query and this graph-based approach to the search method is in-line with the logical view of information retrieval. The methodology described supports knowledge formalization and capitalization of experienced NDT practitioners. As a result, it enables the selection of a NDT technique and outlines its capabilities with acceptable alternatives

Midterm evaluation of DARCOF II. Increased production and closer relationships between organic and inherent qualities

In October 2002 seven international scientists with expertise on organic farming performed an evaluation of the ongoing Danish research effort in organic food and farming (DARCOF II). The evaluation covers 23 individual projects established in 2000 and the DARCOF II programme as a whole

Information barriers in shipping: Assessing effects on stakeholder decision-making with respect to the energy efficiency of vessels in the time charter market

Given the increasing pressure for emission reduction through the Paris Agreement and the International Maritime Organisation’s emission reduction ambition set in 2018, energy performance in shipping is more important than ever. Several studies have identified information barriers lead to uncertainty around energy efficiency and vessel performance. This prevents more efficient vessels from being rewarded and discourages the uptake of energy efficiency technologies and operational measures. Poor in-service data quality, suboptimal performance modelling and information asymmetry between stakeholders regarding vessel performance result in challenging decision-making when choosing energy efficiency technologies, operational measures or when fixing a vessel for a charter. There is very little literature focused on investigating decision-making practices in relation to vessel and technology performance to expose specific problems related to information use. This work explores these problems and evaluates the effect of information related shortcomings in vessel efficiency on decision-making in deep sea cargo shipping. A mixed-methods approach is proposed, starting with an exploratory case study. The aim is to understand the use of information and identify information asymmetries encountered by all parties involved when making decisions on fixtures or energy efficiency technology selection. The insights from the case study are used to develop a probabilistic techno-economic model which quantifies uncertainties arising from identified information asymmetries and the impact they have on different stakeholders. A game theoretic framework is used as a basis for the model. As a third step, solutions to reduce uncertainty are tested. These solutions are focused on increasing transparency between stakeholders and are shown to provide a mutually beneficial scenario for both charterers and owners. The novel model developed can be used as a tool to evaluate risk stemming from stakeholder behaviour and the impact this has on operating profit for owners and charterers based on assumptions related to information flow and use. The work is aimed towards creating an evidence base for targeted commercial tools and policy designed to promote and reward vessel efficiency by bridging the information gap between technical and commercial sides of the shipping industry