Complexity stage model of the medical device development based on economic evaluation-MedDee

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents' responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.Web of Science125art. no. 175

Human Capital Investment and the Gender Division of Labor

We use a model of human capital investment and activity choice to explain facts describing gender differentials in the levels and returns to human capital investments. These include the higher return to and level of schooling, the small effect of healthiness on wages, and the large effect of healthiness on schooling for females relative to males. The model incorporates gender differences in the level and responsiveness of brawn to nutrition in a Roy-economy setting in which activities reward skill and brawn differentially. Empirical evidence from rural Bangladesh provides support for the model and the importance of the distribution of brawn.brawn, health, schooling, gender

Formalism and judgement in assurance cases

This position paper deals with the tension between the desire for sound and auditable assurance cases and the current ubiquitous reliance on expert judgement. I believe that the use of expert judgement, though inevitable, needs to be much more cautious and disciplined than it usually is. The idea of assurance “cases ” owes its appeal to an awareness that all too often critical decisions are made in ways that are difficult to justify or even to explain, leaving the doubt (for the decision makers as well as other interested parties) that the decision may be unsound. By building a well-structured “case ” we would wish to allow proper scrutiny of the evidence and assumptions used, and of the arguments that link them to support a decision. A

The Costs and Benefits of Introducing Mandatory Hygiene Regulations

In an idealised model the costs of capital and maintenance and the resulting flow of income benefits over a period of years enables the analyst to produce computations of present values and internal rates of return that summarise the whole investment process in a micro environment. In approaching an industry investment problem like mandatory hygiene regulations with benefits or costs to other entities involved, identifying the appropriate capital and maintenance costs and the industry and non-industry benefits is a giant task. In this paper, we report an attempt to identify the extra costs involved in the introduction of the regulations where industry recorded data is not available, and an attempt to identify industry and non-industry benefits from modelling market effects when countries impose restrictions on exports of NZ meat products. For the latter we employ the GTAP model and examine the saved costs to NZ when countries do not impose import restrictions on hygiene grounds. The problem involves consideration of private and public costs and benefits and the flow of costs and benefits when inadequate data is only available. Although our results are confined to average responses to the hygiene programme, they do give an indication of the overall necessity for embarking on such programmes in today's trading conditions.HACCP/RMP, Benefit Cost Analysis, Meat, New Zealand, Food Consumption/Nutrition/Food Safety, International Relations/Trade,

Explaining changes in external funds (Part one: Theory)

Capital Structure;finance

CDM: Current status and possibilities for reform

The Clean Development Mechanism (CDM) has seen a spectacular rise of activity since mid-2005 that has led to more than 400 project submissions with a combined estimated emission reduction volume of 570 million t CO2 eq. until the end of the commitment period. Several technologies have been mobilised in a large scale that had not been predicted to play any significant role. However, many observers continue to criticize the CDM Executive Board's handling of the project cycle and the lack of development benefits of CDM projects. Therefore, calls for CDM reform have gained strength. An analysis of the CDM project portfolio shows that Least Developed Countries and Africa have so far been sidelined. However, more small-scale projects have been submitted than expected from theoretical analyses of project cycle transaction cost, maybe due to high CER price expectations and a high share of unilateral projects. While developing country companies have been able to capture almost half of the CDM consultancy market, they have not made an inroad into validation and verification. The concentration of host countries has increased. Development benefits of CDM projects are often limited, especially of the large projects destroying industrial gases. The rejection rate of proposed methodologies remains stubbornly high but consolidation of methodologies simplifies document submissions. The time lag from submission of project documentation to registration has recently been falling. Additionality testing is a key element that also supports the development target of the CDM. --CDM,sustainable development,baselines,additionality,reform

Draft Regional Recommendations for the Pacific Northwest on Water Quality Trading

In March 2013, water quality agency staff from Idaho, Oregon, and Washington, U.S. EPA Region 10, Willamette Partnership, and The Freshwater Trust convened a working group for the first of a series of four interagency workshops on water quality trading in the Pacific Northwest. Facilitated by Willamette Partnership through a USDA-NRCS Conservation Innovation Grant, those who assembled over the subsequent eight months discussed and evaluated water quality trading policies, practices, and programs across the country in an effort to better understand and draw from EPA's January 13, 2003, Water Quality Trading Policy, and its 2007 Permit Writers' Toolkit, as well as existing state guidance and regulations on water quality trading. All documents presented at those conversations and meeting summaries are posted on the Willamette Partnership's website.The final product is intended to be a set of recommended practices for each state to consider as they develop water quality trading. The goals of this effort are to help ensure that water quality "trading programs" have the quality, credibility, and transparency necessary to be consistent with the "Clean Water Act" (CWA), its implementing regulations and state and local water quality laws

Success Factors in Peer-to-Business (P2B) Crowdlending: A Predictive Approach

Peer-to-Business (P2B) crowdlending is gaining importance among companies seeking funding. However, not all projects get the same take-up by the crowd. Thus, this study aims to determine the key factors that drive non-professional investors to choose a given loan in an online environment. To this purpose, we have analyzed 243 crowdlending campaigns on October.eu platform. We have obtained a series of variables from the analyzed loans using logistic regression. Results indicate that loan amount, loan term and overall credit rating are the key predictors of non-professional lender P2B crowdlending success. These findings may be useful for predicting whether the crowd will subscribe to a loan request or not. This information would help businesses to modify specific loan characteristics (if possible) to make their loans more attractive or could even lead companies to consider a different financial option. It could also help platforms select and adapt project parameters to secure their success

Systems Engineering Cost/Risk Analysis Capability Roadmap Progress Review

A viewgraph presentation on the cost/risk analysis capability of systems engineering is shown