Key Recommendations from the MedtecHTA Project

There are particular characteristics ofMedical Devices, such as the device–user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for health technology assessment (HTA). The project explored key aspects of the conduct andmethods ofHTAforMDs. Systematic reviews and original research studieswere conducted todetermine improvements inprocesses andmethods that could enhance the potential forHTAand optimize the diffusion ofMDs. Regulatory processes for MDs should be more closely aligned, the HTA evaluative framework should be harmonized and processes for conditional coverage and evidence development should be used. The methods for HTA should consider MDs as complex interventions, require the establishment of high quality registries, consider an iterative approach to the evaluation over time, recognize and allow for the particular characteristics of devices and use appropriate approaches for confounder adjustment in comparative effectiveness studies. To optimize the diffusion, a common classification should be developed across countries in order to facilitate international comparisons, factors driving diffusion should be explored in HTA reports and physiciansˈ personal goals and motivation should be better understood. The key recommendations of the MedtecHTA project should improve the conduct and use of HTA for MDs

The Competitiveness of Bread: the Analysis and the Ways to Improve

In the article the essence of competitive products was examined and the conclusion based on research connected with search of improvement the competitiveness of bread on the example of Novopolotsk mechanized bakery was made

The Competitiveness of Bread: the Analysis and the Ways to Improve

In the article the essence of competitive products was examined and the conclusion based on research connected with search of improvement the competitiveness of bread on the example of Novopolotsk mechanized bakery was made

World University Rankings as a Method of Analysis the University Competitiveness

The article is devoted to the analysis of world rankings, where Polotsk State University is represented, and contains recommendations for increasing the competitive positions of PSU in the research rankings

Integration Definition for Function Modelling of Business Processes (IDEF0) in Logistics

The article is devoted to the idea of IDEF0 (Icam Definition for Function modelling). It is a function modelling methodology for describing manufacturing functions, which offers a function modelling language for the analysis, development, re-engineering, and integration of information systems, logistics processes, and software engineering analysis

Health technology assessment of medical devices: a survey of non-European union agencies.

PublishedJournal ArticleResearch Support, Non-U.S. Gov'tThis is the final version of the article. Available from Cambridge University Press via the DOI in this record.OBJECTIVES: The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. METHODS: HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies. RESULTS: In total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices. CONCLUSIONS: The lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.This study was supported by a research grant from the European Community’s Seventh Framework Program (FP7 - HEALTH Grant Agreement no. 305694). The sponsor had no role in the study design, collection and analysis of data, writing of the report, or submission of the paper for publication. The authors wish to thank all interviewees and agencies’ assessment forms verifiers for their invaluable contribution to the completion of this study

Integration Definition for Function Modelling of Business Processes (IDEF0) in Logistics

The article is devoted to the idea of IDEF0 (Icam Definition for Function modelling). It is a function modelling methodology for describing manufacturing functions, which offers a function modelling language for the analysis, development, re-engineering, and integration of information systems, logistics processes, and software engineering analysis

ВЗАИМОСВЯЗЬ ОСОБЕННОСТЕЙ ЭКОЛОГИИ И БИОЛОГИИ ВИДА У ТЛЕЙ С ВАРИАБЕЛЬНОСТЬЮ МИТОХОНДРИАЛЬНЫХ ГЕНОВ

The results of comparative analysis of genetic variability of COI, COII, and cyt b genes in aphids (Aphidoidea), which differ in ecology and a type of life cycle, are shown in the paper. It is found out that species being anolocyclic polyphagous with subcosmopolite distribution have the highest level of genetic variability of COI and cyt b nucleotide sequences comparing to aphids from other ecological and biological groups.В работе приведены результаты сравнительного анализа вариабельности нуклеотидных последовательностей генов COI, COII и cyt b у тлей (Aphidoidea) из разных экологических групп, а также реализующих различные варианты биологических циклов. Показано, что виды, относящиеся к полифагам с субкосмополитным распространением, являющиеся анолоцикличными на большей части ареала, демонстрируют наибольший уровень вариабельности последовательности генов COI, cyt b в сравнении с тлями из других эколого-биологических групп.

Challenges in the assessment of medical devices: the MedtecHTA project

Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device–operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing. The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs. This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project