The Crowd, the Cloud and Improving the Future of Medical Device Innovation

2014 ◽  
Vol 17 (1) ◽  
pp. 13-20
Author(s):  
Marco Huesch ◽  
Robert Szczerba
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Business Models ◽  
Regulatory Environment ◽  
New Approach ◽  
Current State ◽  
Development Processes ◽  
Reducing Costs ◽  
Innovation Practices ◽  
Start Ups

Abstract Barriers and delays to medical device innovation are often solely attributable to the regulatory environment instead of both the current state of innovation practices and product development processes in the industry. Increasing the pace of innovation while reducing costs requires the creation of a new approach that fits both established medical device corporations as well as entrepreneurial start-ups. In this commentary we advance the concept of innovation platforms to facilitate ideation in the medical device space. Such platforms could also allow the full health benefits from individual medical devices to be reaped, by overcoming interoperability concerns through simulation and credentialing. Given the dramatic benefits of medical device success, such non-traditional business models for development may be potential solutions for industry, users and regulators.

scholarly journals Marketing authorization of medical devices in China

2016 ◽  
Vol 22 (1) ◽  
Author(s):  
Weifan Zhang ◽  
Rebecca Liu ◽  
Chris Chatwin
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Regulatory Environment ◽  
Doing Business ◽  
The Us ◽  
Research Gap ◽  
Business In China ◽  
China’S Economy

Medical device regulations across the globe have significant variations. The Chinese medical device market, like China’s economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

Developments in Rules of state registration of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 24-27
Author(s):  
Анфиса Миронова ◽  
Anfisa Mironova
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
Regulatory Environment ◽  
The Russian Federation ◽  
State Registration

This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.

The Legislation and Regulation of Medical Devices

2021 ◽  
pp. 177-194
Keyword(s):  
European Commission ◽  
Medical Devices ◽  
Product Safety ◽  
Regulatory Environment ◽  
New Approach ◽  
Legislative History ◽  
The Core ◽  
Regulatory Bodies ◽  
The Impact ◽  
The Eu

This chapter outlines the laws that govern the manufacture and supply of medical devices in the EU and UK, both multi-faceted and internationally well-regarded legislative regimes. It contextualises these laws within the broader framework of the EU’s new approach to product safety legislation, in which these medical devices regimes were established. It discusses the core principles and fundamental statutory concepts under the EU and UK legislation that have been reinforced and improved upon over forty years of legislative history. Recent legislative change and the impact of Brexit is discussed in detail in that regard. The chapter also describes the regulatory environment in which Europe’s substantial medical devices industry operates, an industry which is estimated by the European Commission in 2019 as being comprised of 500,000 different types of medical devices and worth €100 billion. An outline of key regulatory bodies and functions is also provided.

scholarly journals Economic Tendencies of the European and Latvian Medical Device Market

2020 ◽  
Vol 34 (1) ◽  
pp. 297-310
Author(s):  
Nadezhda Semjonova
Keyword(s):  
Human Capital ◽  
Medical Device ◽  
Medical Devices ◽  
Current Situation ◽  
Added Value ◽  
Limited Resources ◽  
Current State ◽  
Lack Of Information ◽  
Key Players ◽  
The Eu

Abstract Due to ageing of the population in developed counties and increase of the demand for the healthcare worldwide, the industry of medical devices (MD) becomes one of the fast-growing businesses. The present paper analyses the current state of the MD sector in Europe and in Latvia on the basis of the data obtained from open sources. Review of the current situation in the MD sector has demonstrated that the MD field still is and will remain an attractive sector of economics. The growth of the EU MD market by 3.5 % per year is sustainable. The market is highly innovative and leaves enough room for small and mediumsize enterprises that provide up to 95 % of all MD sector turnover. This indicates that MD sector manufactures products with high added value that make the sector attractive for countries with limited resources, such as Latvia. Although key players on the market do not changes much, example from Ireland demonstrates that investment in human capital is an important pre-requisite for country’s success in the MD sector. Unfortunately, the development of the MD industry in Latvia is very slow, the growth is around 0.7 % per year that may be explained just by inflation. There is also a lack of information on the Latvian MD industry both for professionals and society.

scholarly journals Classification and evaluation of medical devices

2003 ◽  
Vol 3 (2) ◽  
pp. 42-45
Author(s):  
Edina Vranić
Keyword(s):  
Health Care ◽  
Medical Care ◽  
Medical Device ◽  
Medical Devices ◽  
Public Interest ◽  
Response Times ◽  
Regulatory Environment ◽  
The Public ◽  
High Standards ◽  
Small Manufacturers

Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

Global trends in circulation of medical devices

2019 ◽  
Vol 2019 (3) ◽  
pp. 21-23 ◽  
Author(s):  
Елена Астапенко ◽  
Elena Astapenko ◽  
Анна КОРТОШКИНА ◽  
Anna KORTOShKINA
Keyword(s):  
Medical Device ◽  
Russian Federation ◽  
Medical Devices ◽  
International Medical ◽  
Regulatory Environment ◽  
Global Trends ◽  
Regulatory Aspects ◽  
The Russian Federation

The article presents main tendencies in development of the legal and regulatory environment in circulation of medical devices in world’s major states. The article depicts major developed in regulatory aspects in countries members of the International Medical Device Regulators Forum (IMDRF) that took place in the late 2018 – early 2019, which are important for subjects of circulation of medical devices which planning their activities not only in the Russian Federation territory, but also abroad.

scholarly journals Money for Nothing and Content for Free?

2020 ◽  
Author(s):  
Christian-Mathias Wellbrock ◽  
Christopher Buschow
Keyword(s):  
Willingness To Pay ◽  
Empirical Research ◽  
Business Models ◽  
Media Companies ◽  
Current State ◽  
Digital Business Models ◽  
Digital Journalism ◽  
Paid Content ◽  
Start Ups ◽  
Broad Overview

How can journalism be financed sustainably? This remains the key issue for media companies and news start-ups when they develop and establish digital business models. The authors of this book provide a broad overview of the current state of knowledge on paid content, platforms and the willingness to pay in the field of journalism, and present innovative perspectives on novel platform models as well as on the motives and needs of users of digital journalistic content. Based on empirical research, the book explores recommendations for the user-centred development of paid content as well as new perspectives on the willingness to pay in the field of digital journalism, both of which are relevant for academia and media practice.

The current state of the legislative implementation of criminal law policy

2020 ◽  
pp. 111-118
Author(s):  
Oleksandr Ostrohliad
Keyword(s):  
Law Enforcement ◽  
Criminal Code ◽  
Practical Significance ◽  
New Approach ◽  
Public Discussion ◽  
Current State ◽  
Criminal Offenses ◽  
Legal Technology ◽  
Logical Semantic

Purpose. The aim of the work is to consider the novelties of the legislative work, which provide for the concept and classification of criminal offenses in accordance with the current edition of the Criminal Code of Ukraine and the draft of the new Code developed by the working group and put up for public discussion. Point out the gaps in the current legislation and the need to revise individual rules of the project in this aspect. The methodology. The methodology includes a comprehensive analysis and generalization of the available scientific and theoretical material and the formulation of appropriate conclusions and recommendations. During the research, the following methods of scientific knowledge were used: terminological, logical-semantic, system-structural, logical-normative, comparative-historical. Results In the course of the study, it was determined that despite the fact that the amendments to the Criminal Code of Ukraine came into force in July of this year, their perfection, in terms of legal technology, raises many objections. On the basis of a comparative study, it was determined that the Draft Criminal Code of Ukraine needs further revision taking into account the opinions of experts in the process of public discussion. Originality. In the course of the study, it was established that the classification of criminal offenses proposed in the new edition of the Criminal Code of Ukraine does not stand up to criticism, since other elements of the classification appear in subsequent articles, which are not covered by the existing one. The draft Code, using a qualitatively new approach to this issue, retains the elements of the previous classification and has no practical significance in law enforcement. Practical significance. The results of the study can be used in law-making activities to improve the norms of the current Criminal Code, to classify criminal offenses, as well as to further improve the draft Criminal Code of Ukraine.

STUDY OF THE ORGANIZATION ADAPTIVITY RATE CORRELATION IN RELATION TO ITS INTERNAL INTEGRITY

2020 ◽  
Vol 3 (4) ◽  
pp. 292-304
Author(s):  
Inna O. Hordieieva ◽  
Valentina M. Molokanova
Keyword(s):  
Project Management ◽  
Stable State ◽  
Evolutionary Development ◽  
Current State ◽  
Modern Project ◽  
Development Processes ◽  
Methodological Principles ◽  
Internal Integration ◽  
Strategic Project ◽  
Rate Correlation

The focus of modern project management is increasingly shifting from the management of individual projects to the management of strategic project-oriented development of organizations. Now there is a need to pay more attention to project management as a universal tool for the development of systems at any level. The aim of the article is to study the processes of organization adaptation to constant changes through a synergetic portfolio of projects based on a strategic plan for the development and evolution of the organization. The spiral movement of systems development for studying development processes is considered: the process of transition of an organization from one stable state to another, the process of radical changes that accompanies innovation, as well as the processes of growth and development of crisis phenomena. The methodological principles of the organization evolutionary development management through the implementation of portfolio using its methods and tools are considered. It is proposed to manage the organization evolutionary development by building actions in the form of a synergistic portfolio of appropriate projects content, in order to increase the value of the entire portfolio of projects over the value of individual projects. The synergetic portfolio of projects is seen as a tool for a harmonious transition to the desired evolutionary state, by preserving the internal integrity of the organization and ensuring its sustainability. A mathematical model for estimating the desired properties and relations of the organizational synergetic portfolio of projects is proposed, which allows to determine and minimize the magnitude of the evolutionary goals inconsistency and to stabilize the current state of organization. It is determined that the two main tasks of any organization - external adaptation and internal integration - constantly push the organization to evolutionary development. The article proposes the author's approach to managing the organization evolutionary development through a portfolio of projects identifies indicators of adaptation of the organization to changes in the environment, defines the conditions for maintaining the integrity of the organization in the process of organizational changes.

Use of Business Models within Model Driven Architecture

2009 ◽  
Vol 38 (38) ◽  
pp. 119-130
Author(s):  
Erika Asnina
Keyword(s):  
Business Models ◽  
Business Processes ◽  
Use Cases ◽  
Separation Of Concerns ◽  
Model Driven Architecture ◽  
Model Driven ◽  
Development Processes ◽  
Business Requirements ◽  
Complex Computer ◽  
Independent Model

Use of Business Models within Model Driven Architecture Model Driven Architecture is a framework dedicated for development of large and complex computer systems. It states and implements the principle of architectural separation of concerns. This means that a system can be modeled from three different but related to each other viewpoints. The viewpoint discussed in this paper is a Computation Independent one. MDA specification states that a model that shows a system from this viewpoint is a business model. Taking into account transformations foreseen by MDA, it should be useful for automation of software development processes. This paper discusses an essence of the Computation Independent Model (CIM) and the place of business models in the computation independent modeling. This paper considers four types of business models, namely, SBVR, BPMN, use cases and Topological Functioning Model (TFM). Business persons use SBVR to define business vocabularies and business rules of the existing and planned domains, BPMN to define business processes of both existing and planned domains, and use cases to define business requirements to the planned domain. The TFM is used to define functionality of both existing and planned domains. This paper discusses their capabilities to be used as complete CIMs with formally defined conformity between planned and existing domains.

Sign in / Sign up

Export Citation Format

Share Document