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Front End Innovation is the starting point where opportunities are identified and concepts are developed prior to entering the formal product development process. Innovation on the Front End is where exciting breakthroughs are created through a process that allows for creativity and value creation in a systematic manner different from the formal development process. In the Front End, idea genesis, opportunity validation, and concept development are dynamic and consists of adaptive interactions between involved participants with varied skills
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Frugal innovation or frugal engineering is the process of reducing the complexity and cost of a good and its production. Usually this refers to removing nonessential features from a durable good, such as a car or telephone, in order to sell it in developing countries. Designing products for such countries may also call for an increase in durability and, when selling the products, reliance on unconventional distribution channels
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Gamestorming is a set of practices for facilitating innovation in the business world. A facilitator leads a group towards some goal by way of a game, a structured activity that provides scope for thinking freely, even playfully. The word gamestorming itself, as a neologism, is a portmanteau suggestive of using games for brainstorming
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Grassroots Innovation refers to the voluntary generation and development of innovations by any member of an organization, regardless of function or seniority. It is considered a form of bottom-up innovation (see Top-down and bottom-up design), whereby innovation resides 'deep in the bowels' of an organization, i. e
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The heroic theory of invention and scientific development is the view that the principal authors of inventions and scientific discoveries are unique heroic individuals—i. e. , "great scientists" or "geniuses"
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Hidden innovation or Invisible innovation refers to innovation that is not captured or recognised by traditional indicators such as research and development (R&D) spending or number of patents. The term generally refers to innovation that takes place outside science & technology sectors, which are the primary sectors which invest in formal R&D and patents. For example, although technological innovations are often developed in the oil & gas sector through oil exploration activities, these innovations are unaccounted for in innovation metrics because oil exploration is not counted as formal R&D
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In common usage and in philosophy, ideas are the results of thought. Also in philosophy, ideas can also be mental representational images of some object. Many philosophers have considered ideas to be a fundamental ontological category of being
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Ideation is the creative process of generating, developing, and communicating new ideas, where an idea is understood as a basic element of thought that can be either visual, concrete, or abstract. Ideation comprises all stages of a thought cycle, from innovation, to development, to actualization. Ideation can be conducted by individuals, organizations, or crowds
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Induced innovation is a microeconomic hypothesis first proposed in 1932 by John Hicks in his work The Theory of Wages. He proposed that "a change in the relative prices of the factors of production is itself a spur to invention, and to invention of a particular kind—directed to economizing the use of a factor which has become relatively expensive. " Considerable literature has been produced on this hypothesis, which is often presented in terms of the effects of wage increases as an encouragement to labor-saving innovation
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The innovation butterfly is a metaphor that describes how seemingly minor perturbations (disturbances or changes) to project plans in a system connecting markets, demand, product features, and a firm's capabilities can steer the project, or an entire portfolio of projects, down an irreversible path in terms of technology and market evolution. Origins The metaphor was developed by researchers Anderson and Joglekar. It was conceived as a specific instance of the more general 'butterfly effect' encountered in chaos theory
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An innovation competition is a method or process of the industrial process, product or business development. It is a form of social engineering, which focuses to the creation and elaboration of the best and sustainable ideas, coming from the best innovators. Innovation competition research There are few major works, like Terwiesch and Ulrich, who exclusively focus on innovation competitions
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Innovation economics is new, and growing field of economic theory and applied/experimental economics that emphasizes innovation and entrepreneurship. It comprises both the application of any type of innovations, especially technological, but not only, into economic use. In classical economics this is the application of customer new technology into economic use; but also it could refer to the field of innovation and experimental economics that refers the new economic science developments that may be considered innovative
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Innovation Intermediaries is a concept in innovation studies to help understand the role of firms, agencies and individuals that facilitate innovation by providing the bridging, brokering, knowledge transfer necessary to bring together the range of different organisations and knowledge needed to create successful innovation. The term open innovation intermediaries was used for this concept by Henry Chesbrough in his 2006 book as "companies that help other companies implement various facets of open innovation". Role Innovation intermediaries are variously described as 'bridgers', ' change agents', 'brokers'
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Innovation Journalism is journalism covering innovation. It covers innovation processes and innovation (eco)systems. In 2008, Innovation Journalism was listed by the World Economic Forum as one of seven key dimensions for discussing the redefinition of the media and its roles in a global, interconnected society
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Innovation leadership is a philosophy and technique that combines different leadership styles to influence employees to produce creative ideas, products, and services. The key role in the practice of innovation leadership is the innovation leader. Dr
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Innovation management is a combination of the management of innovation processes, and change management. It refers to product, business process, marketing and organizational innovation. Innovation management is the subject of ISO 56000 (formerly 50500) series standards being developed by ISO TC 279
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Innovation management measurement helps companies in understanding the current status of their innovation capabilities and practices. Throughout this control areas of strength and weakness are identified and the organizations get a clue where they have to concentrate on to maximize the future success of their innovation procedures. Furthermore, the measurement of innovation assists firms in fostering an innovation culture within the organization and in spreading the awareness of the importance of innovation
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Innovation skills are practically the types of skills that allow individuals to become innovative in what they do. These are usually a combination of cognitive skills (e. g
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The concept of the innovation system stresses that the flow of technology and information among people, enterprises, and institutions is key to an innovative process. It contains the interactions between the actors needed in order to turn an idea into a process, product, or service on the market. Development and diffusion of the concept Systems of Innovation are frameworks for understanding innovation which have become popular particularly among policy makers and innovation researchers first in Europe, but now anywhere in the world as in the 1990s the World Bank and other UN-affiliated institutions accepted
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The Innovator's Dilemma: When New Technologies Cause Great Firms to Fail, first published in 1997, is the best-known work of the Harvard professor and businessman Clayton Christensen. It expands on the concept of disruptive technologies, a term he coined in a 1995 article "Disruptive Technologies: Catching the Wave". It describes how large incumbent companies lose market share by listening to their customers and providing what appears to be the highest-value products, but new companies that serve low-value customers with poorly developed technology can improve that technology incrementally until it is good enough to quickly take market share from established business
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The International Innovation Index is a global index measuring the level of innovation of a country, produced jointly by The Boston Consulting Group (BCG), the National Association of Manufacturers (NAM), and The Manufacturing Institute (MI), the NAM's nonpartisan research affiliate. NAM describes it as the "largest and most comprehensive global index of its kind". The International Innovation Index is part of a large research study that looked at both the business outcomes of innovation and government's ability to encourage and support innovation through public policy
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Lateral thinking is a manner of solving problems using an indirect and creative approach via reasoning that is not immediately obvious. It involves ideas that may not be obtainable using only traditional step-by-step logic. The term was first used in 1967 by Maltese psychologist Edward de Bono in his book The Use of Lateral Thinking
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Lead market is a term used in innovation theory and denotes a country or region, which pioneers the successful adoption of an innovative design. It sends signalling effects to other "lag" markets, which in turn helps in triggering a process of global diffusion. Marian Beise, one of the foremost propounders of this theory as it has been understood so far, states: "Innovations that have been successful with local users in lead markets have a higher potential of becoming adopted world-wide than any other design preferred in other countries"
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The Linear Model of Innovation was an early model designed to understand the relationship of science and technology that begins with basic research that flows into applied research, development and diffusion It posits scientific research as the basis of innovation which eventually leads to economic growth. The model has been criticized by many scholars over decades of years. The majority of the criticisms pointed out its crudeness and limitations in capturing the sources, process, and effects of innovation
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Micro-SFP (µSFP) describes an ultra-short science-fiction story written for the specific purpose of capturing inventive ideas for product or service innovations. It is a combination of three concepts, first science-fiction prototyping (a methodology based on writing fictional stories to instantiate and test ideas for new products, businesses or political systems), second flash fiction (a genre that advocates writing stories as small as just 6 words) and finally, Twitter and texting (messaging and social networking in less than 140 / 160 characters). Roots As a tool to influence the future, µSFP has similarities to fables, parables, anecdotes, sayings, proverbs and maxims in that it seeks to capture and communicate an inspirational vision
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Convenient procedures, products and services are those intended to increase ease in accessibility, save resources (such as time, effort and energy) and decrease frustration. A modern convenience is a labor-saving device, service or substance which make a task easier or more efficient than a traditional method. Convenience is a relative concept, and depends on context
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The concept of multiple discovery (also known as simultaneous invention) is the hypothesis that most scientific discoveries and inventions are made independently and more or less simultaneously by multiple scientists and inventors. The concept of multiple discovery opposes a traditional view—the "heroic theory" of invention and discovery. Multiple discovery is analogous to convergent evolution in biological evolution
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The National Innovation System (also NIS, National System of Innovation) is the flow of technology and information among people, enterprises and institutions which is key to the innovative process on the national level. According to innovation system theory, innovation and technology development are results of a complex set of relationships among actors in the system, which includes enterprises, universities and government research institutes. Origins of term The term National System of Innovation originated when Christopher Freeman and Bengt-Åke Lundvall worked together in the late 1980s
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The New Age of Innovation: Driving Cocreated Value Through Global Networks (ISBN 9780071598286) is a book by University of Michigan Ross School of Business professors C. K. Prahalad and M
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The Normalization process model is a sociological model, developed by Carl R. May, that describes the adoption of new technologies in health care. The model provides framework for process evaluation using three components – actors, objects, and contexts – that are compared across four constructs: Interactional workability, relational integration, skill-set workability, and contextual integration
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Novelty (derived from Latin word novus for "new") is the quality of being new, or following from that, of being striking, original or unusual. Novelty may be the shared experience of a new cultural phenomenon or the subjective perception of an individual. From the meaning of being unusual usage is derived the concept of the novelty dance (a type of dance that is popular for being unusual or humorous); the novelty song (a musical item that capitalizes on something new, unusual, or a current fad); the novelty show (a competition or display in which exhibits or specimens are in way some novel); and novelty architecture (a building or other structure that is interesting because it has an amusing design)
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Open innovation is a term used to promote an information age mindset toward innovation that runs counter to the secrecy and silo mentality of traditional corporate research labs. The benefits and driving forces behind increased openness have been noted and discussed as far back as the 1960s, especially as it pertains to interfirm cooperation in R&D. Use of the term 'open innovation' in reference to the increasing embrace of external cooperation in a complex world has been promoted in particular by Henry Chesbrough, adjunct professor and faculty director of the Center for Open Innovation of the Haas School of Business at the University of California, and Maire Tecnimont Chair of Open Innovation at Luiss
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Outcome-Driven Innovation (ODI) is a strategy and innovation process developed by Anthony W. Ulwick. It is built around the theory that people buy products and services to get jobs done
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Pace of innovation is the speed at which technological innovation or advancement is occurring, with the most apparent instances being too slow or too rapid. Both these rates of innovation are extreme and therefore have effects on the people that get to use this technology. The factors that cause rapid pace of innovations include lack of trial and error, technological momentum, ease of entry into a field
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Participatory design (originally co-operative design, now often co-design) is an approach to design attempting to actively involve all stakeholders (e. g. employees, partners, customers, citizens, end users) in the design process to help ensure the result meets their needs and is usable
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Pavitt's Taxonomy categorizes mostly large industrial firms along trajectories of technological change according to sources of technology, requirements of the users, and appropriability regime (Pavitt 1984). The taxonomy aims to classify innovation modes according to different sectoral groups and the flow of knowledge between such groups. It was first proposed by SPRU researcher Keith Pavitt at the University of Sussex and has since been applied in innovation research to describe and categorize industries and the firms therein (Archibugi 2001)
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In diffusion of innovation theory, a pro-innovation bias is a belief that innovation should be adopted by the whole society without the need for its alteration. The innovation's "champion" has a such strong bias in favor of the innovation, that they may not see its limitations or weaknesses and continue to promote it nonetheless. Example A feeling of nuclear optimism emerged in the 1950s in which it was believed that all power generators in the future would be atomic in nature
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Progress is the movement towards a refined, improved, or otherwise desired state. In the context of progressivism, it refers to the proposition that advancements in technology, science, and social organization have resulted, and by extension will continue to result, in an improved human condition; the latter may happen as a result of direct human action, as in social enterprise or through activism, or as a natural part of sociocultural evolution. The concept of progress was introduced in the early-19th-century social theories, especially social evolution as described by Auguste Comte and Herbert Spencer
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In the study of innovation systems, a regional innovation system (RIS) encourages the rapid diffusion of knowledge, skills and best practice within a geographic area larger than a city, but smaller than a nation. The edge of a regional innovation system may be drawn conceptually and organizationally around the economic, social, political and institutional relationships that generate a collective learning process within a related group of technological or functional areas. A recent study has shown that innovation output is higher in regions where both a sizable population of small firms and large firms are present
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Research and development (R&D or R+D; known in Europe as research and technological development or RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existing ones. Research and development constitutes the first stage of development of a potential new service or the production process. R&D activities differ from institution to institution, with two primary models of an R&D department either staffed by engineers and tasked with directly developing new products, or staffed with industrial scientists and tasked with applied research in scientific or technological fields, which may facilitate future product development
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Schumpeterian rents are earned by innovators and occur during the period of time between the introduction of an innovation and its successful diffusion. It is expected that successful innovations, in time, will be imitated, but until that occurs, the innovator will earn Schumpeterian rents. They were named after economist Joseph Schumpeter, who saw profits made by businesses as resulting from the development of new processes which disturb economic equilibrium, temporarily raising revenues above their resource costs
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SWYP (See What You Print) is a printer concept developed by technology product design firm Artefact. The concept was released in 2011. It features simplified interactions and a touch screen that shows the user exactly what the print output will be
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The service blueprint is a technique originally used for service design, but has also found applications in diagnosing problems with operational efficiency. The technique was first described by G. Lynn Shostack, a bank executive, in the Harvard Business Review in 1984
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Service design is the activity of planning and arranging people, infrastructure, communication and material components of a service in order to improve its quality, and the interaction between the service provider and its users. Service design may function as a way to inform changes to an existing service or create a new service entirely. The purpose of service design methodologies is to establish the most effective practices for designing services, according to both the needs of users and the competencies and capabilities of service providers
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Service innovation is used to refer to many things. These include but not limited to: Innovation in services, in service products – new or improved service products (commodities or public services). Often this is contrasted with “technological innovation”, though service products can have technological elements
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A skunkworks project is a project developed by a relatively small and loosely structured group of people who research and develop a project, often with a very large degree of autonomy, primarily for the sake of radical innovation. The term originated with Lockheed's World War II Skunk Works project. Definition Everett Rogers defined skunkworks as an "enriched environment that is intended to help a small group of individuals design a new idea by escaping routine organizational procedures
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Social innovations are new social practices that aim to meet social needs in a better way than the existing solutions, resulting from - for example - working conditions, education, community development or health. These ideas are created with the goal of extending and strengthening civil society. Social innovation includes the social processes of innovation, such as open source methods and techniques and also the innovations which have a social purpose—like activism, crowdfunding, time-based currency, telehealth, cohousing, virtual volunteering, microcredit, or distance learning
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In the field of management, sticky information is information that is costly to acquire, transfer, and use in a new location. Eric von Hippel coined the term around 1994. Because of the importance of sticky, local information for some kinds of innovation and product customization, von Hippel suggests that in certain circumstances the innovation will be increasingly accomplished by end-users (user innovation) rather than an expert provider
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Strategic foresight is a planning-oriented discipline related to futures studies. In a business context, a more action-oriented approach has become well known as corporate foresight. Definition and idea Strategy is a high level plan to achieve one or more goals under conditions of uncertainty
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The success trap refers to business organizations that focus on the exploitation of their (historically successful) current business activities and as such neglect the need to explore new territory and enhance their long-term viability. Overview The success trap arises when a firm overemphasizes exploitation investments, even if explorative investments are required for successful adaptation. Exploitation draws on processes that serve to incrementally improve existing knowledge, while exploration involves the pursuit and acquisition of new knowledge
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The technical progress function is a concept developed by Nicholas Kaldor to explain the rate of growth of labour productivity, as a measure of technical progress. The function is described by the following statements: The larger the rate of growth of capital/input per worker, the larger the rate of growth of output per worker, of labour productivity. The rate of growth of labour productivity is thus explained by the rate of growth of capital intensity
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Technological innovation is an extended concept of innovation. While innovation is a rather well-defined concept, it has a broad meaning to many people, and especially numerous understanding in the academic and business world. Innovation refers to adding extra steps to developing new services and products in the marketplace or in the public that fulfill unaddressed needs or solve problems that were not in the past
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The concept of technological paradigm is commonly attributed to Giovanni Dosi. The concept is sometimes seen as performing a similar role to the concept of "scientific paradigms", as advanced by Thomas Kuhn. Contributions Giovanni Dosi The role of technological progress as an explanation of contemporary economic growth (S
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User innovation refers to innovation by intermediate users (e. g. user firms) or consumer users (individual end-users or user communities), rather than by suppliers (producers or manufacturers)
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Values-based innovation is a theoretical concept and managerial approach that “understands and applies individual, organisational, societal, and global values, and corresponding normative orientations as a basis for innovation”. It demonstrates the potential of values to integrate diverse stakeholders into innovation processes, to direct collaborative efforts, and to generate innovations with a positive impact on societal challenges. It elaborates upon the interrelations between innovation management, an established management practice and field of research, and values-based management, which is generally dealt with in business ethics and focuses on the ethical concerns related to corporate management
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A Virtual Customer Environment (VCE) is a web forum to facilitate customer co-innovation or user innovation. Customers can partner with companies in different phases of product (or service) innovation - in product ideation, in product design & development, in product testing, and in product diffusion. VCEs can be designed so as to facilitate these different customer co-innovation roles
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Obsolescence is the process of becoming antiquated, out of date, old-fashioned, no longer in general use, or no longer useful, or the condition of being in such a state. When used in a biological sense, it means imperfect or rudimentary when compared with the corresponding part of other organisms. The international standard IEC 62402:2019 Obsolescence Management defines obsolescence as the "transition from available to unavailable from the manufacturer in accordance with the original specification"
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Diminishing manufacturing sources and material shortages (DMSMS) or diminishing manufacturing sources (DMS) is defined as: "The loss or impending loss of manufacturers of items or suppliers of items or raw materials. " DMSMS and obsolescence are terms that are often used interchangeably. However, obsolescence refers to a lack of availability due to statutory or process changes and new designs, whereas DMSMS is a lack of sources or materials
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In economics and industrial design, planned obsolescence (also called built-in obsolescence or premature obsolescence) is a policy of planning or designing a product with an artificially limited useful life or a purposely frail design, so that it becomes obsolete after a certain pre-determined period of time upon which it decrementally functions or suddenly ceases to function, or might be perceived as unfashionable. The rationale behind this strategy is to generate long-term sales volume by reducing the time between repeat purchases (referred to as "shortening the replacement cycle"). It is the deliberate shortening of a lifespan of a product to force people to purchase functional replacements
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A free standard or libre standard is a standard whose specification is publicly available. The concept of Free/Libre standards emerged in the software industry as a reaction against closed de facto "standards" which served to reinforce monopolies. Users of a free standard have the same four freedoms associated with free software, and the freedom to participate in its development process
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An open file format is a file format for storing digital data, defined by an openly published specification usually maintained by a standards organization, and which can be used and implemented by anyone. An open file format is licensed with an open license. For example, an open format can be implemented by both proprietary and free and open-source software, using the typical software licenses used by each
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An open standard is a standard that is openly accessible and usable by anyone. It is also a common prerequisite that open standards use an open license that provides for extensibility. Typically, anybody can participate in their development due to their inherently open nature
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Open systems are computer systems that provide some combination of interoperability, portability, and open software standards. (It can also refer to specific installations that are configured to allow unrestricted access by people and/or other computers; this article does not discuss that meaning). The term was popularized in the early 1980s, mainly to describe systems based on Unix, especially in contrast to the more entrenched mainframes and minicomputers in use at that time
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House Flipper is a simulation game developed by Frozen District and published by PlayWay S. A. for macOS, Windows, PlayStation 4, Xbox One, and Nintendo Switch
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I Hate Running Backwards is a 2018 shoot 'em up game developed by Binx Interactive and published by Devolver Digital. One or two players traverse procedurally generated levels using several characters, including Sam "Serious" Stone, the protagonist of the Serious Sam series. The screen scrolls vertically as the player character runs backwards through a partially destructible environment and battles enemies approaching from the bottom of the screen
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Immortal: Unchained is an action role-playing game developed by Toadman Interactive and published by Game Odyssey for Windows, PlayStation 4, and Xbox One. The gameplay is inspired by the Dark Souls series with a focus on futuristic firearms, while the setting and plot are inspired by Norse mythology and the events of Ragnarok. Gameplay Immortal: Unchained is a third-person action game heavily inspired by the hardcore action role-playing game gameplay of the Dark Souls series, with a comparable difficulty level and many identical mechanics
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Infernax is a 2D Metroidvania developed by Berzerk Studio and published by The Arcade Crew. It was released on February 14, 2022, for Nintendo Switch, PlayStation 4, Windows, Xbox One, and Xbox Series X/S. The game follows the young Duke Alcedor, who finds his village overrun by monsters upon returning from the Crusades
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Inscryption is a roguelike deck-building game developed by Daniel Mullins Games and published by Devolver Digital. Inscryption was released for Windows on October 19, 2021. It was released on Linux and macOS on June 22, 2022, which was followed by PlayStation 4 and 5 versions in August
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Just Dance 2014 is a 2013 dance rhythm game developed by Ubisoft Paris, Ubisoft Milan, Ubisoft Reflections, Ubisoft Bucharest, Ubisoft Pune, Ubisoft Montpellier and Ubisoft Barcelona and published by Ubisoft. The fifth main installment of the Just Dance series, it was announced at Ubisoft's E3 2013 press event, and released for PlayStation 3, Xbox 360, Wii, and Wii U on 9 October 2013, and for PlayStation 4 and Xbox One as a launch title on 15 November and 22 November 2013 respectively. The game introduced several new features to the franchise, including expanded second screen support for Wii U and Xbox platforms, the ability to record and share video clips of gameplay on supported platforms, and online multiplayer through the "World Dance Floor" mode
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Just Dance 2020 is a 2019 dance rhythm game developed and published by Ubisoft. It was unveiled on June 10, 2019, during its E3 press conference as the eleventh main installment of the series, in celebration of the series' tenth anniversary, and released on November 5, 2019 for Nintendo Switch, Wii, PlayStation 4, Xbox One and Stadia. It was also the first game in the series to be released on Stadia
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Just Dance 2021 is a 2020 dance rhythm game developed and published by Ubisoft. It was unveiled on August 26, 2020 during the Nintendo Direct Mini: Partner Showcase August 2020 web presentation as the twelfth main installment of the series, and was released on November 12, 2020, for Nintendo Switch, PlayStation 4, Xbox One, and Stadia, and on November 24, 2020, for PlayStation 5 and Xbox Series X/S. It is the first game in the series since the initial title not to be announced at E3, due to the event's cancellation in 2020 as a result of the COVID-19 pandemic
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Just Dance 2022 is a 2021 dance rhythm game developed and published by Ubisoft. It was unveiled on June 12, 2021, during the Ubisoft Forward E3 web presentation as the thirteenth main installment of the series, and was released on November 4, 2021, for Nintendo Switch, PlayStation 4, PlayStation 5, Xbox One, Xbox Series X/S, and Stadia. This is the final installment released for PlayStation 4, Xbox One and Stadia (before its closure on January 18, 2023), the final installment to support PlayStation Move and camera devices and the last known game overall to support Kinect
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Resident Evil: Resistance is a 2020 survival horror game developed by NeoBards Entertainment and published by Capcom as the online component for Resident Evil 3. Released for PlayStation 4, Windows, and Xbox One, it involves four survivor players competing against a mastermind player who can create traps, enemies and other hazards. The game received mixed reviews from critics, who criticized the game for being unbalanced, having technical issues and for lacking dedicated servers
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Signs of the Sojourner is a roguelike deck-building game with role-playing story elements developed by Echodog Games. It was released for PCs on May 14, 2020, with additional console support arriving in March 2021. The game features a card-based puzzle game meant to evoke dialog and communication, with multiple endings based on your relationships and temperament
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Spirit of the North is a third-person adventure game developed by Infuse Studio and published by Merge Games. It was released on November 1, 2019 for PlayStation 4, then on May 7, 2020 for Windows and Nintendo Switch It was re-released as Spirit of the North: Enhanced Edition for PlayStation 5, Xbox One, and Xbox Series X/S on November 26, 2020 and June 29, 2021 respectively. The game contains no dialog or narrative, and is about a fox that gains the powers of a spirit after collapsing from exhaustion
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Star Renegades is a tactical role-playing game developed by Massive Damage and published in 2020 by Raw Fury. It combines influences from JRPGs and roguelite games. Gameplay Star Renegades combines influences from tactical role-playing games, roguelite games, and JRPGs
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Star Wars: Squadrons is a space combat game set in the Star Wars universe developed by Motive Studio and published by Electronic Arts. It was released for PlayStation 4, Windows, and Xbox One, on October 2, 2020 and for Xbox Series X/S on December 3, 2020. The game features both multiplayer game modes and a single-player campaign
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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard created by Steven Essery, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016
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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary standard for the application of risk management to medical devices. "Voluntary standards do not replace national laws, with which standards' users are understood to comply and which take precedence" over voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with IEC/SC62A through Joint Working Group one (JWG1)
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The Medical Device Radiocommunications Service (MedRadio) is a specification and communication spectrum created for and set aside by the U. S. Federal Communications Commission (FCC) for the communication needs of diagnostic and therapeutic medical implants and body-worn medical devices
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Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled. Consumers and health professionals report any adverse event caused by the device to MedWatch program for reporting significant adverse events or product problems with medical products. History Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices
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The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices — is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive
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A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements
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Patient management software (PMS) is referred to as software that is regulated as a medical device. It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient. It can also be software that is an adjunct to a medical device and directly contributes to the treatment of the patient by performing analysis, or providing treatment or diagnosis functionality that replaces the decision and judgment of a physician
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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017
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Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices. Changes compared to the IVDD include changes in device classification, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC), the requirement of UDI marking for devices, common specifications, Eudamed registration, and increased post-market surveillance activities
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Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs professionals (aka regulatory professionals) usually have responsibility for the following general areas: Ensuring that their companies comply with all of the regulations and laws pertaining to their business
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A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and regulations for CE-marked products. EU enforcement authorities may demand a copy of the technical file for many years after the last product was made
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Grady straps are a specific strapping configuration used in full body spinal immobilization. Background Spine trauma and immobilization Prehospital care providers, such as paramedics and Emergency Medical Technicians (EMTs), utilize various immobilization techniques as treatment and management of patients with definite or potential spinal trauma. Common mechanisms of spinal cord injury include motor vehicle crashes, motorcycle crashes, pedestrian-vehicle collisions, falls, blunt trauma, penetrating trauma, and diving accidents
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A litter is a stretcher designed to be used where there are physical obstacles that impair movement, including other hazards such as, in confined spaces, on slopes or uneven terrain, or in densely forested areas. Typically it is shaped to accommodate an adult in a face up position and it is used in search and rescue operations. The person is strapped into the basket, making safe evacuation possible
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The scoop stretcher (or clamshell, Roberson orthopedic stretcher, or just scoop) is a device used specifically for moving injured people. It is ideal for carrying casualties with possible spinal injuries. A scoop stretcher has a structure that can be split vertically into two parts, with shaped 'blades' towards the centre which can be brought together underneath a patient
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A spinal board, is a patient handling device used primarily in pre-hospital trauma care. It is designed to provide rigid support during movement of a person with suspected spinal or limb injuries. They are most commonly used by ambulance staff, as well as lifeguards and ski patrollers
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A stretcher, gurney, litter, or pram is an apparatus used for moving patients who require medical care. A basic type (cot or litter) must be carried by two or more people. A wheeled stretcher (known as a gurney, trolley, bed or cart) is often equipped with variable height frames, wheels, tracks, or skids
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Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. BIS monitors are used to supplement Guedel's classification system for determining depth of anesthesia. Titrating anesthetic agents to a specific bispectral index during general anesthesia in adults (and children over 1 year old) allows the anesthetist to adjust the amount of anesthetic agent to the needs of the patient, possibly resulting in a more rapid emergence from anesthesia
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A breathing system or breathing circuit is a medical device used to deliver oxygen, remove carbon dioxide, and deliver inhalational anaesthetic agents to a patient. Originally developed for use in anaesthesiology, many variants of breathing system are in clinical use, but most comprise a source of fresh gas flow, a length of breathing tubing to direct the gas, an adjustable pressure limiting valve to control pressure within the system and direct waste away, and a reservoir bag to allow assisted ventilation. Types There are many forms of breathing system, each having somewhat different mechanisms of action
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An bronchial blocker (also called endobronchial blocker) is a device which can be inserted down a tracheal tube after tracheal intubation so as to block off the right or left main bronchus of the lungs in order to be able to achieve a controlled one sided ventilation of the lungs in thoracic surgery. The lung tissue distal to the obstruction will collapse, thus allowing the surgeon's view and access to relevant structures within the thoracic cavity. Bronchial blockers are used to achieve lung separation and one lung ventilation as an alternative to double-lumen endotrachealtubes (DLT) and are the method of choice in children and paediatric patients for whom even the smallest DLTs might be too big
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A double-lumen endotracheal tube (also called double-lumen endobronchial tube or DLT) is a type of endotracheal tube which is used in tracheal intubation during thoracic surgery and other medical conditions to achieve selective, one-sided ventilation of either the right or the left lung. Indications There are several conditions that may make one-sided lung ventilation necessary. Absolute indications include separation of the right from the left lung to avoid spillage of blood or pus from an infected or bleeding side to the unaffected side
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Fresh gas flow refers to the mixture of medical gases and volatile anaesthetic agents which is produced by an anaesthetic machine. The flow rate and composition of the fresh gas flow is determined by the anaesthetist. Typically the fresh gas flow emerges from the common gas outlet, a specific outlet on the anaesthetic machine to which the breathing attachment is then connected
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A gas cabinet is a metallic enclosure which is used to provide local exhaust ventilation system for virtually all of the gases used or generated in the semiconductor, solar, MEMS, NANO, solar PV, manufacturing and other advanced technologies. The primary purpose of gas cabinets is to contain potential leaks in piping and fittings at the cylinder connection. The cabinet must be exhausted by a specifically designed fan and exhaust system
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A gas cylinder is a pressure vessel for storage and containment of gases at above atmospheric pressure. High-pressure gas cylinders are also called bottles. Inside the cylinder the stored contents may be in a state of compressed gas, vapor over liquid, supercritical fluid, or dissolved in a substrate material, depending on the physical characteristics of the contents
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