This paper addresses the question of how Responsible Research and Innovation (RRI) can be implemented in Small and Medium-Sized Enterprises (SMEs). It builds on existing knowledge about RRI in business as well as on insights into motivations, drivers and barriers from the related fields of eco-innovation and sustainability innovation. Expert interviews with CEOs of SMEs in the Austrian medical device sector are analyzed to develop insights into the companies' research and innovation activities and potential drivers and barriers for RRI. The findings support the assumption that SMEs are largely unaware of the RRI concept. At the same time, however, it is possible to identify current practices that already operationalize aspects of RRI. It is argued that SMEs could build upon existing practices to further develop ways of being responsible and that implementation of RRI should be in line with specific organizational and contextual factors.

The introduction of the diploma thesis contains basic concepts of testing of plastic moulded products and their general characteristics essential for use in the medical device industry. In the following theoretical part there is described the methodology of practical testing techniques used by Phillips Medisize CZ company. At the closing part of the diploma thesis there is made a summary of the testing methods, their evaluation and potential proposals for improvement of the applied methodology.

abstract: New technologies enable the exploration of space, high-fidelity defense systems, lighting fast intercontinental communication systems as well as medical technologies that extend and improve patient lives. The basis for these technologies is high reliability electronics devised to meet stringent design goals and to operate consistently for many years deployed in the field. An on-going concern for engineers is the consequences of ionizing radiation exposure, specifically total dose effects. For many of the different applications, there is a likelihood of exposure to radiation, which can result in device degradation and potentially failure. While the total dose effects and the resulting degradation are a well-studied field and methodologies to help mitigate degradation have been developed, there is still a need for simulation techniques to help designers understand total dose effects within their design. To that end, the work presented here details simulation techniques to analyze as well as predict the total dose response of a circuit. In this dissertation the total dose effects are broken into two sub-categories, intra-device and inter-device effects in CMOS technology. Intra-device effects degrade the performance of both n-channel and p-channel transistors, while inter-device effects result in loss of device isolation. In this work, multiple case studies are presented for which total dose degradation is of concern. Through the simulation techniques, the individual device and circuit responses are modeled post-irradiation. The use of these simulation techniques by circuit designers allow predictive simulation of total dose effects, allowing focused design changes to be implemented to increase radiation tolerance of high reliability electronics. / Dissertation/Thesis / Ph.D. Electrical Engineering 2014

Orientador: José Wilson Magalhães Bassani / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Engenharia Elétrica e de Computação / Made available in DSpace on 2018-08-16T06:37:49Z (GMT). No. of bitstreams: 1 Silveira_AnaCarolina_M.pdf: 689842 bytes, checksum: 93f964c598955647fad2133fc52a9802 (MD5) Previous issue date: 2010 / Resumo: Neste trabalho foi descrito o desenvolvimento e a aplicação de um método para classificação de equipamentos médicos considerando dados de manutenção corretiva. O método foi desenvolvido para auxiliar os engenheiros clínicos no gerenciamento das tecnologias médicas. Os três indicadores utilizados foram tempo gasto com manutenção corretiva (TMc), custo de manutenção corretiva ($Mc) e número de manutenções corretivas (NCc). Os indicadores foram obtidos da base de dados do Centro de Engenharia Biomédica (CEB) da Universidade Estadual de Campinas (UNICAMP) no período de 2004 a 2006. Foram estudados os seguintes grupos de equipamentos: 1) Bomba de infusão tipo seringa; 2) Bomba de infusão de uso geral; 3) Monitores cardíacos e multiparamétricos; 4) Ventiladores pulmonares e 5) grupo heterogêneo composto por diferentes grupos de equipamentos, participando todos dos grupos de 1 a 5, incluindo aparelhos de anestesia, unidades eletrocirúrgicas e desfibriladores/cardioversores. O método baseia-se na hipótese de que a idade do equipamento é um fator determinante para o aumento dos três indicadores estudados. Os resultados confirmam essa hipótese e a classificação revelou diferenças importantes entre marcas/modelos dos equipamentos de um determinado grupo. Além disso, o método mostrou-se aplicável para grupos homogêneos ou heterogêneos de equipamentos. A classificação proposta pode ser utilizada na gestão de equipamentos médicos, gerando alertas que contribuam para a tomada de decisão pelo engenheiro clínico e a fiscalização por parte de agências reguladoras governamentais. / Abstract: This work describes the development and implementation of a method for classification of medical devices based on corrective maintenance data. The method was developed to assist clinical engineers in the management of medical technologies. The three indicators used were time spent on corrective maintenance (TMc), cost of corrective maintenance ($Mc) and number of corrective maintenance events (NCc). Indicators were obtained from the database of the Center for Biomedical Engineering (CEB), Universidade Estadual de Campinas (UNICAMP) from 2004 to 2006. The following groups of medical devices were studied: 1) syringe infusion pump; 2) general use infusion pump; 3) multiparametric and cardiac monitors; 4) lung ventilators and 5) heterogeneous group composed of different types of equipment, all from groups 1 to 5 plus, anesthesia machines, electrosurgical units and defibrillator / cardioverter. The method relies on the hypothesis that equipment age is a determining factor for the increase of the three indicators studied. The results confirmed this hypothesis, and the classification revealed important differences among brands/models of equipment of a given group. Moreover, it was shown to be possible to apply this method for both homogeneous and heterogeneous groups of equipment. The proposed classification may be used in the management of medical equipment, generating alerts that may contribute to decision making by local clinical engineering teams and government regulatory agencies. / Mestrado / Engenharia Biomedica / Mestre em Engenharia Elétrica

O objetivo geral do estudo proposto é analisar a terminologia presente em manuais de empresas fabricantes de equipamentos médicos utilizados nas Unidades de Terapia Intensiva UTIs, cujo tema foi definido em parceria com os especialistas do Grupo de Engenharia Biomédica da UNIFEI. Primeiramente, levantamos a lista dos equipamentos médicos utilizados em UTIs, com o auxílio dos especialistas, e formamos um corpus de estudo. Verificamos a existência de possíveis variantes denominativas no corpus constituído e, posteriormente, analisamos as relações semânticas estabelecidas entre os termos validados. A identificação e a extração dos termos presentes nos manuais foram realizadas por meio da plataforma Terminus, desenvolvida pelo Grupo IULATERM, do Institut Universitari de Lingüística Aplicada da Universitat Pompeu Fabra. A partir dos dados coletados, pudemos verificar a existência de muitas variantes e propusemos uma análise das relações semânticas existentes entre eles. Para esta pesquisa, adotamos a perspectiva teórica veiculada pela Teoria Comunicativa da Terminologia TCT, que considera que as unidades terminológicas são parte da língua geral e apresentam as mesmas características desta, comportando variações denominativas e outros fenômenos. / The overall goal of the proposed study is to analyze the terminology used in manuals of manufacturers of medical equipment used in Intensive Care Units ICUs, theme established in partnership with UNIFEI´s Group of Experts on Biomedical Engineering. First, with the support from experts, a list of medical devices used in ICUs was raised and a study corpus generated. We searched possible denominational variants in the constituted corpus and then analyzed the semantic relations between the validated terms. The identification and extraction of these terms from the manuals were made by the Terminus platform developed by IULATERM Group, Institute for Applied Linguistics at Universitat Pompeu Fabra. From the data collected, we could confirm the existence of many variants and, therefore, propose an analysis of the semantic relationships among them. For this research, we adopted the theoretical perspective conveyed by the Communicative Theory of Terminology, which considers that the terminological units are part of the general language and have the same characteristics, comprising denominational variations and other phenomena.

No contexto da especificidade da urbanização brasileira, onde as cidades crescem simultaneamente às formas de trabalho com capitais reduzidos e tecnologias menos modernas, nossa pesquisa analisa o território usado por diferentes agentes do sistema produtivo de equipamentos médicohospitalares no Estado de São Paulo, atentando para as diferentes divisões do trabalho existentes na forma dos circuitos da economia urbana. Valorizado de forma seletiva, o meio construído permite que atividades mais e menos rentáveis se instalem, enquanto a coexistência de divisões do trabalho que datam de diferentes épocas assegura uma dinâmica interdependente entre os circuitos da economia urbana. Neste sentido, discutimos a existência de um circuito superior marginal ligado às atividades de produção de equipamentos médicohospitalares em Campinas, Ribeirão Preto e São José do Rio Preto (SP) e o papel complementar que este cumpre para os serviços de saúde do país. / In the context of the specificity of Brazilian urbanization, where simultaneous with the growth of the cities, the types of work with reduced capital and less modern technologies also grow, our research analyses the territory used by different agents of the medicalhospital equipments production system in the state of São Paulo, looking at the different divisions of labor, existing in ways of the circuits of urban economy. Valued in a selective way, the environment building allows installation of more or less profitable activities, while the coexistence of divisions of labor of different ages ensures an interdependent dynamic among the circuits of the urban economy. In this way, we discuss the existence of a marginal upper circuit related to the medicalhospital equipments production in Campinas, Ribeirão Preto e São José do Rio Preto (SP) and its complementary function that it accomplishes for the brazilian health services.

Dentro das exigências restritivas visando à mitigação de danos ambientais, várias ações estão sendo tomadas em termos mundiais, destacando-se os países onde a mobilização social e tomadas de decisão são mais efetivas. Entre estas ações as diretivas RoHS e WEEE, ambas da comunidade européia, destacam-se como interessantes procedimentos que se somam para a prevenção do uso de substâncias tóxicas e redução de emissão ao meio ambiente de resíduos sólidos de eletrônicos após o uso. Atualmente, em termos mundiais, não se observa o uso de tais procedimentos no que tange aos equipamentos eletromédicos após o término de vida útil e descarte. Este trabalho faz um estudo de ambas diretivas utilizando-se um equipamento eletromédico de fabricação nacional, um eletroestimulador. O equipamento foi criteriosamente desmontado e seus componentes classificados com base em sua classe de material e composição química. Após a desmontar e catalogar os componentes quanto à classe de materiais e composição química, foram sugeridos alguns procedimentos. Para atender a diretiva RoHS, a substituição de metais pesados presentes na liga utilizada na soldagem dos componentes eletrônicos. Para atender a diretiva WEEE, o processamento de resíduo de placa de circuito impresso inertizado em vidro. Deste modo verifica-se que os procedimentos adotados para cumprir com as duas diretivas européias foram adequados para os equipamentos eletromédicos tanto de fabricação nacional como internacional. / Within the restrictive requirements aimed at mitigating environmental damage, several actions being taken globally, highlighting the countries where social mobilization and decision making are more effective. Among these actions the RoHS and WEEE, of the European community, stand out as interesting procedures that are in addition to preventing the use of toxic chemicals and reducing emissions to the environment of electronic waste after use. Today, in the world is unusually such procedures with respect to electrical equipment after the end of useful life and its disposal. This work is a study of both using an electromedical equipment manufactured in Brazil, an electrostimutator. The equipment was carefully dismantled and its components classified based on their specific device and chemical composition. After removing and cataloging the components of the different kind of materials and chemical composition, suggested some procedures. To meet the RoHS directive, the replacement of nocive metals in the alloy used in soldering of electronic components. To meet the WEEE directive, the processing of waste printed circuit board inerted glass. Thus it appears that the procedures adopted to comply with two European directives were adequate for the electrical equipment manufacturing both domestically and internationally.

Les plastifiants des dispositifs médicaux stériles (DMS) en PVC souple tels que les tubulures de perfusion ou de nutritionartificielle peuvent migrer vers les liquides de perfusion et ainsi atteindre le patient. Le DEHP (diéthylhexylphtalate) était leprincipal plastifiant utilisé dans ces DMS jusqu’en 2010. Depuis la mise en exergue de sa reprotoxicité, sa classification ensubstance CMR1b et avec sa future interdiction dans les tubulures des services de réanimation néonatale (Loi n° 2012-1442 du 24 décembre 2012), les industriels du DMS ont substitué le DEHP par des plastifiants alternatifs tels que leTOTM*, le DINP*, le DINCH*, le DEHA*, le DEHT* ou encore l’ATBC*. Il est cependant aujourd’hui impossible d’attester del’innocuité de ces molécules via les DMS étant donné le peu d’études de migration réalisées dans les conditions cliniquesd’utilisation, notamment dans les situations médicales à risque telles que la perfusion, la nutrition, l’ECMO (ExtracorporealMembrane Oxygenation), la CEC (Circulation ExtraCorporelle) en chirurgie cardiaque ou l’hémodialyse. L’objectif de cettethèse est d’étudier cette migration, afin d’évaluer le risque d’exposition à ces plastifiants lors de l’utilisation des DMS enpratique clinique. Notre travail bibliographique préliminaire nous a permis d’identifier les techniques analytiques les plusadaptées à la quantification des plastifiants au sein des DMS (méthodes directes ou indirectes associées à une phased’extraction préalable), celles comme la GC (Gas Chromatography) et la LC (Liquid Chromatography), à privilégier pour leuranalyse dans les solutions en contact, médicaments ou simulants et les techniques de pointe très sensibles (LC/MS-MS)(Liquid chromatography coupled to tandem mass spectrometry) utiles pour détecter et quantifier les plastifiants et leursmétabolites présents à des taux très faibles dans des matrices complexes comme les liquides biologiques.Notre analyse des résultats de premiers tests de migration réalisés dans des conditions standardisées adaptées de laméthodologie alimentaire montrent que les plastifiants ont des capacités migratoires variables, qui sont 20 fois et 3 foismoins élevées pour le TOTM et le DEHT respectivement par rapport au DEHP. Quant au DINCH, il migre en proportionsidentiques au phtalate après 24 heures de contact. Ces résultats ont servi de base à l’élaboration d’un modèle de migrationin vitro en situations de perfusion et de nutrition, représentatif des conditions cliniques de worst case. Dans ce modèle,validé par un groupe d’experts pluridisciplinaire, le postulat adulte clinique s’établit ainsi : « 1 patient de 60kg estsusceptible de recevoir chaque jour 2L de médicaments perfusés au moyen de 10 dm2 de tubulure ». Ce modèle servirapour le montage des premiers tests in vitro. En parallèle, le revêtement hybride organique/inorganique déposé par dipcoatingà la surface du PVC permet une bonne protection vis-à-vis du relargage des plastifiants, de l’ordre de 80% sur 48hde contact mais protège encore insuffisamment le PVC de l’absorption de médicaments comme le diazépam ou le dinitrateisosorbide, dont la perte n’est diminuée que de 53% et de 45% respectivement. Il s’agit d’une innovation intéressante,mais dont l’optimisation est nécessaire pour garantir une gestion des risques relatifs aux DMS en PVC plastifié. / Plasticizers in medical devices (MD) made of flexible PVC, such as infusion sets of nutrition tubings, are able to migrate into infused solutions and so come in contact with the patient. DEHP (diethylhexylphtalate) was the main plasticizer used in these MD up until 2010. It has been shown to be reprotoxic has been classified as CMR1b chemical and is soon to be banned from tubings used in neonatalogy, and therefore MD’s manufacturers have replaced DEHP by alternative plasticizers named TOTM*, DINP*, DINCH*, DEHA*, DEHT* or ATBC*. However, it is impossible to ascertain that these new plasticizers are harmless because of the lack of migration studies conducted in clinical situations in which MD are used, particularly in « at risk situations » such as infusion, nutrition, ECMO (Extracorporeal Membrane Oxygenation), ECC (Extracoporeal Circulation) in cardiac surgery and haemodialysis. The aim of this thesis is to study this migration, in order to evaluate the risk of exposure to these plasticizers, during clinical practice. Our preliminary bibliographic review allowed us to identify the most appropriate analytical methods to quantify the plasticizers in the MD matrix (direct methods or indirect methods requiring an extraction step), techniques such as GC (Gas Chromatography) and LC (Liquid Chromatography) suitable for the analysis of plasticizers in solutions, drugs or simulants in contact with, and sensitive advanced techniques such as (LC/MS-MS) (Liquid chromatography coupled to tandem mass spectrometry) which are useful to detect and to quantify the plasticizers and their metabolites at trace levels in complex matrices like body fluids.The results of preliminary migration tests carried out in standardized conditions adapted from agrifood methodology show that the plasticizers have different migration abilities, which are 20 times and 3 times lower for TOTM and DEHT compared to DEHP. As regards DINCH, it does release as much as DEHP does after 24 hours of contact. These results formed the basis for the development of an in vitro migration model for infusion and nutrition situations, reflecting a worst case scenario. In this model, which has been validated by a pluridisciplinary task force, the clinical assumption is as follows: « A 60kg-patient is likely to get two litres of infused drugs via 10 dm2 of tubing in flexible PVC ». This model will be used to make the first tests in vitro. At the same time, an inorganic/organic hybrid coating deposited on the PVC surface by dip-coating provides a good protection against the release of the plasticizers, at a level of about 80% during 48 hours of contact, but is insufficient to protect PVC from drug sorption such as diazepam or isosobide dinitrate, which loss is reduced by only 53% and 45% respectively. It is an attractive innovation but has to be necessarily optimized to ensure a risk management concerning MD in flexible PVC.This thesis is part of tasks 1 and 2 of the ARMED research project (Assessment and Risk Management of Medical devices in PolyvinylChloride), directed by Pr Valérie Sautou, and which has received the financial support of the French Medicine Agency (ANSM, Agence Nationale de Sécurité du Médicament et des Produits de Santé) in the framework of call of research proposals in 2012.

Au cours de l’administration simultanée de plusieurs médicaments injectables, sont utilisées une ligne principale de perfusion et une ou plusieurs ligne(s) en dérivation. La ligne principale est directement reliée au cathéter et permet l’administration des solutions utilisées pour l’apport hydro-électrolytique ou de maintenir une voie d’abord veineuse perméable. Les autres thérapeutiques vont être perfusées en dérivation de cette ligne principale. La prise en charge des patients relevant de soins intensifs et de réanimation nécessite une polymédication. Les traitements d’urgence impliquent majoritairement des médicaments à marge thérapeutique étroite. Lors de l’administration de médicaments en solutions concentrées, de faibles perturbations du débit d’administration peuvent engendrer de fortes perturbations cliniques et notamment, pour les médicaments vasoactifs, créer une instabilité hémodynamique. C’est pourquoi il est important d’étudier la problématique de la perfusion simultanée, de déterminer l’impact sur le débit massique des lignes de perfusion et la technique optimale des changements de seringues pour prévenir les variations intempestives du débit de perfusion. Ce mémoire présente un travail de développement et d’évaluation d’une démarche d’optimisation d’un système de perfusion complexe. Il consiste à étudier au travers d’évaluations in vitro et d’études cliniques la conception d’une ligne de perfusion en évaluant notamment un dispositif médical innovant afin de proposer, in fine, une solution applicable dans un service de soins intensifs. La première partie consiste à présenter l’ensemble des dispositifs médicaux de perfusion utilisés dans un département d’anesthésie-réanimation. La seconde partie s’intéresse à l’administration d’un médicament couramment perfusé sur la voie proximale: la noradrénaline. Les études in vitro, corroborées par des données cliniques, ont permis de montrer la supériorité de l’administration de noradrénaline à 0,5 mg/mL perfusée en Y avec une solution saline isotonique à débit fixe de 5 mL/h. Cette multiperfusion fait intervenir l’utilisation d’un prolongateur trois voies à faible volume résiduel, permettant d’optimiser les conditions de relais de seringues, connues comme étant à l’origine d’instabilités hémodynamiques chez les patients traités par catécholamines. Un programme hospitalier de recherche clinique interrégional est déposé dans le but d’établir des recommandations de perfusion des catécholamines.La troisième partie aborde l’administration des médicaments sur voie distale en sélectionnant l’insuline comme marqueur-médicament. Les résultats de cette étude clinique prospective randomisée contrôlée ont montré que l’utilisation d’un dispositif médical innovant, le dispositif Edelvaiss-Multiline 8 (Doran International) caractérisé par un tube multilumières à faible volume résiduel qui permet de dédier une voie à une seule thérapeutique, permettait de réduire significativement le temps passé en hypoglycémie pour 1000 heures de perfusion d’insuline au cours de perfusion continue d’insuline en soins intensifs périopératoires.Enfin, dans une dernière partie, les critères clés d’un montage optimisé de multiperfusion sont élaborés et sont mis en application dans un département d’anesthésie-réanimation dans le but d’optimiser et uniformiser la ligne de perfusion des patients. Ce travail a permis de valider les caractéristiques clés de la ligne de perfusion définis dans de précédentes études non cliniques : la nature du matériau des dispositifs médicaux utilisés, l’utilisation de valves appropriées, la minimisation des volumes internes des tubulures de perfusion, l’utilisation de systèmes de perfusion automatisés permettant de contrôler au mieux le débit d’administration des médicaments. / For the simultaneous administration of injectable drugs, the infusion line includes a main line with one or several derivative lines. The main line, which is directly connected to the catheter, is dedicated to hydration infusion or to maintain a permeable vein. Other medications will be added on the derivative lines.Intensive care unit patients frequently require lots of medications in the same time. Most of emergency drugs are substances with narrow therapeutic range. When concentrated solutions are employed, tiny mass flow rate disturbances can provoke clinical damages, such as haemodynamic instability. So, several parameters have been studied on simultaneous infusions: mass flow rate and syringes changeovers.The purpose of this work was to develop and optimize complex infusion line systems. An innovative infusion medical device has been evaluated in clinical trials and in vitro studies. The final objective was to design an optimized infusion line, which could be applied to ICUs.The whole medical devices used in ICUs was first listed. Then, noradrenaline has been used as the reference drug to study central venous catheter proximal line. A 0.5 mg/mL noradrenaline solution Y-infused with a saline (5mL/h) has been shown by clinical and in vitro data to be the best solution. Nevertheless, this conclusion was valid only with the use of a very low dead-space volume Y-extension set. Thanks to this device, syringe changeovers optimization is possible.The central venous catheter distal line has been studied in a second time through an open randomized controlled prospective clinical trial. Primary endpoint of the study was the impact of two different insulin infusion lines (Edelvaiss-Multiline 8, Doran International versus standard line) on glycaemic variability. Doran’s innovative device consists of an exten¬sion set with eight accesses connected to nine separated lumens in a single tube. This allows to dedicate an isolated way for insulin. With its use, a significant decrease of hypoglycaemia occurring in 1000h of infusion period was clinically demonstrated. Finally, all the data were synthetized to optimize an ICU multi-infusion line. The one, which has been designed for surgery and intensive care units, was tested on patients.To conclude, items responsible for mass flow rate disturbances have been identified: medical devices material, addition of appropriated valves, internal volume line minimization and use of automated infusion systems (as pumps). The ideal infusion line has to take into account all these parameters.

Following the studies of technology trajectories, Christiansen (1997) coined the concept of disruptive innovation to shed more light on the pattern of discontinuous innovations which were introducing new performance values to the market and mostly led to create a new market. Following his studies there have been a huge amount of scholars who have tried to elucidate the concept of disruptive innovations from different points of views. Among all of these studies, there are few researches about the dynamic of disruptive innovations diffusion in the market while most of the studies have focused on the concept itself. According to Porter (2008) the dynamic of market competition has been totally changed over the past decade and survivance of incumbents in the market mostly depends on their capability to innovate disruptively and keep their dominancy by radical or incremental improvements. Considering the desire of incumbents to set a dominant position in today’s fast growing markets, getting the ultimate benefits of disruptive innovations has become a disputable issue. Therefore, focusing on the dynamic of disruptive innovations, this research tries to elucidate the way that market leaders take an unknown potential disruptive innovation out of its dark corner during its infancy time, raise it and disrupt the mainstream market relying on it to establish a new market. Focusing on the dynamic of innovation diffusion, this research has chosen the high-tech medical market of Iran as the main target of empirical field work. Novelty of this concept in medical markets and also appropriateness of invasive cardiovascular devices business in terms of great amount of disruptive innovation, make this case study appropriate for the purpose of this research. Therefore conducting a longitude case study of Iranian invasive cardiovascular market during the past 10 years, this research conducts 30 semi-structured interviews with the key decision makers of the four main incumbents of Iranian invasive cardiovascular market about launching new innovations including: Johnson and Johnson (Cordis), Abbott Laboratories, Boston Scientific and Medtronic. The findings of these interviews are supported by the results of archival researches for more validity and reliability. Finally these findings will get compared with the conceptual framework of research in the discussion chapter to modify the existing literatures and in some cases add some new theoretical notions to them. The main contribution of this research is to identify the accelerating factors of disruptive innovation diffusion from, strategic, technological and cultural points of views. These findings can help practitioners to accelerate the diffusion rate of their disruptive innovations to disrupt the market earlier than the others and set their dominant position in the market as a market leader. Also it will provide an opportunity for the other scholars to build on more about the concept of disruptive innovation diffusion.