A identificação de fatores relacionados à segurança e qualidade das próteses para artroplastia de quadril na visão do ortopedista especialista, bem como a busca e checagem por informações advindas dos instrumentos legais de regulação, tais como localização do Registro do Ministério da Saúde e rótulo de instruções de uso, com exata descrição das características dos dispositivos, a notificação e procura por alertas da Tecnovigilância podem apontar critérios que minimizem a possibilidade de erros e surgimento de eventos adversos na escolha dos implantes para quadril durante o processo de indicação, solicitação, liberação, implantação e utilização do produto. Investigando este contexto, foram entrevistados os membros da Sociedade Brasileira de Quadril, e do retorno das respostas surgiram dados que mostram que 72% dos sujeitos não acreditam que o Registro da ANVISA faça parte de um processo de segurança e qualidade no cadastramento de produtos para saúde no Brasil, e outros 72% desconhecem a ferramenta Tecnovigilância para monitoramento pós-comercialização. Todavia, 94% da amostra refere já ter constatado falha protética ao longo da carreira, outros 94% indicam que a falha ocorreu com próteses nacionais, e que em 60% das ocorrências o fornecedor foi contatado, e não a ANVISA, e em outros 30% das falhas nada foi feito. Estes dados são preocupantes, pois refletem o descompasso entre a Agência Nacional de Saúde e a classe de médicos assistentes no que tange ao monitoramente de tecnologias em saúde, estes por não notificarem os EA (evento adverso) e QT (queixa técnica) ao órgão regulatório, e a Agência que, por conseguinte, não divulga amplamente esta ferramenta a quem de fato deveria ser o alvo de atenção, pois são estes que utilizam, na prática diária, os produtos registrados no Brasil. Na tentativa de facilitar a conferência de dados imprescindíveis relacionados à OPME(órteses, próteses e materiais especiais) entre eles próteses para quadril, elaborou-se uma revista eletrônica intitulada Guia Prático para checagem de questões sobre segurança e qualidade de dispositivos médicos cirúrgicos de acordo com procedimentos da ANVISA. / Identification factors related to safety and quality of prostheses for total hip arthroplasty according to the orthopedic specialists, as well as the search and checking for information from the legal instruments of regulation such as the registry made by the Ministry of Health and corresponding label functioning instructions containing the exact description of the characteristics of the devices, alert notifications for technical surveillance, etc., can lead to criteria that minimize errors and avoid adverse events when choosing hip implants, during the process of request, release, deliver and use of the product. In order to investigate this context, a survey was made by means of a questionnaire where members of the Hip Brazilian Society answered selected questions. Data from answers have shown that 72% of respondents do not believe that the ANVISA (National Health Agency) product registration is part of a safety and quality process for health products in Brazil, and another 72% are unaware of the pos market monitoring tool called Tecnovigilância. However, 94% of the medical doctors state that they already have found prosthetic failure throughout their career, other 94% indicate that the failure occurred with national prostheses, and in 60% of these cases the supplier was contacted and not the ANVISA, and for other 30 % of failures nothing was done. The exposure of these data is worrying since it reflects the gap between ANVISA and the physicians in regard to monitoring health technologies. Also, the doctors do not notify adverse events to the regulatory Agency and the Agency therefore does not disseminate this tool to those who actually should be the focus of attention since they use the products in their daily practice. Finally, in order to facilitate data verification of health products, in special hip phrostheses, a practical electronic guide was developed where questions and doubts about safety and quality of medical devices can be checked according to the ANVISA procedures.

Os temas pertinentes à introdução e à difusão do Método de Ponseti para o Tratamento do pé torto congênito no Brasil são discutidos. O Método Ponseti é baseado na confecção de gessos seriados de forma específica, tenotomia do Achillis, e manutenção da correção com órtese de abdução. Este tratamento era diferente do tratamento então vigente no país, baseado em maior tempo de confecção de gessos e realização de uma cirurgia extensa do pé. A difusão do Método Ponseti é analisada de forma cronológica, com ênfase na história de sua difusão no Brasil e no mundo a partir da Universidade de Iowa, na influência da Internet, e no Programa de treinamento de ortopedistas denominado Ponseti Brasil. Dados populacionais foram utilizados como avaliação da difusão do Método Ponseti antes do Programa de Treinamento. Quatro formas de avaliação direta do impacto do Programa de Treinamento são propostas: a reação dos participantes, o questionamento dos participantes sobre sua prática clínica após um ano do Programa, a avaliação dos participantes com relação ao tratamento do pé torto em duas cidades do Programa, São Luis e Teresina, e apresentações de casuísticas de nove serviços de ortopedia brasileira em um Painel Nacional no Curso Ponseti Avançado realizado dois anos após o Programa Ponseti Brasil. Para corroborar as informações sobre difusão, as publicações em países em desenvolvimento são discutidas, como ampliações da indicação do Método Ponseti. A tendência da literatura médica sobre pé torto congênito é analisada, por bases de dados em língua inglesa e bases de dados latino-americanas, e também são revisados os anais dos congressos nacionais da Sociedade Brasileira de Ortopedia e Traumatologia (CBOT Congresso Brasileiro de Ortopedia e Traumatologia) e Congresso Brasileiro de Ortopedia Pediátrica para observar a apresentação de trabalhos sobre tratamento pelo Método Ponseti e tratamento cirúrgico do pé torto. A difusão também é discutida em outros países, organizações não governamentais, com relação à visão dos pais e com relação aos custos do tratamento. A difusão do Método no Brasil é considerada na fase de expansão, e sua discussão pode trazer elementos que auxiliem a incorporação dessa tecnologia no Sistema Único de Saúde / Introduction and diifusion of Ponseti Method for congenital clubfoot treatment in Brazil are discussed. Ponseti Method is based on specific serial casting, Achillis tenotomy and use of abduction brace to maintain correction. This was different from standard treatment in Brazil at that time, based in many more months of serial casting and an extensive foot surgery. The Ponseti Method difusion is analized in a cronologic manner, with focus in the history of its difusion in Brazil and in the world, beginning in University of Iowa. Internet influence is discussed, as well as the Program Ponseti Brasil for training orthopaedic surgeons in Ponseti clubfoot treatment. Populational data were used to evaluate Ponseti Method difusion, before the Training Program. Four manners of direct evaluation of the impact of the Training Program are presented: the participants´reaction, enquiries about clinical practice with Ponseti Method after one year, evaluation of the impact of the Training Program in two cities, São Luis and Tesesina, and case series presentations of nine Brazilian Orthopaedic Clinics in a national panel in the Advanced Ponseti Course, two years after the Training ProgramPonseti Brasil. To reinforce information about difusion, publications in developing countries are discussed, extending indications for use of the Ponseti Method. Tendencies of medical literature about clubfoot treatment were analized, through written english and latinoamerican databases, and proceedings of two national meetings Brazilian Orthopaedic Meeting and Brazilian Pediatric Orthopaedic Meeting were revised to evaluate presentations about clubfoot treatment (Ponseti and surgical). Difusion is also discussed in other countries, non governamental organizations, related to parents perspective, and related to costs of treatment. Difusion of Ponseti Method is considered in expansion phase, and its discussion can help in the incorporation of this tecnology into the SUS (Sistema Único de Saúde Brazilian Health System)

Strukturell avbildning med ultraljud kan användas för att upptäcka sjukdomar och störningar i kroppen. För att ställa tillförlitliga diagnoser räcker det inte alltid med en strukturell avbildning utan ibland krävs det även fysiologisk information. Vid användning av funktionell avbildning med ultraljud kan den informationen mätas i kroppens olika fysiologiska system.   Systemen består av funktionellt olika enheter och kallas för motoriska enheter i skelettmuskulatur. Vid sjukdomar som ateroskleros (åderförkalkning) kan dessa enheter vara så kallade kärlplack, som består av vävnad med varierande egenskaper och medicinsk relevans. Möjligheten att kunna analysera funktionella enheter i system som dessa kan bidra mycket till diagnostisering av sjukdomar och störningar.   Den här studien presenterar en metod för att hitta naturliga kluster av funktionella enheter i skelettmuskulatur, från 3D-data inhämtat med ultraljudssekvenser.   I studien genererades syntetiska data från en modell som simulerar sekvenser av aktionspotentialer i kontraherande muskelvävnad. Datat bearbetades med förbehandlingar och klusteranalys och resultaten utvärderades med siluettkoefficienter. Kombinationer av fyra förbehandlingssätt och två klustringsalgoritmer jämförs i studien. Även tester på riktigt ultraljudsdata av muskelkontraktioner utfördes.   Den bästa kombinationen av förbehandling och klustringsalgoritm gav goda resultat och använder datanormalisering samt temporal bandpassfiltrering som förbehandling tillsammans med hierarkisk Complete Linkage-klustring. Den var dessutom relativt okänslig för störningar i datat. Resultaten från riktigt ultraljudsdata gav en grov indelning av områden i muskeln som visuellt överensstämmer med anatomin i den strukturella bilden. / Structural imaging using ultra sound can be used to detect diseases and disorders in the body. It’s not always enough to structurally image these detections for accurate diagnosis, sometimes physiologically functional information is needed. By using functional imaging, this information can be measured in various physiological systems throughout the body.   The systems are built up by functionally different units. In skeletal muscle these units are called motor units and in cases of disease, like atherosclerosis, they can be arterial plack. The placks have a tissue composition of various properties and clinical relevance. If functional units could be analyzed in systems like these, much could be contributed to diagnosis of diseases and disorders.   In this study, a method of detecting natural clusters of functional units in skeletal muscle, using 3D data collected from ultrasound sequences, is presented.   Using a model that simulates a series of actions potentials in contracting muscle tissue, synthetic data was generated. During analysis the data was preprocessed and clustered, the results were analyzed using silhouette coefficients. In this study, combinations of four methods of preprocessing and two clustering algorithms are compared. Real ultrasound data of contracting muscle tissue was also examined.   A combination of preprocessing and clustering that clustered the data particularly well used data normalization and temporal passband filtering for preprocessing together with hierarchical Complete Linkage clustering. It also seemed to be relatively unaffected by noise. Clustering of the real ultrasound data resulted in a coarse sorting of the different areas of the muscle that corresponds to the anatomy seen in structural images.

Bakgrund: Outsourcing är inget nytt fenomen då transaktionskostnadsteorin formades 1937 som beskrev att företag bör vända sig till marknaden i de fall detta gynnade företaget ekonomiskt. Sedan dess har teorier kring outsourcing förändrats och i dag handlar outsourcing om att kunna fokusera på företagets kärnkompetens och vilka möjligheter och risker outsourcing medför. Läkemedelsbranschen har på senare år börjat outsourca forskning och produktutveckling, vilka ses som kärnprocesser. Det råder därför delade meningar om branschen faktiskt har en kärnprocess. Syfte: Syftet med denna uppsats är att förstå hur och varför läkemedelstillverkningsbranschen outsourcar, om de outsourcade processerna har koppling till företags kärnprocesser och hur outsourcing faktiskt påverkar företaget, både monetärt och icke-monetärt. Metod: Det empiriska materialet insamlades med både kvantitativ och kvalitativ metod. En enkätundersökning genomfördes för att få en generell bild av hur läkemedelstillverkningsbranschen outsourcar för att sedan genomföra tre intervjuer för att få djupare kunskap om varför företag gjort de angivna val kring outsourcing. De intervjuade företagen valdes ut genom ett typiskt urval där företag valdes som svarat utifrån vissa bestämda kriterier. Slutsats: Uppsatsen har belyst att den vanligaste processen att outsourca är tillverkning, men att även forskning och produktutveckling outsourcas till viss del. Detta berodde på att företag upplevde resurs- och kunskapsbrist inom de outsourcade processerna. Studien fann även att sambandet mellan anledningen till och utfallet av outsourcing var svagt. Däremot hamnade den ökade lönsamheten sist inom båda kategorierna. Det påvisades också att det är svårt att definiera en kärnprocess till branschen med anledning av den diversifiering som i dag karaktäriserar branschen. Däremot framkom produktutveckling som den vanligaste kärnprocessen inom företag, där det visade sig att företag inte tenderar att outsourca sin kärnprocess. / Background: Outsourcing is not a new phenomenon. Transaction cost theory was formed in 1937, which described that companies should transfer activities externally when this benefited companies financially. Since then, theories of outsourcing have changed and today, it has been switched to outsourcing of core competencies and a discussion of both opportunities and risks. In recent years the pharmaceutical industry has started to outsource their research and product development, which is considered a core process. Due to this there is a debate whether or not the industry has a core process. Purpose: The purposes of this thesis are to understand how and why the pharmaceutical manufacturing industry is outsourcing, how the outsourced processes relate to their core processes and how outsourcing affects the companies, both monetary and non-monetary. Method: The empirical evidence was gathered with both quantitative and qualitative methods. Firstly, a survey was conducted to get a general picture of how the pharmaceutical manufacturing industry outsources which was then followed by three interviews to gain an in-depth knowledge of why companies have made specified decisions regarding outsourcing. The companies were selected according to a number of specific criteria. Conclusion: The thesis has highlighted that manufacturing is the most common process of outsourcing, but also that research and product development is outsourced to some extent. This was due to the fact that companies experienced resource and knowledge shortage in the outsourced processes. The study also found that the relation between the reason and the outcome of outsourcing was weak. However, the increased profitability ended last in both categories. It was also found that it is difficult to define a core process within the industry due to the diversification that today characterizes the industry. On the other hand, product development appear to be the most common core process within companies, where it also shows that companies tend not to outsource their core process.

MedTech firms experience barriers when entering the healthcare sector, although their solutions could solve healthcare challenges. The study provides a conceptual framework for MedTech firms' business environment including institutional alignments and misalignments. These insights support MedTech firms' business model development when aiming for successful commercialization. The research is conducted with a multiple case study analyzing MedTech firms' and healthcare organizations' perspective regarding the business environment and relationship dynamics. The study generated three main findings. Firstly, an organizational and institutional logic analysis outlined essential problem areas where MedTech firms and healthcare organizations align differently. Secondly, suggestions on how the MedTech firm can respond to the identified problem areas through their business model are presented. Thirdly, the study provides an example of how social- and business literature can be connected to understand complex business environments. In contrast to a majority of prior research, the study is designed for the MedTech firm's perspective where the final result answering how the business model can be improved based on healthcare organizational and business insights.

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Die Transplantation eines Organes ist in der Medizin oftmals die letzte Möglichkeit zur Behandlung einer terminalen Organinsuffizienz. Das grundlegende Problem der internationalen Transplantationsmedizin ist die stetig wachsende Diskrepanz zwischen Bedarf und Angebot von Transplantaten. Die Situation wird dramatisiert durch einen Trend der Marginalisierung von Spenderorganen. Marginale Spenderorgane werden häufig aufgrund mangelnder Möglichkeiten zur Funktionsbewertung verworfen. Die Technik der ex-vivo Organperfusion kann maschinell physiologienahe Bedingungen bereitstellen, um ein isoliertes Transplantat zu rekonditionieren und sogar eine Bewertung seines Zustands zu ermöglichen. Perfusionsprozesse sind organsystemindividuell durch eine hohe Komplexität ihrer biologisch-technisch verkoppelten Vorgänge gekennzeichnet. Für nutzer- und sicherheitsorientierte, klinisch taugliche Perfusionssysteme ist eine Prozessautomatisierung unumgänglich. Hier sind in klassischer anwendungsindividueller Entwicklung hohe Kosten die Folge. Auf Basis von Recherchen zum aktuellen Stand von Medizin und Technik konnten Eigenschaften von Perfusionsprozessen für die Organsysteme Herz, Lunge, Leber und Niere bestimmt werden. Aus ähnlichen Anwendungen der extrakoporalen Lebensunterstützung sind Erkenntnisse zur Systemautomatisierung zusammengetragen worden. In Fortführung der Arbeit sind die Organperfusionsprozesse abstrahiert und verallgemeinert worden. Beteiligte Prozessgrößen, sowie deren funktioneller Verkopplungen wurden identifiziert und evaluiert, um schließlich eine generalisierte, organunabhängige Strategie zur dezentralen Mehrgrößenregelung abzuleiten. Die abgeleitete Regelungsstrategie wurde folgend speziell für die ex-vivo Nierenperfusion umgesetzt. Dazu wurde zunächst auf Basis des generalisierten Organperfusionsprozesses ein Gerätesystem zur Nierenperfusion abgeleitet, entwickelt und aufgebaut. Für das entstandene Perfusionssystem wurden Modellbildungen und Parameteridentifikationen des Temperatursystems, des hämodynamischen Systems und des Blutgassystems durchgeführt. Die entstandenen Zustandsraummodelle wurden jeweils in Simulink implementiert und mittels realer Perfusionsexperimente an Schweinenieren im Tiermodell validiert. Simulativ und analytisch wurden für die drei Subsysteme Regelungsstrategien zur robusten Einzelgrößenregelung entwickelt und im realen Perfusionssystem implementiert. Im Zuge von weiteren Perfusionsexperimenten im Tiermodell konnten die Regelungen ebenfalls validiert und deren Robustheit im Mehrgrößenfall evaluiert werden. Die Erkenntnisse der speziellen Umsetzung des generalisierten Mehrgrößenregelungsansatzes zur Organperfusion wurden auf die Organsysteme Herz, Lunge und Leber projiziert. Die Hypothese dieser Arbeit, dass eine organübergreifende generalisierte Regelungsstrategie zur ex-vivo Perfusion bei Nutzung mit verschiedenen speziellen Organsystemen tauglich ist, konnte bestätigt werden. Auf dieser Basis ist eine vereinfachte und kostenreduzierte Entwicklung von Perfusionssystemen für verschiedene Organsysteme möglich. / In many cases the transplantation of an organ is the last way to treat a terminal organ insuffiency. The basic problem of international transplant medicine is a continiously increasing gap between the demand and the proposal of sufficient organ grafts. The situation is compounded by the actual trend of marginalization of organ grafts. Marginal donor grafts often are discarded due to absent options to test their vitality and viability. The technique of ex-vivo organ perfusion provides near physiologic conditions in order to recondition and even to evaluate the state of an isolated organ graft. Perfusion processes are organ individual characterized by highly complex coupled biological-technical processes. For achieving an user- and safety-focussed, clinical suitable perfusion system, an automation of the system is inavoidable. Within classical development of technologies, high costs were following. On the base of research according to the actual status quo of medicine and technology, characteristics of the perfusion processes for the heart, the lungs, the liver and the kidneys could be determined. Knowledge about similar processes of extracorporeal life support were gathered. Subsequently the organ perfusion processes were abstracted and generalized. Participating process values, as well as their couplings, were identified and evaluated in order to extract a generalized, organ independent strategy for decentral multivariable control. The extracted control strategy was then transfered specificly for ex-vivo kidney perfusion. Therefore a device for ex-vivo kidney perfusion was developed and built from the generalized organ perfusion process. According to the implemented device, the temperature system, the hemodynamic system and the blood gas system were modelled mathematically and parameter estimations were performed. The resulted state space models were implemented to Simulink and validated by comparing simulations to the results of experiments on real procine kidneys. Within the simulations and based on analytical methods, robust single variable control strategies for the control of the three subsystems temperature, hemodynamic and blood gases were developed and implemented into the real kidney perfusion device. During further perfusion experiments within the large animal model, the control strategies could be validated an their robustness could be evaluated in the multivariable case. The findings of the special implementation of the generalized multivariableapproach for organ perfusion were projected on the organ systems heart, lungs and liver. The hypothesis of this work, in detail, that a generalized, organ independent control strategy for organ perfusion processes is suitable for the use with several special organ systems, could be confirmed. On this basis, simplified and cost reduced developments of perfusion systems for different organ systems are possible.

Neue Technologien der additiven Fertigung läuten auch im Bereich der Medizin, Medizintechnik und der biomedizinischen Forschung eine neue Ära ein: Über verschiedene Fertigungsverfahren wie lithographische Techniken oder Laser-Sintering ist es bereits jetzt möglich, aus biokompatiblen Materialien entsprechend eines spezifischen Designs und ohne zusätzlich nötige Fertigungsmasken dreidimensionale Implantate in anatomischer oder patienten-individueller Geometrie herzustellen. Großes Potential ergibt sich daraus beispielsweise für Lösungen zu orthopädischen Fragestellungen: Hierzu gehören u.a. die potentielle Korrektur von Fehlbildungen im mund-, kiefer- und gesichtschirurgischen Bereich, der Ersatz größerer Knochendefekte sowie der Ausgleich von kleineren Gelenkdefekten. Letztere beschreiben die Anwendung am Gelenkknorpel-Knochen-Übergang, um Eingriffen zur Implantation einer Totalendoprothese zu entgehen oder diese ggf. hinauszuzögern. Aus diesem Grund finden für entsprechende zukünftige, klinische Konzepte, sowie in den entsprechenden Forschungsbereichen unterschiedlichste Fertigungsmethoden Anwendung. Die additive Fertigung hat nicht nur das Design und die aufbauende Fabrikation von patientenindividuellen Titanimplantaten (Gander et al. 2015) durch Spritzgussverfahren revolutioniert, sondern auch den schnellen Aufbau von Strukturen aus thermoplastischen Polymeren (Probst et al. 2010) und weicheren Materialien durch extrusionsbasierte Techniken ermöglicht. Diese über Rapid Prototyping erhaltenen, individuellen Objekte können im Vergleich zu konventionellen Verfahren sehr schnell und ohne Materialausschuss auch in Kleinserien und Einzelanfertigungen individuell gefertigt werden. Die essentielle Aufgabe für den klinischen Einsatz liegt hier in der Herstellung patientenindividueller Implantate. Allerdings sind die Technologien ebenso hinsichtlich spezifischer Gewebemodelle für forschungsrelevante Fragestellungen, die mittel- bis langfristig zu Erfolgen für die biomedizinische Patientenversorgung beitragen können, von großer Bedeutung. Um hierbei eine Lücke zwischen den individualisierten, bezüglich ihrer äußeren Geometrie spezifisch designten Implantaten und einer intrinsischen Funktionalität zu schaffen, greift die biomedizinische Forschung auf die Kombination von Ansätzen aus dem Tissue Engineering (Langer & Vacanti, 1993) und den Vorteilen der additiven Fertigung sowie der damit verbundenen Konstruktion von anatomischen Geometrien zurück. Das Forschungsfeld und die Methoden der sog. Biofabrikation (Groll et al. 2016; Moroni et al. 2018) bringen die Vorteile und Konzepte dieser doch unterschiedlichen Wissenschaftsfelder zusammen, indem sie biologische Komponenten in den Fabrikationsprozess einbeziehen. [... aus der Einleitung]

The number of deaths due to medical errors in hospitals ranges from 44,000 to 98,000 yearly. More than 7,000 of these deaths have taken place due to medication errors. This project evaluated the implementation of an automated medication dispensing cabinet or PYXIS machine in a 25-bed upper Midwestern critical access hospital. Lewin's stage theory of organizational change and Roger's diffusion of innovations theory supported the project. Nursing staff members were asked to complete an anonymous, qualitative survey approximately 1 month after the implementation of the PYXIS and again 1 year later. Questions were focused on the device and its use in preventing medication errors in the hospital. In addition to the surveys that were completed, interviews were conducted with the pharmacist, the pharmacy techs, and the director of nursing 1 year after implementation to ascertain perceptions of the change from paper-based medication administration to use of the automated medication dispensing cabinet. Medication errors before, during, and after the PYXIS implementation were analyzed. The small sample and the small number of medication errors allowed simple counts and qualitative analysis of the data. The staff members were generally satisfied with the change, although they acknowledged workflow disruption and increased medication errors. The increase in medication errors may be due in part to better documentation of errors during the transition and after implementation. Social change in practice was supported through the patient safety mechanisms and ongoing process changes that were put in place to support the new technology. This project provides direction to other critical access hospitals regarding planning considerations and best practices in implementing a PYXIS machine.

The wide usage of smartphones makes them an interesting and potential medical device. Given that smartphone cameras have a sufficiently high quality - some of the medical photography done at health care facilities could be done telemedically and by non-medically educated per- sons. Therefore a research of the quality of the photos taken with smartphone cameras has been done. This thesis presents guidelines regarding how inexperienced persons could take high qualitative medical photos with a smartphone. This thesis includes a review of current guidelines within medical photography. A compari- son between two popular smartphones and a professional medical camera has been done - where possibilities and limitations in smartphone cameras have been identified. In order to evaluate the sharpness and the color temperature representation in the photos taken with smartphones, an experiment with realistic lighting and easy accessible color-calibration cards has been done. The execution and the achieved result have formed the basis of the proposed guidelines. The result shows that smartphone cameras are of high quality and thereby could be used as a complement to advanced medical camera equipment. With the help of the proposed guidelines inexperienced persons could acquire sufficiently good medical photos, in order to be used as diagnostic material. This thesis provides a foundation for further research and implementation within the area, with the purpose of becoming an important part of the efficiency improvement within the telemedical health care.