In assistive technology, there are mainly two different users that needs to be taken into account when developing products. The first, and most important, is the end-user who requires the product in order to function and live a normal life. The second is the support person who, for some products, needs to assist the end-user by preparing it to be used. This report presents the master thesis project conducted by Mattias Bygge and Sofie Strand at KTH Royal Institute of Technology in Stockholm. The client was Abilia, a company that research, develop, manufacture and sell assistive technology to people with impairments. This main goal of this project was to redesign a cognitive planning board. The product is used as a visual aid by people who has difficulties in planning daily activities and keeping track of time. In order to develop the product in a suitable way, a literature study and interviews with Abilia’s employees laid the foundation for the user studies that were conducted with end-users and support people. Several concepts were generated and five were evaluated against the original product and presented to the company. The two concepts that received the highest ranking, (1) Extra Hours and (2) Extra Hours Bistable, were further investigated and were eventually developed into one single hybrid concept. The final design proposal is Day Master, a flexible planning board intended for people with a cognitive impairment that impedes their ability to plan daily activities and keep track of time. The product visually displays time and weekdays by using coloured LED lights, which support people may program without difficulty to fit the end-user’s preference. The amount of hours is changeable with a range of 12-18 hours of daytime and with the remaining hours distributed to night-time. The accessories that have been developed for this products are a simple protective cover, and two holders, one for images and one for whiteboard markers. All accessories attaches to the planning board with magnets. / I hjälpmedelsteknologi är det fler än en användare som man måste ta hänsyn till när man utvecklar produkter. Den första och viktigaste är slutanvändaren som är den som behöver produkten i vardagen för att kunna leva ett någorlunda normalt liv. Den andra är stödpersonen som i många fall är den som förbereder produkten för användning av slutanvändaren. Denna rapport presenterar masterexamensarbetet utfört av Mattias Bygge och Sofie Strand på KTH Kungliga Tekniska Högskola i Stockholm. Kunden för projektet var Abilia, ett företag som utvecklar, tillverkar, och säljer hjälpmedel till personer med funktionsnedsättning. Målet med detta projekt var att omdesigna deras kognitiva planeringstavla. Produkten används som ett visuellt hjälpmedel av personer som har problem med tidsuppfattning och planering av aktiviteter. Projektet inleddes genom en literaturstudie och intervjuer med personal på Abilia. Detta lade grunden för användarstudierna där både slutanvändare och stödpersoner deltog. Utifrån användarstudierna så genererades ett flertal koncept varav fem stycken evaluerades mot original produkten och som presenterades för företaget under en delpresentation. De två koncept som erhöll högsta ranking i evalueringen var (1) Extra Hours och (2) Extra Hours Bistable. Koncepten undersöktes ytterligare och kom slutligen att kombineras till ett gemensamt koncept. Det slutgiltiga designförslaget är Day Master, en flexibel planeringstavla som riktar sig mot personer med en kognitiv funktionsnedsättning som försvårar för dem att hålla koll på tiden och planera aktiviteter. Produkten visar tid och veckodagar visuellt med hjälp av färgade LED lampor som stödpersonerna lätt och intuitivt kan programmera för att passa slutanvändarens individuella behov. Day Master ger möjligheten att själv bestämma antalet timmar som distribueras mellan dag och natt. Den har ett spann på 12-18 timmar för dagtid och återstående timmar läggs på natttid. Tillbehören som har utvecklats för denna produkt är ett enkelt magnetiskt plastskydd och två stycken olika ställ, ett för bilder och ett för whiteboardpennor. Alla tillbehör fästs på whiteboardtavlan med hjälp av magneter.

Microprocessor-controlled knees (MPK’s) allow amputees to walk with increasing ease and safety as technology progresses. As an amputee is fitted with a new MPK, the knee’s internal parameters are tuned to the user’s preferred settings in a controlled environment. These parameters determine various gait control settings, such as flexion target angle or swing extension resistance. Though these parameters may work well during the initial fitting, the MPK experiences various internal & external environmental changes throughout its life-cycle, such as product wear, changes in the amputee’s muscle strength, temperature changes, etc. This work investigates the feasibility of using a reinforcement learning (RL) control to adapt the MPK’s swing resistance to consistently induce the amputee’s preferred swing performance in realtime. Three gait features were identified as swing performance indicators for the RL algorithm. Results show that the RL control is able to learn and improve its tuning performance in terms of Mean Absolute Error over two 40-45 minute training sessions with a human-in-the-loop. Additionally, results show promise in using transfer learning to reduce strenuous RL training times. / Mikroprocessorkontrollerade knän (MPK) gör att amputerade kan utföra fysiska aktiviteter med ökad lätthet och säkerhet allt eftersom tekniken fortskrider. När en ny MPK monteras på en amputerad person, anpassas knäts interna parametrar till användarens i ett kontrollerad miljö. Dessa parametrar styr olika gångkontrollinställningar, såsom flexionsmålvinkel eller svängförlängningsmotstånd. Även om parametrarna kan fungera bra under den initiala anpassningen, upplever den MPK olika interna och yttre miljöförändringar under sin hela livscykel, till exempel produktslitage, förändringar i den amputerades muskelstyrka, temperaturförändringar, etc. Detta arbete undersöker möjligheten av, med hjälp av en förstärkningsinlärningskontroll (RL), att anpassa MPK svängmotstånd för att konsekvent inducera den amputerades föredragna svängprestanda i realtid. Tre gångegenskaper identifierades som svingprestandaindikatorer för RL-algoritmen. Resultaten visar att RL-kontrollen kan lära sig och förbättra sin inställningsprestanda i termer av Mean Absolute Error under två 40-45 minuters träningspass med en människa-i-loopen. Dessutom är resultaten lovande när det gäller att använda överföringsinlärning för att minska ansträngande RL-träningstider.

The New Medical Device Regulations (MDR) will become affective on 26 May, 2021. The new regulation entails higher requirements for companies that develop medical devices, but also for all parties involved in the medical device industry. The strengthened requirements mean that it will be more difficult to meet all the criteria for placing medical devices on the market. This thesis has been carried out on behalf of the Swedish Institute for Standards (SIS) and examines companies' transition to MDR and how companies can get support from SIS, but also by other organizations and authorities. A qualitative literature study and document study has been carried out to ponder interview questions, which have then been answered by companies, authorities and organizations who are in one way or another affected by the transition to MDR. Part of the work was also to find out how the companies, depending on size, differ from each other to comply with the new regulation. The results showed that the transition to MDR differs significantly between all the interviewed parties, but that everyone agrees that standardization is important. / Den nya förordningen om medicintekniska produkter (MDR) kommer att träda i kraft den 26 maj, 2021. Den nya förordningen innebär högre krav på företag som utvecklar medicintekniska produkter, men även på alla inblandade parter i den medicintekniska industrin. De stärkta kraven innebär att det kommer vara svårare att uppfylla alla kriterier för att kunna placera medicintekniska produkter på marknaden. Detta examensarbete har utförts på uppdrag av Svenska Institutet för Standarder (SIS) och undersöker företagens övergång till MDR och hur företag kan få stöd, bland annat av SIS, men också av andra organisationer och myndigheter. Det har genomförts en kvalitativ litteraturstudie och dokumentstudie för att formulera intervjufrågor som sedan har besvarats av företag, myndigheter och organisationer som på ett eller annat sätt blir påverkade vid övergången till MDR. En del av arbetet var även att ta reda på hur företagen, beroende på storlek, skiljer sig mellan varandra vad gälleratt uppfylla det nya regelverket. Resultatet visade att övergången till MDR skiljer sig markant mellan alla de intervjuade parterna, men att alla är eniga om att standardisering är viktigt.

The medical device manufacturing industry has a deficiency in determining how to improve supplier performance for the components and systems they purchase. Many complex medical devices require components from superb suppliers. But how does a medical device manufacturer (MDM) impartially assess supplier performance to know which suppliers to continuing with (or even boost purchase volumes) and which suppliers they should exit? This study describes which supplier-specific metrics are most important to medical device manufacturers (MDMs) so they can utilize this supplier performance scorecard backed by real-world inputs. This research will focus on five categories to measure MDM supplier performance (Quality, Price, Delivery, Customer Service, and Partnership) across twenty-three (23) metrics. Because this is a focus of MDM supplier performance, we are not focusing on analysis of device sales to the final customer (e.g., distributors or group purchasing organizations {GPO}). The study will follow a framework including research analysis of supplier performance management in other industries, methods to attain data from MDMs via survey, results and analysis of the data, conclusions, and an easily understandable MDM supplier performance scorecard. In the survey, 135 MDM professionals replied when asked to rate twenty-three (23) supplier performance metrics, across five (5) categories aggregated from nine (9) different industries. The survey yielded a myriad of results including, weighting factors of each of the metrics, and those data results were used to compile an MDM supplier performance scorecard utilizing real-world feedback. The analysis revealed the ratings of importance of the categories as: Quality (43%), Delivery (24%), Customer Service (4%), Partnership (13%), Price (8%) and associated weights for the twenty-three (23) metrics that matter most to an MDM when creating a performance scorecard for their supplier base. Three contributions that this research will add to the body of knowledge: An in-depth review of supplier performance across many different industries (i.e., non-healthcare and healthcare) for contrasting/comparing evidence. A detailed MDM survey and statistical analysis on the topic of supplier performance management. An easily understandable and useable MDM supplier performance scorecard (via MS Excel) for MDM supply chain and/or operations users and/or managers.

Digital health tools, platforms, and artificial intelligence– or machine learning–based clinical decision support systems are increasingly part of health delivery approaches, with an ever-greater degree of system interaction. Critical to the successful deployment of these tools is their functional integration into existing clinical routines and workflows. This depends on system interoperability and on intuitive and safe user interface design. The importance of minimizing emergent workflow stress through human factors research and purposeful design for integration cannot be overstated. Usability of tools in practice is as important as algorithm quality. Regulatory and health technology assessment frameworks recognize the importance of these factors to a certain extent, but their focus remains mainly on the individual product rather than on emergent system and workflow effects. The measurement of performance and user experience has so far been performed in ad hoc, nonstandardized ways by individual actors using their own evaluation approaches. We propose that a standard framework for system-level and holistic evaluation could be built into interacting digital systems to enable systematic and standardized system-wide, multiproduct, postmarket surveillance and technology assessment. Such a system could be made available to developers through regulatory or assessment bodies as an application programming interface and could be a requirement for digital tool certification, just as interoperability is. This would enable health systems and tool developers to collect system-level data directly from real device use cases, enabling the controlled and safe delivery of systematic quality assessment or improvement studies suitable for the complexity and interconnectedness of clinical workflows using developing digital health technologies.

Establishment of Chaplaincy Service at the Hospital in Cheb This thesis describes the process of implementation of the hospital chaplain service in a hospital in Cheb, including a description of the obstacles and problems related to organizational culture change in this medical device. The aim of launching this new service was to contribute in improving the quality of services through complementing existing health services with the spiritual dimension of patient care. In the theoretical part the thesis focuses on knowledge about ecumenically-scale pastoral work of the hospital chaplains in the specific environment of hospitals. These findings are derived from publicly available sources - from secondary sources, or from websites. The practical part of the thesis describes the sequential steps that have been made in the implementation of chaplaincy services in Cheb hospital. The practical part contains interview with a professional chaplain, an experienced priest and nurses of Cheb hospital and a subsequent analysis of these interviews. Processed outputs of the interviews were then applied in the process of individualization of services according to the specific needs of this hospital. In this part also the state of new services a month after its launch had been evaluated. In the conclusion of the...

Preliminary investigation at the beginning of this research showed that informatics on point-of-care (POC) devices was limited to basic data generation and processing. This thesis is based on publications of several studies during the course of the research. The aim of the research is to model and analyse information generation and exchange in telehealth systems and to identify and analyse the capabilities of these systems in managing chronic diseases which utilise point-of-care devices. The objectives to meet the aim are as follows: (i) to review the state-of-the-art in informatics and decision support on point-of-care devices. (ii) to assess the current level of servitization of POC devices used within the home environment. (iii) to identify current models of information generation and exchange for POC devices using a telehealth perspective. (iv) to identify the capabilities of telehealth systems. (v) to evaluate key components of telehealth systems (i.e. POC devices and intermediate devices). (vi) to analyse the capabilities of telehealth systems as enablers to a healthcare policy. The literature review showed that data transfer from devices is an important part of generating information. The implication of this is that future designs of devices should have efficient ways of transferring data to minimise the errors that may be introduced through manual data entry/transfer. The full impact of a servitized model for point-of-care devices is possible within a telehealth system, since capabilities of interpreting data for the patient will be offered as a service (c.f. NHS Direct). This research helped to deduce components of telehealth systems which are important in supporting informatics and decision making for actors of the system. These included actors and devices. Telehealth systems also help facilitate the exchange of data to help decision making to be faster for all actors concerned. This research has shown that a large number of capability categories existed for the patients and health professionals. There were no capabilities related to the caregiver that had a direct impact on the patient and health professional. This was not surprising since the numbers of caregivers in current telehealth systems was low. Two types of intermediate devices were identified in telehealth systems: generic and proprietary. Patients and caregivers used both types, while health professionals only used generic devices. However, there was a higher incidence of proprietary devices used by patients. Proprietary devices possess features to support patients better thus promoting their independence in managing their chronic condition. This research developed a six-step methodology for working from government objectives to appropriate telehealth capability categories. This helped to determine objectives for which a telehealth system is suitable.

La littérature abordant les enjeux socio-éthiques et réglementaires associés aux médicaments est relativement abondante, ce qui n’est pas le cas des dispositifs médicaux (DM). Ce dernier secteur couvre une très large diversité de produits qui servent à de multiples applications: diagnostic, traitement, gestion des symptômes de certaines conditions physiques ou psychiatriques, restauration d’une fonction débilitante, chirurgie, etc. À tort, on a tendance à croire que les DM sont réglementés de la même manière que les médicaments, que ce soit pour les exigences concernant leur mise en marché ou des pratiques de surveillance après mise en marché. Or, au cours des dernières années, leur usage élargi, leur impact sur les coûts des soins de santé, et les rappels majeurs dont certains ont fait l’objet ont commencé à inquiéter la communauté médicale et de nombreux chercheurs. Ils interpellent les autorités réglementaires à exercer une plus grande vigilance tant au niveau de l’évaluation des nouveaux DM à risque élevé avant leur mise en marché, que dans les pratiques de surveillance après mise en marché. Une stratégie plus rigoureuse d’évaluation des nouveaux DM permettrait d’assurer un meilleur suivi des risques associés à leur utilisation, de saisir la portée des divers enjeux socio-éthiques découlant de l’utilisation de certains DM, et de préserver la confiance du public. D’emblée, il faut savoir que les autorités nationales n’ont pas pour mandat d’évaluer la portée des enjeux socio-éthiques, ou encore les coûts des DM qui font l’objet d’une demande de mise en marché. Cette évaluation est essentiellement basée sur une analyse des rapports risques-bénéfices générés par l’usage du DM pour une indication donnée. L’évaluation des impacts socio-éthiques et l’analyse coûts-bénéfices relèvent des agences d’Évaluation des technologies de santé (ÉTS). Notre recherche montre que les DM sont non seulement peu fréquemment évalués par les agences d’ÉTS, mais l’examen des enjeux socio-éthiques est trop souvent encore incomplet. En fait, les recommandations des rapports d’ÉTS sont surtout fondées sur une analyse coûts-bénéfices. Or, le secteur des DM à risque élevé est particulièrement problématique. Plusieurs sont non seulement porteurs de risques pour les patients, mais leur utilisation élargie comporte des impacts importants pour les systèmes de santé. Nous croyons que le Principisme, au cœur de l’éthique biomédicale, que ce soit au plan de l’éthique de la recherche que de l’éthique clinique, constitue un outil pour faciliter la reconnaissance et l’examen, particulièrement par les agences d’ÉTS, des enjeux socio-éthiques en jeu au niveau des DM à risque élevé. Également, le Principe de Précaution pourrait aussi servir d’outil, particulièrement au sein des agences nationales de réglementation, pour mieux cerner, reconnaître, analyser et gérer les risques associés à l’évaluation et l’utilisation de ce type de DM. Le Principisme et le Principe de Précaution pourraient servir de repères 1) pour définir les mesures nécessaires pour éliminer les lacunes observées dans pratiques associées aux processus de réglementation, et 2) pour mieux cerner et documenter les enjeux socio-éthiques spécifiques aux DM à risque élevé. / Socio-ethical and regulatory issues about drug development have received substantial coverage in the scientific literature over the years; this has not been the case of medical devices (MD). This latter sector comprises a vast array of products with a multitude of applications: diagnostics, treatment, symptom management for severe physical and psychiatric conditions, restoring physical functioning, surgery, etc. There is a mistaken view that MD are regulated in the same manner as pharmaceutical drugs, whether this be requirements regarding premarket assessment or post-market surveillance. Not only has the extensive use of MD in clinical practice and the resulting impact on healthcare expenditures raised concerns in the scientific and medical communities, but so too have the many recalls for high risk devices in recent years. Regulatory authorities have been challenged to exercise greater vigilance in both the premarket assessment and post-market surveillance of new high risk MD. A more rigorous evaluation strategy for new MD would permit better monitoring of the risks associated with their use, better understanding of the significance of the various socio-ethical issues arising from the use of MD, and thus preserve public confidence. From the outset, it should be noted that national authorities do not have a mandate to assess the significance of socio-ethical issues or the costs associated with the MD that are the subject of an application for marketing approval. This assessment is based primarily on risk-benefit analysis reports generated following the use of MD for a given indication. Evaluation of socioethical impact and cost-benefit analysis are the remit of Health Technology Assessment (HTA) agencies. But research shows that the MD are not only infrequently assessed by HTA agencies, but the consideration of socio-ethical issues is often incomplete; the recommendations of HTA reports are based mostly on a calculation of cost-benefit. However, the high risk MD sector is particularly problematic; many carry risks not only for patients, but their extended use has significant impact on healthcare systems. I argue that Principlism, associated to biomedical ethics, as much to research ethics and clinical ethics, could be adapted to facilitate the recognition and evaluation by HTA agencies of socio-ethical issues involved in high risk MD. The Precautionary Principle could also serve as a tool to help regulatory agencies to enforce understanding, recognition, analysis and management of the risks associated with the use of MD, especially high risk devices. Principlism and the Precautionary Principle could serve as benchmarks to 1) define necessary steps to eliminate gaps observed in the regulatory process, and 2) better understand and document the socio-ethical issues specific to high risk MD.

Magnesium alloys have been widely explored as potential biomaterials, but several limitations to using these materials have prevented their widespread use, such as uncontrollable degradation kinetics which alter their mechanical properties. In an attempt to further the applicability of magnesium and its alloys for biomedical purposes, two novel magnesium alloys Mg-Zn-Cu and Mg-Zn-Se were developed with the expectation of improving upon the unfavorable qualities shown by similar magnesium based materials that have previously been explored. The overall performance of these novel magnesium alloys has been assessesed in three distinct phases of research: 1) analysing the mechanical properties of the as-cast magnesium alloys, 2) evaluating the biocompatibility of the as-cast magnesium alloys through the use of in-vitro cellular studies, and 3) profiling the degradation kinetics of the as-cast magnesium alloys through the use of electrochemical potentiodynamic polarization techqnique as well as gravimetric weight-loss methods. As compared to currently available shape memory alloys and degradable as-cast alloys, these experimental alloys possess superior as-cast mechanical properties with elongation at failure values of 12% and 13% for the Mg-Zn-Se and Mg-Zn-Se alloys, respectively. This is substantially higher than other as-cast magnesium alloys that have elongation at failure values that range from 7-10%. Biocompatibility tests revealed that both the Mg-Zn-Se and Mg-Zn-Cu alloys exhibit low cytotoxicity levels which are suitable for biomaterial applications. Gravimetric and electrochemical testing was indicative of the weight loss and initial corrosion behavior of the alloys once immersed within a simulated body fluid. The development of these novel as-cast magnesium alloys provide an advancement to the field of degradable metallic materials, while experimental results indicate their potential as cost-effective medical devices.

The Master’s thesis deals with the area of conducting process audits in a large multinational corporation focused on manufacturing and distribution of medical devices, which has a subsidiary in the Czech Republic. The thesis discusses the analysis of the current set up of the internal audits‘ system in the corporation and there are changes of the quality system being proposed on the basis of the analysis, whose aim is to achieve a full compliance with the requirements of the US administration FDA, the standard ISO 13485 as well as the recent requirements on performing process audits. The emphasis is also put on the setting of the system such that it provides the highest possible added value for its users, can be easily implemented in practice and is flexible as well.