The interest in environmental issues is increasing and for this reason, assessing the potential environmental impacts of a product or system is of interest. A methodology developed for this particular purpose is the life cycle assessment, also known as LCA. It is not purely of interest these aspects are investigated though, as increasing requirements on organizations also matter. The purpose of this thesis was to investigate the feasibility to implement the methodology of LCA in the aspect of complex medical devices. To do this, the framework for the methodology has been reviewed and a case study performed. The case study comprised of conducting an LCA study on the radiosurgery device Leksell Gamma Knife® IconTM.  The outcome of the investigation showed that conducting an LCA study means a wide range of aspects need to be considered and specified to a high degree. A particular issue was the data requirements, as obtaining data meeting several objectives was challenging. The modeling was also identified as a difficulty. Tools such as software and databases with predefined processes were used, though as complex medical devices can use materials not common in other fields, a lack of appropriate predefined processes hinders the feasibility. The conducted case study was able to attain valuable insights even though the study did not comply with the standards providing the framework, the ISO 14040 series. To conduct a compliant LCA study for complex medical devices, extensive resources would be required as well as the involvement of relevant parties along the supply chain. It is seen improbable to achieve a compliant study the first time a particular type of complex medical device is investigated. However, it is believed the feasibility would increase as studies are repeated, as the data quality is likely to increase. Advancements of the tools, as well as ongoing research on the environmental impacts of more materials, are other factors thought to increase the feasibility of conducting LCA studies on complex medical devices in the future. / Intresset för miljöfrågor ökar och därav finns det ett intresse att undersöka vad den potentiella miljöpåverkan är för en produkt eller ett system. En metodologi utvecklad för detta specifika syfte är livscykelanalys som även kallas LCA. Det är inte enbart utav intresse som aspekterna utreds, de ökande krav som ställs på olika aktörer spelar också roll. Syftet med detta examensarbete var att undersöka genomförbarheten av livscykelanalyser med avseende på komplexa medicintekniska produkter. Detta gjordes genom att granska regelverken för LCA samt genomförandet av en fallstudie, vilken utgjordes av en livscykelanalys på strålkniven Leksell Gamma Knife® IconTM. Resultaten av undersökningen visade att genomförandet av en livscykelanalys innebär att ett stort spann av aspekter måste beaktas och specificeras i hög grad. Ett särskilt problem var kraven på data då det var utmanande att samla in data som skulle möta flera behov. En annan identifierad svårighet var modelleringen. Verktyg användes i form av mjukvara och databaser med fördefinierade processer men då komplexa medicintekniska produkter kan bestå av material som inte är vanliga inom andra områden, var bristen på passande fördefinierade processer ett hinder för genomförbarheten. Den genomförda fallstudien gav värdefulla resultat trots att den inte var utförd helt enligt standarderna i ISO 14040 serien. För att en LCA studie för komplexa medicintekniska produkter skall möta dessa krav krävs omfattande resurser och att flera berörda parter längs försörjningskedjan involveras. Det ses därför som osannolikt att en studie som genomförs för första gången på en viss typ av komplex medicinteknisk produkt kan leva upp till regelverket. Dock så förmodas genomförbarheten öka i takt med att studier upprepas, då kvaliteten på data tros öka. Utveckling av verktygen samt pågående forskning om miljöpåverkan från olika material är andra faktorer som anses öka genomförbarheten av livscykelanalyser på komplexa medicintekniska produkter i framtiden.

Medical devices used for surgical or therapeutic purposes require a high degree of safety and effectiveness. Software is critical component of many such medical devices. The software architecture of a system defines organizational structure and the runtime characteristic of the application used to control the operation of the system and provides a set of frameworks that are used to develop that. As such, the design of software architecture is a critical element in achieving the intended functionality, performance, and safety requirements of a medical device. This architecture uses object-oriented design techniques, which model the underlying system as a set of objects that interact to achieve their goals. The architecture includes a number of frameworks comprised of a set of classes that can be extended to achieve different functionality required for a medical device. The Input/ Output (IO) framework includes a number of core classes that implement periodic and a periodic input output with varying priority requirements, provides a hardware neutral interface to the application logic, and a set of classes that can be extended to both meet the hardware IO specifics of a target platform and create new sensor and actuator types for client applications. The Devices framework provides a blueprint to develop the controller logic of the medical device in terms of abstractions that parallel the hardware components of the medical device. The Configuration framework allows creation and configuration of a medical device from an XML (Extensible Markup Specification) specification that specifies the configuration of the device based on abstract factories that can be extended to meet requirements of a specific medical device. The Controller is the component of the architecture that defines classes that implement reception of commands from and transmission of status and data to a local or remote client and dictate the structure of threads, thread priorities and policies for this purpose. The Diagnostics package of the architecture defines a framework for developing components that monitor the health of the system and detect emergency conditions. The architecture is implemented in C++ and runs on a real-time LINUX operating system. At this time, the architecture is used in development of two of the St. Jude Medical Atrial Fibrillation Division’s medical devices; one of these has FDA class III and the other class II classification.

<p>    </p> <p>Healthcare is one of the most critical and valuable industries. This report is a systematic literature review of the usability and safety of medical devices used extensively for patient care. Safety has been broadly considered to mean in-patient safety and improving patient care. As part of the literature review and bibliometric analysis, a search of all the articles containing the keywords “medical device” AND “usability” AND “safety” was conducted on both Web of Science and Google Scholar (through Harzing’s Publish or Perish). The results that also contained the metadata were exported to VOS Viewer for cluster generation and co-citation analyses. As part of data mining, statistical tests such as regression analysis were conducted to find the causal relationship and significance between the variables. Following this, a core set of articles, some of which demonstrated strong ties to the topic at hand, were chosen from various databases and co-citation analyses. The core set also included a relevant chapter from the <em>Handbook of Human Factors and Ergonomics, Fourth Edition </em>by Salvendy. The articles were added to Mendeley and then exported to MAXQDA for the word-cloud generation. As part of the lexical search, Springer’s AuthorMapper and Digital Science’s Dimensions were used to extract trending keywords, author information, and metadata of relevant contributions made to the topic by institutions worldwide. The regression analysis revealed a significant tie between the database and the number of articles. Additionally, the regression showed that cites per year in Google Scholar had a significant effect on g-index. Finally, the discussion section included a case study of three different drug delivery systems. This aimed to perform a risk assessment of pre-existing “smart” medical devices. The analysis revealed that there is a high risk of malfunction in all the devices due to pre-programmed dose error. None of the devices were capable of “learning’ from patient behavior and adapting accordingly. Finally, the paper discusses Human-Computer Interaction and Human Factors Problems that exist in software medical devices that utilize AI/ML methodologies. Overall, the main keywords of human cognition, health informatics, precision medicine, applied ergonomics, and design safety showed high relevance within all the chosen articles. These keywords are highly reflective of the fields that are currently disrupting the conventional governance of healthcare. </p>

To date, there are no existing models for evaluating foreign markets, adapted to mobile health (mHealth) consumer medical device (CMD) start-ups seeking to launch their products or services in new countries. This calls for the development of a suitable international market selection (IMS) model that captures the complexity of and opportunities for mHealth. mHealth is a sub-segment of electronic health (eHealth), which furthermore is part of the wider phenomenon of digital health. mHealth covers medical and public health practice supported by mobile devices. This paper proposes a multidimensional IMS model comprising both macro and micro level factors. Our specialized approach integrates tools and theories by a number of researchers and is showcased in the assessment of the European Union (EU) for the mHealth CMD company AdhereBox. AdhereBox is a Swedish start-up that has developed a CMD consisting of a “smart” pillbox and a complementary mobile software application. We propose a number of dimensions that should be evaluated when assessing the potential  of the different EU health care markets in regards to mHealth CMD start-ups. Our suggested approach includes factors which are categorized into two groups of parameters: (i) stakeholders (which comprises consumers, providers, payers, distributors and collaborators) and (ii) barriers &amp; enablers (consisting of incentives, reimbursement models, technological infrastructure, regulations and existing solutions). In summary, our study identifies critical factors that mHealth CMD start-ups should consider when evaluating foreign markets in an IMS. By applying our IMS model on AdhereBox, we illustrate how our model can be used, its parameters assessed and the interdependencies between these analyzed in order to arrive at a set of recommendations for further market analysis and conclusions on country attractiveness. As such, we believe that our research could provide valuable insights and guidelines for firms within mHealth seeking to expand their business within the EU, as well as for governmental organizations that want to better leverage and stimulate the potentials of a flourishing domestic mHealth ecosystem.

[pt] Os procedimentos atuais de localização de corpos estranhos ferromagnéticos utilizados na prática clínica envolvem as técnicas de imageamento de radioscopia e radiografia, que apresentam diversas limitações e riscos. Assim, técnicas de localização baseadas em magnetômetros como SQUID, GMI e GMR têm sido desenvolvidas, com variados graus de complexidade e sucesso. Uma das principais dificuldades de ordem prática, além do custo e das dimensões do sistema de medição no caso do SQUID, que opera a temperaturas criogênicas, é a necessidade de o paciente estar posicionado em uma estrutura móvel de grandes dimensões que permita a determinação das coordenadas da posição bidimensional do mapeamento magnético. Por outro lado, as pequenas dimensões dos sensores GMR ou GMI possibilitam o desenvolvimento de um sistema de medição portátil que poderia integrar outros sensores que em conjunto viabilizem a determinação da posição espacial do sensor magnético em relação ao paciente. Esta dissertação de mestrado investiga técnicas de determinação da posição espacial de um dispositivo portátil, baseado em uma plataforma Raspberry Pi, integrando sensor GMR, câmera, sensores inerciais e um sensor de distância, visando ao futuro desenvolvimento de um protótipo de dispositivo médico portátil para localização de corpos estranhos ferromagnéticos. A pesquisa também investiga técnicas de resolução do problema inverso magnético em tempo real baseadas em filtros de Kalman e ajuste por mínimos quadrados, de modo a acelerar o procedimento diagnóstico na futura aplicação clínica do dispositivo. / [en] The current procedures for locating ferromagnetic foreign bodies used in the clinic involve radioscopy and radiography image techniques, which presents several limitations and risks. Thus, localization techniques based on magnetometers were developed as SQUID, GMI and GMR, with varying degrees of complexity and success. One of the main difficulties, in addition to the cost and dimensions of the system, in the case of the SQUID, which operates at cryogenic temperatures, is the need for the patient to be positioned in a large structure that allows flexibility in the configurations of the two-dimensional position of the magnetic mapping. On the other hand, the small dimensions of the GMR or GMI sensors allow the development of a portable measurement system that could integrate other sensors that together make it possible to determine the spatial position of the magnetic sensor in relation to the patient. This master s dissertation investigates techniques for determining the spatial position of a portable device, based on a Raspberry Pi platform, integrating GMR sensor, camera, inertial sensors and a distance sensor, aiming at the future development of a prototype of a portable medical device for localization of ferromagnetic foreign bodies. The research also investigates real-time inverse magnetic problem solving techniques based on Kalman filters and least squares adjustment, in order to accelerate the diagnostic procedure in the future clinical application of the device.

[pt] Esta dissertação apresenta um projeto de sistema portátil de localização de corpos estranhos metálicos não ferromagnéticos por meio de mapeamento magnético. O sistema baseia-se na indução de correntes parasitas no corpo estranho por um estágio de excitação e na medição por um magnetômetro GMI comercial de elevada resolução (25 pT). A topologia do instrumento é baseada no desacoplamento dos estágios de excitação e medição, com uma configuração que produz linhas de campo magnético primário elevadas na região do corpo estranho e tênues na região do sensor. Esta característica supera as limitações de um instrumento previamente desenvolvido, permitindo aumentar o campo magnético primário de excitação sem saturar o magnetômetro. O projeto é baseado em simulações computacionais, considerando dois tipos de excitação e duas orientações para o eixo de sensibilidade do magnetômetro. Diretrizes internacionais para os limites de exposição à radiação não-ionizante, aspectos biometrológicos, construtivos e elétricos também foram levados em consideração no projeto. A análise de desempenho das configurações mais promissoras confirmou a viabilidade do instrumento de medição proposto, otimizando a operação linear do magnetômetro durante o procedimento de medição e contribuindo para a futura construção de um protótipo de sistema de medição completo, com características de desempenho e segurança asseguradas para a aplicação biomédica pretendida. / [en] This dissertation presents a portable system for the localization of nonferromagnetic foreign metal bodies by magnetic mapping. The system is based on the induction of eddy currents in the foreign body by an excitation stage and the measurement by a high resolution commercial GMI magnetometer (25 pT). The instrument topology is based on the decoupling of the stages of excitation and measurement, with a configuration that produces a high primary magnetic field in the foreign body region and a weak one in the sensor region. This feature surpasses the limitations of a previously developed instrument, allowing to increase the primary excitation magnetic field without saturating the magnetometer. The project is based on computational simulations, considering two types of excitation and two orientations for the magnetometer sensitivity axis. International guidelines for exposure limits to non-ionizing radiation, biometrological, constructive and electrical aspects were also taken into consideration in the project. The performance analysis of the most promising settings confirmed the viability of the proposed measurement instrument, optimizing the linear operation of the magnetometer during the measurement procedure and contributing to the future construction of a complete measurement system prototype, with performance and safety characteristics ensured for the intended biomedical application.

Sedan 2021 regleras medicintekniska produkter inom EU av förordningen MDR (EU 2017/745). Det primära syftet med regelverket är att säkerställa ändamålsenliga produkter med hög säkerhet. Det nya regelverket ställer högre krav på företag som tillverkar medicintekniska produkter samt andra aktörer inom den medicintekniska industrin. De mer omfattande kraven innebär att det blir mer utmanande att uppfylla samtliga kriterier som krävs för att kunna lansera medicintekniska produkter på unionsmarknaden. Detta examensarbete har undersökt hur företag som tillverkar specifika medicintekniska produkter som rullstolar och personlyftar upplever förutsättningarna för att nå marknaden. För att undersöka tidigare studier kring ämnet har en litteraturstudie genomförts och sedan utformades intervjufrågor med hjälp av samtliga handledare. Frågorna besvarades av företag som tillverkar rullstolar eller personlyftar. Som komplement till de semistrukturerade intervjuerna har upphandlingar undersökts med syfte att kartlägga vilka standarder som refereras till som skall-krav vid inköp av rullstolar och personlyftar. Resultatet visar att de ökade kraven påverkar större medicintekniska företag, men att mindre företag påverkas i högre utsträckning enligt intervjuobjekten. Dessutom noteras att standarder nämns mindre frekvent i upphandlingar än vad de intervjuade personerna hävdar. Slutligen anser intervjuobjekten att det är värdefullt att följa standarder vid utveckling och marknadsföring av personlyftar och rullstolar. / Since 2021, the Medical Device Regulation (MDR) has regulated medical devices within the EU (EU2017/745). The regulation’s primary purpose is to ensure fit-for-purpose products with high safety standards. The new regulatory framework imposes strict requirements on companies manufacturing medical devices and other actors within the medical device industry. The more extensive requirements make meeting all the criteria necessary for launching medical devices on the European Union market more challenging. This thesis has examined how companies that manufacture medical devices, especially wheelchairs and patient lifts, perceive the conditions for reaching the market. A literature review was conducted to examine previous studies on the subject. Then, interview questions were formulated with the assistance of supervisors to participate by companies manufacturing wheelchairs or patient lifts. Procurements were examined to complement the semi-structured interviews and map out which standards are mandatory requirements in procuring wheelchairs and patient lifts. The results indicate that the increased requirements affect larger medical device companies, but the interviewees say smaller companies are more affected.  Additionally, standards are mentioned less frequently in procurements than what the interviewed individuals claim. Finally, the semi-structured interviews revealed that the interviewees consider it valuable to adhere to standards in developing and marketing wheelchairs and patient lifts.

Computing technology has been getting more reliable and cheaper every year for the past several decades. Consequently, IoT devices have now become a part of medical technology. One example of this is a new open-source technology that has emerged for type-1 diabetes patients, which regulates the patients’ blood glucose levels. One component of this open-source system is AndroidAPS, a mobile application that manages and controls the system by communicating with the two other components: a blood glucose sensor and an insulin pump. Another component is Nightscout, a web application for monitoring T1D patients. Together they form the APS ecosystem that automatically i) reads blood glucose values, ii) syncs the data with Nightscout, iii) stores patient information into Nightscout database, iv) calculates optimal treatment plan, and v) regulates pump for the ideal insulin intake. The whole system bears several critical assets to guarantee patient health. In this thesis, the security of a representative APS ecosystem is studied. We found 5 critical vulnerabilities in the ecosystem: 1) an XSS vulnerability in the web application due to ineffective input sanitization which lead to stealing administrator password from browser cache, 2) highly sensitive patient data is open to public by default, 3) the web application login mechanism, where all system data is managed, is weak against password guessing attacks together with 4) insecure GET requests used for authentication, and lastly 5) any type of database hijack does not trigger any alarms for Nightscout. Successful attacks result in malicious values synchronized from Nightscout to tamper correct insulin delivery calculations. Possible attack scenarios, devised from existing vulnerabilities in this work, show how an attacker can physically harm their victims through their internet-connected insulin pump. / Datorteknik har blivit mer pålitlig och billigare varje år under de senaste decennierna. Följaktligen har IoT-enheter nu blivit en del av medicinsk teknik. Ett exempel på detta är en ny öppen källkodsteknik som har utvecklats för typ 1- diabetespatienter, som reglerar patienternas blodsockernivåer. En komponent i detta öppen källkodssystem är AndroidAPS, en mobilapplikation som hanterar och kontrollerar systemet genom att kommunicera med de två andra komponenterna: en blodsockersensor och en insulinpump. En annan komponent är Nightscout, en webbapplikation för övervakning av T1D-patienter. Tillsammans bildar de APSekosystemet som automatiskt i) läser blodsockervärden, ii) synkroniserar data med Nightscout, iii) lagrar patientinformation i Nightscout-databasen, iv) beräknar optimal behandlingsplan och v) reglerar pumpen för perfekt insulinintag. Hela systemet har flera kritiska tillgångar för att garantera patientens hälsa. I denna avhandling studeras säkerheten för ett representativt APS-ekosystem. Vi hittade 5 kritiska sårbarheter i ekosystemet: 1) en XSS-sårbarhet i webbapplikationen på grund av ineffektiv sanering av ingångar som leder till att stjäla administratörslösenord från webbläsarens cache, 2) mycket känsliga patientdata är öppna för allmänheten som standard, 3) webben applikationsinloggningsmekanism, där all systemdata hanteras, är svag mot gissningar av lösenord tillsammans med 4) osäkra GET-förfrågningar som används för autentisering, och slutligen 5) någon typ av databaskapning utlöser inga larm för Nightscout. Framgångsrika attacker resulterar i skadliga värden som synkroniseras från Nightscout för att manipulera korrekta insulinleveransberäkningar. Möjliga attackscenarier, utformade utifrån befintliga sårbarheter i detta arbete, visar hur en angripare fysiskt kan skada sina offer genom sin internetanslutna insulinpump.