Topic of this thesis is design of medical bed for magnetic therapy for one person with two tube aplicators. The goal is create magnetic therapy device for magnetic therapy and create new cocnept of megnetic therapy devices which approximate by their quality to currently used high standard medical appliances.

The topic of this diploma thesis is the design of a device for dialysis, which is intended for medical institutions. During this thesis existing products were analyzed from the design and technical side. Also was achieved an understanding of the problem of existing dialysis devices. The result is a new conceptual solution with an emphasis on creating clean forms of equipment and taking into ergonomic, technical and aesthetic requirements.

The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. This study aims to elaborate on a practical and objective situation of this latest shift and picture out a predictable scenario for the implementation of future technology like Additive Manufacturing (AM) in healthcare. These two objectives are addressed from the perspective of the core role in this system, Notified Bodies (NBs). Specifically, it answers the following questions: What is the impact of the MDR on the NBs’ operations? What is the impact of the MDR on the device building on AM from NBs’ perspective? A literature review is conducted on existing researches in the relevant fields mentioned in the research questions of this study. Then a self-completion questionnaire is generated and sent to NBs who offer the CE marking granting service for the medical devices around the EU. The eight responses for the survey indicate that the MDR influences NBs and the device building on AM from several perspectives. For the NBs, the number of NBs will decrease while the workload and new recruitment will increase. Also, the independence and competences of NBs will be improved by MDR. In the case of AM-relevant medical devices, MDR will pose specific issues on them while the market will be developed by ensuring the product quality and raising public awareness. These findings are valuable practical evidence to examine the application of MDR and the implementation of technology like AM in healthcare under MDR. Overall, it found that the MDR will cause a tough situation in the short term. At the same time, the far-reaching influence for the regulatory system, as well as the medical device market, is affirmative and expectable worthy.

Medical technology industry which produces the whole range of medical devices from eye droppers to computer tomography scanners is characterized by serious learning problems of industry stakeholders due to its high technological complexity and product diversity. Majority of firms populating the sector are small companies with no revenues, and therefore, depending strongly on venture capital to get their products on the market. At the same time due to technologies which are successfully launched, this industry employs highly qualified staff, promotes jobs and tax revenues. The industry progress is fueled by process of incremental innovation which occasionally produces technological breakthroughs. Medical device regulations, i.e. the mechanism of granting by a state to a manufacturer the rights to market her products in return of proof of their safety and effectiveness/performance, are an important element of innovation ecosystem of medical technology industry. They serve as a tool for decreasing uncertainty of stakeholders’ interactions on the market, ensuring public safety and legitimacy for manufacturers and their products. Supportive medical device regulations improve the investment climate in the industry by reducing related risks, and, hence, contribute to promotion of innovation in the short run and better and cheaper healthcare in the long run. In the regional context, therefore, particular design of medical devise regulations can be a source of competitive advantage of the whole region in the international arena. The present study compares two dominant regulatory frameworks: American and European. It attempts to answer the question: Which specific features of national/regional medical device regulations contribute to sustaining or improvement of a current and future position of a country/region on a world leadership chart? The two approaches are studied at present as well as in dynamics, the parameters determining the regulatory approach success are pointed out and then specific traits of regulatory approaches underpinning success parameters are defined and conjectures are made regarding the future trends of development for each of the two approaches. It has been shown that US and EU regulatory frameworks are likely to ensure similarly high safety level of devices, while European approach seems to be more efficient. Such traits of European framework as use of international performance standards and diversified responsibility among actors involved into regulatory process contribute to its higher efficiency.

Cationic steroid antimicrobials (CSAs or ceragenins) are a novel class of synthetic, cholic acid-based mimics of endogenous antimicrobial peptides. These small molecule compounds display broad bactericidal activity against gram-negative and gram-positive bacteria, potent ability against fungal pathogens, and cidal effects against drug resistant and multidrug resistant microbes. Implantable medical devices provide an abiotic surface upon which bacteria and fungi can accumulate--thereby leading to localized or systemic infection. We proposed that CSA antibiotics can be incorporated into medical device surface coatings which can be optimized for the active release or elution of the CSA compounds over time to prevent device-associated infections. This report will discuss the progress of developing and testing coating systems for 3 such devices: cardiac implantable electronic devices (CIED), silicone nasal splints, and breast tissue expanders. In the case of CIEDs, an envelope material containing CSA was created using bioresorbable polymers. We found that this envelope elutes CSA antibiotics and kills all surrounding bacteria or fungi in both planktonic and biofilm forms within 1 hour of exposure. We also developed a nasal splint coating which is directly adhered to the surface of the silicone splint. This coating system demonstrated more than 8 days of protective ability (full microbicidal activity to the detection limit) against Candida albicans, and reduced microbial growth of P. aeruginosa, Candida auris, and MRSA for approximately 6 days. Lastly, in the case of tissue expanders, we developed a layered coating which displays fully-reductive antimicrobial activity against MRSA for 8 days with reintroduction of bacteria every 24 hours. Additionally, this work will discuss our investigations into the secondary properties of ceragenin compounds. On the basis of studies which have demonstrated the pro-osteogenic properties of CSA, we probed the mechanism of this effect. We studied the potential effects of ceragenins on the proliferation, differentiation, and migration of bone-derived mesenchymal stem cells (MSCs). We have determined the absence of any positive proliferative effects of ceragenins on these cells; however, we have demonstrated the significant migration-promoting chemoattractant properties of CSA. In the case of CSA-13, we have observed up to a 400% increase in migration compared to the control. Also, we demonstrated that the P2X7 receptor is strongly implicated in the cellular mechanism of this effect. Our studies of the differentiation-promoting properties of CSA on MSCs have been largely inconclusive, but further investigations are proposed in this report. Lastly, this work includes a report on our investigations into the potential synergistic interactions between CSA-131/CSA-44 with amphotericin B or caspofungin, two commonly used antifungal agents.

The healthcare sector has become a key area for the development and application of new technology and, not least, Artificial Intelligence (AI). New reports are constantly being published about how this algorithm-based technology supports or performs various medical tasks. These illustrates the rapid development of AI that is taking place within healthcare and how algorithms are increasingly involved in systems and medical devices designed to support medical decision-making.  The digital revolution and the advancement of AI technologies represent a step change in the way healthcare may be delivered, medical services coordinated and well-being supported. It could allow for easier and faster communication, earlier and more accurate diagnosing and better healthcare at lower costs. However, systems and devices relying on AI differs significantly from other, traditional, medical devices. AI algorithms are – by nature – complex and partly unpredictable. Additionally, varying levels of opacity has made it hard, sometimes impossible, to interpret and explain recommendations or decisions made by or with support from algorithmic decision systems. These characteristics of AI technology raise important technological, practical, ethical and regulatory issues. The objective of this thesis is to analyse the relationship between the EU regulation on medical devices (MDR) and algorithmic decision systems (ADS) used within the medical domain. The principal question is whether the MDR is enough to guarantee safe and robust ADS within the European healthcare sector or if complementary (or completely different) regulation is necessary. In essence, it will be argued that (i) while ADS are heavily reliant on the quality and representativeness of underlying datasets, there are no requirements with regard to the quality or composition of these datasets in the MDR, (ii) while it is believed that ADS will lead to historically unprecedented changes in healthcare , the regulation lacks guidance on how to manage novel risks and hazards, unique to ADS, and that (iii) as increasingly autonomous systems continue to challenge the existing perceptions of how safety and performance is best maintained, new mechanisms (for transparency, human control and accountability) must be incorporated in the systems. It will also be found that the ability of ADS to change after market certification, will eventually necessitate radical changes in the current regulation and a new regulatory paradigm might be needed.

Master of Public Health - MPH / South Africa had a stillbirth rate of 16.4/1000 in 2019. Umbiflow is a sophisticated portable continuous wave Doppler device with bidirectional indication of blood flow velocity in the umbilical cord. Umbiflow clinical trial results have indicated that several stillbirths were avoided by screening pregnant women classed as low risk. The study aimed to describe the perceptions of health professionals on the Umbiflow screening tool. The objectives were to explore the health professionals’ perceptions on the usability, acceptability and the perceived challenges with implementation of Umbiflow

Masks have become an important part of everyday life, protecting both the wearer and individuals nearby from the spread of infectious diseases, most notably severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the coronavirus that causes coronavirus disease 2019 (COVID-19). However, these masks are easily contaminated, whether through continued use or by the wearer touching the mask fabric with contaminated hands, therefore reducing the efficacy and exposing the user to these contagions. When the mask becomes contaminated, it can be discarded, which produces large amounts of waste that will end up in a landfill, or it can be washed, which is costly, wasteful, and time consuming. Our solution to this problem is a mask apparatus that can sanitize itself quickly on demand. The user wears the shell, which contains the fully retracted mask, on a string like they would a necklace. When the mask is required, it is easily pulled out of the shell and can be worn for as long as the user needs it. When it is safe to remove the mask, the user simply pushes a button and the mask retracts back into the shell, where it is then sanitized for the next use. The design of the apparatus features a retractable cloth mask that is sanitized using ultraviolet-C (UVC) radiation while confined safely within an outer shell, minimizing unwanted exposure to the wearer. UVC radiation at wavelength 222 nm has been shown to destroy the outer shell of coronaviruses similar to SARS-CoV-2, inactivating 99.9% of the virus when exposed at a dosage of 2 mJ/cm2. The 28 light-emitting diode (LED) lamps used in this prototype produce this specified wavelength UVC and are separated into 4 strips located in different locations within the shell. Glass rods were used within the shell to guide the mask fabric into a zig-zag shape when fully retracted to maximize exposure to the UVC. To further reduce waste, two lithium-ion rechargeable batteries were used as the power supply for the lamps. The efficacy of this design for inactivating the SARS-CoV-2 coronavirus on the mask was determined indirectly using nano membrane UV sensors placed on the mask fabric, showing that the specified wavelength of UVC radiation can be applied for the required time on all surfaces of the mask. This mask apparatus can directly benefit both front-line healthcare workers as well as individuals going about their daily lives by eliminating pathogens present on their masks, therefore reducing the spread of deadly infectious diseases.

Background: Medical device companies must consider different laws and regulations when developing new products. Not just laws and regulations put on themselves, but also laws and regulations put on the market, including the public sector. New product development consists of what is known as the fuzzy front end (FFE) of innovation, where companies must make ill-defined decisions with limited information. Problem formulation: There is a vast number of studies within the FFE of innovation, many of which focus on what causes the fuzziness, namely uncertainty, complexity and equivocality. There are, however, limited studies focusing on the FFE within the medical device industry, emphasising the public sector. Purpose: The purpose of this thesis is to explore the FFE of innovation within the Swedish medical device industry, where the public sector is prominent. The aim is also to highlight industry-specific aspects of the whole FFE for medical device companies to consider when commercialising their products to the public sector, which is arguably an even fuzzier market. Method: To be able to answer the research question, this thesis is built upon a qualitative, multiple case study with an abductive approach to theory development. Five interviews were conducted with four different companies within the medical device industry in Sweden., and two interviews were conducted with two different county councils in Sweden. Findings: The main findings of this thesis are that the public sector creates higher amounts of uncertainty and complexity within the medical device industry. Thus, the FFE of innovation is industry-specific and also depends on what type of product is being developed. Equivocality as well is found to have other dimensions within FFE in the Swedish medical device industry. Conclusion: Many aspects of the FFE of innovation from previous studies exist in the medical device industry in Sweden, but the FFE seem to contain higher amounts of each cause of fuzziness.

Artificial intelligence (AI) is the study of science, engineering, and the development of intelligent machines. AI is based on human intelligence with the exception that it is not restricted by biologically observable limitations. AI has developed rapidly over the past few years and has become important all over the world. This Master’s thesis brings up AI as a medical device and the European market. The thesis provides guidance in the form of important aspects to be considered by small and medium-sized enterprises (SMEs) when marketing products in Europe. There is a lack of guidance and clear descriptions regarding AI/ML-based medical devices in Europe. Both MDR and medical devices with AI/ML are relatively new and uncharted. There are no clear guidelines, instructions, or articles that clearly describe what is needed to get an AI/ML-based medical device on the European market. In summary, there is no guidance that SMEs could benefit from when it comes to AI/ML-based medical devices and the European market. With this thesis the subject is enlightened and hopefully, the gap in knowledge about this is reduced. The chosen method to achieve the goal of this thesis is both a literature review and qualitative research in the form of interviews with relevant experts within the field. The results show that there is a lack of guidelines and regulations for AI-based medical devices, it is harder for SMEs to market such devices and it is complicated to put an AI-based medical device on the European market due to MDR. SMEs should consider certain aspects important when developing an AI/ML-based medical device and placing it on the European market. The identified aspects are creating a regulatory plan, using guidelines from example FDA, procuring regulatory competence from the start, risk classification, economics, clinical evaluation, risk management, having end-user in mind during the development, and data management/cybersecurity. The results also show that if guidelines are developed, they should contain thresholds for different characteristics in AI/ML-based medical devices, risk classification of the device, classification requirements, checklists, templates, actions, good manufacturing process description, data management, cybersecurity, patient safety process description, clinical evaluation process description, regional regulatory adaptions, and risk mitigation. The results of this thesis can be used in many ways and by many. By solely using this report for AI/ML-based medical devices, complete compliance with MDR is not fulfilled.