Needle Stick Injuries (NSIs) are a significant occupational hazard for healthcare workers, exposing them to life-threatening pathogens such as HIV and Hepatitis B and C. Although safety-engineered devices have successfully reduced NSI rates in high-income countries, their high costs, limited adaptability, and environmental impact hinder their adoption in low- and middle-income countries.

This thesis addresses the need for a cost-effective, sustainable, and user-friendly needle safety system applicable to low- and middle-income countries, particularly in Nepal. The objective is to explore the solution space and propose an optimal blueprint for a needle safety system for this context, in order to provide the foundation for a novel needle safety system.

To achieve this, multiple design phases and a field trip are performed. The exploration of the solution space is guided through the elimination by aspects decision-making strategy through multiple design phases. The first started with conceptual strategies ought to solve the composed design brief; the remaining two strategies were translated into concepts that were ultimately developed into MVPs. Within this process, concepts were discontinued on the basis of the elimination by aspects method. This resulted in one efficient strategy. From this process, two effective devices employing the strategy are identified.

Validation trials in six Nepali hospitals demonstrated their effectiveness, usability, and acceptance among healthcare workers, emphasizing their potential to address the challenges faced. In addition, the field trip validated the problem analyses and underscored the need for such solutions. Both systems can meet the design requirements described and perform well in the performance metrics. The concepts provide a foundation for future development, marking a step toward safer, more affordable, and sustainable needle practices.

Future research should explore the market need for the proposed one-handed and handheld solutions. Finally, the proposed solutions can be optimized to lower force requirements and must be refined for large-scale production and ensure compliance with medical standards.

Leprosy is a neglected tropical disease affecting people worldwide. Left untreated or starting therapy too late, the infection can cause permanent damage to the nerves, skin, eyes, and limbs of patients. While current standard diagnostic techniques generally detect the disease once symptoms have manifested, infrared thermography presents a potential tool for the early detection of leprosy-related neuropathy. A research initiative has been established to explore whether autonomic nerve impairment in the hands can be identified using infrared thermography, necessitating a new method for temperature evaluation. This work discusses the development of a semi-automatic temperature analysis method for twelve regions of interest on the hands. The approach utilises real-time landmark tracking based on an existing machine-learning model, adapted to the context of the application. After applying a cold impulse and recording the response with an infrared camera, the rewarming temperature and recovery values are determined within the regions. Results presented in this report indicate no significant improvement compared to the existing manual method. The success of the model outcomes highly depends on the accuracy of the machine-learning-based hand landmark detection, resulting in insufficiently reliable outcomes. The underlying explanations and the potential for future improvements are further discussed in this thesis, considering the evident potential and benefits of the automated approach.

This thesis proposes a method of detecting autonomic neuropathy in low-income countries using an infrared camera. Access to healthcare is often limited in low-income countries delaying the detection of neuropathy. If neuropathy can be detected in the earliest stage, often the autonomic state, damage to motor and sensory nerves can be prevented. To develop the method for detecting autonomic neuropathy, first the autonomic system was researched, followed by looking into the effects of neuropathy on the autonomic system to discover what physical properties might be measured with the detection device.
Four affected physical properties were determined through literature research: blood flow, blood pressure, skin resistance, and skin temperature. Of these properties, skin temperature was found to be the most promising based on a literature study, as it seemed to be both easily measurable and relatively independent of other bodily functions. Then the constraints of healthcare in low-income countries were examined and devices that work within these constraints were identified. Of these, the infrared camera showed the most promise, because of its ease of use and cost to accuracy ratio.
A single-subject study was performed to test the restorative capacity of the autonomous system by deliberately changing the temperature of the hand with a heating and cooling agent. Four locations were used on both hands, and both palmar and dorsal side of the hand, using different doses of the agents. The temperature change of the skin was measured using an InfraRed (IR) camera.
A large variation in results was found, but the results did show some evidence for structural differences in the temperature normalization between the affected and unaffected hand. The palmar side shows a stronger reaction than the dorsal side. The cooling agent seems to be more effective, but there are some caveats attached to its use. An interesting observation is that the most noticeable difference between left and right was measured in an area of low circulation. This gives some indication that this area has the most difficulty with returning to the neutral state.
Conclusion: This research shows that skin temperature variation as a result of applying heating or cooling agents to the skin can be measured using an infrared camera, suggesting that minor variations in skin temperature as a result of neuropathy can also be measured, further research with more test subjects should be done.

The prevalence of chronic and complex wounds is high in low- and middle-income countries (LMICs). Due to the lack of adequate treatment wound conditions are likely to worsen. Improving access to wound care in LMICs is crucial for enhancing the quality of life for the people living there. Vacuum- assisted closure (VAC) therapy is an effective treatment for chronic and complex wounds. By applying a negative pressure to the wound the healing process is promoted. However, due to the high cost of VAC devices, their availability in LMICs is limited. A. Knulst works as a biomedical engineer at GPH and recognized this problem. In GPH the AquaVAC, a converted aquarium pump, is used to be able provide VAC therapy to patients. The use of the AquaVAC is not meeting the users’ requirements. Recognizing this problem, A. Knulst initiated the WOCA project to develop a VAC device tailored for LMICs. Over the past three years, the project has progressed to creating three simple yet functional prototypes using locally available materials in GPH. Based on the findings of A. Knulst a suitable next step for the WOCA is determined to conduct a clinical trial to evaluate the WOCA’s effectiveness in wound healing.
Designing the goal of this graduation project; preparation of the WOCA for the performance of a clinical trial conducted in GPH. Based on analysation of this goal preparation of the WOCA consists of veri- fication, and validation of the design requirements, verification of the applicable ISO-criteria, and the performance of a risk assessment. By making a redesign the current WOCA at GPH will also be made compatible with these stated requirements.
By making a redesign during this graduation project the canister is implemented and the noise is re- duced for the WOCA. This new version of the WOCA is verified for its design requirements as well as validated, also the applicable ISO-norms are verified and a risk assessment is performed.
Based on this performed effort it is shown that the WOCA is exceeding the allowed noise level deter- mined to be reached before the WOCA can start the clinical trial. Furhtermore, recommendations have been given for additional validation and verification of the WOCA before conducting the clinical trial.
Steps have been taken during this graduation project to improve the access to wound care in LMICs by a contribution to the open-source-publication of the WOCA device, and the development of a study protocol for the performance of a clinical trial.

Ensuring reliable and safe performance of medical devices in healthcare institutions is crucial for the wellbeing of patients. For this, physiological simulators may be used, which provide reference signals to compare against. The usage of physiological simulators, such as ECG simulators, as medical device testers is widely extended in high-income countries. However, their high cost and need for frequent calibration by the manufacturer make their availability and usage in low-resource settings (LRs) unfeasible. Remote healthcare facilities, low- and middle-income countries (LMICs), and hospitals in general would highly benefit from new designs of simulators that can be produced, repaired and maintained locally. Therefore, we present the design of an affordable, portable Arduino UNO-based prototype ECG simulator with the novel feature of visual indicators for self-calibration checks. The ECG simulator was built with affordable and broadly available components and tools, retrieved from an educational electronics workshop. The current prototype can be used to test 3-lead ECG meters. It reproduces a lead II waveform extracted from MIT-BIH database, with 1.3 mV peak-to-peak and 0.1 mV negative offset. Heart rage simulation ranges from 35 to 130 bpm, in steps of 5 bpm. Signal data points defining a desired waveform and heart rate can be uploaded into the simulator via the user-friendly and open-source Arduino software. The simulator could also be modified to generate 10- or 12-leads by upscaling the electronics and adding more storage space. Analog signal generation is based on a pulse-width modulation signal, which is smoothened by a low-pass filter and decreased in amplitude with operational amplifiers, which also add a negative voltage offset. Visual indicators enable simulated frequency and amplitude checks without the need of external tools, while amplitude can be calibrated manually. Additionally, rechargeable batteries facilitate on-site testing of medical equipment. Evaluation of the prototype included performance and functionality tests. HR and amplitude accuracy of the simulated signal were quantified and compared to those from a commercial simulator. Lastly, the performance of the simulator in a real scenario was tested at the Green Pastures Hospital of Pokhara, Nepal. Functionality tests proved the correct detection of the simulated signal by 6 patient monitors of different models, manufacturers and purchase year.

The objective of this thesis project is to develop an economically viable design for a titanium total ossicular replacement prosthesis (TORP) that caters to the needs of low- and middle-income countries (LMICs). The author focused on addressing the problem from the manufacturing aspect and two primary approaches, additive manufacturing (AM or 3DP) and metal forming, were selected in the literature review attached in Appendix A. One concept was generated for 3DP, utilizing selective laser melting (SLM) to fabricate a straightforward structure using Ti6Al4V. Additionally, two similar concepts, 2A and 2B, were proposed for metal forming, involving precise metal laser cutting of a two-dimensional piece and subsequent bending to achieve a three-dimensional TORP shape. Concept 2A features a fixed-length shaft, whereas Concept 2B incorporates an adjustable zigzagged shaft, aiming to obviate the need for storing multiple sizes of TORPs. These concepts were manufactured into prototypes and systematically evaluated based on predetermined assessment criteria including affordability, manufacturing process, precision, sound transmission property, and simplicity. After assessment, Concept 1 was omitted from the final solutions due to its high cost and demanding post processing steps. And Concept 2A and 2B were deemed as potential TORP designs for the costs of 3.5 and 0.9 euros, dimensional errors of 2.22 % and 2.33 %, preparation duration of 0 and 5 minutes, and the comparable performances in manufacturing process and sound transmission with the commercial products. In conclusion, the TORP designs produced by precision laser cutting were considered the more cost-effective and accessible solutions for LMICs in need of ossiculoplasty.

The goal of this project is to design and create a low cost total ossicular reconstruction prosthesis (TORP) for use in low-middle income countries (LMIC). These middle ear prostheses are available on the market but are unaffordable for the general populace in LIMCs. A mould is designed with which a titanium wire TORP could be created . A multitude of wire TORPs are made and measured to test the performance of the mould. Transmission properties of the TORP are measured by using a Mechanical Middle ear Model(MMM), a synthetic recreation of the middle ear. This model is used to make a comparison of transfer functions between the wire TORP and a commercial model. The comparison showed slightly worse transmission properties for the wire TORP compared to its commercial counterpart. The result is a production method suitable for LIMCs that can create affordable TORPs that can fit in every middle ear.

AIM: In order to contribute to the research concerning the large quantities of out-of-service medical equipment in LMIC, this master thesis will focus on evaluating which combination of factors related to a MOOC’s design, structure, logistics, content and delivery method; result in a better course performance, engagement and experience for the user; and consequently, how to translate these findings to the design of the future BMET MOOC to maximise its impact. Additionally, it will also evaluate whether the delivery of materials through interactive content could exhibit potential benefits for the students, directly reflected on the performance, by encouraging their involvement in the course and promoting active engagement. METHODS: A single blinded pilot study was created on edX Edge, in collaboration with local experts (NSI). It covered topics related to the Patient Monitor in four modules. To validate the hypothesis, the participants were allocated in two groups, related to the delivery method they were exposed to, after a stratified randomisation. Following a Pre-test/Post test design, the performance was measured as the mean of difference between the grades on each test. The corresponding statistical analyses on the independent variables and covariates were performed. The content was validated by experts on the field; and the methodology behind the pilot was approved by the HREC of the Delft University of Technology. RESULTS: The differences in the delivery method, lead to a significant improvement in the performance of 11.9%, compared to regular content. The female students were more prone to this enhancement, as well as the African participants. Besides, these findings suggest that this new delivery method not only boosted the involvement in the course, and was able to take up part of the responsibility placed on the students in online education courses; but it also prevented the reduction in engagement.
The structure, and materials provided were sufficient and successful to teach the key concepts of this module. Moreover, there was no evidence found that suggested the need to segregate the future MOOC in difficulty levels based on the participants previous experience or location. However, since the main challenge faced by the students to finalise a MOOC, is to allocate sufficient time to work on it; it was recommended if the amount of work load per week could be reduced to 6 hours maximum. CONCLUSIONS: The overall analysis presented in this project concluded with a series of key factors, issues, and barriers related to the course’s design, structure, logistics, content and delivery method. The study was not only fairly successful in reaching its targeted audience, but it also built a network of BMETs from diverse backgrounds, locations, and experience, interested in the pilot, and willing to collaborate in the versions to come.
On that account, the BMET MOOC presents itself as a great alternative to prevent the great amount of out-of-service medical equipment in LMICs, and these outcomes can be of great value in eventually transferring and implementing the complete curriculum to an online platform to train these professionals on how to properly use, maintain, and repair medical devices; and therefore, have a direct impact on the maintenance of medical equipment in these countries, to ensure a proper quality of the health care delivery.