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This Master's thesis describes the redesign of the HeartEye portable Electrocardiogram (ECG) device to enable home use for patients with coronary artery disease (CAD). The initiative aimed to transition the medical-grade 12-lead ECG from a clinical setting to a user-friendly, home-based application, maintaining the device’s diagnostic integrity while enhancing accessibility for non-expert users. The project was done in collaboration with HeartEye, TU Delft, and NPK Design, applying the double diamond design framework that works with four key phases: Discover, Define, Develop, and Deliver. Discover Phase: The redesign began with an examination of the existing HeartEye ECG device, assessing its design and functionality. Following research explored the opportunities in E-Health, highlighting trends and innovations that could inform HeartEye's integration into telemonitoring service centres. In-depth user group research was conducted to understand the specific needs, behaviours, and experiences of CAD patients, guiding the development of user personas. This phase also looked at the regulatory landscape to ensure that the redesigned device would comply with the most important medical device standards and to address potential future regulations related to AI and sustainability in healthcare. A quick dive into machine learning interpretability was completed. Additionally, market strategies were evaluated to discover if they would have an impact on the to be designed device. Gender-specific issues of heart disease and care were addressed as well. Lastly, a qualitative study enriched by direct patient feedback provided deeper insights into the personal impact of CAD. Define Phase: Using the knowledge from the Discover phase, a start was made to discover potential use scenarios. A well evaluated choice was made to choose for the rehabilitation to rehabilitation period as the use scenario to be designed for. Once this was defined, we sc, Integrated Product Design

This graduation project consists of the journey of developing a context-specific training system for nurses to administer a paracervical block (PCB) using the medical Chloe Syringe Extension Device (SED). This six-month during project is being carried out on behalf of TU Delft and Chloe Company. The aim of the project is to enable nurses in sub-Saharan Africa (SSA) in low-resource settings (LRS) to competently use the Chloe device for pain management during Manual Vacuum Aspiration (MVA). The outcome of this project is a two-component training system: a job aid and a demonstration device designed to enhance the training experience and guidance for use. The project approach was implemented using a context-driven design approach, consisting of Research & Analysis, Ideation, Conceptualisation and Evaluation. Literature research on the topic and its context is carried out, while further knowledge is gathered through contacts with sixteen Dutch and Kenyan medical professionals. In addition to individual interviews, two studies are conducted in the Dutch and Kenyan contexts. A six-week field trip to Kisumu, Kenya, during which ten medical professionals in three hospitals were visited, made it possible to ensure that the design truly fits its context. These medical professionals provided valuable input to the iterative design process and helped to shape the final concept design of the training system. Further designing is enabled through prototyping, the use of decision-making methods and continuous iteration. This allowed new ideas to be generated, tested, and therefore new improvements to be made. Ultimately, new requirements could be identified, providing the opportunity to create even more valuable designs. Future research should focus on further developing these designs, giving them an embodiment, and creating the possibility of actually implementing the training system in its intended context., Integrated Product Design | Medisign

This project focuses on developing a functional wearable prototype that can monitor changes in breathing behaviour by integrating textile sensors. The project was initiated by Mediventic, a healthcare industry start-up aiming to simplify the diagnoses and treatment of Chronic Hyperventilation Syndrome (CHVS) by creating affordable home-use smart clothing embedded with sensors that objectively record a patient’s biomedical data. Medical literature highlights the challenges of accurately diagnosing medical conditions in the healthcare industry, particularly CHVS, which is prone to errors due to the unusual range of complaints and symptoms. Medical professionals underline the need for wearable instruments to detect tell-tale signs and provide preventative treatment. On the other hand, current applications of smart textile wearables often lack focus on a specific problem. To better comprehend the problem and solution space, fundamental medical themes and the current status of wearable technology are reviewed. Important annotations about CHVS are concluded, emphasizing the close link between psychological and physiological elements that drive the self-perpetuating cycle of chronic hyperventilation and the development of symptoms. To assist the patient in gaining respiratory control, the use of wearable technology to support treatment processes is investigated. In particular, ‘smart textiles’ resemble an attractive medium for the integration of sensors and electronics. Respiratory movements can be captured at various points on the upper body utilizing strain sensors embedded in the textile medium. This allows a wearable to preserve valuable qualities for user experience typical for textiles such as comfort, flexibility, and aesthetics. During prototype development, performance, manufacturability, and usability requirements are translated into tangible prototypes, such as the fabrication of working knitted strain sensors for tracking breathing behavio, Integrated Product Design

Cystic fibrosis is the most common fatal recessive hereditary disease and affects about one out of every 3,000 newborns. There is no cure for this disease. Patients rely on treatment on a daily basis like medical treatment with both tablets and inhaled medication, airway clearance therapy and physical exercise to slow the decline in lung function and prolong their lives.

This project aims to reduce the environmental impact of an endoscopic product, the Polyp trap. The polyp trap is a single use device, that is used during endoscopy to catch removed polyps. Endoscopy is a department that has a relatively high reliance on single-use devices. This is one of the reasons why endoscopy has a high carbon footprint. Through observations in hospitals, literature and product research, the context of endoscopy, the polyp trap and other single-use devices are analysed. Additionally, circular frameworks and strategies specific to the medical context were explored, to identify circular opportunities for the polyp trap. A fast-track LCA of the current polyp trap is used to estimate its current environmental impact and analyse how interventions in design, function or material could influence its carbon footprint. The insights from this research are used to generate ideas aimed at decreasing the polyp traps environmental impact. The resulting idea directions are presented to various healthcare professionals, such as nurses and infection prevention specialists during interviews. During these interviews, opportunities and risks for the redesign are discussed. Insights from the interviews are used to further develop the idea direction into the final design. The final design consists of two concepts: The first concept is more conceptual, and reduces its impact by using some components for a longer amount of time; one day rather than per patient. The second concept is more traditional, and decreases its CF through minimising the required amount of material, leading to a smaller design that uses lower-impact materials. The environmental footprint of the final concepts is evaluated with a fast-track LCA., Integrated Product Design

The client of this graduation project, Dune Innovation, aims to facilitate and execute a structured design process for medical device development. This is a complex task most notably during the early ‘discover’ phase, or fuzzy front end. In medical device development, the first stages of the design process are crucial in ensuring the adoption chances of a new product. During the discover phase, the focus is to gather design inputs or requirements to reduce the uncertainty and risk in future project development. By logic, Dune Innovation does not have sufficient knowledge on all design criteria to solve these uncertainties. Therefore, the company seeks interaction with stakeholders to find unknown design inputs that can help to make progress. To do so, the intention is to organize meetings or interviews with these stakeholders. Unfortunately, this is no easy task. Stakeholders in the medical field often are short on time and don’t prioritize collaboration with Dune Innovation. Even if they manage to make time, standard interview methods are suboptimal for creativity and exploration. This struggle leads to ongoing uncertainties and longer lead times in projects. This thesis project delivers a new approach to interview settings during the discover phase of medical device development for Dune Innovation. This is achieved by developing a tool which embraces co-design strategies during stakeholder interview settings. By providing transparency on the clients’ design process towards the interviewee, the desired effect is to increase engagement, improve the quality of discussion and outputs. The goal of the session is to generate new design inputs together with the interviewee that are relevant for the projects design process. The concept of the co-design tool is based on these issues and aims to enable a structured co-design session between a facilitator and a stakeholder in a physical interview setting. The tool offers a functionality that should help in reaching, Integrated Product Design

Prostheses and orthoses are trending towards digital methods and automation. Adopting these methods is especially a challenge at Frank Jol, a clinic where patients' wide variety in residual limb characteristics and high activity demands pose a challenge for digital workflows which utilise 3D scanning to arrive at a final prosthesis. This is because certified prosthetists and orthotists (CPOs) who design and produce prostheses, apply a series of tactile adjustments to the residual limb using plaster that result in a more optimal fitting and distribution of weight in the socket, which cannot easily be captured and digitised. In collaboration with Gyromotics, a high-tech prosthetic foot start-up, and Frank Jol, this graduation project is an exploration into the potential for a pressure-sensing textile tool to capture the tacit knowledge of CPOs in the fitting of below-knee prostheses. The project begins with a detailed analysis. First, the clinical situation of the residual limb and the biomechanics of transtibial prosthesis is studied to understand what factors influence prosthesis fit, and how CPOs manipulate the residual limb to that effect. Then the process towards producing a prosthesis is analysed as it is executed at Frank Jol, in order to then compare to alternative processes that incorporate digital methods to understand the barriers and opportunities for intervention. Finally, CPOs and patients are interviewed to uncover their needs and values in the process. This analysis reveals the need for an intervention that captures and standardises the stump modification process in a digital way, while retaining CPO control and tactiliy, and keeping the patient in the communication loop. The design result is PressFit: a pressure-sensing textile tool to be worn by the patient, which registers CPO applied pressures and provides visual feedback during stump measuring and plastering. PressFit is introduced as it fits into an envisioned future prosthesi, Integrated Product Design

This design thesis explored the possibilities of recycling medical waste from the Intensive Care Unit of the Erasmus MC Hospital in the transition towards Circular ICUs. Through a combination of qualitative research methods, such as observations, interviews and waste audit, the medical context and the waste composition were explored. By selecting the most promising waste types for recycling, proposals for their collection and following parts of the waste journey were prepared. In close collaboration with the main stakeholders and several sessions with the nurses, two directions for the final design were defined. Both solutions bring part of the waste stream upwards in the hospital waste hierarchy, ensuring better environmental scenarios in the short term. The first part of the design provides a process for separately collecting the packaging of special infusions bags used for dialysis. This process is aided by several physical and graphical tools which help the waste generating group, the nurses, to integrate the separation into their practices easily and correctly. The second part of the design promotes the correct usage of existing waste shredders through simplified rules and aided decision making. By implementing the proposed solutions, nearly 10.000 kg of plastic waste can be derailed from incineration towards mechanical recycling, and 2000 kg of infectious waste can be saved from high intensity hazardous waste incineration. The overall environmental impact of the design is calculated to reach a reduction of 26.000 kg CO2 yearly and more importantly, poses an example to other hospitals, that recycling of their waste is a possible scenario., Integrated Product Design

Understanding how medical-grade Chemical Sterilization and High-Level Disinfection (HLD), and usage of the device in context affect the integrity of the device within its expected lifetime, and to suggest material choice, manufacturing method and recommend design changes for a syringe extension device, to be used for Manual Vacuum Aspiration Procedures in East Africa., Integrated Product Design

[ES] Desarrollo de una propuesta conceptual de un producto para mejorar la calidad de vida de las personas con ELA. El proyecto utiliza como metodología principal el Design Thinking con un enfoque centrado en el usuario. El proyecto está influenciado por mejorar e influir positivamente en el desarrollo psicológico del paciente, intentando mejorar su autosuficiencia. Se ha realizado una búsqueda de la enfermedad haciendo hincapié en sus síntomas y fases. En consecuencia, se ha realizado una investigación y encuesta a pacientes, familiares y sanitarios relacionados con la enfermedad para tener una base para la creación de conceptos viables. A lo largo de este informe se puede ver cómo se han desarrollado las ideas y los conceptos, cómo se han generado y evolucionado. Como resultado final, se propuso una grúa de techo, monitorizada mediante seguimiento ocular, así como un diseño de interfaz, que facilita la movilidad y la autosuficiencia del paciente. Se considera que el concepto final cumple todos los objetivos, aunque hay algunos requisitos cuestionables, como los materiales y las cargas físicas, que requieren un mayor desarrollo. Las metodologías seleccionadas se consideran herramientas eficaces para trabajar con proyectos de diseño de productos que buscan resultados innovadores, ya que proporcionan una combinación adecuada de investigación y selección de ideas, así como una aportación adecuada para la participación de los usuarios, [EN] Development of a conceptual proposal for a product to improve the quality of life of people with ALS. The project uses Design Thinking as the main methodology with a user-centered approach. The project is influenced by improving and positively influencing the psychological development of the patient, trying to improve their self-sufficiency. Research of the disease has been carried out with emphasis on its symptoms and phases. Consequently, a research and survey of patients, relatives and health care providers related to the disease has been carried out to have a basis for the creation of feasible concepts. Throughout this report it can be seen how ideas and concepts have been developed, how they have been generated and evolved. As a result, an overhead lift, monitored by eye-tracking as well as an interface design, which facilitates patient mobility and self-sufficiency, was proposed. The final concept is considered to meet all objectives, although there are some questionable requirements, such as materials and physical loads, which require further development. The selected methodologies are considered effective tools for working with product design projects seeking innovative outcomes, as they provide an appropriate combination of research and idea selection, as well as adequate input for user involvement., [CA] Desenvolupament d'una proposta conceptual d'un producte per a millorar la qualitat de vida de les persones amb ELA. El projecte utilitza com a metodologia principal el Design Thinking amb un enfocament centrat en l'usuari. El projecte està influenciat per millorar i influir positivament en el desenvolupament psicològic de l'pacient, intentant millorar la seva autosuficiència. S'ha realitzat una recerca de la malaltia posant l'accent en els seus símptomes i fases. En conseqüència, s'ha realitzat una investigació i enquesta a pacients, familiars i sanitaris relacionats amb la malaltia per tenir una base per a la creació de conceptes viables. Al llarg d'aquest informe es pot veure com s'han desenvolupat les idees i els conceptes, com s'han generat i evolucionat. Com a resultat final, es va proposar una grua de sostre, monitoritzada mitjançant seguiment ocular, així com un disseny d'interfície, que facilita la mobilitat i l'autosuficiència de l'pacient. Es considera que el concepte final compleix tots els objectius, encara que hi ha alguns requisits qüestionables, com els materials i les càrregues físiques, que requereixen un major desenvolupament. Les metodologies seleccionades es consideren eines eficaces per treballar amb projectes de disseny de productes que busquen resultats innovadors, ja que proporcionen una combinació adequada d'investigació i selecció d'idees, així com una aportació adequada per a la participació dels usuaris

The industry devoted to keeping us healthy is also one of the largest contributors to climate change: one of the greatest threats to our well-being. Medical devices and services are often designed in and for high-income countries. However, they are also used in low- and middle-income countries. Due to this mismatch of context, they are often not functioning properly in these emerging markets. This results in a lack of proper healthcare and a large (e-)waste problem in countries where the majority of the world’s population resides. This aforementioned situation asks for the next generation of medical practices: innovations targeting the large global need for healthcare. This thesis explores the three design domains Medical, Inclusive, and Circular Design simultaneously for the first time. The answer to the stated research question is found through an extensive exploratory literature review, many low- and high-fidelity prototypes, interviews, and test sessions. An iterative design process led to (1) creating a theoretical model that provides a structured, understandable, and descriptive design journey, and (2) a physical toolkit to offer a low-barrier, engaging and memorable usage of this model. The final concept is the COEVOLVE toolkit which includes the COEVOLVE approach. This approach provides grip on the process of redesigning a medical practice more inclusive and circular. The intrinsic value of a medical device/service increases by being beneficial to the planet and being prosperous to people. Likewise, the concept encourages designers in education to change their mindsets to tackle our future challenges. The developed theoretical model provides design students with a design process fulfilling their ambition to have an impact. It aids in exploring the different perspectives needed, creating awareness of the life cycle of a medical device/service, and finding opportunities that emerge to improve its circularity and inclusivity. Likewise, the model facilitates the, Integrated Product Design

Most women opt for so called cosmesis, a cover which mimics the look of a leg, on their prostheses in order to get real-looking legs. Their male counterparts usually choose to show the entire construction or parts of the raw prosthesis. However the cosmesis is in many cases lowering the functionality of the prosthetic leg. In this project, 8 female and 2 male lower-leg amputees were interviewed in order to find out what might be the driving force to go for one or the other and find a common ground that works for most people. Additionally, a prosthesis engineer and a prosthesis technician were interviewed in order to understand the existing system. The findings resulted in a concept for an active lower-leg prosthesis which can be adapted to different shoes and heel heights - a titanium base with a 3D-knit sleeve which moves with the amputee.

Orthopedic surgery is dangerous, especially for the surgeon! Tool failures belong to the ten most frequent causes of operation delays. Nowadays, hospitals are pressured to optimize procedures and lower costs. Especially, orthopedic surgery is physically demanding for the ergonomics of the surgeon and tools wear out more quickly. Could the evolution of a surgical power tool be used in these scenarios to ease and support the surgeons work, increase the efficiency and flexibility of usage and at the same time offer more control and knowledge about the condition of the tools?

A ventricular assist device (VAD) is a surgically implanted mechanical pump attached to the heart to assist its function in patients with advanced heart failure. This paper investigates the current state of training being provided to VAD patients and caregivers, and whether it adequately prepares them for the VAD lifestyle. The study consisted of a literature review, a content analysis and interviews conducted with stakeholder representatives. A co-design process led to the development a holistic interactive prototype that was evaluated by one VAD caregiver, one VAD biomedical engineer, and one VAD surgeon. Four key themes emerged from the research examining the VAD patient and caregiver training experience: (i) uncertainty, (ii) misinformation, (iii) gratitude, and (iv) preparation. Five overarching themes emerged as design recommendations: (1) artificial onboarding, (2) contextual empathy, (3) ongoing support, (4) physician connectivity, and (5) emergency scenarios. Findings suggest the need to focus on not just the patient, but equally on the VAD caregiver. Design opportunities include the optimisation of both training tools and VAD communication relating to emergency scenario preparation.

A ventricular assist device (VAD) is a surgically implanted mechanical pump attached to the heart to assist its function in patients with advanced heart failure. This paper investigates the current state of training being provided to VAD patients and caregivers, and whether it adequately prepares them for the VAD lifestyle. The study consisted of a literature review, a content analysis and interviews conducted with stakeholder representatives. A co-design process led to the development a holistic interactive prototype that was evaluated by one VAD caregiver, one VAD biomedical engineer, and one VAD surgeon. Four key themes emerged from the research examining the VAD patient and caregiver training experience: (i) uncertainty, (ii) misinformation, (iii) gratitude, and (iv) preparation. Five overarching themes emerged as design recommendations: (1) artificial onboarding, (2) contextual empathy, (3) ongoing support, (4) physician connectivity, and (5) emergency scenarios. Findings suggest the need to focus on not just the patient, but equally on the VAD caregiver. Design opportunities include the optimisation of both training tools and VAD communication relating to emergency scenario preparation.

This paper aims to answer the question ‘What are the initial experiences of people who use Continuous Positive Air Pressure (CPAP) therapy, and how can design address barriers that influence engagement within the first week of therapy?’ Obstructive Sleep Apnoea (OSA) is a respiratory sleep condition that is characterised by a repetitive collapse of the upper airway during sleep, causing a lack of oxygen and build up on carbon dioxide within the body. Left untreated, OSA can lead to serious medical conditions that may significantly reduce one’s quality of life and risk early death. The primary treatment for OSA is Continuous Positive Air Pressure (CPAP) therapy. This is a machine that pumps pressurised air through a facial mask to keep the airway open during sleep. Even though CPAP is the most effective treatment for OSA, it is known to be burdensome and adherence is problematic. This thesis identifies the barriers that influence CPAP engagement through literature reviews, online surveys, cultural probes, and interviews with manufacturers, clinicians and CPAP users. The barriers identified include first impressions, product-related and social stigma, the ability to troubleshoot issues and the level of support, education and feedback present in the initial stages of therapy. The outputs from this research focus on improving the user experience through design-based interventions. First, packaging solutions that focus on the interaction, the user’s first impressions, display of product information, and ease of assembly of the equipment. Second, a website that addresses education, support, customisation and the ability to troubleshoot issues. Third, customisable aspects that focus on personalisation of the CPAP equipment through 3D knitting processes that develop customised fabric hose covers. Lastly an application that addresses feedback, support and troubleshooting issues. Concepts are assessed against their relevance to the design criteria.

Healthcare systems are becoming increasingly conscious of the quality of care delivered, along with the provision of value-driven services. Nevertheless, the majority of innovation in the realm of healthcare has been focused on products and services. Beyond being the major contributor to healthcare expenditure, these technology-driven innovations treat medical staff as the primary stakeholder and do little in the way of improving the quality of care for patients. This presents an opportunity to explore other forms of innovation in the context of healthcare. As a human-centred approach, design offers a method for holistically exploring problems, meeting stakeholder needs, and has been established as a means of driving innovation. This paper suggests that a design-led approach to innovation could increase quality of care and assist in creating value-driven services. To conclude, the paper contributes a framework, along with a set of examples, detailing four design objectives in the context of health and medicine.

The framework of design for the circular economy is increasingly used in industry to improve product sustainability and decrease costs, and in academia various models have been developed to guide circular design. However, in the medical sector, although it generates a large amount of waste, application of circular design principles is difficult because of the clinical challenges of safety and sterility that reuse of products or materials entail. This paper categorizes and analyses existing instances of circular economy in the medical sector, using a literature review and examination of existing industry examples. This is used to identify challenges and unmet opportunities for circular design in the medical sector. The key factors affecting circular medical design are found to be device criticality in terms of sterilization requirements, device value and the organizational support structure around the device. A design heuristic and suggested strategies for circular design of medical products are proposed based on these findings., Circular Product Design