Neurodegenerative diseases like Parkinson’s and Alzheimer’s have a huge impact on patients, their close ones and society as a whole. The negative consequences of these diseases are ever increasing due to our ageing society and growing shortage of healthcare personnel. Worldwide research efforts have thus far been unable to find effective treatment options.

Brain deterioration in neurodegenerative diseases sets in 15 to 20 years before clinical symptoms become noticeable. This means that even if better treatment options become available, much irreversible damage has been inflicted before we know to administer the treatment.

Early deterioration of smelling ability has been shown to provide a good risk indicator for future disease development. This thesis dives into the sense of smell as a means of recognizing neurodegenerative diseases preclinically.

An olfactory evaluation tool, called Knowse, was developed. This concept product was designed to make the well-known ODOFIN Sniffin’ Sticks test suitable for the context of case-finding for neurodegenerative diseases. Knowse transforms the Sniffin’ Sticks into an automatic self-test that people may use at a brain health clinic or optician. The product provides people with a relative trendline of their smelling ability, from which conclusions can be drawn over time.

This thesis report features a deep-dive into the neurodegenerative diseases Alzheimer’s and Parkinson’s, their impact and their current procedures. Possible future test locations, ethics of diagnostics and the current olfactory test market are explored through interviews and literature research.

Several design methods, prototypes and design iterations are described as they lead towards the final concept product of this thesis, Knowse. Design focused much on the technical, usability and error-proofing aspects of the concept product.

This project explores the integration of a microfluidic system within the MedRing device, aimed at enhancing women’s health monitoring by non-invasively tracking fertility-related biomarkers. The primary goal is to leverage MedRing’s capabilities to provide real-time, accurate health insights, thereby contributing to the advancement of personalised healthcare technologies.

The advent of wearable technologies has opened new avenues for personal health monitoring. This project focuses on the MedRing, a device designed for continuous health data collection, specifically targeting women’s reproductive health. By incorporating a microfluidic system, the project aims to extend the device’s functionality to include precise fertility monitoring, addressing the growing demand for non-invasive health management solutions.

The development process involved performing desktop research, interviews with experts, and analysing the current market. Then it moves on to designing and simulating the microfluidic system using computational fluid dynamics. Simulations were conducted to evaluate fluid flow, ensuring the system’s compatibility with the compact form factor of the MedRing.

A microfluidic system that can be assembled into the MedRing was designed. CFD simulations confirmed that the system achieves the objectives set in terms of laminar flow and fluid path, crucial for the system's correct operation. Design adjustments were made to optimise fluid path efficiency and ensure comprehensive sampling within the system’s reading chamber. The simulations demonstrated the system’s potential to accurately monitor, store, transport, and gather molecular samples within the constraints of the MedRing’s design.

While the project successfully demonstrated the theoretical feasibility of integrating a microfluidic system into the MedRing, the transition from simulation to real-world application necessitates further development. Future work should focus on prototyping and extensive testing to validate the system’s functionality in practical settings. Collaboration with biomedical experts will be essential to refine the system’s design, ensuring it meets both technical specifications and user needs. This project lays the groundwork for future innovations in wearable health technologies, emphasising the importance of integrating advanced diagnostic capabilities into everyday devices.

In medical applications such as medical endovascular catheters, adaptable and morphing devices capable of changing shape and properties become important. These devices allow for safer therapeutic and diagnostic procedures by reducing time to reach target vessels and organs, trauma to the vessel wall and physical stress on the body while increasing the accuracy, benefits and positive outcomes. A catheter with these properties will also reduce X-ray exposure during procedures, recovery time and could save lives in the acute setting.

In the field of emerging materials, several materials demonstrate variable properties when exposed to a stimulus. This, when combined with the field of minimally invasive surgery, holds significant potential for the development of a catheter with variable shape and properties.

This thesis investigates the latest developments in endovascular catheter design through a materials lense. It begins with a thorough examination of material-based advancements in catheters with variable properties, and puts a particular focus on shape memory materials. Using a combination of literature review, field work examination and expert consultations, the design of a catheter with variable properties is comprehensively analyzed and evaluated.
Prototyping was done to evaluate the potential of two material systems to achieve variable behaviour in the design of a catheter.

The study presents a conceptual shape memory material-based design for a catheter with variable shape and properties and demonstrates this with a visual prototype. Additionally, potential directions for further refinement of this conceptual design are explored. This thesis serves as an initial reference and guiding framework for designers working with emerging materials in the field of medical devices and in particular the development of endovascular catheters with variable properties.

Rural India faces many challenges in providing adequate health care for all. Health awareness among the Indian population is low due to poor functional literacy and low emphasis on education within the health sector.

Minimally Invasive Surgery (MIS), such as laparoscopy, offers many advantages, including smaller incisions, less tissue damage and faster recovery for patients compared to traditional open surgery. The use of laparoscopy in low- and middle-income countries (LMICs) is particularly influential because it can minimise the morbidity associated with laparotomies and provide benefits such as fewer postoperative infections and faster return to work. The laparoscopic instruments must be carefully cleaned and sterilised after each use to prevent infection. In any surgery, there is a risk of infection. Postoperative wound infections (POWIs) occur after surgery on the part of the body being operated on. Globally, the rate of POWIs varies between 0.5 and 15 per cent, while in India, rates between 23 and 38 per cent are consistently measured (Arora et al., 2018). These complications lead to revision surgery, delayed wound healing, increased use of antibiotics and longer hospital stay, all of which have a significant impact on patients and healthcare costs. Antimicrobial resistance (AMR) is one of the greatest threats to human health we face worldwide. (World Health Organisation, 2012a, 2012b).

This project focuses on making minimally invasive surgery such as laparoscopy safely applicable in low- and middle-income countries through a medical washer. It aims to find a research-based solution to improve the reprocessing of laparoscopic instruments to reduce POWIs and the need for antibiotics. The current method of reprocessing in hospitals in rural India does not result in sterile laparoscopic instruments and is harmful to patient, nurse and all other staff present in the OR. Instruments are also damaged during the cleaning process. These problems mainly stem from lack of training of nurses, time pressure and due to lack of cleaning equipment.

The project approach was implemented using the Double Diamond Design Model. In the final phase, a prototype was built and this prototype was evaluated in the context of rural India. The aim of this study was to investigate the medical washer loading system for laparoscopic instruments in rural hospitals and to understand how the loading system is used by nurses without any prior explanation. We also investigated how the concept of the medical washing machine is perceived by the end user.

The medical washer for laparoscopic instruments for the context of rural India has been developed can improve current reprocessing practices. By automating the cleaning process, the medical washer reduces the risk of human error and ensures that instruments are thoroughly cleaned. The inclusion of a loading system that can be used without extensive training ensures that the system can be used safely and correctly by all healthcare workers. With the combination of these systems in an integrated design, the medical washer can additionally provide value by reducing cleaning time and allowing nurses to take rest breaks or do other tasks.

People who suffer from tremor, experience uncontrollable, involuntary movements. Depending on the underlaying cause, these movements occur during rest, or simultaneous with voluntary movements.
STIL is a YES!Delft based, med-tech startup that is developing a non-invasive, anti-tremor orthosis that helps people with tremors in their upper limbs. The current anti-tremor orthosis helps with the reduction of upper limb tremor. However, it limits the mobility of the user’s hand and wrist. Motion in the Wrist Radial and Ulnar Deviation (WRUD) degree of freedom are limited due to the way the orthosis is designed.

By redesigning several parts of the orthosis, a new degree of freedom has been added to the device.
This increased mobility makes the orthosis more comfortable in daily use, and could even be beneficial to the suppression of upper limb tremor.

By integrating a small mechanical damper, the friction in the WRUD degree of freedom can be controlled.
A system of interlocking parts, supported by dampers ensure a durable and smooth rotation when the wrist is moved.
The fully functional prototype was manufactured and handed over to STIL bv for further testing, along with recommendations to optimize the design .

This graduation report describes the design of a new suitable menstruation product for Beppy that collects blood, is reusable, has a similar (deployable) size and function as a tampon, and which is perceived as less intimidating to insert and extract than a menstrual cup. The new design, the Beppy Clover, is made from silicone and has Nitinol, which is a shape memory alloy (SMA), wire embedded. Before insertion, the Clover has a diameter similar to a single use tampon by folding it in three sections. There is no constant external force needed to keep the Clover folded. Once the product is inserted and gets into contact with the body heat and blood in the vagina, the SMA wire (Af = 35°C) reacts and will return to its programmed shape. This results in the three sections with the SMA loops embedded deploying and adapting to the vagina canal. The product will stay in place, collect blood and after 8 hours or less, depending on the flow, can it be retracted by the loop or the attachable silicone extraction cord. The cleaning process works the same as a menstrual cup, rinsing between uses and sterilising at the beginning or end of the period.
To come to this final concept, an analysis, development and evaluation were performed. In the analysis, relevant information about the menstrual cycle, the dimensions of the vagina and current insertable (period) products is gathered. Furthermore, interviews with ten people were conducted to get insights into the user experience regarding their period and period products. At last, the materials and production methods of the Beppy cup are inspected, and new possible materials are looked at to integrate into the product, like shape memory alloy. This information is brought together in a list of requirements.
In the development, three main challenges are tackled: how to integrate deployment (1), insertion (2), and extraction (3) in the design, which would satisfy the requirements and, in particular, make it look less intimidating than a cup. Prototypes were made with silicones out of 3D printed moulds to test shapes, and the proof of concept of the composite of SMA wire with silicones was tested. A concept is made from the combinations of ideas and evaluated by three people focussing on perception and first impression of the Beppy Clover. With the feedback a final design is created.
The end result of the project is a promising final concept that could be the first step in the right direction regarding development of reusable blood collecting tampons. Utilising emerging materials was interesting to research its possibilities in period products. More tests and research on the combination of silicones and SMA wire reacting to body temperature will be necessary to optimise the force of the deployment of the product. Nevertheless, the Beppy Clover achieved its goal of being a blood collecting, reusable product that is perceived as less intimidating than the cup and has a similar (deployable) size and function as a tampon.

When flying with an infant, parents typically choose the option to travel with their infant on their lap. This is the cheapest way for an infant to travel by plane, and is an available option for all destinations with all European airlines. However, this travel method causes discomfort for parents, as they are constantly required to hold their infant and attend to the child s needs in a tight surrounding.

The Amsterdam based company, Wick Wings, has come up with an idea that could offer parents a comfortable solution for travelling with their infant by plane: a baby carrier designed specifically for use on a plane*. This concept forms the base of this graduation project for the master Integrated Product Design, with the following objective:

‘Designing, building, and testing a hands-free travel solution in the form of a baby carrier for use on a plane, during medium-haul and long-haul flights with a baby of 0-12 months old, taking into account European regulations only.’*

To complete this project, a design approach was used with a strong focus on prototyping to make decisions about the embodiment of the final product. The design process started with a research phase, which included research methods such as market analysis, expert interviews, participatory research, and the studying of many online sources. This research phase was followed by intertwined ideation, conceptualisation and embodiment phases, resulting in a working prototype for a new baby carrier design for travelling by plane with an infant.

The research phase showed that there are many different baby carriers available on the market that meet the specific requirements to enable ergonomically sound carrying for both parent and infant. These carriers do contain some attributes that are convenient for travelling by plane, however they also contain attributes that are inconvenient for this use context.

Baby carriers are not allowed for use on a plane during all stages of a flight, and must be detached when the fasten seatbelt light is turned on. However, baby carriers are not easy detachable in the tight space available to individual passengers on a plane. Additionally, parents’ desires to alternate parental duties during a flight requires easy attaching and detaching of a baby carrier as well.

The product solution that was created for the project is The Wick Carrier. The product introduces a new baby carrier system, that allows for easy attaching and detaching of the infant to the parent, both while standing and sitting.

The final prototype of The Wick Carrier was tested with parents and infants to validate the design, and formulate additional design recommendations for further developing the product for introduction on the market.

* Slightly adjusted to follow an embargo on the results of this graduation report.

The Intensive Care Unit (ICU) of the Leids Universitair Medisch Centrum (LUMC) focuses on vitally threatened patients, who cannot survive without daily intensive treatment. As the patients in this department could easily deteriorate and (potentially) pass away, the staff members of LUMC’s ICU often need to act rapidly and make decisions within a short period of time, while they experience severe (time) pressure. This pressure causes stress and increases the chance of human errors by the staff members, which eventually could lead to adverse events (incidents that caused irreversible damage to patients). In order to minimise the human errors made by the staff members and thereby, the amount of adverse events, the ICU physicians and nurses of the LUMC currently need to participate with two training exercises, called Advanced Life Support+ (ALS+) and Crew Resource Management (CRM). Despite the fact that they are encouraged to reflect on- and expand their non-technical skill set, the (ALS+/CRM) trainers still notice that the non-technical skills of the staff members differ with their expectations. Initially, they believed that the difference in desired behaviour (by the trainers) and shown behaviour (by the staff members) is caused by the current set-up of the ALS+ and CRM training. However, it was found that this difference is mainly caused by two other factors. First, although they need to participate with the ALS+ and CRM training, the staff members still have little awareness about their behavioural impact on acute procedures, meaning that they do not precisely know how they can stimulate effective teamwork. Second, the staff members are barely triggered to reflect on their behaviour or to apply their learnings/action points (in practice) once they participated with the ALS+ and CRM training. As a result, (sustainable) behavioural change is not established and the staff members continue to show their old behavioural patterns. Based on these two factors, I developed the iCare-initiative. The iCare-initiative consists of four product solutions: an application, renewed (digital) patient boards, pocket cards and debriefing-flyers.
In the short term, the staff members can reflect more structuredly on their behaviour with the use of the debriefing-flyers. Next, they are reminded of their action points and other important behaviours (during acute procedures) via the pocket cards. In the long term, once the staff members feel more comfortable to think about- and reflect on their behaviour (in teams), the application and renewed patient boards will be launched. The application offers a platform to the staff members to individually develop/train their non-technical skill set and reflect more consciously on their behavioural impact. Furthermore, the patient boards aim to create continuous awareness amongst the staff members to reflect on their behaviour, but also to encourage them to share useful insights via a convenient (accessible) platform. Although the iCare-initiative consists of four separate product solutions, they all work together in one integrated system. This system mainly aims to prepare the staff members for acute procedures, to expose which non-technical skills they should improve, and to allow the staff members to individually develop their non-technical skills. Eventually, these new opportunities will accelerate the transition towards desired behaviour in LUMC’s ICU.

Access to safe and affordable surgery is nothing short of a basic human right and people from all walks of life are entitled to it. But, five people from resource-constrained low and middle-income countries are vulnerable and left to fend for themselves when the need for surgery is a life governing event. Inhabitants of these regions are scourged by high mortality and morbidity due to surgical infection caused by the use of unclean and unsterile surgical instruments. Reduction in infections can be achieved by using clean and sterile surgical instruments. Laparoscopy, is a promising technique of surgery developed to efficiently perform complex abdominal surgeries with the use of small and minimum incisions on the patient. Laparoscopy’s minimally invasive nature allows complex surgeries to take place without the need of an absolutely sterile operating room, although the sterility of the surgical instruments cannot be compromised. The added benefit of faster recovery from smaller wounds makes it even more desirable for this context. The Minimally Invasive Surgery and Interventional Techniques Lab of the TU Delft has initiated projects addressing the health and well-being of resource-constrained, underdeveloped communities like rural India through frugal innovation. Rural Indian hospitals are grossly underfunded, under-maintained, and understaffed. Sterile processing practices in rural India are rudimentary compared to high-income hospitals like the ones in the Netherlands. In high-income hospitals, all used surgical instruments are cleaned and sterilized in dedicated central sterile processing departments (CSSD) by highly trained and well protected sterile processing technicians. However, rural India usually employs small teams of local undertrained and semi-literate nurses to carry out every primary and ancillary duty in the hospital. The lack of dedicated CSSDs exacerbates the nurse’s workload and exposure to harmful pathogenic surgical instruments. Laparoscopic instruments developed in high-income nations are seldom designed keeping low resource contexts in mind. The geometrical complexity of instruments keeps increasing but cleaning methods in rural India have stagnated. Resource constraints are a major reason as to why proper international and national guidelines for reprocessing cannot be followed. Hence hospitals cannot guarantee 100% safe and sterile instruments as compared so standardized outcomes in high-income hospitals. In this graduation project, the distinct reprocessing journey of surgical instruments for the two diverse economic contexts were studied. A comparative analysis of both reprocessing journeys uncovered severe unsafe and unfavorable practices in rural India. Significant data and insights from the research have hence paved the way for focusing on the “Cleaning” stage of the laparoscopic instrument reprocessing journey in rural India. This MSc graduation project aims at designing a frugal solution for cleaning and repurposing laparoscopic instruments, dedicated to hospitals in rural India where the demand for laparoscopy is high but surgeries are less due to resource constraints like lack of laparoscopic instruments and repurposing devices. The involvement of an Indian nurse and laparoscopic surgeon provided first-hand information about the problems and requirements in the rural Indian context. Prototyping and testing of various cleaning setups were conducted to extract the most viable design solution. Insights from the research and testing were combined into the concept design of a frugal mechanical washer and subsequently an “Envisioned Reprocessing Journey” for rural Indian hospitals to suggest a standard protocol for keeping most of their existing infrastructure in mind. Evaluations with the Indian nurse revealed that this device could indeed be a game-changer to the existing practices of reprocessing laparoscopic instruments in rural India.

The focus of this master thesis is to design a holistic solution to the problem of laparoscope lens tip contamination during the surgery while complying to the complex contextual factors. The stakeholder needs and the environment of the operating room were the key considerations during the design process.

Asthma is one of the most common chronic diseases worldwide, and it is expected that the prevalence of asthma will only increase in the coming years (Masoli et al., 2004). Medical self-management by asthma patients will be of essential importance to keep the burden of disease as low as possible.

Medical self-management is critical in obtaining asthma control. Research suggests that the majority of patients can obtain asthma control, yet most adults are still living with uncontrolled asthma. Both extensive literature research and qualitative research with asthma patients and healthcare providers were executed to uncover what the barriers are that asthma patients face in medical asthma self-management.

The research uncovered three main problems that form barriers to efficient self-management.: beliefs, low motivation, and inability. Each of these problems has its underlying causes. Beliefs are caused by (1) paternalistic care, (2) lack of stimulation, (3) shortcomings in knowledge sources. Low motivation is the result of (1) paternalistic care, (2) lack of awareness, (3) discouragement due to inadequate tools. At last, inability is caused by (1) lack of knowledge, (2) lack of skills (3) lack of insight.

Several opportunity areas to enhance the self-management of asthma patients were discovered: (a) patient education, (b) self-tailoring, and (c) increasing competence.

Patient education can be enhanced by creating awareness and providing a better knowledge source through (1) personalization, (2) spreading knowledge. Enabling the patient to self-tailor can induce more active participation of the patient. Increasing the asthma patient’s competence can be done by (1) increasing self-knowledge (2) enabling action.

To overcome the barriers to self-management a design was proposed: vea. Vea consists of an app and a physical product.

The app enables the user to set goals and supports the user to achieve these goals. Through working on the goals, the app learns about the user and gets personalized. The physical device supports the app by measuring the air quality in the home of the user and gives feedback on this.

Key user benefits of the design are:

Personalization
Vea is designed to match the patients’ needs. Through personalizing its approach and content, the app becomes relevant to the user.

Being in control
The user is in charge of the goals they want to achieve. The app assists them by making the once invisible complaints and effects of self-management explicit.

Increased capability
Vea provides structured tools that increase the capability of the user to self-manage their asthma. Through seamlessly collecting data and providing relevant feedback and tips, the user is motivated and capable of acting.

User evaluation demonstrated that the proposed design is undoubtedly promising. Both asthma patients and general practitioners indicated that the design could lead to increased insight, motivation, and enhanced competence of medical self-management.

The main limitation of this master thesis is, however, determining the long-term effect of the design. Although the design has shown to be promising, unfortunately, no statement can be made of the long-term effect of vea on the actual improvement of medical self-management. To be able to do so, the design should be further developed and tested in the long term.