Redesigning Diplora’s ECG-wearable

Abstract

Cardiovascular diseases (CVDs) are the leading cause of death globally with 33% (Dattani et al., 2023). Unfortunately, cardiovascular research has been primarily performed on men over the centuries (Wittekoek, 2017). It was not until the 1960s that more research was conducted on the female heart (Hartstichting Nederland, 2024). This was urgently needed, as heart conditions are responsible for more fatalities in women than in men, and the specific symptoms express themselves differently across gender (Wittekoek, 2017). Something else that doesn’t help is that cardiac analysis and -monitoring systems are predominantly designed with male physiology in mind (Market Analysis, 2024). This gap in care calls for a solution that is inclusive, user-friendly, and effective for all users, regardless of gender.

Whenever someone – male or female – suspects something is wrong with their heart, a general practitioner (GP) is consulted. Yet here, another problem arises. GPs often encounter patients with symptoms like palpitations, dizziness, or fatigue. To disclose whether the patient could have a suspected intermittent arrhythmia – such as atrial fibrillation, bradycardia, supraventricular tachycardia, ventricular tachycardia, or second- or third-degree atrioventricular block – long-term ECG tracking is often needed. However, as traditional ECG Holters are typically worn for only 24 to 72 hours, most of the conditions mentioned may not be detectable with such short-term ECG monitoring.

The company Diplora B.V. aims to address this need by developing an intelligent AI-driven ECG system where a sensor continuously collects 3-lead ECG input and reconstructs a 12-lead ECG for deeper clinical insights. By streamlining arrhythmia detection and providing actionable, real-time insights, the system empowers GPs and intermediate care providers to make confident, informed decisions regarding treatment or specialist referral. This innovation improves diagnostic accuracy, enhances early intervention, and contributes to better patient outcomes.
To embody this AI system, and to redesign the traditional ECG Holter, the project focused on three goals:

Primary goal
“Redesigning a wearable ECG device, prioritising user confidence, optimised for a reusable, two-week wearing period”

Side objective 1
Optimise the overall interaction of the app & process of application of the device and patch. This, to also support and empower the users confidence during the interaction.

Side objective 2
Explore strategies for repair, reuse and recycling and incorporate these findings in the main objective.

The research was structured around four pillars: product requirements, optimal placement, user needs, and sustainability. These pillars formed the foundation for the iterative design process, which focused on six key themes: comfort, attachment, application, adjustability, feedback, and practicalities. Confidence emerged as the overarching topic, tying these themes together, ensuring the final design addressed both physical and psychological user needs. With the created personas Edith and Emily in mind, multiple iterations were tested with diverse user groups.

Key findings from the research and iterative phases revealed critical insights into user behaviour and design requirements. Participants highlighted the importance of clear feedback mechanisms, intuitive application methods, and designs that accommodated diverse body shapes. Comfort and attachment were important in ensuring long-term wearability, while the use of sustainable materials and modular components was evaluated for environmental impact reduction.
The final design integrates all these insights into a solution combined of three main components: the device, the patch, and the app / manual. The device features a durable and waterproof casing, designed for comfort and effective placement. The patch is made from a Mepitel One-inspired material, ensuring secure attachment and user comfort. The app provides intuitive guidance for the device setup and monitoring, emphasising on confidence and usability. Together, these elements form a system that addresses both functional and emotional needs.

Moving forward, several recommendations have been identified to ensure the project’s success. The device proves to be desirable, as shown by positive user feedback, but some additional refinements could benefit the feasibility and viability of the product. Manufacturing processes must be optimised for cost efficiency, the patch requires additional iterations to improve durability and adhesion, and clinical testing under MDR guidelines remains necessary. The FMEA analysis identified potential risks that need addressing, considering the device, patch and overall system. A roadmap has been developed to guide future steps, with short-, mid-, and long-term goals on the horizon.