Capitainer AB aims to develop a business plan for the broad-scale commercial launch of Capitainer-B – an innovative tool for quantitative blood microsampling. For kidney transplant patients, a new organ eliminates the need of frequent dialysis and improves the quality of life, but to prevent rejection of the new organ by the patient’s own immune system, lifelong treatment with immunosuppressive drugs is necessary. To ensure that the concentration of drugs remain within their therapeutic windows, drug levels are continuously measured through blood testing after transplantation: TDM - Therapeutic Drug Monitoring. Traditional phlebotomy at the hospital consumes substantial resources from the healthcare system and for patients, frequent visits to the hospital/test station is a source of inconvenience. As such, the development of an accurate “use-at-home” blood sampling tool that can alleviate this heavy burden is in great demand. Filling this market gap, Capitainer AB proposes Capitainer-B - a portable, cost effective and easy-to-use microsampling system which enables the patient to take a blood sample at home through a finger prick. The sample can be sent via regular mail to the laboratory for analysis. Our design philosophy was to create a reliable and easy to use tool for monitoring drug concentrations in blood, thereby reducing the risk of organ refusal. From the business perspective, Capitainer-B expands into the market space delineated by the variables of volume accuracy, patient proximity, mobility and low cost. The device has already attracted attention of one EU-based medical centre in Germany (Labor Dessau GmbH) which resulted in a research partnership and low scale sales. In this Phase 1 Project, Capitainer AB intends to prepare a multispectral market feasibility assessment for Capitainer-B. Furthermore, we plan to study the market capacity for the further Capitainer-B-type devices, aiming at providing a comprehensive blood testing platform.

Europe currently has a leading position in key digital technologies. However, functional electronics is one of several emerging digital transformation areas with no established players, but with the potential to significantly disrupt strategic sectors. Harnessing the full potential of functional electronics will enable Europe to exploit cutting-edge climate-neutral digital solutions to strengthen its leadership, and to seize on emerging opportunities by addressing existing technological gaps in multiple sectors. Functional Electronics has found application in a wide range of sectors and domains including in hybrid Integrated circuits (ICs) or flexible systems. Its global market was worth €15.4billion in 2017 and is expected to reach €37.7billion by 2023, a CAGR of 11%. Despite this growth, functional electronics can generate additional value via the adoption and implementation of new and efficient eco-design approaches at product, process, and business model levels. SusFE will advance the development of functional electronics for green and circular economy by developing a sustainable design and production platform for roll-to-roll manufacturing of the next generation of wearable and diagnostic devices that combine a SusFE toolbox of sustainable components comprising novel flexible integrated circuit (FlexIC) on polymer substrate with ultra-low power printed sensors/biosensors, and wireless communication driven by an organic and recyclable bioenzymatic fuel cell. This will lead to highly integrated and autonomously operating systems that are lightweight, environmentally sustainable, and low-cost. SusFE uses of a combination of sustainable materials and processes to deliver climate-neutral digital solutions including wound monitoring, self-blood sampling/testing and point-of-care devices.

Urinary Tract Infections (UTIs) and antimicrobial resistance (AMR) pose significant global health threats, characterised by high incidence and mortality. However, in Sub-Saharan Africa (SSA), there is often a lack of accessible diagnostics to guide proper treatment and therapy monitoring. Our objectives are as follows: (1) Develop and validate a two-tier diagnostic toolbox: (a) Implement a Lateral Flow Test (LFT) for detecting urinary biomarkers at primary care for triage; (b) Deploy a compact, portable Point-of-Care (POC) instrument for secondary care (hospitals, clinics), integrating pathogen detection via isothermal nucleic acid amplification and host-response biomarker quantification for evidence-based therapy and antibiotic prescription; (c) Introduce novel (self)-sampling cards for transport without the need for a cold chain; (d) Establish a digital health platform for clinical decision support. (2) Evaluate the toolbox's field deployability, acceptance, usability, and integration into clinical practice. (3) Maximise the adoption, implementation, and accessibility of the proposed diagnostic toolbox. (4) Prepare for post-project regulatory approval and market launch. (5) Enhance capacity building and surveillance structures through local manufacturing transfer and improvement of the supply chain and logistics. We will recruit diverse patient groups, including under-represented segments of society, from various African settings to ensure the broad applicability, sustainability, and customisability of our solutions. This project is expected to have a significant impact, improving the quality of UTI/AMR diagnostics, reducing unnecessary antibiotic use, preventing resistance, strengthening health systems and their response to epidemics, and increasing accessibility and quality of diagnostics through interdisciplinary and robust industrial collaboration.

Background Health systems face a time of unprecedented change, with spiraling costs, increasing cultural disparity in access to healthcare and research, and an infrastructure that is decades old. Today, telehealth is a realistic alternative making care and research more accessible and personalised with less burden to better support the most vulnerable and under-served in our society. The ability to test and monitor for illnesses using Patient Centric micro-Sampling (PCmS) is at the centre of this reform. Aim and main objectives This project is designed to build upon existing pilots and knowledge, then collaborate cross-sectorially to co-create and test the logistics, infrastructure and tools required to make PCmS a core healthcare tool and an acceptable alternative to venous blood-draw across Europe. This project aligns with many IHI’s objectives focusing on cross-sectorial collaboration, emphasizing patient and end-user- centric co-design of outputs, harmonised regulatory and data generation approaches enhancing the potential of digital innovations in healthcare, while aiming to reduce the environmental footprint during the project and in final outputs to ensure that the expected long-term impact is a reachable reality that will deliver significant benefit to the community and address unmet public health needs at scale. To achieve our objectives, we bring together a broad group of required expertise, know-how and end-users (i.e., public and patients) to form a public-private-partnership specifically equipped to tackle this challenge. This collaborative approach where the relevant stakeholders such as healthcare professionals, regulatory agencies and patients are involved and integrated to deliver solutions and innovation across healthcare systems and ensure the best chances for success and long-term positive impact from this project. Key deliverables include: 1) An optimized, tested and validated ‘Gold Standard’ infrastructure and workflow for PCmS across Europe as a proven and reliable alternative to venipuncture 2) Harmonised and clear regulatory and HTA pathways, standards and acceptability, measures and cost-benefit models across Europe 3) Documented evidence to draw a citable ‘line in the sand’ for future research to support decisions to integrate PCmS into decentralised trials and care pathways 4) Stakeholder engagement and patient involvement models and research on preferences and acceptability for PCmS 5) Foundation for future: Enable access to the developed PCmS scientific findings, tools and assessment measures for rapid uptake and integration of PCmS approaches into decentralised clinical studies and healthcare Expected impact: - Patient-centric microsampling becomes an accepted alternative to the current standard of care venipuncture and the data gathered can be leveraged in healthcare planning. - Lowered patient burden and lowered barrier to access in situations where blood samples need to be collected, whether as part of diagnosis, care plan, health monitoring etc. - A solution to leverage high amounts of data gathered from increased testing can be explored already in this project so that it can pave the way for future research that can improve health outcomes.