Different approaches to improve the healthcare in Africa through biomedical engineering

My thesis work has been developed in African Biomedical Engineering Consortium (ABEC) framework and in particular during the development phase of UBORA project that has been financed by European Union. Highlighted the major issues relating to the conditions of medical devices in Africa, the thesis's goal is going to analyze four different approaches to address these issues with the goal of improving health through biomedical engineering. The first approach is focused on the development of an affordable and sustainable system for the regulation of medical devices in African Biomedical Engineering Consortium (ABEC) partner countries to establish a sustainable healthcare system. The second one describes the advantages of Open Source Medical Devices considering their accessibility, sustainability and lower costs. In support of this approach two examples are evaluated. The third approach is addressed to the development of human capital through a direct experience in Africa with the goal to help provide for the sustainable maintenance of medical equipment through the provision of training programs for the recipients, including test equipment and workshop facilities. The last approach analyze the condition of donated medical equipments through direct experience in Africa hospitals. To understand the real needs and personal opinions about the situation of medical device in Africa the author of thesis collected surveys, in particular during the period in Ethiopia and Uganda, which results are evaluated during thesis

Open-source automated external defibrillator

The Automated External Defibrillator (AED) is a medical device that analyzes a patient's electrocardiogram in order to establish whether he/she is suffering from the fatal condition of Sudden Cardiac Arrest (SCA), and subsequently allows the release of a therapeutic dose of electrical energy (i.e. defibrillation). SCA is responsible for over 300,000 deaths per year both in Europe and in USA, and immediate clinical assistance through defibrillation is fundamental for recovery. In this context, an open-source approach can easily lead in improvements to the distribution and efficiency of AEDs. The proposed Open-Source AED (OAED) is composed of two separate electric boards: a high voltage board (HV-B), which contains the circuitry required to perform defibrillation and a control board (C-B), which detects SCA in the patient and controls the HV-B. Computer simulations and preliminary tests show that the OAED can release a 200 J biphasic defibrillation in about 12 s and detects SCA with sensitivity higher than 90% and specificity of about 99%. The OAED was also conceived as a template and teaching tool in the framework of UBORA, a platform for design and sharing medical devices compliant to international standards

Palpreast - A New Wearable Device for Breast Self-Examination

Breast cancer is the most commonly diagnosed cancer in women worldwide. Although targeted screening programs using mammography have facilitated earlier detection and improved treatment has resulted in a significant reduction in mortality, some negative aspects related to cost, the availability of trained staff, the duration of the procedure, and its non-generalizability to all women must be taken into consideration. Breast palpation is a simple non-invasive procedure that can be performed by lay individuals for detecting possible malignant nodules in the breast. It is a simple test, based on the haptic perception of different stiffness between healthy and abnormal tissues. According to a survey we carried out, despite being safe and simple, breast self-examination is not carried by women because they are not confident of their ability to detect a lump. In this study, a non-invasive wearable device designed to mimic the process of breast self-examination using pressure sensing textiles and thus increase the confidence and self-awareness of women is proposed. Combined with other screening methods, the device can increase the odds of early detection for better prognosis. Here, we present the physical implementation of the device and a finite element analysis of the mechanics underlying its working principle. Characterization of the device using models of large and medium breast phantoms with rigid inclusions demonstrates that it can detect nodules in much the same way as does the human hand during breast self-examination

Safe innovation: On medical device legislation in Europe and Africa

Objectives: The principal motivation for regulating medical devices is to protect patients and users. Complying with regulations may result in an increase in development, manufacturing and service costs for medical companies and ultimately for healthcare providers and patients, limiting the access to adequate medical equipment. On the other hand, poor regulatory control has resulted in the use of substandard devices. This study aims at comparing the certification route that manufactures have to respect for marketing a medical device in some African Countries and in European Union. Methods: We examined and compared the current and future regulations on medical devices in the European Union and in some countries in Africa. Contextually we proposed future approaches to open design strategies supported by emerging technologies as a means to enhance economically sustainable healthcare system driven by innovation. Results: African medical device regulations have an affinity to European directives, despite the fact that the latter are particularly strict. Several states have also implemented or harmonized directives to medical device regulation, or have expressed interest in establishing them in their legislation. Open Source Medical Devices hold a great promise to reduce costs but do need a high level of supervision, to control their quality and to guarantee their respect for safety standards. Conclusion: Harmonization across the two continents could be leveraged to optimize the costs of device manufacture and sale. Regulated open design strategies can enhance economically sustainable innovation

european regulatory framework for the clinical translation of bioprinted scaffolds and tissues

Tissue Engineering and Regenerative medicine, empowered by Biofabrication technologies, hold the premises to provide solutions to unmet clinical needs, such as organ donor shortage or genetic diseases. These huge advancements are determining a changing scenario, with a quite confusing understanding about the steps toward the clinical translation of new researches and products, giving as result an overestimation or an underestimation of the required in vitro and in vivo tests for their validation. The proper definition and classification of the research products can be considered an action toward the refinement of animal experiments. An appropriate classification is crucial because the complications due to the combination of biological and non-biological materials need the application of specific rules. This paper aims at helping the academic and industrial community to clarify the identification and classification of their research products

Open source technology in biomedical engineering: fast track towards sustainable development

Recently the concept of Open Source Medical Devices (OSMD) has gained some attention, particularly with stunt-like displays of 3D printed prostheses capturing the imagination of the public. In this paper we argue that OSMD technology can be used to propel advancements in healthcare in developing countries in Africa, with equally beneficial consequences in more established economies, provided that the correct framework of training, sharing and safety and efficacy assessment is constructed.We demonstrate how such a framework can be created and show some examples of open-source engineering-based activities which we have conducted. The pros and cons of our approach are discussed in the context of biomedical engineering education, innovation and regulatory harmonizatio

Towards Open Source Medical Devices - Current Situation, Inspiring Advances and Challenges

Open Source Medical Devices may be part of the solution towards the democratization of medical technologies pursuing Universal Health Coverage as part of the Sustainable Development Goals for United Nations. Recent technological advances, especially in information and communication technologies, combined with innovative collaborative design methodologies and manufacturing techniques allow for the mass-personalization of biodevices and help to optimize the related development times and costs, while keeping safety in the foreground through the whole life cycle of medical products. These advantages can be further promoted by adequately fostering collaboration, communication, high value information exchange, and sustainable partnerships and by extending the employment of open source strategies. To this end, within the UBORA project, we are developing a framework for training the biomedical engineers of the future in open-source collaborative design strategies and for supporting the sharing of information and the assessment of safety and efficacy in novel biodevices. An essential part of this open-source collaborative framework is the UBORA e-infrastructure, which is presented in this study, together with some initial success cases. Main future challenges, connected with regulatory harmonization, with educational issues and with accessible and open design and manufacturing resources, among others, are also presented and discussed

UBORA: Euro-African Open Biomedical Engineering e-Platform

1. Some reflections towards a new model 2. Collaborative biomedical engineering: Cases of success 3. The UBORA Project (Horizon 2020, EU-African collaboration) 4. The UBORA e-platform: Implementation and validatio

Genetic variants associated with gastrointestinal symptoms in Fabry disease.

Gastrointestinal symptoms (GIS) are often among the earliest presenting events in Fabry disease (FD), an X-linked lysosomal disorder caused by the deficiency of α-galactosidase A. Despite recent advances in clinical and molecular characterization of FD, the pathophysiology of the GIS is still poorly understood. To shed light either on differential clinical presentation or on intervariability of GIS in FD, we genotyped 1936 genetic markers across 231 genes that encode for drug-metabolizing enzymes and drug transport proteins in 49 FD patients, using the DMET Plus platform. All nine single nucleotide polymorphisms (SNPs) mapped within four genes showed statistically significant differences in genotype frequencies between FD patients who experienced GIS and patients without GIS: ABCB11 (odd ratio (OR) = 18.07, P = 0,0019; OR = 8.21, P = 0,0083; OR=8.21, P = 0,0083; OR = 8.21, P = 0,0083),SLCO1B1 (OR = 9.23, P = 0,0065; OR = 5.08, P = 0,0289; OR = 8.21, P = 0,0083), NR1I3 (OR = 5.40, P = 0,0191) and ABCC5 (OR = 14.44, P = 0,0060). This is the first study that investigates the relationships between genetic heterogeneity in drug absorption, distribution, metabolism and excretion (ADME) related genes and GIS in FD. Our findings provide a novel genetic variant framework which warrants further investigation for precision medicine in FD

A framework for assessing healthcare facilities in low-resource settings : field studies in Benin and Uganda

Purpose. The aim of this paper is to present and validate a framework for assessing healthcare facilities in low-resource settings to collect evidence and inform policies on the harmonisation, regulation and contextualised design of medical devices. Methods. A literature review and focus groups with several experts of medical device design, clinical engineering, health technology assessment and management, allowed the creation of a protocol, comprising two parts: a semi-structured interview and electrical safety measures. Results. Three hospitals were assessed in Benin and three in Uganda. All the health centres resulted to be facing typical challenges for low-resource settings, including the lack of funding, expertise, a well-established maintenance program, spare parts and consumables, and unreliable power supplies. Conclusion. As there is a paucity of information regarding low-resource settings, the proposed framework can be used by clinical or biomedical engineers to assess and thereby propose actions for improving the conditions of healthcare settings