Most medical technology is employed and accepted passively by patients and doctors who have little or no influence in its design or usability. Patients are not involved in the development of medical technology, which is undertaken behind closed doors and whose global impact is hindered by proprietary know-how and by costs. This has so far impeded equitable healthcare as most of the world does not have access to the technology or healthcare coverage. Understanding the relevance of international partnerships for achieving the Sustainable Development Goals, feeling specially committed to the promotion of the Goal on "Good Health and Well-Being", and convinced about the role that open-source biomedical engineering approaches may play in the future of medical technology, we commit ourselves, through the Kahawa Declaration, to enlighten the transformation of the biomedical engineering field, towards the democratization of medical technology as a key for achieving universal equitable health care. This paper presents the content of the Kahawa Declaration, which was signed in Nairobi in December 2017.
AbstractSupporting the expansion of best practices in Biomedical Engineering (BME) can facilitate pathway toward the providing universal health coverage and more equitable and accessible healthcare technologies, especially in low- and middle-income (LMI) settings. These best practices can act as drivers of change and may involve scientific-technological issues, human intervention during technology development, educational aspects, social performance management for improved interactions along the medical technology life cycle, methods for managing resources and approaches for the establishment of regulatory frameworks.The aim of our study was to identify weaknesses and strengths of the scientific, technological, socio-political, regulatory and educational landscape in BME in LMI resource settings. We thus analysed the current state-of-the-art through six dimensions considered fundamental for advancing quality and equity in healthcare: 1) relevant and 2) emergent technologies, 3) new paradigms in medical technology development, 4) innovative BME education, 5) regulation and standardization for novel approaches, and 6) policy making. In order to evaluate and compare their relevance, maturity and implementation challenges, they were assessed through a questionnaire to which 100 professionals from 35 countries with recognized experience in the field of BME and its application to LMI settings responded.The results are presented and discussed, highlighting the main challenges and pinpointing relevant areas where intervention, including local lobbying and international promotion of best practices is necessary. We were also able to identify areas where minimal effort is required to make big changes in global health.
Objetivo: En nuestro trabajo presentamos el desarrollo de texturas superficiales con diferentes geometrías fabricadas por manufactura aditiva. Metodología: Los sustratos con diferentes texturas superficiales son diseñados por medio de programas asistidos por computador (CAD). La fabricación de las diferentes superficies se realiza capa a capa, en un solo proceso, por medio de la técnica de estereolitografía láser (SLA), directamente desde los archivos CAD. Resultados: Las superficies de los sustratos fueron evaluadas mediante ensayos ópticos con el objetivo de medir la topografía de las superficies, validar el acabado superficial y controlar los métodos de fabricación a través de las estrategias de medición en diferentes perfiles. Conclusión: En este estudio mostramos que las texturas superficiales impresas presentaron una reducción de los valores de medidas de longitud, volumen y masa en comparación con la definida en el diseño.Palabras clave: Manufactura aditiva, Microscopía óptica, Resina fotocurable. Abstract Objective: This work shows surface texture development using several different geometries produced by additive manufacturing. Methodology: The substrates with different surface textures are designed by computer aided programs (CAD). Manufacture of the different surfaces is performed in a layer by layer basis, in a single process using the laser stereolithography technique (SLA), directly from CAD files. Results: substrates surfaces were evaluated by optical tests in order to measure the topography of such surfaces, to validate the surface finishing and to control manufacturing methods by using the strategy of measurement in different profiles. Conclusion: In this study we demonstrated that the printed surface textures showed a reduction in the values of length, volume and mass measurements when compared to the ones defined in the design.Keywords: Additive Manufacturing, optical microscopy, photo-curable resin. Resumo Objetivo: Em nosso trabalho, apresentamos o desenvolvimento de texturas de superfície com diferentes geometrias produzidas por manufatura aditiva. Metodologia: Os substratos com diferentes texturas superficiais são projetados por programas assistidos por computador (CAD). A fabricação das diferentes superfícies é realizada camada por camada, em um processo por meio da técnica de estereolitografia laser (SLA), diretamente dos arquivos CAD. Resultados: As superfícies dos substratos foram avaliadas por meio de ensaios ópticos, a fim de medir a topografia das superfícies, validar o acabamento superficial e controlar métodos de fabricação por meio das estratégias de medição em diferentes perfis. Conclusão: Este estudo mostrou que as texturas superficiais impressas apresentam uma redução dos valores das medidas de comprimento, volume e massa, em comparação com o definido no desenho.Palavras-chave: Manufatura aditiva, Microscopia óptica, Resina fotocurável.
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.
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.
Biomedical engineering (BME) has the potential of transforming medical care towards universal healthcare by means of the democratization of medical technology. To this end, innovative holistic approaches and multidisciplinary teams, built upon the gathering of international talent, should be encouraged within the medical industry. However, these transformations can only be accomplished if BME education also continuously evolves and focuses on the internationalization of students, the promotion of collaborative design strategies and the orientation towards context relevant medical needs. In this study we describe an international teaching-learning experience, the ''UBORA (Swahili for 'excellence') Design School''. During an intensive week of training and collaboration 39 engineering students lived through the complete development process for creating innovative open-source medical devices following the CDIO (''conceivedesign-implement-operate'') approach and using the UBORA e-infrastructure as a co-design platform. Our post-school survey and analyses showed that this integral teaching-learning experience helped to promote professional skills and could nurture the future generation of biomedical engineers, who could transform healthcare technology through collaborative design oriented to open source medical devices.
