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Supporting 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.

The development of medical devices with open source and collaborative design methodologies has the potential to increase the access to medical technologies, thanks to a feasible reduction of design, management, maintenance, and repairing costs linked to the open access of device blueprints. UBORA is an e-infrastructure for the co-design of open source medical devices, which promotes the compliance with internationally recognized quality standards and regulations for safety and efficacy of devices, taking the EN ISO 13485:2016 and the EU MDR 2017/745 as inspiration. UBORA guides the user through a systematic design process, from the identification of clinical needs, of risks class and relevant standards for the device, and provides project management tools, including a repository, finalized to the preparation of the pre-production device dossier. The process is supervised by expert mentors, which ensure that safety and efficacy criteria are fulfilled. The UBORA e-infrastructure is in line with the 2030 Agenda for the Sustainable Development Goals, promoting and strengthening the initiatives of an international community of designers, healthcare providers and policy-makers, toward the reduction of inequalities in the access to medical devices., QC 20200114

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., QC 20181105

Purpose: Thorough this experimental study, the physic features of a modified 23-gauge vitrectomy probe were evaluated in vitro.Methods: A modified vitrectomy probe to increase vitreous outflow rate with a small-diameter probe, that also minimized tractional forces on the retina, was created and tested. The "new" probe was created by drilling an opening into the inner duct of a traditional 23-gauge probe with electrochemical or electrodischarge micromachining. Both vitreous outflow and tractional forces on the retina were examined using experimental models of vitreous surgery.Results: The additional opening allowed the modified probe to have a cutting rate of 5,000 cuts per minute, while sustaining an outflow approximately 45% higher than in conventional 23-gauge probes. The modified probe performed two cutting actions per cycle, not one, as in standard probes. Because tractional force is influenced by cutting rate, retinal forces were 2.2 times lower than those observed with traditional cutters.Conclusion: The modified probe could be useful in vitreoretinal surgery. It allows for faster vitreous removal while minimizing tractional forces on the retina. Moreover, any available probe can be modified by creating a hole in the inner duct.

Atriphasic scaffold (TPS) for the regeneration of the bone-ligament interface was fabricated combining a 3D fiber deposited polycaprolactone structure and a polylactic co-glycolic acid electrospun. The scaffold presented a gradient of physical and mechanical properties which elicited different biological responses from human mesenchymal stem cells. Biological test were performed on the whole TPS and on scaffolds comprised of each single part of the TPS, considered as the controls. The TPS showed an increase of the metabolic activity with culturing time that seemed to be an average of the controls at each time point. The importance of differentiation media for bone and ligament regeneration was further investigated. Metabolic activity analysis on the different areas of the TPS showed a similar trend after 7 days in both differentiation media. Total alkaline phosphatase (ALP) activity analysis showed a statistically higher activity of the TPS in mineralization medium compared to the controls. A different glycosaminoglycans amount between the TPS and its controls was detected, displaying a similar trend with respect to ALP activity. Results clearly indicated that the integration of electrospinning and additive manufacturing represents a promising approach for the fabrication of scaffolds for the regeneration of tissue interfaces, such as the bone-to-ligament one, because it allows mimicking the structural environment combining different biomaterials at different scales.

The medial patello-femoral ligament is considered the most important passive patellar stabilizer and its proper functionality is essential for the patello-femoral joint stability. In this work, 18 human knees were randomly divided into two groups and reconstructed through two different surgical techniques: the "Through tunnel tendon" and the "Double converging tunnel" reconstructions. Subsequently, the samples were mechanically tested to evaluate the structural properties of reconstructed femur-MPFL-Patella complex (rFMPC). Particular attention was given to maintain the anatomical orientation between the patella and the graft. Both procedures showed lower stiffness and higher ultimate strain and absorbed energy compared to the native MPFL, but the advantages of the double converging tunnel technique are related to the restoration of the native MPFL sail-shape, to a better stress distribution on the patella, to the use of a single interference screw as fixation device and to the simplicity, rapidity and cost-effectivity of the surgical procedure. The evaluation of the structural properties of rMPFL is fundamental to evaluate the adequacy of the different techniques to restore the physiological structural properties of the native MPFL.