Methods for preclinical validation of software as a medical device

Software as a medical device is subject to dedicated regulatory requirements before it can be used on human beings. The certification process in Europe requires that sufficient data on clinical benefits are available before the device is CE marked. This position paper describes our proposal of a risk-based approach to technical and preclinical validation of software as medical devices. This approach ensures that all technical solutions for safety are implemented in the software and that all information for safe use is consistent before the software can be made available to patients. This approach is compliant to the main international standards ISO 13485 on quality systems and ISO 14971 on risk management and therefore ensures regulatory compliance as well as patient protection. This integrated approach allows the designers of the software to integrate regulatory and safety testing in the technical testing of the candidate release version of the device. This approach ensures patient safety and regulatory compliance at the same time as technical functionality

Usability assessment of an intraoperative planning software

Usability is a crucial aspect of medical device safety. The brand-new European Regulation requires the manufacturer to assess the usability of the new medical devices. In this study, we evaluate the usability of a new medical device intended to assist the intraoperative planning with the visualization of 3d patient-specific organ models. The usability study started from the early stage of the device design and iterated through an early formative, completed with desk-based activities, late formative, completed with a focus group, and summative phase, that comprised a user test, and questionnaire filling. The identified usability issues are mitigated, the safety of the device user interface is confirmed and the training contents are defined and confirmed. Additional information regarding the user experience is collected and analyzed to identify further improvements of the device

Biomedical engineering in low- and middle-income settings : analysis of current state, challenges and best practices

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

Incorporação de métodos de engenharia de usabilidade no desenvolvimento de dispositivos médicos com foco em certificação

Regulatory agencies concerned with controlling the new Medical Devices (MD) that go on the market started to require that manufacturers follow standards. Among these, an IEC 62366 standard establishes a Usability Engineering (UE) process. Within the scope of the scientific literature, authors present ways of including the user in product devel-opment and point out practical difficulties in the selection and execution of different methods, in understanding the requirements and in inserting the EU process in existing processes. These difficulties can be aggravated by deficiencies in capacity and cultural aspects, treating or topic only as documentary compliance. This thesis presents a model of UE methods for the development of MD, with a primary focus on meeting regulatory requirements. To assess the suitability of the proposal, case studies were planned in four different companies, first the goal was to apply the model by outsourced specialists into two companies and then to apply in another two companies, by the internal com-pany team. It was possible to conclude by the first application of the model that the results contributed to the certification of products in the studied companies. For a mod-el application in the second stage of verification, as teams of companies passed through a process of training in the methods and structuring of the model. In both companies, an UE process was established for a product under development, with the creation of a documentary procedure, plan and auxiliary documents. Some of the proposed methods have been successfully implemented by the teams. It was possible to conclude that the model showed a good option for MD companies to implement the EU process according to IEC 62366, even if they do not have specialists or professionals with experience in this area. It was possible to observe that, when a company implements the model, applies the proposed methods, the results can generate not only regulatory compliance, but also a cultural transformation. The companies that applied the model based on internal training, after the results, mentioned that they could do more than what was proposed in the model, in order to go beyond compliance with requirements, impacting general use and innovation.Agência 1Agências reguladoras, preocupadas em controlar os novos Dispositivos Médicos (DM) que irão ao mercado, passaram a exigir que fabricantes sigam normas e padrões. Dentre estes, a norma IEC 62366 que estabelece um processo de Engenharia de Usabili-dade (EU). No âmbito da literatura científica, autores apresentam formas de inclusão do usuário no desenvolvimento de produtos e apontam dificuldades práticas na seleção e execução de diferentes métodos, entendimento dos requisitos, e inserção do processo de EU dentro dos processos já existentes. Estas dificuldades podem ser agravadas por deficiências de capacitação e aspectos culturais, tratando o tópico somente como con-formidade documental. Esta tese visa apresentar um modelo de métodos de EU para desenvolvimento de DM, com o foco principal no cumprimento de requisitos regulató-rios. Para avaliar a adequação da proposta, estudos de casos foram planejados em quatro empresas diferentes, primeiramente com uma aplicação do modelo por especia-lista terceirizado em dois casos, e depois duas aplicações pelo time interno de outras duas empresas. Pôde se concluir pela primeira aplicação do modelo que os resultados obtidos contribuíram para a certificação dos produtos nos casos estudados. Para a veri-ficação de adequação do modelo na segunda etapa de verificação, as equipes das empresas passaram por um processo de capacitação nos métodos propostos e proces-sos relacionados. Em ambas as empresas houve o estabelecimento do processo de EU para um produto em desenvolvimento, sendo realizada a criação de um procedimento documental, plano e documentos auxiliares. Alguns dos métodos propostos no modelo foram implementados com sucesso pelas equipes. Foi possível concluir que o modelo se mostrou uma boa opção para as empresas de DM em como implementar o processo da EU de acordo com a norma IEC 62366, mesmo não tendo especialistas ou profissionais com experiência prévia nessa área. Foi possível observar que quando uma empresa im-plementa o modelo, aplicando os métodos propostos, os resultados podem gerar não apenas conformidade normativa, mas também uma transformação cultural. Das em-presas que aplicaram o modelo na segunda etapa de avaliação, ao verem os resultados obtidos, mencionaram que poderiam fazer mais do que o proposto, a fim de ir além do cumprimento de requisitos, impactando na usabilidade geral e em inovação

Techniques for usability risk assessment during medical device design

Human errors during the use of medical devices, due to pitfalls in the design of the user interface, may lead to substantial risk to users and to patients. There are multiple techniques for the identification and for the assessment of user related risks, that may be chosen according to the step of the design (preliminary feasibility studies, minimum viable product assessment, verification and validation) and considering cognitive processes and information processing mechanisms of users, which may lead to errors. Some techniques are more adequate for a quick-and-dirty approach, during early stages of design: these include expert reviews, discussions among focus groups, standard reviews and heuristic analyses. Other techniques are adequate for a more detailed and systematic analysis of risk, in more advanced design stages, with a failure mode and effect analysis (FMEA) approach, including time-and-motion studies and task analyses. Lastly, user tests with the help of rapid prototypes, perhaps involving alternative embodiments to be studied, are very adequate for verification and validation of the interface. Usability analysis techniques should be part of the toolbox of a biomedical engineer and they should be carefully chosen. Each technique, regardless the step it is used, should allow the designers to define a precise level of risk in terms of probability, severity. Moreover, usability risk minimisation measures shall be measurable and able to be quantified, as well as the impact of risk mitigation strategies. For this reason, usability risk minimisation measures should be classified according to regulatory requirements as “safe by design”; “alarms and protections” and “information for safe use”. Each class of risk minimisation measure should be then given a measurable risk reduction score, so that the risk assessment can be completed in a repeatable and regulatory compliant way