Project Management for Engineering Design

Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA

Development in medical technology has played a crucial role in increasing disease survival rate and life expectancy. And the development of medical devices has led to the development of portable medical devices that can be conveniently used in homes to accommodate modern people’s busy lives. Infrared therapy devices, portable physical therapy devices, and electric massage machines are now commonly used in homes. An acoustic vibration health care device is now one such device. The device was developed based on research that showed when micro acoustic and vibration signals were applied to the damaged body parts, the resulting microscopic stimulation healed wounded cells, shortened the recovery time, and promoted cell division. We conducted this study to understand acoustic vibration health care device’s electromagnetic field characteristics and improve their performance. Using the ANSYS Workbench, we analyzed the magnetic flux density of the device’s permanent magnets. To increase the device’s vibration force, we stacked the magnets of equal size and identical material properties, ran a simulation, and compared the results. We aim to use the data collected from analyzing the magnetic field characteristics and the permanent magnets’ characteristics to improve the designs of acoustic vibration health care devices.

For medical devices, there might have clinical differences in medical device efficacy and safety among different racial and ethnic subgroups. The acceptability of various data generated during the design and development stage of medical devices between different regions and national regulatory agencies faces huge challenges. This study discusses the considerations of racial and ethnic factors in the design and development of medical devices, with a view to improve the quality and availability of safety and effectiveness data under one framework.

Background: Deaths from drug overdose have reached a crisis level, with more than 100,000 reported from April 2020 to April 2021. Novel approaches to address it are urgently needed. Objectives: National Institute on Drug Abuse (NIDA) is leading novel comprehensive efforts to develop safe and effective products that address the needs of the citizens affected by SUD. NIDA aims to support research and development of medical devices intended to monitor, diagnose, or treat substance use disorders. Results: NIDA participates in Blueprint MedTech program is part of the large NIH Blueprint for Neurological Research Initiative. It supports the research and development of new medical devices through product optimization, pre-clinical testing, and human subject studies, including clinical trials. The program is structured in two main components - Blueprint MedTech Incubator and Blueprint MedTech Translator. It offers free to the researcher services that are typically unavailable in academic environment - business expertise facilities and staffing to successfully develop minimum viable devices, pre-clinical bench testing, clinical studies, planning and executing in manufacturing, as well as regulatory expertise. Conclusions: Through Blueprint MedTech, NIDA provides innovators with expanded resources to ensure the success of the research.

The Fast Forward MBA in Project Management

Making project status visible in complex aerospace projects

BackgroundAcademic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so.MethodsIn-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process.ResultsA number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.ConclusionsMedical device manufacturers often do not see the benefit of employing formal human factors engineering methods within the MDDD process. Research is required to better understand the day-to-day requirements of manufacturers within this sector. The development of new or adapted methods may be required if user involvement is to be fully realised.

Demand for health products in Indonesia is increasing, with an estimated annual growth of 11.9% until 2024. This is driven by population growth and public awareness of the importance of health. Indonesian government believes developing medical devices industry is essential in supporting health resilience in Indonesia. The development and marketing of medical devices does not only focus on the benefits of a product but requires planning and control so that the product can be safe and effective for users, such as by paying attention to quality standardization, patient safety, regulation, and market licensing. This exploratory qualitative research approach yields results in the form of patterns that can increase the availability of safe and quality medical devices, namely 1) research and development of medical devices, 2) regulation of medical devices, 3) assessment of medical devices (health technology evaluation), and 4) management of medical devices (health technology management). The results of this trial will provide valuable information on the process of developing medical device products to choose an approach that suits your needs and conditions.

The development of medical devices currently faces several challenges, like the urgent need for new products in a pandemic situation and the release of a new regulatory framework for medical devices in the European Union, which shall ensure the safety and effectiveness of newly developed medical devices. At the same time, the desire for smart, user-friendly products is growing. These can be realized through agile and flexible process models. Based on agile values and the integration of customer feedback, this need can be achieved in iterative development cycles. What at first sight does not seem to be combinable, however, be well integrated into the regulated area of medical technology through the targeted use of agile processes and the adaptation of individual steps. This paper presents a framework for the integration of Scrum into the regulated design control process for medical devices. This framework facilitates flexible product development of smart medical devices.

This research explores the role of communication in project management, highlighting its importance in enhancing the efficiency of project execution and ensuring the achievement of objectives. The study shows that ineffective communication can lead to issues such as misunderstandings and delays, hindering workflow. A descriptive and analytical methodology was employed to examine the challenges faced by communication in projects, as well as effective communication tools and techniques. The study aims to analyze the impact of effective communication on various project phases, from planning and execution to monitoring and closure. It also addresses the challenges related to improving communication among team members and presents strategies for enhancing communication effectiveness, including training in communication skills, clearly defining roles, and utilizing modern communication tools. The findings emphasize that effective communication enhances team productivity and reduces obstacles, contributing to success in project management. Recommendations include the importance of developing communication management plans and implementing best practices to achieve a collaborative work environment based on transparency and effective coordination.

A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.

The purpose of this research was to plan an approach to a project framework that integrated a model for sustainability and CSR, with the process groups of the Project Management Body of Knowledge (PMBOK®) standard, in its application to the training of a group of students in Project Design, Management, and Evaluation. The integration was justified by the scarce explicit references to sustainability and CSR found in traditional project management guidelines, norms, and standards. The new framework was used to structure a Sustainability Management Plan, which made it possible to incorporate sustainability criteria throughout the life cycle of the training project. The training proposal in Project Design, Management, and Evaluation was chosen, among several alternatives, by a multi-criteria selection process (fuzzy AHP) in the context of project scope management. The results reveal a great heterogeneity among the models and the lack of a base of key indicators in sustainability and CSR measurement tools as well as of explicit references to sustainability in project management standards. It is therefore necessary to develop a Sustainability Management Plan that can be introduced in the Project Management Plan and thus influence the strategic and operational guidelines of the Institution.

This research identified drivers and barriers to routine National Health Service (NHS) adoption of Computer Aided Design (CAD) and Additive Manufacturing (AM) for the production of patient-specific devices. It proposed and verified a design process intervention, which aimed to overcome the most important barriers and better exploit the drivers. The data generated and recorded in this work spanned qualitative and quantitative findings from fourteen real-world clinical case studies, a fully-realised structure for a Quality Management System (QMS), prototyping of a design intervention in a paper-based format, and verification of its intended impacts with three users across commercial and clinical contexts. Key barriers to routine adoption were identified as being the nature of existing publications, evolving regulatory requirements, poor awareness of design or design control, and inconsistent approaches to procuring custom devices.The literature featured necessarily short clinical follow-up, and often reported on design and fabrication methods in very poor detail – to the detriment of reproducibility. Health economics evidence was scarce. In the short to medium term future, new regulatory requirements will compel all institutions, including hospitals, to implement a Quality Management System for the design of medical devices. As such, generalisable procedures, forms, and records for compliance with the BS EN ISO 13485 quality standard were devised, and used as the foundation of the design intervention. The QMS-led design intervention form aimed to: create fully-populated product requirements lists before commencing modelling; introduce project management, identification, traceability, review, verification, and feedback activities; improve the confidence and experience of the designer or acting designer; and prompt record keeping in-line with the requirements of ISO 13485. It achieved all of these aims, at least as far as could be ascertained within the research constraints. Further expansion and verification of the framework is required in future – across different specific surgeries and across more users.Thesis completed in 2018.

Ms. Masters is Director of Electrical, Software and Systems Engineering at Battelle and heads Battelle’s DeviceSecure Services. Ms. Masters has more than 15 years of experience in product development as a project manager, systems engineer and design engineer, serving as the project manager and lead systems engineer on medical device development and sustaining engineering programs. Ms. Masters is a voting member of the Association for the Advancement of Medical Instrumentation (AAMI) working group on cybersecurity for medical devices and contributed to the vulnerability model for AAMI’s TIR 57. She has given conference presentations, been published and widely quoted on a variety of medical cybersecurity topics in AAMI Horizons, Mass Device, ExecutiveGov.com, and Fierce Medical Devices. In addition, Ms. Masters holds a Regulatory Affairs Certification (RAC) and has a working knowledge of domestic and international regulatory requirements for medical devices.

Software development in project teams has become more and more complex, with increasing demands for information and decision making. Software development in projects also hugely depends on effective interaction between people, and human factors have been identified as key to successful software projects. Especially in this context, managing and analyzing social networks is highly important. The instrument of social network analysis (SNA) provides fine-grained methods for analyzing social networks in project teams, going beyond the traditional tools and techniques of project management. This paper examines the importance of the application of SNA in software development projects. We conducted a systematic literature review (SLR) of research on software development projects and social network data published between 1980 and 2019. We identified and analyzed 86 relevant studies, finding that research on software development projects spans the topics of project organization, communication management, knowledge management, version and configuration management, requirement management, and risk management. Further, we show that most studies focus on project organization and that the most common method used to gather social data relies on automated extraction from various software development repositories in the SNA context. Our paper contributes to the software development literature by providing a broad overview of published studies on the use of social networks in helping software development projects. Finally, we identify research opportunities and make suggestions for addressing existing research gaps.