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Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.

Equal accessibility to public places and services is now required by law in many countries. For the vision-impaired, specialised technology often can provide a fuller enjoyment of the facilities of society, from large scale meetings and public entertainments to reading a book or making music. This volume explores the engineering and design principles and techniques used in assistive technology for blind and vision-impaired people. This book maintains the currency of knowledge for engineers and health workers who develop devices and services for people with sight loss, and is an excellent source of reference for students of assistive technology and rehabilitation.

Background To date (April 2021), medical device (MD) design approaches have failed to consider the contexts where MDs can be operationalised. Although most of the global population lives and is treated in Low- and Middle-Income Countries (LMCIs), over 80% of the MD market share is in high-resource settings, which set de facto standards that cannot be taken for granted in lower resource settings. Using a MD designed for high-resource settings in LMICs may hinder its safe and efficient operationalisation. In the literature, many criteria for frameworks to support resilient MD design were presented. However, since the available criteria (as of 2021) are far from being consensual and comprehensive, the aim of this study is to raise awareness about such challenges and to scope experts’ consensus regarding the essentiality of MD design criteria. Results This paper presents a novel application of Delphi study and Multiple Criteria Decision Analysis (MCDA) to develop a framework comprising 26 essential criteria, which were evaluated and chosen by international experts coming from different parts of the world. This framework was validated by analysing some MDs presented in the WHO Compendium of innovative health technologies for low-resource settings. Conclusions This novel holistic framework takes into account some domains that are usually underestimated by MDs designers. For this reason, it can be used by experts designing MDs resilient to low-resource settings and it can also assist policymakers and non-governmental organisations in shaping the future of global healthcare.

3D printing is revolutionizing the medical device landscape through its ability to rapidly create patient-specific anatomic models, surgical instruments, and implants. Recent advances in 3D printing technology have allowed for the creation of point-of-care (PoC) 3D printing centers. These PoC centers blur the line between healthcare provider, medical center, and device manufacturer, creating regulatory ambiguity. The United States Food & Drug Administration (FDA) currently regulates 3D printed devices through existing medical device regulations. However, the FDA is increasingly interested in developing guidelines and regulations specifically for PoC 3D printing due to its rapid adoption across the healthcare institutions. In this article, we review the regulatory framework that governs medical devices, discuss how PoC 3D printing falls within this framework, and describe a novel conceptual framework that the FDA has proposed. Finally, through analysis of the aforementioned regulations and discussions with industry medical 3D printing regulatory experts, we provide recommendations for PoC medical 3D printing best practices so that institutions are best positioned to utilize this revolutionary technology safely and effectively.

In recent decades, extensive attention has been paid to the study and development of robotic devices specifically designed for hand rehabilitation. Accordingly, a many concepts concerning rigid, soft, and hybrid types have emerged in the literature, with significant ongoing activity being directed towards the development of new solutions. In this context, the paper focuses on the technical features of devices conceived for the robotic rehabilitation of the hand with reference to the three kinds of exoskeleton architecture and the clinical requirements demanded by the target impairment of the end-user. The work proposes a roadmap (i) for both the design and selection of exoskeletons for hand rehabilitation, (ii) to discriminate among the peculiarities of soft, rigid, and hybrid devices, and (iii) with an impairment-oriented rationale. The clinical requirements expected for an exoskeleton are identified by applying a PICO-inspired approach focused on the impairment analysis; the technical features are extracted from a proposed design process for exoskeletons combined with a narrative literature review. A cross-analysis between device families and features is presented to provide a supporting tool for both the design and selection of exoskeletons according to an impairment-oriented rationale.

Objective This systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy. Methods A systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) guidelines. Eligibility criteria included peer‐reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed. Results From 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods used for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception. Significance User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy. Plain Language Summary This review covers studies that have involved users in the development process of medical devices for epilepsy. The studies reported here have focused on getting input from people with epilepsy, their caregivers, and healthcare providers. These devices include tools for detecting seizures, stimulating nerves, and tracking brain activity. Most user feedback was gathered through surveys, usability tests, interviews, and focus groups. Users were involved in nearly every stage of device development except production. The review highlights that involving users can improve device quality and patient outcomes, but more effective involvement is needed in commercial device development. Future research should focus on the benefits and challenges of user involvement.

The COVID-19 pandemic has challenged the status quo of engineering education, especially in highly interactive, hands-on design classes. Here, we present an example of how we effectively adjusted an intensive hands-on, group project-based engineering course, Medical Device Design & Innovation, to a remote learning curriculum. We first describe the modifications we made. Drawing from student pre and post feedback surveys and our observations, we conclude that our adaptations were overall successful. Our experience may guide educators who are transitioning their engineering design courses to remote learning.

Percutaneous pancreatic core biopsy is conclusive but challenging due to large-diameter needles, while smaller-diameter needles used in aspiration methods suffer from buckling and clogging. Inspired by the ovipositor of parasitic wasps, which resists buckling through self-propulsion and prevents clogging via friction-based transport, research has led to the integration of these functionalities into multi-segment needle designs or tissue transport system designs. This study aimed to combine these wasp-inspired functionalities into a single biopsy needle by changing the interconnection of the needle segments. The resulting biopsy needle features six parallel needle segments interconnected by a ring passing through slots along the length of the needle segments, enabling a wasp-inspired reciprocating motion. Actuation employs a cam and follower mechanism for controlled translation of the segments. The needle prototype, constructed from nitinol rods and stainless steel rings, measures 3 mm in outer diameter and 1 mm in inner diameter. Testing in gelatin phantoms demonstrated efficient gelatin core transport (up to 69.9% ± 9.1% transport efficiency) and self-propulsion (0.842 ± 0.042 slip ratio). Future iterations should aim to reduce the outer diameter while maintaining tissue yield. The design offers a promising new avenue for wasp-inspired medical tools, potentially enhancing early pancreatic cancer detection, thus reducing healthcare costs and patient complications.

Microscopes are indispensable devices of laboratories. They are widely used in industry and science, such as medicine, geology, biology, chemistry and so on. Thanks to the developing technology, manual microscopes are leaving their place to automatic systems. However, automatic microscopy systems are difficult to obtain due to their high costs. The best way to circumvent this problem is to reduce device costs as much as possible. Based on this idea, a fully automated digital microscope system (FADMS) has been proposed as a low-cost prototype. The FADMS can scan and autofocus for various microscopic samples. In addition, it can be controlled over the internet thanks to a developed software and can store scanned microscopic images. The total cost of the developed system is around 2500 US dollars. In experimental studies, mechanical motion sensitivity and focusing tests of the FADMS were performed. Five different methods were tested on peripheral blood smear images for autofocus. According to the results obtained based on six different measurement criteria, Brenner’s and Geusebroek’s method showed the best performance. In positioning tests for the mechanical stage (X and Y axes), the motors in the driving system were moved forward and backward for a distance of 100 μm. The results obtained showed a deviation of 2.6 μm for the X-axis and 3.6 μm for the Y-axis. Experimental results show that micron-sized biological cells can be observed in detail. The FADMS has been designed in a modular structure that allows it to be replaced with lighting, optical system and imaging device alternatives. In terms of performance/cost ratio, the FADMS is attractive for high-throughput microscopy applications ranging from digital pathology to health screening in low-income countries and is considered to be an alternative solution for many industries.

In percutaneous interventions, needles are used to reach target locations inside the body. However, when the needle is pushed through the tissue, forces arise at the needle tip and along the needle body, making the needle prone to buckling. Recently, needles that prevent buckling inspired by the ovipositor of female parasitic wasps have been developed. Building on these needle designs, this study proposes a manual actuation unit that allows the operator to drive the wasp-inspired needle through stationary tissue. The needle consists of six 0.3-mm spring steel wires, of which one is advanced while the others are retracted. The advancing needle segment has to overcome a cutting and friction force while the retracting ones experience a friction force in the opposite direction. The actuation unit moves the needle segments in the required sequence using a low-friction ball spline mechanism. The moving components of the needle have low inertia, and its connection to the actuation unit using a ball spline introduces a small friction force, generating a small push force on the needle that facilitates the needle’s propulsion into tissue while preventing needle buckling. Experimental testing evaluated the needle’s ability to move through stationary 15-wt% gelatin tissue phantoms for different actuation velocities. It was found that the needle moved through the tissue phantoms with mean slip ratios of 0.35, 0.31, and 0.29 for actuation velocities of π, 2π, and 3π rad/s, respectively. Furthermore, evaluation in 15-wt%, 10-wt%, and 5-wt% gelatin tissue phantoms showed that decreasing the gelatin concentration decreased the mean slip ratios from 0.35 to 0.19 and 0.18, respectively. The needle actuation system design is a step forward in developing a wasp-inspired needle for percutaneous procedures that prevents buckling.