Journal articles: 'Design of medical devices'

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Fries, R. C. "Reliable Design of Medical Devices." Journal of Clinical Engineering 23, no. 3 (May 1998): 150. http://dx.doi.org/10.1097/00004669-199805000-00003.

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Haiduven, Donna J., Christine McGuire-Wolfe, and Shawn P. Applegarth. "Contribution of a Winged Phlebotomy Device Design to Blood Splatter." Infection Control & Hospital Epidemiology 33, no. 11 (November 2012): 1069–76. http://dx.doi.org/10.1086/668030.

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Background.Despite a proliferation of phlebotomy devices with engineered sharps injury protection (ESIP), the impact of various winged device designs on blood splatter occurring during venipuncture procedures has not been explored.Objectives.To evaluate the potential for blood splatter of 6 designs of winged phlebotomy devices.Design.A laboratory-based device evaluation without human subjects, using a simulated patient venous system.Methods.We evaluated 18 winged phlebotomy devices of 6 device designs by Terumo, BD Vacutainer (2 designs), Greiner, Smith Medical, and Kendall (designated A-F, respectively). Scientific filters were positioned around the devices and weighed before and after venipuncture was performed. Visible blood on filters, exam gloves, and devices and measurable blood splatter were the primary units of analysis.Results.The percentages of devices and gloves with visible blood on them and filters with measurable blood splatter ranged from 0% to 20%. There was a statistically significant association between device design and visible blood on devices (P< .0001) and between device design and filters with measurable blood splatter (P< .0001), but not between device design and visible blood on gloves. A wide range of associations were demonstrated between device design and visible blood on gloves or devices and incidence of blood splatter.Conclusions.The results of this evaluation suggest that winged phlebotomy devices with ESIP may produce blood splatter during venipuncture. Reinforcing the importance of eye protection and developing a methodology to assess ocular exposure to blood splatter are major implications for healthcare personnel who use these devices. Future studies should focus on evaluating different designs of intravascular devices (intravenous catheters, other phlebotomy devices) for blood splatter.

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KOMATSUBARA, Akinori. "Human Centred Design on Medical Devices." Journal of the Japan Society for Precision Engineering 74, no. 2 (2008): 118–20. http://dx.doi.org/10.2493/jjspe.74.118.

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Almeida, Henrique A., and Rui B. Ruben. "Medical devices: from design to production." Advances in Mechanical Engineering 9, no. 9 (September 2017): 168781401772989. http://dx.doi.org/10.1177/1687814017729895.

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Cramer, Sarah D., Juliana S. Lee, Mark T. Butt, Jaime Paulin, and William C. Stoffregen. "Neurologic Medical Device Overview for Pathologists." Toxicologic Pathology 47, no. 3 (January 1, 2019): 250–63. http://dx.doi.org/10.1177/0192623318816685.

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Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.

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Baird, Pat. "Reliable Design of Medical Devices (Third Edition)." Biomedical Instrumentation & Technology 47, no. 5 (September 1, 2013): 439. http://dx.doi.org/10.2345/0899-8205-47.5.439.

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King, P. H. "Reliable Design of Medical Devices [Book Reviews]." IEEE Engineering in Medicine and Biology Magazine 18, no. 2 (March 1999): 128. http://dx.doi.org/10.1109/memb.1999.752995.

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Bitterman, Noemi. "Design of medical devices—A home perspective." European Journal of Internal Medicine 22, no. 1 (February 2011): 39–42. http://dx.doi.org/10.1016/j.ejim.2010.09.017.

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Harp, Steven, Todd Carpenter, and John Hatcliff. "A Reference Architecture for Secure Medical Devices." Biomedical Instrumentation & Technology 52, no. 5 (September 1, 2018): 357–65. http://dx.doi.org/10.2345/0899-8205-52.5.357.

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Abstract We propose a reference architecture aimed at supporting the safety and security of medical devices. The ISOSCELES (Intrinsically Secure, Open, and Safe Cyber-Physically Enabled, Life-Critical Essential Services) architecture is justified by a collection of design principles that leverage recent advances in software component isolation based on hypervisor and other separation technologies. The instantiation of the architecture for particular medical devices is supported by a development process based on Architecture Analysis and Design Language. The architecture models support safety and security analysis as part of a broader risk management framework. The models also can be used to derive skeletons of the device software and to configure the platform's separation policies and an extensive set of services. We are developing prototypes of the architecture and example medical device instantiations on low-cost boards that can be used in product solutions. The prototype and supporting development and assurance artifacts are being released under an open-source license.

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Sackner-Bernstein, Jonathan. "Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety." Journal of Diabetes Science and Technology 11, no. 2 (November 11, 2016): 198–202. http://dx.doi.org/10.1177/1932296816678264.

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Background: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

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Targhotra, Monika, Geeta Aggarwal, Harvinder Popli, and Madhu Gupta. "Regulatory aspects of medical devices in India." International Journal of Drug Delivery 9, no. 2 (October 6, 2017): 18. http://dx.doi.org/10.5138/09750215.2147.

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Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.

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Malinin, Len. "Design of Medical Devices That Meet Contradictory Requirements." Open Medical Devices Journal 3, no. 1 (December 30, 2011): 9–18. http://dx.doi.org/10.2174/1875181401103010009.

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Barbero, Silvia, Amina Pereno, and Paolo Tamborrini. "Systemic innovation in sustainable design of medical devices." Design Journal 20, sup1 (July 28, 2017): S2486—S2497. http://dx.doi.org/10.1080/14606925.2017.1352763.

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Fairbanks, Rollin J., and Robert L. Wears. "Hazards With Medical Devices: The Role of Design." Annals of Emergency Medicine 52, no. 5 (November 2008): 519–21. http://dx.doi.org/10.1016/j.annemergmed.2008.07.008.

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Seabra, Eurico. "DESIGN, DEVELOPMENT AND CONSTRUCTION OF A MEDICAL WRIST REHABILITATION DEVICE." Gulustan-Black Sea Scientific Journal of Academic Research 48, no. 05 (July 5, 2019): 8–16. http://dx.doi.org/10.36962/gbssjar08.

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The research and development of new kinds of technologies to support the recovery of human injuries have orientated the design, development and construction of new devices for the treatment and rehabilitation of wrist injuries. With limited founds, the construction of a new prototype was carried out with off-the-shelf components. After a detailed research and design work, the obtained device can be divided into two main components: it is capable to provide an adequate rehabilitation of the wrist and adequate proprioception exercises, allowing the patient to relax and to decrease the focus of pain. The development and construction of the device upholds the idea of portability, multifunctional operation and special designed hardware and software control, so it can be simple and user-friendly, allowing the control over the progress of rehabilitation with data recording for later analysis by physiotherapists and/or patients without any special training. The mentioned multifunctional operation, low-cost, user-friendly and portability makes it a good choice when compared to other complex robotic rehabilitation devices. This paper will present, discuss and analyse the proposed portable device, as well as its ability for the purpose of wrist rehabilitation.

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Pietzsch, Jan B., Lauren M. Aquino, Paul G. Yock, M. Elisabeth Paté-Cornell, and John H. Linehan. "Review of U.S. Medical Device Regulation." Journal of Medical Devices 1, no. 4 (October 19, 2007): 283–92. http://dx.doi.org/10.1115/1.2812429.

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Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.

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Pietzsch, Jan B., and M. Elisabeth Paté-Cornell. "Early technology assessment of new medical devices." International Journal of Technology Assessment in Health Care 24, no. 01 (January 2008): 36–44. http://dx.doi.org/10.1017/s0266462307080051.

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Objectives:In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages.Methods:The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage.Results:The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives.Conclusions:The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.

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Meadows, Susan. "Human Factors Applications to Health Care Systems." Proceedings of the Human Factors Society Annual Meeting 33, no. 17 (October 1989): 1167. http://dx.doi.org/10.1518/107118189786757923.

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This demonstration program shows how human factors design and evaluation principles can be applied to the area of medical device and healthcare systems. The objective is to provide examples of evaluations and new designs for healthcare products which reduce human error and improve medical devices and instructional materials. International performance and design standards incorporating human factors principles are gaining more attention because of the efforts of the European medical device industry to standardize products.

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Vranić, Edina. "Classification and evaluation of medical devices." Bosnian Journal of Basic Medical Sciences 3, no. 2 (May 20, 2003): 42–45. http://dx.doi.org/10.17305/bjbms.2003.3554.

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Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

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Hoglund, David, and Vince Varga. "Building a Reliable Wireless Medical Device Network." Global Clinical Engineering Journal, no. 1 (March 25, 2018): 42–49. http://dx.doi.org/10.31354/globalce.v0i1.26.

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How to design and test the most effective and secure wireless medical device connectivity applications that will provide the true mobility experience that is needed in the 2018 healthcare marketplace. Today’s medical devices will need to be connected to provide the data to the electronic medical record. This connectivity will be either real time or on a non real time basis. In either case; the majority of this data transfer will move toward a wireless medium from a legacy wired connection. The following will discuss best practices for wireless network design based upon application requirements; but also the protection of any data regarding cybersecurity requirements. The author has over three decades of medical device knowledge sense but also two decades of wireless and security integration knowledge sense. The take away is to understand the best practices and how to apply this to product design and the overall enterprise implementation into the healthcare ecosystem of connected devices.

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Fisher, Jennifer, and Beth Loring. "Usability of Emergency Medical Devices: Assessment and Design Implications." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 46, no. 16 (September 2002): 1491–95. http://dx.doi.org/10.1177/154193120204601618.

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The goal of this study was to assess the usability of portable electronic emergency medical equipment. The study consisted of field interviews conducted with emergency medical workers, including emergency medical technicians (EMTs), paramedics, and firefighters. We sampled a varied population, including workers from urban and suburban areas as well as private and public organizations. Equipment manufacturers can use the results of this study to enhance the usability, efficiency, and acceptability of future emergency medical devices.

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King, Paul H. "Analyzing How Devices Are Used [Review of "Contextual Inquiry for Medical Device Design"]." IEEE Pulse 7, no. 1 (January 2016): 62. http://dx.doi.org/10.1109/mpul.2015.2498501.

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Lucas, Anne D., Srinidhi Nagaraja, Edward A. Gordon, and Victoria M. Hitchins. "Evaluating Device Design and Cleanability of Orthopedic Device Models Contaminated with a Clinically Relevant Bone Test Soil." Biomedical Instrumentation & Technology 49, no. 5 (September 1, 2015): 354–62. http://dx.doi.org/10.2345/0899-8205-49.5.354.

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Reusable medical devices need to be cleaned prior to disinfection or sterilization and subsequent use to prevent infections. The cleanability of medical devices depends in part on the design of the device. This study examined how models of orthopedic medical devices of increasing complexity retain calcium phosphate bone cement, a relevant test soil for these devices. Methods: The dye Alizarin Red S and micro-computed tomography (μCT) were used to assess the amount and location of bone cement debris in a series of model orthopedic devices. Testing was performed after soiling and cleaning once, and soiling and cleaning 10 times. Results: The color change of the dye after reacting with the bone cement was useful for indicating the presence of bone cement in these models. High-resolution μCT analysis provided the volume and location of the bone cement. Models that were more complex retained significantly more bone debris than simpler designs. Model devices repeatedly soiled and cleaned 10 times retained significantly more bone debris than those soiled and cleaned once. Conclusion: Significantly more bone cement was retained in the more complex lumen structures. This information may be useful in designing reusable orthopedic devices, and other complex medical devices with lumens.

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Peters, Wesley, Carl Pellerin, and Cory Janney. "RESEARCH: Evaluation of Orthopedic Hip Device Recalls by the FDA from 2007 to 2017." Biomedical Instrumentation & Technology 54, no. 6 (November 1, 2020): 418–26. http://dx.doi.org/10.2345/0899-8205-54.6.418.

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Background: Medical device recalls have increased in the previous two decades. Orthopedic devices are estimated to constitute 12% of all medical devices recalled. Medical devices enter the market via the Food and Drug Administration's (FDA's) premarket approval (PMA) or 510(k) pathways. This article evaluates orthopedic hip device recalls between Jan. 1, 2007, and Dec. 31, 2017. We hypothesized that the 510(k) approval process would have substantially higher recall rates for defective devices. Methods: The FDA's device recall database was queried for all orthopedic hip devices from Jan. 1, 2007, to Dec. 31, 2017. Each recall included product description, recall number, device class, date of recall posting, date of recall termination, manufacturer, FDA-determined cause for recall, number of recalled units, distribution, product classification, and method of approval [510(k), PMA, or unspecified]. Results: In total, 774 orthopedic hip devices were recalled between Jan. 1, 2007, and Dec. 31, 2017. The 510(k) approval process constituted 85% of hip device recalls. The most common FDA-determined cause of hip device recalls was device design, which constituted 37% of 510(k)-approved device recalls but only 6% of PMA-approved device recalls. The most recalled hip devices were hip prostheses. Orthopedic hip device recalls have shown a decrease of about 10 recalls per year during the 11-year period of analysis. Conclusion: Devices approved through the 510(k) process, compared with the PMA process, were more likely to be recalled for design defects. Although device design is the most common reason for device recall, many recalls are due to suboptimally standardized processes (e.g., packaging, process controls, device labeling). Overall, orthopedic hip device recalls decreased during the period of analysis (2007–17).

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Gausepohl, Kim, Woodrow W. Winchester, James D. Arthur, and Tonya Smith-Jackson. "Using Storytelling to Elicit Design Guidance for Medical Devices." Ergonomics in Design: The Quarterly of Human Factors Applications 19, no. 2 (April 2011): 19–24. http://dx.doi.org/10.1177/1064804611408017.

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Medical device designers must understand the complex context of use within a health care environment to ensure product usability. Designers must overcome domain-specific obstacles during usability research, such as patient privacy standards, which prevent designers from observing practitioners in context. In this project, we investigated storytelling as an alternative elicitation method for medical device requirements when direct observations are limited or not possible. While gathering requirements for an infusion pump, we compared the types of information elicited by focus groups, interviews, and storytelling sessions. Several advantages and implications for the use of storytelling in usability research are discussed.

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Weinger, M. B. "Incorporating Human Factors Into the Design of Medical Devices." JAMA: The Journal of the American Medical Association 280, no. 17 (November 4, 1998): 1484—a—1484. http://dx.doi.org/10.1001/jama.280.17.1484-a.

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Colombo, Giorgio, Caterina Rizzi, Daniele Regazzoni, and Andrea Vitali. "3D interactive environment for the design of medical devices." International Journal on Interactive Design and Manufacturing (IJIDeM) 12, no. 2 (January 29, 2018): 699–715. http://dx.doi.org/10.1007/s12008-018-0458-8.

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Aguwa, Celestine C., Leslie Monplaisir, and Prasanth A. Sylajakumari. "Effect of Rating Modification on a Fuzzy-Based Modular Architecture for Medical Device Design and Development." Advances in Fuzzy Systems 2012 (2012): 1–14. http://dx.doi.org/10.1155/2012/106354.

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The goal of this research is to determine the effect of customer ratings on the optimal number of modules for medical device design. Medical devices have a 90% failure rate in their first prototype tests according to the international testing body, Intertek. To address this key issue of quality, we present an integrated, collaborative, modular architecture method for medical device design and development. A typical glucometer is used as proof of concept to demonstrate the methodology and analyze the impact of changing the customer ratings on the optimal number of modules and minimum deviation. The implication of this research is to generate scholarly work and to reduce the number of potential failure points in medical devices by determining the optimal number of modules.

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Koomen, Erik, Craig S. Webster, David Konrad, Johannes G. van der Hoeven, Thomas Best, Jozef Kesecioglu, Diederik AMPJ Gommers, Willem B. de Vries, and Teus H. Kappen. "Reducing medical device alarms by an order of magnitude: A human factors approach." Anaesthesia and Intensive Care 49, no. 1 (January 2021): 52–61. http://dx.doi.org/10.1177/0310057x20968840.

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The intensive care unit (ICU) is one of the most technically advanced environments in healthcare, using a multitude of medical devices for drug administration, mechanical ventilation and patient monitoring. However, these technologies currently come with disadvantages, namely noise pollution, information overload and alarm fatigue—all caused by too many alarms. Individual medical devices currently generate alarms independently, without any coordination or prioritisation with other devices, leading to a cacophony where important alarms can be lost amongst trivial ones, occasionally with serious or even fatal consequences for patients. We have called this approach to the design of medical devices the single-device paradigm, and believe it is obsolete in modern hospitals where patients are typically connected to several devices simultaneously. Alarm rates of one alarm every four minutes for only the physiological monitors (as recorded in the ICUs of two hospitals contributing to this paper) degrades the quality of the patient’s healing environment and threatens patient safety by constantly distracting healthcare professionals. We outline a new approach to medical device design involving the application of human factors principles which have been successful in eliminating alarm fatigue in commercial aviation. Our approach comprises the networked-device paradigm, comprehensive alarms and humaniform information displays. Instead of each medical device alarming separately at the patient’s bedside, our proposed approach will integrate, prioritise and optimise alarms across all devices attached to each patient, display information more intuitively and hence increase alarm quality while reducing the number of alarms by an order of magnitude below current levels.

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Branaghan, Russell J., L. Bryant Foster, Mark Palmer, and Jessica Crosby. "Design Considerations for Life-Sustaining Medical Devices Used at Home." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 6, no. 1 (May 15, 2017): 185–88. http://dx.doi.org/10.1177/2327857917061040.

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New technologies follow a predictable pattern of democratization over time. Specifically, a product that begins as merely useful over time often evolves into one that is usable, providing easy access to all functionality. If the technology survives the usability transition, it must become desirable. In this stage, the product evokes positive emotions from its users. This has been the case for the automotive industry as it moved from black colored cars driven by professional drivers and provided with its own toolbox to computers which initially required mathematicians and physicists to operate but which can now be operated by a four-year-old. This transition is now occurring before our eyes in healthcare, as medical diagnostic and treatment devices are taken out of the hands of specialized healthcare providers and placed into the hands, and homes, of patients. These useful devices now need to become usable and desirable. A successful transition will require the contributions of many disciplines, from environmental psychology, to user experience, from biomedical engineering to furniture design. It is exactly the kind of situation in which user experience thrives. This panel discusses the human capabilities, limitations, emotions and motivations which will determine whether this transition is a success. SynCardia’s Total Artificial Heart (TAH) Freedom Driver is an example of a life-sustaining medical device that is used by patients and caregivers at-home. To design the next generation Freedom Driver, SynCardia has implemented a user centered design approach. A research team performed contextual interviews and participatory design sessions with current patients, former patients, caregivers, and experienced clinicians. The research uncovered the following design considerations to be addressed in the design of the new Freedom Driver.

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Cherne, Naomi, Rebecca Moses, Sarah M. Piperato, and Carmen Cheung. "Research: How Medical Device Instructions for Use Engage Users." Biomedical Instrumentation & Technology 54, no. 4 (July 1, 2020): 258–68. http://dx.doi.org/10.2345/0899-8205-54.4.258.

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Abstract Instructions for use (IFUs) often are used as risk control measures for medical devices with the potential to expose users or others to use-related hazards and hazardous situations that are not entirely mitigated by device design. In the authors' extensive experience observing representative users interact with medical devices in simulated-use studies, individuals' engagement with medical device IFUs varies widely. This variance raises questions regarding how various user groups use IFUs and the factors that make an IFU stronger or weaker for its intended users, uses, and use environments. An online survey was conducted to examine (1) first-time use of medical device IFUs, (2) how first-time use strategies vary across typical user groups for medical devices (e.g., patients, lay caregivers, and healthcare professionals), and (3) which design elements promote initial engagement with IFUs. The results showed that IFUs are used in a variety of ways, including as preparation before use, as guides during use, and as troubleshooting resources during use, as well as that IFUs are not used at all. Overall, the user groups tested responded similarly across all of the survey questions. Bullet point organization, figures, and logical flow were reported to be the most engaging design elements. Small font size and poor organization and flow were reported to be the least engaging design elements. IFU designers can use various usability testing methods to assess their assumptions regarding how a product's users will use the IFU and to make the IFU more engaging.

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Ravichandran, Rajganesh, Raveena Pachal Balakrishnan, Jaya Shree Dilli Batcha, Abarna Lakshmi Ravi, and Nikhil Cherian Sam. "Medical device: a complete overview." International Journal of Clinical Trials 7, no. 4 (October 20, 2020): 285. http://dx.doi.org/10.18203/2349-3259.ijct20204487.

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Medical device means any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Medical devices are generally classified based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose. Development of an entirely new device typically begins with a concept by a physician or bioengineer for a solution to a medical problem. If the idea is determined to be workable and practical (proof of concept) an early design of the device, known as a prototype, will be built. A prototype device will undergo a cycle of preclinical testing, redesigning, preclinical testing of the redesign and so forth, until the design has been refined and tested to a point that it is ready for production and testing in humans. Preclinical animal tastings are conducted to provide reasonable evidence that novel technologies and therapies are safe and effective. When studying medical devices, clinical trials are not always required, and whether or not one will be conducted depends on a risk assessment. Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market.

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Siddiqui, Areej Aftab, and Parul Singh. "Identifying export markets for Indian medical devices." International Journal of Pharmaceutical and Healthcare Marketing 14, no. 4 (September 21, 2020): 587–605. http://dx.doi.org/10.1108/ijphm-09-2019-0059.

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Purpose Medical device industry in India is a niche sector with few key players but it possesses huge potential for both domestic and international trade. In recent years, a number of regulatory relaxations have been provided to medical device manufacturers in India to enhance production and further trade especially exports. Though the industry is highly dependent on imports, the purpose of this paper is to identify key medical devices using the revealed comparative advantage, which can be exported from India by identifying new markets. Design/methodology/approach For the selected medical devices, India’s exports to the world and the newly identified markets are forecasted using the autoregressive integrated moving average model of regression. Findings It is seen that three major medical devices emerge to be the ones where India has the capacity and potential to manufacture and export. These medical devices are electro-cardiographs, magnetic resonance imaging apparatus and oscilloscopes and oscillographs being exported to the USA, Australia; China and the USA, respectively, which is rising in recent years. Research limitations/implications As the forecasted values indicate that there is an increasing potential in exports from India to the world of the selected medical devices, there is an urgent need to develop this industry and enhance exports from India. Very few studies have been carried out to examine and forecast exports from specific sectors or industries which is the need of the hour now. Originality/value The paper also provides suggestions to exporters and policymakers on leveraging the future export potential of selected medical devices.

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Kuhl, J., O. Sankowski, and D. Krause. "INVESTIGATION ON METHODS AND CHARACTERISTICS IN MEDICAL DEVICE DEVELOPMENT." Proceedings of the Design Society: DESIGN Conference 1 (May 2020): 1969–78. http://dx.doi.org/10.1017/dsd.2020.95.

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AbstractA 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.

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Alcaraz, Jean-Pierre, Gauthier Menassol, Géraldine Penven, Jacques Thélu, Sarra El Ichi, Abdelkader Zebda, Philippe Cinquin, and Donald K. Martin. "Challenges for the Implantation of Symbiotic Nanostructured Medical Devices." Applied Sciences 10, no. 8 (April 23, 2020): 2923. http://dx.doi.org/10.3390/app10082923.

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We discuss the perspectives of designing implantable medical devices that have the criterion of being symbiotic. Our starting point was whether the implanted device is intended to have any two-way (“duplex”) communication of energy or materials with the body. Such duplex communication extends the existing concepts of a biomaterial and biocompatibility to include the notion that it is important to consider the intended functional use of the implanted medical device. This demands a biomimetic approach to design functional symbiotic implantable medical devices that can be more efficient in mimicking what is happening at the molecular and cellular levels to create stable interfaces that allow for the unfettered exchanges of molecules between an implanted device and a body. Such a duplex level of communication is considered to be a necessary characteristic of symbiotic implanted medical devices that are designed to function for long periods of time inside the body to restore and assist the function of the body. We illustrate these perspectives with experience gained from implanting functional enzymatic biofuel cells.

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Reed, Laurie, and Jennifer Fisher. "A Comparison of the Opinions of Nurses and Emergency Medical Workers regarding Medical Device Usability." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 46, no. 16 (September 2002): 1477–81. http://dx.doi.org/10.1177/154193120204601615.

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In this study critical care nurses and emergency medical workers (including firefighters, emergency medical technicians (EMTs), and paramedics) were surveyed regarding their opinions of medical device usability. The goal of the study was to determine how the two populations fared in terms of general product understanding, proficiency, usability, and functionality. Furthermore, the study identified similarities and differences between the two populations, and explored areas of medical technology design upon which manufacturers can improve. Results showed that a major concern of both populations was training; nurses and emergency medical workers felt that workloads do not allow time for sufficient mastery of the devices. The respondents also felt that medical devices could be more consistent and less complex. Both groups indicated that it is most important to design products that are easy to learn, easy to use upon first use, and efficient to use long-term.

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Liebel, Teresita C., Tara Daugherty, Alexandra Kirsch, Sharifah A. Omar, and Tara Feuerstein. "Analysis: Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices." Biomedical Instrumentation & Technology 54, no. 3 (May 1, 2020): 178–88. http://dx.doi.org/10.2345/0899-8205-54.3.178.

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Abstract This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.

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Babušiak, Branko, and Štefan Borik. "Bluetooth Communication for Battery Powered Medical Devices." Journal of Electrical Engineering 67, no. 1 (January 1, 2016): 65–68. http://dx.doi.org/10.1515/jee-2016-0010.

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Abstract wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.

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Elson, Ila J. "Designing Diagnostic Medical Devices for Your Lab Tests." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 6, no. 1 (May 15, 2017): 143–49. http://dx.doi.org/10.1177/2327857917061031.

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Diagnostic medical devices used in homes, hospitals, reference labs, blood banks, and physician offices and clinics generate laboratory data that provide critical information needed to make medical decisions. This article profiles the product development process and sciences used to design these advanced diagnostics systems to be human-centered. Systems are becoming smarter, faster and friendlier for users. Specific benefits are identified along with the methods, challenges and design tradeoffs to achieve them. Users of diagnostic devices will be able to recognize and understand the impact of ergonomics in the design from this product development history.

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K. Alexander, P. J. Clarkson. "Good design practice for medical devices and equipment, Part II: design for validation." Journal of Medical Engineering & Technology 24, no. 2 (January 2000): 53–62. http://dx.doi.org/10.1080/030919000409311.

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Rebelo, N., and M. Perry. "Finite element analysis for the design of Nitinol medical devices." Minimally Invasive Therapy & Allied Technologies 9, no. 2 (January 2000): 75–80. http://dx.doi.org/10.3109/13645700009063053.

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Zhang, Hong Xing, Yang Liu, and Xue Kui Shi. "Framework Design on Customer Relationship System for Medical Devices Industry." Applied Mechanics and Materials 513-517 (February 2014): 3143–46. http://dx.doi.org/10.4028/www.scientific.net/amm.513-517.3143.

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Medical devices industry is facing severe challenges of foreign-funded enterprises and foreign products and services and other aspects. It is difficult to increase operating efficiency, so establish a scientific and comprehensive customer relationship management system is an effective way to solve the current predicament. This paper studies framework structure design in order to improve the development efficiency and quality of CRM system. First, system framework structure design can be carried on by way of graphical; then, we can conduct function framework structure design. Function system is decomposed into four subsystems: the first is sales management, the second is marketing management, the third is support and service management, the fourth is system management. Finally, we are able to do the technology framework structure design and then design three-tier architecture that includes presentation layer, business logic layer and data access layer based on B / S. The results show that it is an effective means to improve the core competitiveness of enterprises used CRM developed by design results of the paper.

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Shen, Konlin, and Michel M. Maharbiz. "Design of Ceramic Packages for Ultrasonically Coupled Implantable Medical Devices." IEEE Transactions on Biomedical Engineering 67, no. 8 (August 2020): 2230–40. http://dx.doi.org/10.1109/tbme.2019.2957732.

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Kalsher, Michael J., and Michael S. Wogalter. "Warnings and Instructions: Design Factors for Medical Devices and Systems." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 44, no. 28 (July 2000): 537–40. http://dx.doi.org/10.1177/154193120004402833.

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Rodriguez-Villegas, Esther, Saam Iranmanesh, and Syed Anas Imtiaz. "Wearable Medical Devices: High-Level System Design Considerations and Tradeoffs." IEEE Solid-State Circuits Magazine 10, no. 4 (2018): 43–52. http://dx.doi.org/10.1109/mssc.2018.2867247.

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Wan Kim, Sung, and Harvey Jacobs. "Design of Nonthrombogenic Polymer Surfaces for Blood-Contacting Medical Devices." Blood Purification 14, no. 5 (1996): 357–72. http://dx.doi.org/10.1159/000170288.

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Xia, Xiaoling, Xiaolin Lin, Wenbin Dong, and Zhi He. "Design of traceability system for medical devices based on blockchain." Journal of Physics: Conference Series 1314 (October 2019): 012067. http://dx.doi.org/10.1088/1742-6596/1314/1/012067.

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Panescu, D. "Design and Medical Safety of Neuromuscular Incapacitation Devices [Emerging Technologies]." IEEE Engineering in Medicine and Biology Magazine 26, no. 5 (September 2007): 57–67. http://dx.doi.org/10.1109/emb.2007.901792.

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Luk, Andrew, and Gunjan Junnarkar. "Critical challenges to the design of drug-eluting medical devices." Therapeutic Delivery 4, no. 4 (April 2013): 471–77. http://dx.doi.org/10.4155/tde.13.17.

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Duarte, Ricardo, Michel Mesnard, and Jean-Pierre Nadeau. "An innovative design approach to develop external articular medical devices." International Journal on Interactive Design and Manufacturing (IJIDeM) 11, no. 2 (July 19, 2016): 375–83. http://dx.doi.org/10.1007/s12008-016-0341-4.

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Journal articles on the topic 'Design of medical devices'

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