Relevant bibliographies by topics / Design of medical devices

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Design of medical devices'

Author: Grafiati
Published: 28 June 2021
Last updated: 1 February 2022

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Journal articles on the topic "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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Dissertations / Theses on the topic "Design of medical devices"

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Sutcliffe, Laura Francesca Rose. "Environmentally conscious design of medical devices." Thesis, University of Cambridge, 2012. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.610758.

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Murphy, Robert S. "The design of safety-critical medical infusion devices." Thesis, University of South Wales, 2007. https://pure.southwales.ac.uk/en/studentthesis/the-design-of-safetycritical-medical-infusion-devices(1557c702-3087-43f9-a399-99a9ba65ae9b).html.

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Intravenous infusion devices - commonly known as infusion pumps - provide clinicians with mechanisms to automate the accurate dosing of potent fluid therapies to critically ill patients. In critical care applications, fluid dosing must be both accurate and safe since unwanted flow disturbance can cause physiological harm to the patient. This study consists of three discrete projects based on these vital themes of safe device design and accurate fluid delivery. The first project, commissioned by Medical Magnetics Ltd during the period 1998 onwards, proposed that the fail-safe design philosophy universally used in the design of infusion pumps, and implemented in embedded software, is lengthy and provides the manufacturer with difficulties in demonstrating the exhaustive fail-safe validation needed for an instrument to be released speedily for sale. An alternative and innovative strategy employing the design of hardware modules and using re-configurable VLSI, is proposed and shown to offer a significant reduction of the design and validation phase of development with consequent financial benefit to the manufacturer. The second project conducted as part of the Manukau Institute Research Programme for 2003 examined the manner in which dosing accuracy is assessed for infusion pumps. The International Standard used by clinicians to select apparatus suitable for treatment of 'critically-ill' patients is shown to be flawed and potentially misleading - a finding of international significance. An innovative mathematical simulation model is described that enables prediction of flow accuracy for various expected operating scenarios previously impossible to investigate using current laboratory measurement techniques. Use of this simulation model indicates that various mechanical design factors influencing system compliance and hence dosing accuracy have been previously ignored by designers and suggests that contemporary infusion pump designs are far from optimum. These findings offer an explanation for instances of dosing error previously reported in the clinical literature and are of international value. The third project of the study utilises the findings of, and is subsequent to, the second project. An innovative design is proposed for an infusion therapy device in which dosing accuracy may be maintained under operating conditions such as height change and patient venous pressure variation that cause unwanted errors in conventional equipment designs. This design is the subject of patent application, commercial exploitation and further development.
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Alexander, K. L. "Design for validation of medical devices and equipment." Thesis, University of Cambridge, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.595422.

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Design for validation is aimed at designing medical devices to make them easier and more economic to validate. Changes to the medical device regulations within the past few years have forced the industry to focus attention on design and validation in order to ensure that a device and its associated manufacturing and test equipment are reliable and fit for purpose. In order for this to happen, design must affect validation and validation must affect design. However, current guidance on validation as it applies to design is inadequate and, as a result, validation is generally not well understood amongst medical device designers. The goal of design for validation is to provide guidance in order to help designers achieve integrated design, development and validation. It forms part of a wider definition of Good Design Practice which aims to encourage fitness for purpose within commercial reality. Exploratory research was carried out in the form of studying ideal practice and current practice in order to identify the factors which contribute to integrated design, development and validation. Case studies were analysed, a model of ideal practice was developed and interviews were carried out with various medical device designers and project managers. From the information gathered, two basic designer needs were identified which had to be fulfilled in order for designers to integrate design, development and validation. A practical approach to design for validation was formulated in order to address the two designer needs through the use of a model of design for validation and a series of six design tactics. The approach was evaluated by sending questionnaires to industry. The feedback was very positive and, based on the evaluation, revisions were made to the design for validation model and design tactics. The revisions will be carried forward to the next phase of the research which is the development of a Design for Validation Workbook.
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Çetin, Aslı Seçkin Yavuz. "Applying product design methods to medical device design with a case study on home care devices/." [s.l.]: [s.n.], 2004. http://library.iyte.edu.tr/tezler/master/endustriurunleritasarimi/T000449.pdf.

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Sagoo, Jeevan. "Design rationale for the regulatory approval of medical devices." Thesis, Cranfield University, 2012. http://dspace.lib.cranfield.ac.uk/handle/1826/8014.

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Design rationale is a methodology aimed at capturing and representing design decisions according to a designated structure. Additionally, these design decisions and their underlying arguments can be made available for examination at a later date. The literature review identified that there is currently a lack of information describing the use of design rationale methods and computational support tools with the medical device domain. Furthermore, the review of literature has also recognised that there are no existing guidelines available for medical device manufacturers and regulatory authorities to follow in order to capture and represent the design decisions in the case of medical devices. Medical devices are instruments which are used for diagnosis, screening, monitoring, or the treating of patients suffering from disease, injury, or disability. Medical devices are products that require rigorous regulation before they can be placed onto the market. If problems are encountered with a device once it has been placed onto the market, the device is recalled by the relevant regulatory authority. Device recalls can often result in the device manufacturers having to evaluate the design decisions that were made during the product development stages in order to address the reported problems and implement a solution. As a result, medical device manufacturers can incur unexpected rework and/or redesign costs, and in even more severe circumstances, incur high litigation costs. This research; reviews the state-of-the-art in design rationale and identifies its key capabilities, analyses design rationale’s feasibility for use with the medical device domain, identifies the regulatory approval processes for medical devices and compares them, analyses the possibilities of utilising design rationale with the regulatory approval of medical devices, and develops a set of guidelines. The guidelines detail the necessary steps that are required to capture and represent the design decisions for medical devices. The utility of this contribution has been verified through the process of validation with experts and researchers.
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Stead, Thomas. "An investigation into the application of design processes to novel self-use molecular diagnostic devices for sexually transmitted infections." Thesis, Brunel University, 2017. http://bura.brunel.ac.uk/handle/2438/15197.

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The purpose of this research was to investigate the application of design processes to the development of novel self-use molecular diagnostic devices for sexually transmitted infections. The argument proposed in this thesis is that the application of design methods at the earliest research stages into miniaturised, low cost, molecular diagnostic technologies will accelerate and improve the process of translating proof of concept diagnostic technologies into usable devices. Concept development requirements and potential issues and barriers to development were identified through interviews with expert stakeholders. These requirements were further refined through a survey of a multidisciplinary diagnostic medical device research group. An action research method was applied to develop a proof of concept prototype to the preclinical trial stage. Through these research studies, a design process model was formulated for use in a research environment. The application of design methods to the proof of concept prototype described in the thesis have resulted in a preclinical trial prototype that exhibits the necessary features for development into a self-use molecular diagnostic device. Issues and barriers were identified and discussed, design guidelines for further development beyond preclinical trial were defined and a generalised design process model for self-use molecular diagnostic devices for sexually transmitted infections was proposed. This research highlights the need for design methods to be applied at the earliest possible stages of the development of novel molecular diagnostic devices.
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Schubert, Maxi. "Modular design for a product family ofaesthetic medical laser devices." Thesis, KTH, Maskinkonstruktion (Inst.), 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-226145.

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This thesis covers a product development process carried out at the company “Asclepion Laser Technologies” for a product family of aesthetic medical laser devices. Due to different dimensions and dates of origin, an obvious divergence in the appearance of the present products within the product family had emerged in the company. Since the recognition value of a brand is greatly influenced by its product design the company aspired the development of a uniform design for the whole product family.   For this purpose, the objective of this thesis was the development of a new housing design. A modular design was pursued, to make it applicable for different devices of the same product family. Building multiple devices from the same housing modules reduces the overall production costs by decreasing tooling costs and decreasing the diversity of parts from suppliers. With the use of thermoforming as the predetermined production method, the production costs are kept low in addition.   During the master thesis project, the whole product development process was executed. The present thesis describes the development process in its four different phases, beginning with the pre-studies over ideation, concept development till the development of a final product ready for production. The implementation of suitable methods and tools in this design process, like observational studies and morphological idea generation, is outlined.   In collaboration with a thermoform specialist a CAD-model, ready for production, was delivered. After a revision of the developed product design by a commercial design company the design has been immediately transferred into serial production.
Denna uppsats beskriver den produktutvecklingsprocess som genomförts i samarbete med “Asclepion Laser Technologies” i syfte att ta fram ett gemensamt formspråk för en produktfamilj av medicinska lasrar. Eftersom att dessa produkter varierar i storlek såväl som utvecklingsår fanns stora skillnader i deras respektive formspråk. Eftersom att formspråk och design är viktiga för varumärkets identitet så eftersträvade företaget att införa ett gemensamt formspråk för sina produkter.   Examensarbetets syfte var sålunda att ta fram en design för nya kåpor. För att göra designen applicerbar över hela produktfamiljen så eftersträvades ett modulärt system. Genom att nyttja samma kåpor till flera produkter kan dessutom produktionskostnad, verktygskostnad och antal underleverantörer sänkas. Varmforming som preliminär tillverkningsmetod bidrar även det till en låg produktionskostnad.   Arbetet omfattade hela produktutvecklingsprocessen i fyra steg, med förstudie, idégenerering, konceptutveckling och produktionsklart koncept. Användandet av metoder och verktyg för utvecklingsprocessen, såsom observationsstudier morfologisk idégenerering, beskrivs övergripande.   I samarbete med en varmformningsspecialist levererades en produktionsklar CAD-modell. Efter att ha reviderats av ett kommersiellt designföretag har den framtagna designen satts i serieproduktion.
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Andriani, Rudy Thomas. "Design and Validation of Medical Devices for Photothermally Augmented Treatments." Thesis, Virginia Tech, 2014. http://hdl.handle.net/10919/50503.

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*1-Dimensional Advective-Diffusion Model in Porous Media Infusion of therapeutic agents into tissue is makes use of two mass transport modes: advective transport, and molecular diffusion. Bulk infusion into a 0.6% wt agarose phantom was modeled as an infinite, homogenous, and isotropic porous medium saturated with the same solvent used in the infused dye tracer. The source is assumed to be spherical and isotropic with constant flow rate and concentration. The Peclet numberdecreases with power function Pe = 15762t0.337 due to the decrease in mean dye-front pore velocity as V goes to Vfinal. Diffusive mass transport does not become significant during any relevent time period. *Arborizing Fiberoptic Microneedle Catheter We have developed an arborizing catheter that allows multiple slender fused-silica CED cannulae to be deployed within a target volume of the brain via a single needle tract, and tested it in a widely accepted tissue phantom. The arborizing catheter was constructed by bonding and encapsulating seven slender PEEK tubes in a radially symmetric bundle with a progressive helical angle along the length, then grinding a conicle tip where the helical angle is greatest. The catheter was tested by casting 0.6% wt agarose around the device with all needles deployed to a tip-to-tip distance of 4 mm. Phantom temperature was maintained at 26 ± 2°C. 5% wt Indigo Carmine dye was infused at a rate of 0.3 uL/min/needle for 4 hours. N=4 infusions showed a Vd/Vi of 139.774, with a standard deviation of 45.01. This is an order of magnitude greater than single-needle infusions under similar conditions [45]. The arborizer showed the additional benefit of arresting reflux propagating up the lengths of individual needles, which has historically been a weakness of single-needle CED catheter designs. *In Vivo Co-Delivery of Single Walled Carbon Nano-horns and Laser Light to Treat Human Transitional Cell Carcinoma of the Urinary Bladder in a Rodent Model Using a rodent model we explored a treatment method for Transitional Cell Carcinoma (TCC) in the urinary bladder in which Single Walled Carbon Nanohorn (SWNH) solution and 1064 nm laser light are delivered into tumorous tissue via a co-delivery Fiberoptic Microneedle Device (FMD). Preliminary treatment parameters were determined by injecting SWNH solutions with concentrations of 0 mg/mL, 0.17 mg/mL, or 0.255 mg/mL into ex vivo porcine skin and irradiating each for three minutes at laser powers of 500 mW, or 1000 mW. The combination with the greatest temperature increase without burning the tissue, 0.17 mg/mL at 1000 mW, was selected for the in vivo treatment. TCC tumors were induced in a rodent model by injecting a solution of 106 AY27 urothelial carcinoma cells into the lateral aspect of the left hind leg of young, female F344 rats. When tumors reached 5-10 mm3, rats were anesthitized and treated. SWNH solution was injected directly into the tumor and irradiated until the target temperature of 60degC was achieved. The rats were then recovered from anestesia and monitored for 7-14 days, at which point they were humanely sacrificed, and the tumors prepared for histological examination. Histological assessment of areas of FMD treatment correlated well with gross morphological appearance. Foci of tumor necrosis showed sharp (1-2 mm) delineation from areas of viable tumor (not treated) and normal tissue. We believe we have demonstrated the feasibility of using the FMD for treatment of urothelial carcinoma using an animal model of this disease, and are encouraged to continue development of this treatment and testing in larger animal models.
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Brunberg, Marike. "User optimized design of handheld medical devices -applications and casing." Thesis, Umeå universitet, Institutionen för tillämpad fysik och elektronik, 2010. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-36270.

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Boelen, E. "Innovations in medical image processing for the design of custom medical devices and implants." Journal for New Generation Sciences, Vol 8, Issue 2: Central University of Technology, Free State, Bloemfontein, 2010. http://hdl.handle.net/11462/557.

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In this article we will describe the use of 3D medical image information of individual patients as well as selected patient populations, combined with CAE tools and processes, in the rapid product development of custom and standard implantable devices. The combination of medical image information with CAE methods such as CAD, RP, FEA and CFD, allows the engineer to develop implantable devices faster and better, with optimized designs tailored to the anthropometry of the targeted patient (population), using virtual instead of mechanical prototype testing. Case studies will be demonstrated for a variety of surgical fields such as orthopaedic, cranio-maxillofacial and cardiovascular surgery.
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Books on the topic "Design of medical devices"

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Reliable design of medical devices. 3rd ed. Boca Raton: CRC Press, 2013.

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Reliable design of medical devices. 2nd ed. Boca Raton, Fl: Taylor&Francis, 2005.

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Reliable design of medical devices. New York: Marcel Dekker, 1997.

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Fries, Richard C. Reliable design of medical devices. 2nd ed. Boca Raton, Fl: Taylor & Francis, 2006.

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Fries, Richard C. Reliable design of medical devices. 2nd ed. Boca Raton, FL: CRC/Taylor & Francis, 2004.

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David, Hill. Design engineering of biomaterials for medical devices. Chichester: Wiley, 1998.

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Justiniano, Jose M. Practical design control implementation for medical devices. Boca Raton: Interpharm/CRC, 2003.

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C, Fries Richard, ed. Design of biomedical devices and systems. New York: Marcel Dekker, 2003.

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King, Paul H. Design of biomedical devices and systems. 2nd ed. Boca Raton: Taylor & Francis, 2009.

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Fries, Richard C. Handbook of medical device design. New York: M. Dekker, 2001.

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Book chapters on the topic "Design of medical devices"

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Ferrer, Inés, Jordi Grabalosa, Alex Elias-Zuñiga, and Ciro Angel Rodriguez. "Design Issues in Medical Devices." In Biomedical Devices, 23–48. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2016. http://dx.doi.org/10.1002/9781119267034.ch2.

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Halt, Gerald B., John C. Donch, Amber R. Stiles, Lisa Jenkins VanLuvanee, Brandon R. Theiss, and Dana L. Blue. "Design Protection for Medical Devices." In FDA and Intellectual Property Strategies for Medical Device Technologies, 201–14. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-04462-6_10.

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Nonoguchi, Yoshiyuki. "Materials Design for Flexible Thermoelectric Power Generators." In Flexible and Stretchable Medical Devices, 139–60. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co. KGaA, 2018. http://dx.doi.org/10.1002/9783527804856.ch6.

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Branaghan, Russell J., Joseph S. O’Brian, Emily A. Hildebrand, and L. Bryant Foster. "Human Factors Regulations for Medical Devices." In Humanizing Healthcare – Human Factors for Medical Device Design, 201–25. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-64433-8_9.

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Ransford, Benjamin, Shane S. Clark, Denis Foo Kune, Kevin Fu, and Wayne P. Burleson. "Design Challenges for Secure Implantable Medical Devices." In Security and Privacy for Implantable Medical Devices, 157–73. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-1674-6_7.

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Lantada, Andrés Díaz, Pilar Lafont Morgado, and Carlos Jahel Ojeda Díaz. "Medical Imaging-Aided Design of Personalized Devices." In Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices, 75–94. Boston, MA: Springer US, 2013. http://dx.doi.org/10.1007/978-1-4614-6789-2_5.

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Wayne, David A. "Low Voltage Low Power Design Techniques for Medical Devices." In Analog Circuit Design, 105–26. Boston, MA: Springer US, 1995. http://dx.doi.org/10.1007/978-1-4757-2353-3_6.

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Colombo, Giorgio, Giancarlo Facoetti, Caterina Rizzi, and Andrea Vitali. "Low Cost Hand-Tracking Devices to Design Customized Medical Devices." In Lecture Notes in Computer Science, 351–60. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-21067-4_36.

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Ogrodnik, Peter J. "Classifying Medical Devices." In Medical Device Design, 11–26. Elsevier, 2013. http://dx.doi.org/10.1016/b978-0-12-391942-7.00002-7.

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Ogrodnik, Peter. "Classifying medical devices." In Medical Device Design, 17–49. Elsevier, 2020. http://dx.doi.org/10.1016/b978-0-12-814962-1.00002-8.

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Conference papers on the topic "Design of medical devices"

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Lowndes, Bethany, Dawn Finnie, Julie Hathaway, Jennifer Ridgeway, Kristin Vickers-Douglas, Charles Bruce, and Susan Hallbeck. "Human Factors Applications to Mitigate Design Limitations of a Wearable Telemedicine Heart Rate Monitor." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3461.

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The time required to get a device to market is critical to a successful design, development, and manufacturing process [1]. Achieving status of the first device to market is often a priority for manufacturers and developers. Upon market introduction, it is well known that device performance must meet at least minimum standards in order to provide consumer satisfaction and be a successful product to prevent competitive devices from taking over the market [1]. However, if a design only meets minimum expectations, it may struggle to maintain market control. This demonstrates the tradeoffs of speed-to-market and performance, for which optimization has not been clearly defined [2]. Product performance and usability can be designed in, evaluated and enhanced in order to avoid user errors and achieve optimal profitability. For medical devices, clinical trials are a key step in preparing to take a device to market. Clinical trials can allow for analyses of the effectiveness of the device in the patient care process. For wearable medical devices, patient usability is crucial to patient adherence and safety since the device will be operated by non-medically trained individuals [3,4]. Without adequate usability, adherence and continuity of care are greatly reduced which will reduce the overall effectiveness of the device [5,6]. Human factors principles can best be incorporated in the design process to improve the usability of medical devices and patient safety [5,6,7], specifically for those used in telemedicine [4] and cardiovascular treatment [3]. The objective of this project was to evaluate a telemedicine heart rate monitoring device for patient usability in order to improve the next device’s performance and lead to greater patient adherence for the current version via an improved user manual.
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Valenzuela, Thomas, Jorge Zhingre Sanchez, Mikayle Holm, Tinen Iles, and Paul Iaizzo. "Using Computational Modeling Derived From Micro CT Scanning for the Post-Implant Analyses of Various Cardiac Devices." In 2020 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/dmd2020-9071.

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Abstract There are few medical devices currently utilized that have not had, at the very least, a second iteration. Medical device companies continually strive to improve their product to make it the best on the market. Medical devices are often optimized by defining the size of the device, making it more efficient and/or improving the device to tissue interface. Using the capabilities of the Visible Heart® Laboratories various cardiac devices can be implanted in reanimated swine and human hearts for the assessment of the various aforementioned parameters. After the implantation of these devices and assessment in functional anatomies, specimens were perfusion-fixed and then a micro-CT scanner was utilized to take high-resolution scans of the resultant device and tissue interfaces. These scans are used to generate high-resolution (∼20 microns) 3D models of the numerous implanted devices, measurement analyses, device simulations, and the creation of virtual reality scenes. All can then be used for detailed visual analyses. These abilities to render high-resolution models will allow medical device designers to closely evaluate their designs, in order to optimize their next iterations.
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Smith, Mark E., and Yan Chen. "Thrombogenicity Testing Results for Control Legally Marketed Comparator Devices (LMCD): Comparison Between Traditional Non-Anticoagulated Venous Implant (NAVI) Assay and an In Vitro Ovine Blood Loop Test." In 2020 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/dmd2020-9073.

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Abstract Legally marketed comparator devices (LMCD) are required by many regulatory bodies in as a control for thrombogenicity testing when evaluating new devices. It is assumed by both the medical device manufacturing industry and regulatory bodies that these LMCD’s have good clinical history and should perform with no to minimal thrombus accumulation and thereby serve as valid negative controls for the assay. APS regularly performs these assays for many medical device manufacturers, all of whom select a predicate comparator device (required by FDA to be an LMCD), for both the in vivo Non-Anticoagulated Venous Implant (NAVI) assay as well as a custom in vitro blood loop AVI. In this retrospective analysis, we have compiled thrombogenicity scores of control/predicate devices (limited to assays which used LMCD’s), both the discrete score from the classification standard scoring scheme and the continuous values obtained from the percent surface area associated with thrombus. We have compared results from 37 NAVI studies and 22 in vitro blood loop studies. These compiled results show ∼25% of LMCDs score ≥ 3 (&gt; 50% of the surface covered in thrombus) in the NAVI model while &lt; 5% of LMCDs score ≥ 3 (&gt; 50% thrombus) in the Blood-Loop assay. In addition, the median score and mean % thrombus for LMCD in the blood loop assay is substantially lower than the median and mean scores for LMCD in the NAVI assay. This retrospective assessment highlights a high proportion of false-positive scores for LMCD in a large number of NAVI assays.
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Sango, Marc, Jean Godot, Antonio Gonzalez, and Ricardo Ruiz Nolasco. "Model-Based System, Safety and Security Co-Engineering Method and Toolchain for Medical Devices Design." In 2019 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2019. http://dx.doi.org/10.1115/dmd2019-3210.

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The increasing complexity of the medical regulatory environment and the inherent complexity of medical devices, especially due to the increased use of connected devices and embedded control software, impose adoption of new methods and tools for the system design, safety and security analyses. In this paper, we propose a method and an associated toolchain to couple model-based system engineering and safety/security analyses at the design phase of medical devices. The method is compliant with ANSI/AAMI/ISO TIR57 safety and security guidance, and compatible with INCOSE Biomedical-Healthcare Model-Based Systems Engineering works. The toolchain is based on a system architecture modelling tool and supports medical device domain specific reference architecture, as well as tools for safety and security risk analyses. The proposed method and toolchain are illustrated by considering a RGB’s TOF-CUFF monitor device analyzed in the scope of the AQUAS project as a medical device use case.
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Zhang, Bolun, Daniel Farley, Heidi-Lynn Ploeg, and Michael Zinn. "Validation of Feedback Control Approach for an Implantable Limb Lengthening Device." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3456.

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Lower limb length discrepancy (LLD), defined by unequal length of paired lower limbs, contributes to lower back pain, osteoarthritis of the hip, and stress fractures [1–3]. The Center for Disease Control and Prevention estimated that there were approximately 700 children born with LLD each year in US [4]. Patients may receive distraction osteogenesis treatment, in which an osteotomy is performed on the shorter limb, and mechanical force is applied to gradually distract the two halves of the bone during the healing process. This stretches the bone callus during healing to achieve desired limb length upon callus consolidation [5]. The current correction devices are external fixators that leave unsightly scars and are prone to infection [6]. While recently developed intramedullary devices address many of the persistent issues with external lengthening devices, size limitations and potential damage to the bone growth plates make them impractical for use in children [7, 8]. The proposed research addresses an unmet need by developing a novel implantable extramedullary device for LLD correction that is targeted for pediatric use. The device will be implantable, submuscular, and fixed to the outside surface of the bone (extramedullary), thus allowing for use in children without concern for injury to the growth plates. The device’s function will be similar to an external fixator; however, it will not require exposed hardware, which increases risk of infection, or muscle penetration from the pins, which causes pain. Additionally, the device incorporates real-time control of the distraction rate, reducing the risk of complications arising from fixed rate distraction such as premature consolidation and non-union of the callus. [9–11]. The investigators of this study have previously designed and constructed a distraction mechanism prototype and test frame [10]. The current study aims to validate the real-time controller of the prototype.
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Lang, Virginia A., and David Nalan. "Combination Product Patient Training: How Are Patients Trained and Who Conducts the Training?" In 2018 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/dmd2018-6956.

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Patients are frequently prescribed a medication that must be administered either by a nasal spray, an inhaler, or a self-injection device. These devices are classified as combination devices by the Food and Drug Administration (FDA) and the Medical Device Regulations (MDR). However, there has been an issue of who and how do these patients get trained. It has long been the stance of the pharmaceutical companies they will not provide training because they provide an Information for Use (IFU) and/or a demo on their website. The issues with either of these means is that neither the FDA, nor the MDR permit them as mitigation for use errors. And, in human factors testing there are considerable numbers of use errors when patients attempt to use the devices.
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Yeh, Hsiang-Lan, Jonathan V. Garich, Ian R. Akamine, Jennifer M. Blain-Christen, and Seth A. Hara. "Laser Micromachining of Thin-Film Polyimide Microelectrode Arrays: Alternative Processes to Photolithography." In 2020 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/dmd2020-9057.

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Abstract Thin-film microelectrode arrays have a wide variety of applications in research and medical devices. Conventionally, these arrays are fabricated through the use of photolithography, which can be problematic for innovative medical device fabrication due to long process times, inflexibility to design changes, and the reliance on potentially harmful chemicals. Here, we present the use of laser micromachining as an alternative to photolithography processes to fabricate thin-film polyimide microelectrode arrays. This fabrication method lends itself to an iterative design process as it can reduce fabrication steps and is attractive for medical devices since it can be used without harmful chemicals. Several process parameters were explored and the performance of the fabricated electrodes was compared to similar electrodes that were fabricated with conventional photolithography processes.
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Fan, Junfeng, Oscar Reparaz, Vladimir Rožić, and Ingrid Verbauwhede. "Low-energy encryption for medical devices." In the 50th Annual Design Automation Conference. New York, New York, USA: ACM Press, 2013. http://dx.doi.org/10.1145/2463209.2488752.

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Bertsch, J. Michael, and Stephen P. Gent. "Design of a Wearable Health Monitoring System for In-Home and Emergency Use." In 2020 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2020. http://dx.doi.org/10.1115/dmd2020-9091.

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Abstract Recent advancements in wearable medical technologies have streamlined health monitoring with simple, non-invasive measurements. These devices, however, are rarely capable of monitoring all the necessary parameters for an accurate measure of health, such as blood pressure, and can cost the user hundreds to thousands of dollars. The objective of this project was to design an affordable, user-friendly, wearable device capable of monitoring multiple parameters: body temperature, blood pressure, heart rate, blood oxygen, and body positioning. By combining wearable sensors with Inter-Integrated Circuit (I2C) technology, the data from many sensors can be transmitted while maintaining a compact size for a wearable. In parallel with this device, a mobile application was designed as an interface to receive real-time comprehensive measurements. This device could be used to reduce monitor application time in emergency medical settings and monitor patients in rural communities who are often hours away from the nearest medical centers.
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Snyder, Trevor A., Phillip Coghill, Kooroush Azartash-Namin, Jingchun Wu, J. Ryan Stanfield, and James W. Long. "Design of an Implantable Blood Pump for Mechanical Circulatory Support in Pediatric Patients." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3520.

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While the use of pulsatile- and continuous-flow ventricular assist devices (VADs) has become widely accepted as an acceptable treatment for end-stage heart failure in adults over the last three decades, the technology development for pediatric-specific patients is lagging behind that of adult devices. Only one pulsatile-flow VAD has been approved for use in pediatric patients in the U.S., just five years ago [1]. One continuous-flow device was approved specific to this population under Humanitarian Device Exemption (HDE), but is not in clinical use today [2]. As continuous-flow rotary blood pumps (RBPs) have become commonplace for mechanical circulatory support (MCS) in adults due to smaller size and greater reliability, significant resources have gone into the development of RBPs for pediatric use [3]. Further, RBPs designed for adult MCS have been used off-label in pediatric patients [4]. Development of an implantable device specific to a pediatric population includes challenges of anatomic placement and fixation. We have developed a RBP for adult MCS specific to right heart failure using computational fluid dynamics (CFD) and flow visualization [5]. The miniaturized device includes a rotating impeller and a vaned-diffuser in a 7 mm axial hydraulic diameter. As seen in Figure 1, the hydrodynamic characteristics suitable for a right-VAD (RVAD) may also be suitable for pediatric patients. Currently, the only approved device is placed extracorporeal due to size constraints in the intended population [1]. This report shows results of computational simulations for anatomic fit and fluid flow studies of our device geometry in pediatric patients.
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Reports on the topic "Design of medical devices"

1

Johnson, Leah, Stephanie Swarner, Ariane van der Straten, and Ginger Rothrock. Methods for Assessing the Adherence to Medical Devices. RTI Press, October 2016. http://dx.doi.org/10.3768/rtipress.2016.mr.0036.1610.

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Bates, J. B., and T. Sein. Development of Thin-Film Battery Powered Transdermal Medical Devices. Office of Scientific and Technical Information (OSTI), July 1999. http://dx.doi.org/10.2172/10434.

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Nikiforov, Vladimir. Laser technology and integrated system devices in devices and tools for dentists and other medical technologies. Intellectual Archive, June 2019. http://dx.doi.org/10.32370/iaj.2132.

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Lussie, W. G., W. A. Neuman, J. L. Jones, R. L. Drexler, J. A. Lake, M. L. Griebenow, R. R. Hobbins, D. R. deBoisblanc, and C. F. Leyse. Medical therapy reactor preconceptual design studies. Office of Scientific and Technical Information (OSTI), December 1988. http://dx.doi.org/10.2172/6417636.

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Nguyen, Loc. Logic design using programmable logic devices. Portland State University Library, January 2000. http://dx.doi.org/10.15760/etd.5987.

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Ula, N. Design of GaAs charge coupled devices. Office of Scientific and Technical Information (OSTI), January 1990. http://dx.doi.org/10.2172/7122238.

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Author, Not Given. Design of a Medical X- Band LINAC. Office of Scientific and Technical Information (OSTI), May 2018. http://dx.doi.org/10.2172/1484254.

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Drexler, Elizabeth S., William F. Regnault, and John A. Tesk. Measurement methods for evaluation of the reliability of active implantable medical devices :. Gaithersburg, MD: National Institute of Standards and Technology, 2006. http://dx.doi.org/10.6028/nist.sp.1047.

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Grennan, Matthew, and Robert Town. Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices. Cambridge, MA: National Bureau of Economic Research, February 2015. http://dx.doi.org/10.3386/w20981.

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Grennan, Matthew, Charu Gupta, and Mara Lederman. Firm Scope and Spillovers from New Product Innovation: Evidence from Medical Devices. Cambridge, MA: National Bureau of Economic Research, October 2018. http://dx.doi.org/10.3386/w25183.

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