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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.Master of Science
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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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Published ArticleIn 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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Arredondo, Cecilia. "Imbued Medical Device Design." University of Cincinnati / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926108.
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Grant, Tom. "The involvement of users in the design of home use medical devices : challenges and incentives for change." Thesis, Loughborough University, 2014. https://dspace.lboro.ac.uk/2134/16283.
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The prevalence and use of medical devices in the home environment continues to grow in the United Kingdom (UK) and Worldwide. It is recognised that such devices offer significant benefits to both patients and the National Health Service in the UK. The design of home use medical devices however represents a considerable challenge to designers and manufacturers alike. Developing devices that are usable and understandable by inexperienced, lay or dexterity impaired users requires an understanding across a breadth of disciplines. Previous research in this field has explored these challenges in attempt to offer support for developers of home use medical devices. There have been very few studies however that have explored whether the design community actually need, want or use such guidance, before considering whether this literature is adopted correctly. Through case studies, an online survey and in depth interviews this thesis suggests that industry practitioners are sceptical of the value of design guidance towards user involvement in home use medical device design. Consequently the practitioners in this research make little or no use of the formal design methods and supportive guidance documents available to them. More typically, practitioners in the home use medical device field use their own personal experiences and knowledge from working in the industry to adapt their own approaches to design. This thesis reports that the greatest challenge to involving users in the design of home use medical devices are the internal corporate and traditionally hierarchical barriers between stakeholders within the design process. In contrast to previous research offering support for designers and developers of home use medical devices this thesis calls for a wider change in design practice to facilitate the application of usability principles. As a conclusion to this thesis, recommendations for further research to address these changes in practice are proposed to industry professionals in the medical device industry. This thesis is submitted as part of the requirement for the Degree of Doctor of Philosophy at Loughborough University.
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Svensson, Andreas. "Design of Inductive Coupling for Powering andCommunication of Implantable Medical Devices." Thesis, KTH, Skolan för informations- och kommunikationsteknik (ICT), 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-105112.
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Technological advances over the years have made it possible to reduce the size and power consumption of electronics. This has led to significant advances for biomedical sensors. It is now possible to reduce the size enough to create implantable sensors. This type of sensors can for instance be used to measure the glucose level of diabetes patients. An implantable sensor can significantly simplify the measurement procedure. Taking a measurement can be as simple as turning on a device, capable of receiving the data sent by the sensor. Unfortunately, the lifetime of this type of sensors can be limited by the battery of the implanted sensor. To improve the lifetime, the battery has to be replaced. Instead of a battery, energy harvesting can be used. One promising such method is to transfer power from outside the body to the implanted sensor. This thesis focuses on one such way, inductive coupling. Inductive coupling, can be used both to transfer power from an external device to the sensor, and to transfer data from the sensor to the external device. In this thesis a system for wireless power transfer has been proposed. The system is based on state of the art circuits for inductive powering and communication, for implantable devices. The system is adapted for powering an implantable biomedical sensor including a PIC16LF1823 microcontroller. The system includes asynchronous serial communication, from the microcontroller in the implantable device to the external reader device using load shift keying. The external device of the system, has been implemented in two different versions, one using a printed circuit board (PCB), and one simplified version using a breadboard. The implantable device has been implemented in three different versions, one on a PCB, one simplified version using a breadboard and finally one application specific integrated circuit (ASIC). All three implementations of the implantable devices use a resistor to simulate the power consumption of an actual biomedical sensor. The ASIC implementation contains only the parts needed for receiving power and transmitting data. The ASIC was designed using a 150nm CMOS process. The PCB implementations of both devices have been used to measure the system performance. The maximum total power consumption was found to be 107 mW, using a 5 V supply voltage. The maximum distance for powering the implantable device was found to be 4.5 cm in air. The sensor, including the microcontroller, is provided with 648 μW of power at the maximum distance. A raw data rate of 19200 bit/s has been used successfully to transfer data. Additionally, oscilloscope measurements indicates that a data rate close to 62500 bit/s could be possible. Simulations of the proposed ASIC show that the minimum total voltage drop from the received AC voltage to the regulated output voltage is 430 mV. This is much smaller than for the PCB implementation. The reduced voltage drop will reduce the power dissipation of the implantable device and increase the maximum possible distance between the external device and the implanted devices. The ASIC can provide 648 μW of power at a coupling coefficient k=0.0032.Tekniska framsteg genom åren har gjort det möjligt att minska storleken och effektforbrukningen hos elektronik. Detta har lett till stora framsteg för biomedicinska sensorer. Det är nu möjligt att tillverka elektronik liten nog att användas i sensor implantat. En sådan sensor skulle till exempel kunna användas for att mäta glukos värden i blodet hos diabetes patienter. Ett sådant Implantat kan forenkla mätningar, genom att endast en mottagare behövs for att kunna få mätvarden från sensorn. Livslängden för denna typ av sensor kan forbättras genom att undvika att använda ett batteri som energikalla. Istället kan energin överföras från en apparat utanför kroppen till implantatet. Denna rapport handlar om ett sadant sätt, namligen induktiv energiöverföring. Denna teknik kan användas både till att överfora energi till implantatet, och till att överfora data från implantatet till den externa enheten. I den har rapporten beskrivs ett system for tradlös energiöverforing. Systemet ar baserat på den senaste tekniken for induktiv överforing, och har anpassats for att förse en sensor som inkluderar en PIC16LF1823 mikrokontroller. Systemet inkluderar också asynkron seriell kommunikation från mikrokontrollern i implantatet till den externa enheten genom att använda lastmodulering. Den externa enheten har implementerats i två versioner. En full version på ett kretskort, samt en förenklad version pa ett kopplingsdäck. Tre versioner av kretsarna for implantatet har använts, en förenklad version på ett kopplingsdäck, en version på kretskort och en applikations specifik integrerad krets. Den applikations specifika integrerade kretsen har simulerats med modeller från en 150 nm CMOS tillverkningsprocess, medans de andra versionerna har konstruerats av diskreta komponenter och använts för mätningar. Mätresultat från kretskortsimplementationen visar på en maximal räckvidd pa cirka 4,5 cm i luft, med en total effektforbrukning pa 107 mW. Vid det maximala rakvidden mottags 648 μW. En dataöverföringshastighet pa 19200 bitar/s har uppnåtts med kretskorts versionen. Mätningar med oscilloskop visar att det kan vara möjligt att öka överforingshastigheten till 62500 bitar/s. Simuleringsresultat for den integrerade kretsen visar att det lägsta spänningsfallet från den mottagna växelspanningen till den reglerade likspänningen är 430 mV. Detta ar betydligt mindre for den integrerade kretsen än för kretskorts versionen, vilket resulterar i en lagre effektforbrukning och troligen en längre räckvidd för systemet. Den integrerade kretsen kan leverera 648 μW vid en kopplingsfaktor pa k=0.0032.
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Alley, Krista I. "Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard." University of Cincinnati / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614.
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Gausepohl, Kimberly Ann. "Investigation of Storytelling as a Requirements Elicitation Method for Medical Devices." Thesis, Virginia Tech, 2008. http://hdl.handle.net/10919/36401.
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Medical device usability directly impacts the practitionerâ s ability to perform their diagnostic task in an effective, efficient, and safe manner. A device with poor usability may frustrate the practitioner, increasing the workerâ s stress level in a high-stress work environment. In addition, a device with poor usability may facilitate operator error, increasing the patientâ s risk of injury.
Designers of healthcare systems and devices face a unique conundrum that has been documented in the literature (Martin, Murphy, Crowe, & Norris, 2006; Martin, Norris, Murphy, & Crowe, 2007; Ward & Clarkson, 2007). Standards require the use of user research techniques, yet patient privacy standards prevent designers from observing users in context. The inability to observe users in their work environment impedes understanding the context-of-use. Since understanding context-of-use is required to ensure usability, further exploration into alternative methods for requirements gathering is needed.
This study explored the storytelling as an elicitation method for medical device requirements by comparing the information elicited from nurses during requirements gathering for an infusion pump by two methods: focus groups followed by interviews (Group #1) and focus groups followed by storytelling sessions (Group #2). Results suggest further exploration of storytelling is warranted as Group #2 contributed similar quantity and breadth of information in significantly less time. Results also indicate potential support for the efficacy of storytelling within the healthcare domain as Group #2 participants contributed more distinct context-of-use information with an emphasis on the social context. Contributions of this study include a plan for mixed-method data analysis, a protocol for conducting a storytelling session, and a framework for defining requirements within the healthcare domain.Master of Science
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Pokorný, Martin. "Design defibrilátoru." Master's thesis, Vysoké učení technické v Brně. Fakulta strojního inženýrství, 2010. http://www.nusl.cz/ntk/nusl-228921.
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This master’s thesis deals with design of defibrillator. It is a medical device for restoration of proper heart rhythm. The proposal respects the current production, but should draw their own concepts. The actual solution consisting in a combination of manual and fully automatic defibrillator. Applicability should include a wide range of expertise. The proposal is completely prepared in compliance with all aspects of construction of defibrillator.
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Amiri, Atila. "ST. JUDE MEDICAL: AN OBJECT-ORIENTED SOFTWARE ARCHITECTURE FOR EMBEDDED AND REAL-TIME MEDICAL DEVICES." DigitalCommons@CalPoly, 2010. https://digitalcommons.calpoly.edu/theses/374.
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Medical devices used for surgical or therapeutic purposes require a high degree of safety and effectiveness. Software is critical component of many such medical devices. The software architecture of a system defines organizational structure and the runtime characteristic of the application used to control the operation of the system and provides a set of frameworks that are used to develop that. As such, the design of software architecture is a critical element in achieving the intended functionality, performance, and safety requirements of a medical device. This architecture uses object-oriented design techniques, which model the underlying system as a set of objects that interact to achieve their goals. The architecture includes a number of frameworks comprised of a set of classes that can be extended to achieve different functionality required for a medical device. The Input/ Output (IO) framework includes a number of core classes that implement periodic and a periodic input output with varying priority requirements, provides a hardware neutral interface to the application logic, and a set of classes that can be extended to both meet the hardware IO specifics of a target platform and create new sensor and actuator types for client applications. The Devices framework provides a blueprint to develop the controller logic of the medical device in terms of abstractions that parallel the hardware components of the medical device. The Configuration framework allows creation and configuration of a medical device from an XML (Extensible Markup Specification) specification that specifies the configuration of the device based on abstract factories that can be extended to meet requirements of a specific medical device. The Controller is the component of the architecture that defines classes that implement reception of commands from and transmission of status and data to a local or remote client and dictate the structure of threads, thread priorities and policies for this purpose. The Diagnostics package of the architecture defines a framework for developing components that monitor the health of the system and detect emergency conditions. The architecture is implemented in C++ and runs on a real-time LINUX operating system. At this time, the architecture is used in development of two of the St. Jude Medical Atrial Fibrillation Division’s medical devices; one of these has FDA class III and the other class II classification.
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Bamford, James Stuart. "The design of mechanical test rigs for the testing of medical devices." Thesis, Teesside University, 2004. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.521878.
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The design of biomechanical devices is often difficult because it is not feasible to test them within human or animal patients. Initial designs may be tested using mechanical rigs or finite element models to simulate the complex loading conditions within biological environments. Recent advances in computer technology have allowed computer simulations to become more detailed. However, educated assumptions must be made to simplify the conditions that will effect the device. Highly accurate results can be obtained but it is essential that these results are verified using a mechanical test rig. This will identify if human error or inaccurate assumptions have occurred. Mechanical test rigs were designed to simulate the forces acting within four different biomechanical systems. This involved simulating the forces applied to the lumbar spine, the greater trochanter of the hip, and to the shin; for the testing of inter-vertebral cages, hip protectors and floor coverings, and shin pads respectively. Load cells were used to measure the resultant impact forces applied to the hip and shin. The time-domain data were recorded for each impact and from these data it was possible to calculate the maximum impact force and the total energy absorbed by the greater trochanter. Mechanical testing of intervertebral cages involved pressure sensitive paper to measure resultant pressure trends at the interface between the vertebral end plate and the cages. This instantly revealed pressure trends and computer programs were written to determine the contact area, calibrate pressure values, and to allow the improved visualisation of results. Results from the mechanical test rigs are also suitable for validation of finite element analysis studies. New information has been generated to improve understanding about the pressure trends under intervertebral cages and the key design features have been identified. The hip test rig was used in the design of a novel hip protector, to determine the role of floor coverings in an impact, and to compare numerous hip protectors using typical impact conditions. Results show that a combination of energy absorbent flooring with a hip protector is the best environment for a reduced risk of a hip fracturing. Design recommendations were made regarding the material composition and the thickness of the materials used. This allowed the novel hip protector to be designed as small as possible but still sufficiently reduces the impact force from a person falling onto their hip. The hip test rig was modified to simulate the shin and was used to compare several commercially available shin guards. New information was generated to identify which design features are best to reduce impact forces. Further developments have been made to the first version of the hip impact test rig. The latest version of this hip test rig is currently being used as a benchmark for all hip protectors and is a likely contender as the basis of a standard testing system for a European Standard.
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Gupta, Suresh Prasad. "Design and delivery of medical devices for home-use : drivers and challenges." Thesis, University of Cambridge, 2007. https://www.repository.cam.ac.uk/handle/1810/283832.
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This research attempts to investigate two fundamental questions: what factors are driving the move towards the increasing use of medical devices in the home environment, and more importantly, what the challenges are to product developers who want to design and deliver medical devices for the home-use marketplace. In addition to describing the current healthcare system in relation to the objectives posed above, the research identifies fourteen major driving factors behind the increasing use of medical devices in the home environment and ranks them into high, medium and low categories according to their prominence. The research also recognizes a number of key issues and challenges to product developers in designing and delivering home-use medical devices. These issues are grouped into ten core issues which are then integrated into a model that conforms to the different stages of the product life cycle of a medical device. The core issues are related to business, technology, the design and development process, regulation, manufacture, point of provision, use, support, liability and disposal of home-use medical devices. Finally based on the understanding of the issues and challenges, a design tool is formulated. The tool is a diagram, based on the idea of Gough’s design tool for packaging, that presents all the challenges and issues in a succinct form and allows product developers to assess whether they have considered the issues, and if so, to what extent. This tool also gives an opportunity to product developers to make comparison between their different products. Compiling and developing the results of this research into a form more suitable for professional use form, such as a quick-reference workbook, evaluating its usefulness and effectiveness to product developers through case studies methods, and disseminating it to a broader audience has been proposed as future work.
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Khan, Suleman. "Design and optimization of parallel haptic devices : Design methodology and experimental evaluation." Doctoral thesis, KTH, Mekatronik, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-90746.
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The simulation of surgical procedures, in the case of hard tissues such as bone or teeth milling, using a haptic milling surgery simulator requires a haptic device which can provide high stiffness and transparency. To mimic a real milling process of hard tissue, such as for example creating a narrow channel or cavity, the simulator needs to provide force/torque feedback in 5–6 degrees of freedom (DOF). As described in this thesis, research has been performed to develop and optimize a haptic device that can provide high stiffness and force/torque capabilities to facilitate haptic interaction with stiff tissues. The main contributions of this thesis are: (i) The use of a model-based design methodology for the design of haptic devices. The proposed methodology is applied to a case study, i.e. the design and optimization of a haptic device based on parallel kinematics. Device requirements were elicited through dialogues with a prospective user from a neurosurgery clinic. In the conceptual design phase, different parallel concepts have been investigated and analyzed based on functional qualities such number of degrees of freedom, workspace size and force/torque capabilities. This analysis led to the selection of a specific 6 DOF kinematic structure for which dimension synthesis was performed including multi-objective optimization followed by control synthesis. Finally, a device prototype was realized and its performance verified. (ii) Optimization of the device for best kinematic and dynamic performance. For optimization, performance indices such as workspace-to-footprint ratio, kinematic isotropy and inertial indices were used. To cope with the problem of non-uniform units in the components of the Jacobian matrix, various normalization techniques were investigated. A new multi-objective optimization function is introduced to define the optimization problem, which is then resolved using multi-objective genetic algorithms. A sensitivity analysis of the performance indices against each design parameter is performed, as a basis for selecting a final set of design parameter values. (iii) A control strategy is investigated to achieve high transparency and stability of the device. The control strategy is based on careful analysis of the dynamics of the haptic device, computed torque feed-forward control and force control based on current feedback. (iv) Finally, experiments both separately in the lab and by using the device in a haptic milling surgery simulator were performed. Results from a face validity study performed in collaboration with orthopedists verify that the new haptic device enables high-performance force and torque feedback for stiff interactions.QC 20120302
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Lang, Alexandra R. "Medical device design for adolescents." Thesis, University of Nottingham, 2012. http://eprints.nottingham.ac.uk/12501/.
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Adolescents have been identified as users of medical devices who are currently overlooked in the design and development of these products. This research presents a set of studies that investigate the non-clinical user requirements of adolescent medical device users. Interviews with a range of healthcare professionals provided guidance into chronic conditions and devices which are relevant to adolescent populations. Workshops involving healthy adolescents in schools were carried out to elicit adolescent perspectives of current medical device design. The results of this study showed that the range of medical devices presented did not satisfy adolescent user requirements and provided insight into factors which are important to this specific user group. The workshop also identified the acapella® physiotherapy device, used for chest and airway clearance in the treatment of cystic fibrosis, as a suitable case study for further evaluation with real adolescent users. Case study interviews were carried out with adolescents with cystic fibrosis: the users of the acapella®. The interviews identified a range of unmet requirements and expanded on the results from the workshops. In addition to the more general design factors, users of the acapella® highlighted the effect of device use on clinical effectiveness. The data from the workshops and case study interviews was used in a co-design project with an adolescent user of the device. A design specification was interpreted from the data to produce a visual representation of the adolescent requirements. The research has produced two outputs. The first is the development of a prototype tool for eliciting adolescent design priorities for medical devices - The Adolescent Medical Device Assessment Tool (AMDAT) The second deliverable is a set of guidelines which detail the specific requirements and goals of adolescent users of medical devices - Adolescent Medical Device Requirements. This guidance aims to facilitate the consideration of adolescent user requirements in the design and development of new medical devices. The research investigation has contributed new understanding to the fields of human factors and adolescent healthcare. The findings from these studies demonstrate how adolescent populations can be successfully engaged in research tasks. This research investigation has shown that adolescents have specific needs of medical devices and that meeting these needs through user-centred methods may lead to better adherence of use and improved health outcomes.
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Privitera, Mary B. "Collaborative Medical Device Design (cMDD)." Thesis, Loughborough University, 2016. https://dspace.lboro.ac.uk/2134/22524.
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The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights. The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.
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Balgos, Vincent H. "A systems theoretic application to design for the safety of medical diagnostic devices." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76814.
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Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 87-89).
In today's environment, medical technology is rapidly advancing to deliver tremendous value to physicians, nurses, and medical staff in order to support them to ultimately serve a common goal: provide safe and effective medical care for patients. However, these complex medical systems are contributing to the increasing number of healthcare accidents each year. These accidents present unnecessary risk and injury to the very population these systems are designed to help. Thus the current safety engineering techniques that are widely practiced by the healthcare industry during medical system development are inadequate in preventing these tragic accidents. Therefore, there is a need for a new approach to design safety into medical systems. This thesis demonstrated that a holistic approach to safety design using the Systems Theoretic Accident Model and Process (STAMP) and Causal Analysis based on STAMP (CAST) was more effective than the traditional, linear chain-of-events model of Failure Mode Effects and Criticality Analysis (FMECA). The CAST technique was applied to a medical case accident involving a complex diagnostic analyzer system. The results of the CAST analysis were then compared to the original FMECA hazards. By treating safety as a control problem, the CAST analysis was capable of identifying an array of hazards beyond what was detected by the current regulatory approved technique. From these hazards, new safety design requirements and recommendations were generated for the case system that could have prevented the case accident. These safety design requirements can also be utilized in new medical diagnostic system development efforts to prevent future medical accidents, and protect the patient from unnecessary harm.
by Vincent H. Balgos.
S.M.in Engineering and Management
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Udvardy, Zoltán. "Design of a Testbed for Haptic Devices Used by Surgical Simulators." Thesis, KTH, Medicinsk teknik, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-214038.
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Nowadays surgery simulations are aiming to apply not just visual effects but forcefeedback as well. To carry out force feedback, haptic devices are utilized that are mostlycommercial products for general purposes. Some of the haptic device features are moreimportant than others in case of surgery simulator use. The precision of the output forcemagnitude is one such property. The specifications provided by haptic devicemanufacturers are lacking details on device characteristics, known to cause difficulties inplanning of accurate surgery simulations.This project shows the design of a testbed that is capable of measuring the precision ofoutput forces within the haptic devices’ workspace. With the testbed, a set ofmeasurements can be run on different haptic devices, giving as a result a betterknowledge of the utilized device. This knowledge aids the design of more precise andrealistic surgery simulations.
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Zhao, Jing. "Design and evaluation of a screen-CCD imaging system for medical radiology /." Online version of thesis, 1992. http://hdl.handle.net/1850/11253.
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Pitts, David Geoffrey. "The design and evaluation of discrete wearable medical devices for vital signs monitoring." Thesis, Cranfield University, 2015. http://dspace.lib.cranfield.ac.uk/handle/1826/10298.
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The observation, recording and appraisal of an individual’s vital signs, namely temperature, heart rate, blood pressure, respiratory rate and blood oxygen saturation (SpO2), are key components in the assessment of their health and wellbeing. Measurements provide valuable diagnostic data, facilitating clinical diagnosis, management and monitoring. Respiratory rate sensing is perhaps the most under-utilised of all the vital signs, being routinely assessed by observation or estimated algorithmically from respiratory-induced beat-to-beat variation in heart rate. Moreover there is an unmet need for wearable devices that can measure all or most of the vital signs. This project therefore aims to a) develop a device that can measure respiratory rate and b) develop a wearable device that can measure all or most of the vital signs. An accelerometer-based clavicular respiratory motion sensor was developed and compared with a similar thoracic motion sensor and reference using exhalatory flow. Pilot study results established that the clavicle sensor accurately tracked the reference in monitoring respiratory rate and outperformed the thoracic device. An Ear-worn Patient Monitoring System (EPMS) was also developed, providing a discrete telemonitoring device capable of rapidly measuring tympanic temperature, heart rate, SpO2 and activity level. The results of a comparative pilot study against reference instruments revealed that heart rate matched the reference for accuracy, while temperature under read (< 1°C) and SpO2 was inconsistent with poor correlation. In conclusion, both of the prototype devices require further development. The respiratory sensor would benefit from product engineering and larger scale testing to fully exploit the technology, but could find use in both hospital and community-based The design and evaluation of discrete wearable medical devices for vital signs monitoring DG Pitts ii Cranfield University monitoring. The EPMS has potential for clinical and community use, having demonstrated its capability of rapidly capturing and wirelessly transmitting vital signs readings. Further development is nevertheless required to improve the thermometer probe and resolve outstanding issues with SpO2 readings.
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Aranda, Jan Clara Beatriz. "Understanding context in design research : the case of medical devices in resource-limited settings." Thesis, University of Cambridge, 2018. https://www.repository.cam.ac.uk/handle/1810/273186.
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The design of medical devices has failed to satisfy the needs of resource-limited settings (RLSs). Whether purposefully designed for RSLs or transferred from a high-income country, the resulting devices often misalign with the characteristics of the context and the real needs of users. The challenges of contextualising medical devices in RLSs are widely acknowledged, but research to overcome these issues in practice is lacking. This study focuses on examining and defining the context for medical devices in RLSs. Two perspectives were employed for the study of context of medical devices in RLSs. The first approach, using design expert interviews and a systematic literature review, resulted in a contextual framework with factors relevant for the design, use and deployment of medical devices in RLSs. These factors were categorised in eight groups: public health, industrial, technological, institutional, financial, socio-cultural, geographical or environmental and economic. This approach, however, falls short in understanding the complexities behind these contextual factors. In order to tackle these limitations, the second approach used generative techniques for network mapping and mixed-methods for network analysis. This network approach resulted in the identification of networks surrounding MDs in RLSs, and the roles played by medical devices in these networks. These roles were categorised by type of interaction in six types: wellbeing, affiliation, organisational, clinical practice, cognitive and technical. Three assemblies of entities were also identified that were responsible for ensuring that MDs stay in the network and are available, used, maintained, and ultimately replaced when they fail. From this perspective, the investigation focused on how devices move in the network, change roles and are supported by other actors. In other words, the elements that assemble and allow medical devices to exist and subsist in the networks of care. Complexity and non-reducibility are at the core of this approach. The results from the exercise show that the approach sheds light on interesting and unexpected aspects of the use, adoption or deployment of medical devices in RLSs. However, the approach is abstract and overwhelmingly difficult to grasp in practical research. The approaches are compared and contrasted using an example of a MDs designed for RLSs. The approaches are not seen as competing but as complementary views of context. Their advantages and disadvantages are described, and recommendations are made for their application and improvement. The conclusions from this study contribute to new approaches to exploring the context of use for products in Design research by using, on the one hand, the concept of the collectives---as proposed by the actor-network theory---and, on the other hand, the idea of a holistic contextual framework for product design and development. For the field of global health, this research contributes to improving the design of much-needed technologies as solutions to global challenges.
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Edström, Hampus. "Emotionally Meaningful Homecare : Designing for good relationships between patients and devices." Thesis, Konstfack, Industridesign, 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:konstfack:diva-3825.
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Industrial design is an expanding field. Through new research, discussion and explorations the definitions of what designers can and should do is constantly discussed and redefined. The starting point for my master thesis is the investigation of the concept of emotional durability. In other words, I have looked into how designers could create more meaningful relationships between users and products. It concerns product style norms, terminologies for describing relationship types, as well as a product’s meaning to a user. In order to put learning outcomes into practice, this master thesis also involves a design project where I created a proposal for a new rehabilitation product. There is great potential in investigating how meaningful medical devices for the home should be designed. During my design process I try to dig into what it means to design medical products for a home environment. At the same time, I explore how to create emotionally durable experiences for the patients and increase the motivation in their rehabilitation. My proposal is a balance exercising device that introduces a new level of user interaction, which connects back to my research on emotional durability.
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El, Musleh Khaled. "Design setup for haptic devices for surgery applications." Thesis, KTH, Maskinkonstruktion (Inst.), 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-192188.
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In a way to help doctors and medical students train on performing difficult surgeries before entering the stressful operating room, DevinSense is developing a generic hardware platform for medical simulation. The system is used together with specific simulation software derived from real patient data and optimized towards the user specifications. The hardware platform will enable training for the operator to develop basic surgical skills effectively without the risk of losing the patients and avoiding the hospital daily contrails. The trainee on the simulator sees the scene displayed in real 3D-stereoscopic mode through a semi-transparent mirror and controls the surgery tools with a 6-DOF force feedback device. Thus, the simulated procedure becomes nearly identical to the real surgery. This project aims to develop a conceptual hardware platform for the medical simulator. The proposed solution should be height adjustable to different users. It must also include additional ergonomic functions such as mobility and suitable for use within the working environment. Accordingly, two conceptual prototypes are manufactured and evaluated. The first conceptual prototype is developed to check if the setup provides a good experience for the users, and to dimension the size of the components and to determine their location to set targets for the second prototype. The resulting product of the second prototype is one leg-lifting column with aluminum profile mounted on the top of it. The semi-transparent mirror, secondary monitor, haptic device and additional components are mounted on the setup to deliver the desired functions. The mechanical development is done using Autodesk Inventor. ANSYS is used to simulate the setups’ stresses and vibrational response to ensure that the system will perform optimally. MATLAB is used for mathematical modeling. The test results of the second prototype were promising where the height can be adjusted for users between 155 cm and 200 cm. Furthermore, the prototype provides stable and stiff design while operating on the simulator as well as transporting it.För att hjälpa läkare och läkarstudenter att träna på att utföra svåra operationer, utvecklar DevinSense en generisk hårdvaruplattform för medicinska kirurgi-simulatorer. Systemet används för specifika simuleringsprogram som kommer ifrån verkliga patientdata och är optimerad med avseende på användarens specifikation. Hårdvaruplattformen möjliggör utbildning för operatören att utveckla grundläggande kirurgiska färdigheter effektivt utan risk för patienterna. Den som utbildas på simulatorn ser operationssimuleringen som en verkligt 3D-stereoskopisk bild genom en halvgenomskinlig spegel och styr kirurgiverktyget med en 6-DOF haptisk-enhet. Simuleringen kommer att kännas som en riktig operation. Syftet med projektet är att utveckla en prototyp av en haptisk plattform för en medicinsk simulator. Prototypen bör vara justerbar i höjdled för att passa olika användare. Den måste också innefatta ytterligare ergonomiska funktioner som till exempel att vara lätt att transportera. Följaktligen har två prototyper tillverkats och utvärderats. Den första prototypen utvecklades för att kontrollera om den ger en bra upplevelse för användaren, för att dimensionera komponenterna och för att bestämma deras platser. Detta för att sätta upp mål för den slutgiltiga prototypen. Den slutgiltiga prototypen har en linjärenhet som är monterad på en bottenplatta och en aluminiumprofil som är monterad ovanpå linjärenheten. Den halvgenomskinliga spegeln, sekundära bildskärmen, haptiska enheten och ytterligare funktionsenheter har även monterats på aluminiumprofilen. Autodesk Inventor användes för att designa prototypen. ANSYS användes för att analysera spänningar och vibrationsbeteende hos prototypen för att säkerställa att systemet kommer att fungera tillfredställande. MATLAB användes för matematisk modellering. Testresultaten för den andra prototypen blev lovande. Höjden kan justeras för användaren, som är mellan 155 och 200 cm lång, den är stabil när användaren använder haptikenheten och den är även stabil när användaren ska förflytta prototypen till ett annat rum.
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Shefelbine, Sandra J. "Requirements capture for medical device design." Thesis, University of Cambridge, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.287242.
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Jedryszek, Jakub. "A model-driven development and verification approach for medical devices." Thesis, Kansas State University, 2014. http://hdl.handle.net/2097/18222.
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Master of ScienceDepartment of Computing and Information Sciences
John Hatcliff
Medical devices are safety-critical systems whose failure may put human life in danger. They are becoming more advanced and thus more complex. This leads to bigger and more complicated code-bases that are hard to maintain and verify. Model-driven development provides high-level and abstract description of the system in the form of models that omit details, which are not relevant during the design phase. This allows for certain types of verification and hazard analysis to be performed on the models. These models can then be translated into code. However, errors that do not exist in the models may be introduced during the implementation phase. Automated translation from verified models to code may prevent to some extent. This thesis proposes approach for model-driven development and verification of medical devices. Models are created in AADL (Architecture Analysis & Design Language), a language for software and hardware architecture modeling. AADL models are translated to SPARK Ada, contract-based programming language, which is suitable for software verification. Generated code base is further extended by developers to implement internals of specific devices. Created programs can be verified using SPARK tools. A PCA (Patient Controlled Analgesia) pump medical device is used to illustrate the primary artifacts and process steps. The foundation for this work is "Integrated Clinical Environment Patient-Controlled Analgesia Infusion Pump System Requirements" document and AADL Models created by Brian Larson. In addition to proposed model-driven development approach, a PCA pump prototype was created using the BeagleBoard-xM device as a platform. Some components of PCA pump prototype were verified by SPARK tools and Bakar Kiasan.
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Cifter, Abdusselam. "An inclusive approach towards designing medical devices for use in the home environment." Thesis, Brunel University, 2011. http://bura.brunel.ac.uk/handle/2438/5515.
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An emerging trend of the healthcare industry is the huge increase in the number of medical devices being used by lay people at home. Home use medical devices range from simple inhalers to very complicated devices such as defibrillators. This research aimed to assist designers in developing home use medical devices by providing information and suggestions regarding lay users and how to address their needs and expectations. For this purpose a qualitative and inductive approach was adopted and several studies were carried out, including: (1) a comprehensive literature review to understand the background of the phenomena; (2) observational studies with 40 lay users (i.e. 10 younger lay users, 10 older lay users, 10 users with mobility and sensory disabilities, and 10 users with cognitive disabilities) in order to identify their characteristics when interacting with products; (3) an online questionnaire survey with 53 designers to understand designers‟ requirements when designing home use medical devices, as well as their expectations for a proposed design support tool; (4) the development of the design support tool; and (5) an evaluation study with 12 professional designers in order to assess the effectiveness of the tool (in a format of a design guidance). This research adopted an inclusive approach which investigated both lay users‟ characteristics and designers‟ perspectives. It has, for the first time, outlined lay user characteristics based on empirical studies with different groups of people. It is also one of few studies focussing on designing home use medical devices; the requirements of professional designers have provided an in-depth insight into the challenges of designing medical devices for use in the home environment. The design guidance, as commended by the designers in the evaluation, was the first comprehensive information source in the UK for the emerging home use medical device field where little support is currently available.
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Grames, Clayton L. "Design and Manufacture of Mesoscale Robot-Actuated Surgical Instruments." BYU ScholarsArchive, 2015. https://scholarsarchive.byu.edu/etd/5689.
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Minimally Invasive Surgery (MIS) is a growing field including both laparoscopic androbotic operations. Surgeons and engineers are making continual efforts to reduce the negative effects of procedures on patients. Reducing the size of the surgical instruments is one effective method pursued in this effort. When the instruments approach 3 mm in diameter, they reach a threshold where the entry incisions can be small enough that no scar is left on the patient. Laparoscopic instruments on this scale exist but typically lack wrist articulation and only have 1 degree of freedom (DoF). Alternatively, robotic surgical instruments can achieve high levels of dexterity but at a greater diameter. Smaller diameter robotic instruments employ snake wrists but this results in large swept volumes. There is a need for smaller robotic instruments with 3 DoF that preserve a small operational volume. Several unique challenges result when trying to develop small-scale instruments. Friction forces due to the relative motion of actuation cables and other parts in the mechanisms become more significant, as do the challenges of producing and assembling parts with extremely small features. These challenges have been limiting factors for the size of instruments. Traditional mechanisms use pin joints and pulleys which result in higher part counts and higher internal friction. To overcome these challenges, two alternative designs that reduce part count and minimize friction are presented as potential mechanisms that could be used as surgical instruments on the mesoscale (1-5 mm). Both designs implement rolling contact and gearing in place of pin joints and pulleys to realize their motion. Additionally, alternative manufacturing methods that are ideally suited to mesoscale production are presented. Micro metal laser sintering and composite carbon nanotude structures are shown to have the resolution required to create the detailed features necessary for these new designs. The result are two mechanisms suited to be produced as mesoscale, robotically actuated, surgical instruments. One of the two designs has been physically prototyped and has demonstrated clinical capabilities at 4 and 5 mm diameter instrument sizes.
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Reinauer, Eva [Verfasser], and Gerhard [Akademischer Betreuer] Winter. "Design of an anti-inflammatory coating for invasive medical devices / Eva Reinauer ; Betreuer: Gerhard Winter." München : Universitätsbibliothek der Ludwig-Maximilians-Universität, 2018. http://d-nb.info/1188200119/34.
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Ward, James R. "Design verification in the medical device industry." Thesis, University of Cambridge, 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.423867.
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Kumar, Nitish. "Design and development of devices for robotized needle insertion procedures." Thesis, Strasbourg, 2014. http://www.theses.fr/2014STRAD024/document.
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Ces travaux de thèse apportent plusieurs contributions à la conception de dispositifs d'assistance robotisés pour la réalisation de procédures d'insertion d'aiguille sous imageur à rayons X. Partant de la tâche de positionnement et d'orientation d'une aiguille, plusieurs architectures mécaniques inédites à quatre degrés de liberté ont été proposées. Un algorithme de synthèse dimensionnelle a été conçu pour calculer les paramètres structuraux de ces mécanismes en étudiant leurs singularités, tout en tenant compte des contraintes antagonistes de compacité du système, de capacité d'actionnement et de taille d'espace de travail. Une décomposition modulaire du dispositif d'assistance a permis de proposer des solutions pour un outil dédié à l'insertion d'aiguille avec retour d'effort. Cet outil comporte un dispositif d'insertion, un système de préhension d'aiguille et un capteur d'effort spécifique pour le retour d'effortThis thesis focuses on finding solutions for the design and the technological bottlenecks involving development of a slave robotic assistant for needle insertion procedures. The needed functionalities for the slave device were sought to be achieved by adopting a modular approach. This required the design and the development of different devices which satisfy targeted functionalities. A study of needle positioning devices was carried out which led to the synthesis of novel mechanisms for the task of needle axis translation and the needle axis orientation. A novel dimensional synthesis algorithm was developed to calculate the structural parameters of these mechanism while studying their singularities and considering the antagonistic constraints of system compactness, actuation torques and workspace size. The modular decomposition also allowed to offer solutions for an insertion tool dedicated to needle insertion with force feedback. This insertion tool consists of a device for inserting the needle, a device for grasping the needle and a force sensor for force feedback
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Gausepohl, Kimberly Ann. "The Storytelling + Design Framework: Design Guidance for the Concept Phase of Medical Device Design." Diss., Virginia Tech, 2012. http://hdl.handle.net/10919/38579.
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The National Institute for Occupational Safety and Health’s (NIOSH) “Prevention through Design” (PtD) initiative encourages the exploration of different methods to foster dialogue between engineers and healthcare workers. Although engineers are encouraged to follow a user-centered design (UCD) process to identify user needs (ANSI/AAMI, 2009; IEC, 2007), NORA (2009) warns that engineers may “fail to get the full range of healthcare worker input on the usability of a device”. The primary goal of this research was to present storytelling as an elicitation method that addressed the PtD call for methods that improve usability within healthcare.
This work provides three contributions to the PtD initiative. First, a conceptual model for the role of storytelling in design, which represents a synthesis of narrative and design research, is presented. The conceptual model explicitly states how the elicitation and analysis of stories results in the identification of a design opportunity that addresses user needs. Second, the Design + Storytelling framework, which guides designers’ use of storytelling, is presented. An instantiation of the framework specific to the identification of a design opportunity within an emergency room (ER) is investigated to determine the framework’s impact on design. Findings resulted in the study’s third contribution: design guidance comprised of storytelling guidelines, decision support tools for storytelling method selection, and traceability support for design evaluation.
The investigation of the framework focused on two primary stages: (1) story elicitation and (2) story analysis. Storytelling sessions, which varied in context, collected 573 stories (i.e., 441 habitual, 132 hypothetical) from 28 ER nurses. Qualitative analysts used the framework’s instructions to identify and specify 383 user needs within the narratives. Empirical comparisons of the compiled needs across groups informed decision rules for elicitation method selection. The impact of the framework’s analysis instructions during design practice was investigated. Student design teams analyzed nurses’ safety stories to create a conceptual design for an identified design opportunity. Findings indicated a trend for stakeholder experts to rank conceptual designs created by teams with the instructions as more usable than teams without the framework’s instructions. The theoretical and practical exploration indicated a positive impact on design.Ph. D.
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Maric, Danilo. "Firmware development of a User Interface on medical devices of DIMA ITALIA Srl." Master's thesis, Alma Mater Studiorum - Università di Bologna, 2018.
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This dissertation was written based on an internship experience at Dima Italia Srl, a leader in designing, production and marketing of medical ventilators. Once these ventilators were simple machines for breathing support, manually pumping the air in and out. Today, medical ventilators are computerized machines, electronically controlled by a small embedded system. They feature a plethora of available modes and an easy-to-use graphical interface. Exactly this is the topic of the thesis: developing a firmware with graphical interface for the next ventilator, produced and sold by Dima Italia. The firmware is based on C++ language and was developed in a Qt Creator framework, ideal for developing applications with graphical interfaces on Linux-based devices. In the paper are found all the pages of the firmware, along with the logic of operation of the application. Moreover, all the details about the operation and modes of a medical ventilator are also found in the document. In the end, there's a section related to deployment of a Qt application on a device, along with the issues and bugs encountered during the development process.
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Hubbard, Arlesa E. (Arlesa Elizabeth). "Investigating the transformation of a medical enterprise : can a medical device company truly become agile?" Thesis, Massachusetts Institute of Technology, 2019. https://hdl.handle.net/1721.1/122246.
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Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, System Design and Management Program, 2019Cataloged from PDF version of thesis. Vita.
Includes bibliographical references (pages 85-87).
With the competitive landscape of technology increasing at a rapid pace, medical device manufacturers are struggling to keep up with the demands of the market and provide hardware and software solutions to support connected health technologies. Over the last decade, in an attempt to match the pace of the market, an increasing number of enterprises have shifted their product development processes from traditional stage-gated models to iterative development models, including Agile. Using the architecting innovative enterprise strategy (ARIES) framework, literature reviews, and gathered knowledge from subject matter experts and stakeholders relevant to the enterprise, this thesis explores the benefits, challenges, and impact of transforming a medical device enterprise's product development process from waterfall to Agile methodologies. The interfaces of the enterprise within both its internal and external ecosystems were assessed in this research; due to the complexity of the medical device industry, stakeholder analysis was used as a tool to identify and prioritize the key interfaces which are critical for a successful enterprise transformation. Approaching the challenge of imposing organizational change in a systems manner ensures that the enterprise and the environment within which it operates are viewed in a holistic sense and that the proposed solution(s) satisfy key beneficiaries and stakeholders. The research demonstrates that the voice of the project team, cross-functional team alignment, and support and empowerment of senior management are crucial to the success of this transformation and ultimately will impact the ability of the enterprise to meet their objectives and sustain their envisioned future.
by Arlesa E. Hubbard.
S.M. in Engineering and Management
S.M.inEngineeringandManagement Massachusetts Institute of Technology, System Design and Management Program
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Song, Qingyang S. M. Massachusetts Institute of Technology. "A system theoretic approach to design safety into medical device." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76510.
Full textAbstract:
Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed.
by Qingyang Song.
S.M.in Engineering and Management
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Gautreau, Leigh (Leigh Ann). "Green manufacturing in the medical device industry : a case study." Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/55209.
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Thesis (S.M.)--Massachusetts Institute of Technology, System Design and Management Program, 2009.Cataloged from PDF version of thesis.
Includes bibliographical references.
Introduction: Med Dev (name changed to protect confidentiality), is a medical device start-up using tissue engineering and drug delivery techniques to help combat the negative effects associated with secondary injury. Med Dev's first generation technology is a polymer scaffold that will be inserted into the injury site immediately post injury during a routine procedure. The scaffold prevents secondary injury (bruising and scarring) formation by filling the void space left by the injury, promoting cell growth over deleterious apoptosis (cell death), and slowly degrading away over the course of approximately one month. Med Dev's second generation technology is a photopolymerizable hydrogel which would function identically to the first generation, except that it would be injected into the injury rather than surgically inserted. Med Dev's first and second generation technologies, differ not only in their method of administration, but also in their manufacture. Commercially available polymers are mechanically processed for scaffold manufacture, whereas Med Dev must synthesize their own polymers for hydrogel manufacture. Polymer synthesis requires vast quantities of often toxic solvents to solubilize and later extract the polymer. In the first generation technology toxic solvent responsibilities lie with Med Dev's suppliers, whereas in the second generation technology Med Dev is directly responsible for their toxic solvents use. This is not to say Med Dev should not be aware of their supplier's use of toxic solvents when they are producing polymers for Med Dev's end-use, but rather to point out that Med Dev is more directly responsible for toxic solvent use when they produce their own polymers. In January, as Med Dev's director of operations I applied for a grant which required that I detail how Med Dev intended to build a green manufacturing facility. Understanding all the toxic solvents involved in a polymer synthesis, I thought while building a green manufacturing facility was a positive step toward becoming more environmentally sustainable, why stop there, why not incorporate green thinking into polymer synthesis process design. A thesis was born. The US EPA defines green chemistry as: "...the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. Green chemistry applies across the life cycle, including the design, manufacture, and use of a chemical product." ' Green chemistry is essentially a pollution prevention methodology, resulting in resource conservation, waste reduction, and enhanced product safety. Companies are beginning to realize that pursuing green chemistry is not only good for the environment, but also for their bottom line; they are becoming increasingly aware that continued competitiveness in the allied chemicals industry actually requires the implementation of green chemistry principles. Paul Anastas and John Warner published what have become the central tenets of green chemistry in their 1998 book entitled "Green Chemistry: Theory and Practice."
by Leigh Gautreau.
S.M.
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Dunn, Taylor B. "Development of an Improved Medical Transport Device: Stair Chair." Miami University Honors Theses / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=muhonors1303407927.
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Nycz, Christopher Julius. "Modeling & Analysis of Design Parameters for Portable Hand Orthoses to Assist Upper Motor Neuron Syndrome Impairments and Prototype Design." Digital WPI, 2018. https://digitalcommons.wpi.edu/etd-dissertations/501.
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Wearable assistive robotics have the potential to address an unmet medical need of reducing disability in individuals with chronic hand impairments due to neurological trauma. Despite myriad prior works, few patients have seen the benefits of such devices. Following application experience with tendon-actuated soft robotic gloves and a collaborator's orthosis with novel flat-spring actuators, we identified two common assumptions regarding hand orthosis design. The first was reliance on incomplete studies of grasping forces during activities of daily living as a basis for design criteria, leading to poor optimization. The second was a neglect of increases in muscle tone following neurological trauma, rendering most devices non-applicable to a large subset of the population. To address these gaps, we measured joint torques during activities of daily living with able-bodied subjects using dexterity representative of orthosis-aided motion. Next, we measured assistive torques needed to extend the fingers of individuals with increased flexor tone following TBI. Finally, we applied this knowledge to design a cable actuated orthosis for assisting finger extension, providing a basis for future work focused on an under-represented subgroup of patients.
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Luan, Shiwei. "Modularized PCA pump design for an ICE-informed medical device coordination framework." Thesis, Kansas State University, 2015. http://hdl.handle.net/2097/20385.
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Master of ScienceElectrical and Computer Engineering
Steven Warren
Medical device interoperability and re-configurability continue to be important areas of research toward the realization of verifiable medical systems that can be rapidly assembled to meet the needs of specific patients. This thesis addresses the modularized design of a patient-controlled analgesia (PCA) pump to be used within the context of the Medical Device Coordination Framework (MDCF), an open source framework under development by Kansas State University and the University of Pennsylvania that is informed by the Integrated Clinical Environment (ICE) specification managed by the MD PnP program and its collaborators. The thesis illustrates how to set up the MDCF development environment with Eclipse so that a developer can create software for both a remote MDCF console and a local PCA pump, where ICE channels are used for message transmission. Software development on the MDCF console side includes the development of apps that communicate with a local PCA pump through ICE channels and (b) the development of a GUI that can be launched from an MDCF console to configure, control, and monitor a PCA pump. Software development on the PCA pump side includes the creation of (a) ICE channels that can communicate with an MDCF console and (b) multiple threads for corresponding UART ports that support a modularized design. Several hardware modules were implemented to demonstrate the modularized design approach: an alarm module, a patient button module, a pump module, and a control panel module. These modules employ BeagleBone, Arduino, and MSP430 boards. Status information is displayed on an MDCF console GUI, a PCA pump GUI, and a local LCD screen. An enhanced PCA pump or general medical sub-system with more modules can be developed using a similar method by connecting individual modules to UART ports and then creating the corresponding threads to support device-console communication.
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Bach, Jason Samuel. "Design and evaluation of a prosthetic anterior cruciate ligament replacement medical device." Diss., Georgia Institute of Technology, 2012. http://hdl.handle.net/1853/47580.
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Rupture of the anterior cruciate ligament (ACL) is a relatively common sports-related injury for which the current treatment is reconstruction with an autograft or allograft. Drawbacks associated with each of the current options would make a prosthetic alternative advantageous, however, artificial ligaments are not widely used, having failed due to lack of biocompatibility and mechanical insufficiencies. To develop the next-generation prosthetic ACL, design control principles were applied including specification of comprehensive design inputs, risk analysis, and verification testing. A design was proposed utilizing polyvinyl alcohol and ultrahigh molecular weight polyethylene, selected for good biocompatibility and mechanical strength and stiffness suitable for ACL replacement. A biomimetic fibrous rope pattern was designed for the intra-articular ligament section of the prosthetic that produced a close match the static tensile behavior of the native ACL and which also demonstrated good resistance to fatigue and creep. A calcium phosphate coating was recommended for the sections of the device lying within the bone tunnel to increase the rate of osseointegration. The proposed design was then evaluated in a computational simulation to assess functional restoration and the effects of installation parameters such as tension and tunnel orientation on knee kinematics. The encouraging results of preclinical verification testing support further in vivo evaluation of the proposed design.
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Jersenius, Ylva, and Erika Möller. "A medical device for spinal motion restriction : Development of a device for safe and efficient patient handling." Thesis, Luleå tekniska universitet, Institutionen för ekonomi, teknik och samhälle, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:ltu:diva-80042.
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Prehospital emergency care is facing a paradigm shift. Spinal motion restriction (SMR) is a way to treat trauma patients with symptoms of spinal injury. It was earlier entitled as ‘routine SMR’, and included spine board and cervical collar. During the 2000s, it has been noted that there is a lack of scientific evidence that proves the benefits with ‘routine SMR’. This led an expert group to the development of the national guidelines, that were published in 2019. The national guidelines can be described as ‘selective SMR’, where the cervical collar and spine board is excluded. It means that the SMR shall be adapted to the patient and not the equipment. Furthermore, the patient should be involved as much as possible in the treatment. This master thesis has been conducted at the Luleå University of Technology (LTU), in collaboration with AB Germa. The objective was to enable paramedics (the users in this project) to provide trauma patients with safe and efficient SMR by improving the usability of available or future products for SMR. Therefore, the project aim was to deliver a conceptual suggestion with feedback from the users. Furthermore, a mapping with experienced problems was delivered, and a review of the available medical devices with recommendations on how the future product development of medical devices for SMR could head in a user-centred direction. The theoretical framework included both ergonomics, including anthropometry and anatomy, and semiotics to involve both the physical and cognitive aspects of good usability, as a complement to the contextual immersion to be able to develop a thought through conceptual suggestion. The contextual immersion involved contact with Sweden’s 21 regions, and 16 paramedics. Through visits, interviews, and observations information was gathered about available medical devices for SMR, and challenges that paramedics are facing with them where mapped. This was compiled in a user need specification, which formed the basis for the idea generation. The ideation resulted in over 200 ideas. Iterative feedback sessions together with the users generated five concepts, that by further feedback, and iterative work converged into one final concept. The project delivers a vest with vacuum technology that enables paramedics to perform safe and efficient SMR of trauma patients with various anatomy. The concept has the flexibility of a KED and the adaptability of a vacuum mattress. It enables ’selective SMR’ in confined spaces, and facilitates the patient to be more involved in the treatment. The project has generated insights about ’selective SMR’, and the meaning of it for future product development. Generally, we are moving towards medical devices for SMR that does not restrict movement as strictly as before. Many products in ambulance care have not been updated for a long time, and there is no doubt that there is a need for it.Inom prehospital akutsjukvård pågår just nu ett paradigmskifte. Spinal rörelsebegränsning (SRB) är ett sätt att vårda patienter som varit utsatta för trauma och som uppvisar symtom på spinal skada. Det benämndes till en början som ’rutinmässig SRB’ och inkluderade användning av spineboard och nackkrage. Under 2000-talet visade det sig finnas en avsaknad av vetenskapliga bevis som talade för fördelarna med ’rutinmässig SRB’, vilket ledde till att nackkrage och spineboard exkluderades. Det här föranledde en expertgrupp att ta fram nya nationella riktlinjer som publicerades 2019. De nationella riktlinjerna kan beskrivas som ’selektiv SRB’, vilket handlar om att SRB ska anpassas utifrån patientens tillstånd och inte efter utrustningen. Patienten ska även involveras så mycket som möjligt i omhändertagandet. Det här examensarbetet har utförts vid Luleå Tekniska Universitet (LTU), tillsammans med AB Germa. Syftet var att underlätta för ambulanssjukvårdare (användarna i det här projektet) att utföra säker och effektiv SRB på traumapatienter, genom att förbättra användbarheten hos befintliga eller framtida produkter för SRB. Målet var därför att leverera ett konceptuellt förslag med feedback från användarna. Utöver detta skulle en kartläggning av dagens utrustning och problem med dessa undersökas, med rekommendationer om hur den framtida utvecklingen kan gå mot en mer användarcentrerad riktning. För att få med de fysiska såväl som de kognitiva aspekterna av en god användbarhet så inkluderades både ergonomi, inkluderande antropometri och anatomi, samt semiotik i den teoretiska referensramen. Det här användes som ett komplement till den kontextuella undersökningen för att försäkra sig om att det framtagna konceptet var väl genomtänkt. Den kontextuella undersökningen inkluderade kontakt med Sveriges 21 regioner och 16 ambulanssjukvårdare. Genom besök, intervjuer och observationer samlades information om dagens utrustning för SRB, som utgjorde underlag för en kartläggning av de upplevda problemen. Allt sammanställdes som användarbehov i en lista. Det här kom att ligga till grund för den kommande idégenereingen, som resulterade i över 200 idéer. Iterativa feedbacksessioner tillsammans med användarna resulterade i fem koncept, som genom ännu mer feedback och iterativt arbete resulterade i ett slutgiltigt koncept. Projektet levererar en väst med vakuumteknologi som möjliggör för användarna att utföra säker och effektiv SRB på traumapatienter med varierande anatomi. Konceptet har smidigheten av en KED och följsamheten av en vakuummadrass. Den möjliggör ’selektiv SRB’ i trånga utrymmen och underlättar för patienten att vara deltagande i omhändertagandet. Projektet har också levererat insikter om vad ’selektiv SRB’ kan innebära för framtida produktutveckling. Det har visat sig att trenden går mot att utrustningen inte ska rörelsebegränsa lika mycket som den gjort tidigare. Många produkter inom ambulansen har inte uppdaterats på länge och det finns inga tvivel om att det finns ett behov för detta.
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Hinrichs, Saba. "A systems approach to improving patient safety through medical device purchasing." Thesis, University of Cambridge, 2010. https://www.repository.cam.ac.uk/handle/1810/238973.
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The purchase of medical devices involves engaging various stakeholders as well as balancing clinical, technical and financial requirements. Failure to consider these requirements can lead to wider consequences in the delivery of care. This study first builds a general knowledge base of current purchasing practice in a sample of NHS Trusts, which confirms the direction and guidance given by policy documents and literature as to the extent of the challenges faced by purchasing stakeholders. This then leads to an analysis to identify inefficiencies in the purchasing process, and how such practice can lead to risks in the delivery of care. These risks range from injury to individuals, impacts to the healthcare delivery service, and financial and litigation risks. Finally, a framework that highlights these potential risks in the life-cycle of medical devices in hospitals is presented. Key policy guidance has encouraged both researchers and implementers of healthcare services to approach patient safety from a systems perspective, acknowledging that medical device errors are not only directly related to device design, but to the design of the healthcare delivery service system in which the device operates. Little evidence exists of successfully applying systems approaches specifically to medical device purchasing practice. Medical device purchasing, because of its implications to patient safety on the one hand, and the uniqueness of the healthcare context, requires a unique approach. By demonstrating the influence of purchasing practice to service delivery and patient care, the thesis made is that taking a holistic systems approach is one method to improve device purchasing practice, and hence influence better care.
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Stenberg, Mattias. "Concept design and In Vitro evaluation of a novel dynamic displacement Ventricular Assist Device." Licentiate thesis, Stockholm : KTH Technology and Health, 2006. http://www.diva-portal.org/kth/theses/abstract.xsql?dbid=3991.
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Wittner, Bernd. "A stakeholder focused study on the use and design of medical device alarms." Thesis, University of Cambridge, 2010. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.608895.
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Cauchi, Abigail. "Using analytical and empirical techniques for improving medical device number entry systems design." Thesis, Swansea University, 2014. https://cronfa.swan.ac.uk/Record/cronfa42965.
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User interfaces that employ the same display and buttons may look the same but can work very differently depending on how they are implemented. In healthcare, it is critical that interfaces that look the same are the same. Hospitals typically have many types of visually similar infusion pumps, but with different software versions and variation between pump behaviour, and this may lead to unexpected adverse events. For example, when entering drug doses into two similar infusion pumps, different results may arise when pushing identical sequences of buttons. These differences arise as a result of subtle implementation differences and may lead to large errors that users do not notice. 'Differential formal analysis' is a new user interface analytic evaluation method based on stochastic user simulation. The method is particularly valuable for helping evaluate safety critical user interfaces, which often have subtle programming issues. This new approach starts with the identification of operational design features that define the design space to be explored. All combinations of design features are analysed by simulating keystroke sequences containing keying slip errors. Finally, each simulation produces numerical values that rank the design combinations on the basis of their sensitivity to key slip errors. Differential formal analysis is demonstrated through case studies of number entry systems, many of which represent a common safety-critical user interface styles found in medical infusion pumps and elsewhere. The results uncover critical design issues, and are an important contribution of this thesis since the results provide device manufacturers guidelines to improve their device firmware. The analysis is complemented with models of usage based on 1,362 days of use of number entry systems from 19 infusion pumps over a 3 year period in a UK hospital. This thesis also suggests some improvements to medical device logging, which will help further evidence-based improvement to medical device safety. Previously, empirical methods and analytic methods have been used independently to analyse and improve number entry system designs. This thesis identifies key contrasts in exploring number entry errors using laboratory studies and analytic methods. The implications of combining methods to more thoroughly analyse safety critical design are discussed.