Rozprawy doktorskie: „Medical Devices and Systems”

1

Basu, Probal, i Eun Kyun Kim. "Customer segmentation in the medical devices industry". Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/40110.

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Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2007.
Includes bibliographical references (p. 73-76).
This thesis addresses Company X's concerns about its product shipment options. The company ships over 70% of its products to its customers using the primary service provider that ensures that the product is at the customer site by 10:30 AM next day. As per the understanding with its customers, the company, absorbs the cost of premium shipping and does not pass it on to most of its customers. The company believes that this priority service is a source of competitive advantage that helps it get customer loyalty and thereby increases sales. However it is not a normal industry practice to provide this service free to the customers. Keeping in mind this enormous cost burden, Company X wants to minimize this cost. Medical device sales are non-seasonal and do not show promotional effects. We analyzed data for the months of June and October, 2006 as a part of our research. The objective of our data analysis was to validate the proposed approaches we reviewed as a basis for proposing ways to segment customers for improving service while reducing cost. We proposed three types of segmentation: by region, by order method and by division. Segmentation by region looks at dividing the customers by into 4 regions based on their location.
(cont.) Segmentation by ordering method splits the customers in terms of whether they order using phone, fax or EDI while segmentation by division breaks up the customer base in terms of the various divisions the company has. Our study revealed that the company can expect to save over 3 million dollars annually by not offering this service free of charge to its customers. If customers are not convinced that the lower level of service meets their needs, they may pay for use of premium shipping. We demonstrate that the lower level of service will likely be just as effective and hence the company can guarantee that the product would reach the customer on time. Given the criticality of the parts that the company ships, it is advised to take its customers into confidence before making major policy changes.
by Probal Basu [and] Eun Kyun Kim.
M.Eng.in Logistics

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Hillstrom, Nichole L. (Nichole Leigh), i Renato A. Malabanan. "Strategic inventory management of externally sourced medical devices". Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/81099.

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Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 59).
The purpose of this research was to determine inventory strategies for externally sourced medical devices. In the medical device industry, the desire for high levels of customer service often results in less than optimal inventory levels. In this study, we analyzed the details of the current inventory model utilized by the medical device company. In assigning appropriate inventory levels, we determined that key inputs were not regarded. When evaluating inventory levels, it was determined that pipeline inventory should be removed from the target on hand inventory levels if inventory ownership occurs upon receipt. When calculating safety stock, we determined that supply variability should be incorporated into the safety stock formula and extra buffers currently in place should be removed. In addition, a more robust measure of demand variability such as the Root Mean Squared Error (RMSE) or the Mean Absolute Percent Error (MAPE) should be incorporated into the formula instead of the use of the maximum of standard deviation of demand and standard deviation of forecast. Also, a gap was identified between the customer service safety factor used in the safety stock formula and the measurement of customer service by the company. Following the analysis of the current inventory modeling approach, we segmented the medical device SKU's based on key factors that drive inventory: demand, lead time, criticality and customer service. We also redefined the model used to determine slow moving inventory levels by incorporating the lead time of the part in setting cycle and safety stock levels and simulating the results to validate the relationships between the various inventory drivers. The application of the methodologies, concepts and findings in this research covering externally sourced medical devices can be extended to other subsidiaries and other industries.
by Nichole L. Hillstrom and Renato A. Malabanan.
M.Eng.in Logistics

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Arad, Ron 1973. "Sterilization resource forecasting in the medical devices industry". Thesis, Massachusetts Institute of Technology, 2005. http://hdl.handle.net/1721.1/33333.

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Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2005.
Includes bibliographical references (leaf 73).
Sterilization is an example of a procedure that has been outsourced by medical device companies. Sterilization is required for all medical devices and the process used is based on product type. As demand for medical devices increases, production is ramping up, and the need for additional sterilization capacity increases. The time required to build more sterilization capacity can be between six to nine months, and therefore companies are looking into their future production to estimate when will be the right time to start building more capacity. This thesis analyzes the change in sterilization capacity utilization using a simulation model. The model replicates the current production distribution based on data provided from the sterilization facility.
y Ron Arad.
M.Eng.in Logistics

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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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5

Jellen, Isabel. "Towards Security and Privacy in Networked Medical Devices and Electronic Healthcare Systems". DigitalCommons@CalPoly, 2020. https://digitalcommons.calpoly.edu/theses/2141.

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E-health is a growing eld which utilizes wireless sensor networks to enable access to effective and efficient healthcare services and provide patient monitoring to enable early detection and treatment of health conditions. Due to the proliferation of e-health systems, security and privacy have become critical issues in preventing data falsification, unauthorized access to the system, or eavesdropping on sensitive health data. Furthermore, due to the intrinsic limitations of many wireless medical devices, including low power and limited computational resources, security and device performance can be difficult to balance. Therefore, many current networked medical devices operate without basic security services such as authentication, authorization, and encryption. In this work, we survey recent work on e-health security, including biometric approaches, proximity-based approaches, key management techniques, audit mechanisms, anomaly detection, external device methods, and lightweight encryption and key management protocols. We also survey the state-of-the art in e-health privacy, including techniques such as obfuscation, secret sharing, distributed data mining, authentication, access control, blockchain, anonymization, and cryptography. We then propose a comprehensive system model for e-health applications with consideration of battery capacity and computational ability of medical devices. A case study is presented to show that the proposed system model can support heterogeneous medical devices with varying power and resource constraints. The case study demonstrates that it is possible to signicantly reduce the overhead for security on power-constrained devices based on the proposed system model.

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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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7

Yip, Marcus. "Ultra-low-power circuits and systems for wearable and implantable medical devices". Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/84902.

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Thesis (Ph. D.)--Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 219-231).
Advances in circuits, sensors, and energy storage elements have opened up many new possibilities in the health industry. In the area of wearable devices, the miniaturization of electronics has spurred the rapid development of wearable vital signs, activity, and fitness monitors. Maximizing the time between battery recharge places stringent requirements on power consumption by the device. For implantable devices, the situation is exacerbated by the fact that energy storage capacity is limited by volume constraints, and frequent battery replacement via surgery is undesirable. In this case, the design of energy-efficient circuits and systems becomes even more crucial. This thesis explores the design of energy-efficient circuits and systems for two medical applications. The first half of the thesis focuses on the design and implementation of an ultra-low-power, mixed-signal front-end for a wearable ECG monitor in a 0.18pm CMOS process. A mixed-signal architecture together with analog circuit optimizations enable ultra-low-voltage operation at 0.6V which provides power savings through voltage scaling, and ensures compatibility with state-of-the-art DSPs. The fully-integrated front-end consumes just 2.9[mu]W, which is two orders of magnitude lower than commercially available parts. The second half of this thesis focuses on ultra-low-power system design and energy-efficient neural stimulation for a proof-of-concept fully-implantable cochlear implant. First, implantable acoustic sensing is demonstrated by sensing the motion of a human cadaveric middle ear with a piezoelectric sensor. Second, alternate energy-efficient electrical stimulation waveforms are investigated to reduce neural stimulation power when compared to the conventional rectangular waveform. The energy-optimal waveform is analyzed using a computational nerve fiber model, and validated with in-vivo ECAP recordings in the auditory nerve of two cats and with psychophysical tests in two human cochlear implant users. Preliminary human subject testing shows that charge and energy savings of 20-30% and 15-35% respectively are possible with alternative waveforms. A system-on-chip comprising the sensor interface, reconfigurable sound processor, and arbitrary-waveform neural stimulator is implemented in a 0.18[mu]m high-voltage CMOS process to demonstrate the feasibility of this system. The sensor interface and sound processor consume just 12[mu]W of power, representing just 2% of the overall system power which is dominated by stimulation. As a result, the energy savings from using alternative stimulation waveforms transfer directly to the system.
by Marcus Yip.
Ph.D.

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GOMES, LEILA CRISTINA NUNES. "PRODUCTION SYSTEMS IN THE MEDICAL IMAGE DEVICES INDUSTRY: AN ANALYSIS OF MAGNETIC RESONANCE". PONTIFÍCIA UNIVERSIDADE CATÓLICA DO RIO DE JANEIRO, 2004. http://www.maxwell.vrac.puc-rio.br/Busca_etds.php?strSecao=resultado&nrSeq=6081@1.

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COORDENAÇÃO DE APERFEIÇOAMENTO DO PESSOAL DE ENSINO SUPERIOR
Nas últimas décadas, vem ocorrendo uma importante revolução na área da tecnologia médica, em particular nos equipamentos de diagnóstico por imagem. O propósito central da presente tese concentra-se na análise e compreensão das estratégias e sistemas produtivos empregados na produção desses equipamentos, com enfoque específico na produção de equipamentos de Ressonância Magnética, pela importância de se dispor de dados e informações principalmente em países como o Brasil que, apesar de ainda não apresentarem produção nacional, fazem uso de toda essa tecnologia e necessitam preparar recursos humanos não só para a sua própria utilização, mas também para o desenvolvimento e produção de componentes e periféricos específicos. Um grande motivador para esta pesquisa foi o Projeto ToRM, desenvolvido pela Universidade de São Paulo. O projeto constava do desenvolvimento local de um equipamento de ressonância para que fosse possível a formação de mão-de-obra especializada e a realização de estudos para acessórios e componentes. A metodologia empregada neste estudo, o qual é de caráter exploratório, envolve uma pesquisa bibliográfica e dois estudos de casos realizados em empresas produtoras de equipamentos de diagnóstico por imagem - Philips Medical Systems e Siemens Medical. Assim, com a compreensão dos sistemas produtivos aplicados, objetiva-se subsidiar as empresas e universidades com informações atualizadas referentes a essa indústria, principalmente pela falta de material acadêmico sobre o assunto.
In the last decades, an important revolution has taken place in the medical technology field, particularly in image diagnosis equipment. The central purpose of the present thesis is to analyze and understand the strategies and productive systems used in the production of such equipment, with specific focus on the production of Magnetic Resonance equipment. It is important to make data and information available especially in countries like Brazil, which, despite still not having a national production, make use of this technology and need to prepare human resources not only for its own use but also for the development and production of specific components. A great motivation to this research was the ToRM Project, developed by the University of São Paulo. This project consisted in the local development of a resonance machine, which would allow for the preparation of specialized professionals and the development of studies about accessories and components. The methodology used in the present study, which is exploratory in character, involves a literature review and case studies performed in two major manufacturers of image diagnosis equipment - Philips Medical Systems and Siemens Medical. Thus, by understanding the productive systems applied, our goal is to provide companies and universities with updated information about this industry, especially considering the lack of academic material on this subject.

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9

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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10

Kiani, Mehdi. "Wireless power and data transmission to high-performance implantable medical devices". Diss., Georgia Institute of Technology, 2014. http://hdl.handle.net/1853/53396.

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Novel techniques for high-performance wireless power transmission and data interfacing with implantable medical devices (IMDs) were proposed. Several system- and circuit-level techniques were developed towards the design of a novel wireless data and power transmission link for a multi-channel inductively-powered wireless implantable neural-recording and stimulation system. Such wireless data and power transmission techniques have promising prospects for use in IMDs such as biosensors and neural recording/stimulation devices, neural interfacing experiments in enriched environments, radio-frequency identification (RFID), smartcards, near-field communication (NFC), wireless sensors, and charging mobile devices and electric vehicles. The contributions in wireless power transfer are the development of an RFID-based closed-loop power transmission system, a high-performance 3-coil link with optimal design procedure, circuit-based theoretical foundation for magnetic-resonance-based power transmission using multiple coils, a figure-of-merit for designing high-performance inductive links, a low-power and adaptive power management and data transceiver ASIC to be used as a general-purpose power module for wireless electrophysiology experiments, and a Q-modulated inductive link for automatic load matching. In wireless data transfer, the contributions are the development of a new modulation technique called pulse-delay modulation for low-power and wideband near-field data communication and a pulse-width-modulation impulse-radio ultra-wideband transceiver for low-power and wideband far-field data transmission.

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Foe, Owono Guy. "Impact of EU Medical Device Directive on Medical Device Software". ScholarWorks, 2015. https://scholarworks.waldenu.edu/dissertations/353.

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Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.

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Costa, Nuno Miguel Cerqueira da. "User friendly knowledge acquisition system for medical devices actuation". Master's thesis, Faculdade de Ciências e Tecnologia, 2012. http://hdl.handle.net/10362/8257.

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Dissertação para obtenção do Grau de Mestre em Engenharia Biomédica
Internet provides a new environment to develop a variety of applications. Hence, large amounts of data, increasing every day, are stored and transferred through the internet. These data are normally weakly structured making information disperse, uncorrelated, non-transparent and difficult to access and share. Semantic Web, proposed by theWorldWideWeb Consortium (W3C), addresses this problem by promoting semantic structured data, like ontologies, enabling machines to perform more work involved in finding, combining, and acting upon information on theWeb. Pursuing this vision, a Knowledge Acquisition System (KAS) was created, written in JavaScript using JavaScript Object Notation (JSON) as the data structure and JSON Schema to define that structure. It grants new ways to acquire and store knowledge semantically structured and human readable. Plus, structuring data with a Schema generates a software robust and error – free. A novel Human Computer Interaction (HCI) framework was constructed employing this KAS, allowing the end user to configure and control medical devices. To demonstrate the potential of this tool, we present the configuration and control of an electrostimulator. Nowadays, most of the software for Electrostimulation is made with specific purposes, and in some cases they have complicated user interfaces and large, bulky designs that deter usability and acceptability. The HCI concedes the opportunity to configure and control an electrostimulator that surpasses the specific use of several electrostimulator software. In the configuration the user is able to compile different types of electrical impulses (modes) in a temporal session, automating the control, making it simple and user-friendly.

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Do, Khoa Tat. "Universal Engineering Programmer - An In-house Development Tool For Developing and Testing Implantable Medical Devices In St. Jude Medical". DigitalCommons@CalPoly, 2011. https://digitalcommons.calpoly.edu/theses/488.

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During development and testing of the functionality of the pacemaker and defibrillator device, engineers in the St. Jude Medical Cardiac Rhythm Management Division use an in-house development tool called Universal Engineering Programmer (UEP) to ensure the device functions as expected, before it can be used to test on an animal or a human during the implantation process. In addition, some applications of UEP are incorporated into the official releases of the device product. UEP has been developed and used by engineers across departments in the St. Jude Medical Cardiac Rhythm Management Division (CRMD). This thesis covers the flexible and reusable design and implementation of UEP features, to allow engineers to easily and effectively develop and test the devices.

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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.

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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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Bai, Xinye, i Yaniv Rosenberg. "Improving supply chain agility of a medical device Manufacturer". Thesis, Massachusetts Institute of Technology, 2015. http://hdl.handle.net/1721.1/99802.

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Thesis: M. Eng. in Logistics, Massachusetts Institute of Technology, Engineering Systems Division, 2015.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 68-69).
This thesis focuses on a medical device manufacturer, DeCo, which offers surgical instruments to customers at no cost in order to facilitate the sale of implantable products that require the use of such instruments. DeCo is facing challenges in managing the supply chain for these outsourced instruments, such as long lead times, inaccurate forecasting, and excess inventory. Deco is interested in building a more responsive supply chain. To this end, our thesis investigated strategies to increase the supply chain agility by realizing opportunities in information flows, material movement, and channel alignment to achieve shorter lead time, lower inventory levels, and higher levels of service. We conducted interviews and analyzed forecast, inventory, and lead time data files to evaluate the company's supply chain agility in terms of key attributes such as: Inventory management, supply chain visibility, forecast, distribution channel management, supplier manufacturing flexibility, forecast, level of service, lead-time, and product lifecycle. Gaps between the current state and an agile supply chain were identified, and recommendations were made based on these weaknesses. Gaps in the supply chain were divided into three categories: information barriers, operational inflexibilities, and supply chain misalignments. Similarly, our recommendations were broken up into three main groups: Distributor strategies, supplier strategies, and DeCo's practices. By improving supply chain visibility, Deco can cut lead time to customers and significantly lower inventory. By gaining operational flexibility, DeCo can cut lead time from suppliers by 50%, avoid excess ordering due to minimum order quantity, and cut cost per unit. Key recommendations to achieve agility were to build a database of inventory at distributors' warehouses and implement a process to ship instruments between these warehouses; and to work with suppliers to build dedicated capacity on the production floor.
by Xinye Bai and Yaniv Rosenberg.
M. Eng. in Logistics

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Zelkha, Sassan. "Benchmarking of a medical device company's product development process". Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/79426.

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Thesis (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, 2012.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from student-submitted PDF version of thesis.
Includes bibliographical references (p. 88-90).
In todays' global economy, having a lean operation is no longer considered a competitive edge; rather has become the new necessity and norm [15]. The new source of this competitive edge is innovation [15]. What sets an organization apart from its competitors is the ability to develop products that constantly meet customers' demands. An organization must have a New Product Development Process (NPDP) that enhances, expedites and fosters development of innovative products on consistent basis in order to tie innovation to market success. Many organizations have a difficult time determining whether or not the NPDP they are using is adequate because there are no standard methods or processes that organization can use to assess their NPDP [16]. In order to assist a specific medical device organization to assess its NPDP, a partnership with Performance Measure Group (PMG) was established. PMG is a leader in benchmarking and performance measurement. This thesis gives insight into the various new product development and benchmarking processes that are in practice today. It also explores the challenges and benefits associated with conducting benchmarking. Finally, this thesis reveals some of the challenges that this particular medical device company confronts with their NPDP.
by Sassan Zelkha.
S.M.

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Li, Tieyu. "Systems Theoretic Accident Model and Process application : quality control in medical device manufacturing". Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/90689.

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Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, June 2013.
Cataloged from PDF version of thesis. "September 2012."
Includes bibliographical references (pages 102-103).
The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, most manufacturers did not always attain this goal. It is a challenge to balance the demands of meeting government regulations and containing production costs, in an effort to produce the most effective, reliable and safest medical devices. The increasing complexity on product structures, production process and usage context make this task even more formidable. The increase in serious adverse events has outpaced industry growth by 8 % since 2001[1], which reflects the insufficiency of traditional quality control measures. The disastrous consequences of quality hazards usually have profound impact on customers, manufacturers, and communities. Therefore, it is imperative to look for a better way to achieve effective quality control in medical device industry. The purpose of the thesis is to compare the traditional quality control measures, which are now widely adopted in quality systems of medical device industry for designing and development, process control and non-conformance handling, with the approach of Systems Theoretic Accident Model and Process (STAMP) based System-Theoretic Process Analysis (STPA) method. Through the case study on real quality issue in manufacturing control, this work analyzes the current states of complex manufacturing process controls that are designed by utilizing traditional principles and tools, and demonstrates the improvement after the STPA techniques was applied to the same cases. The advantages of STPA technique is to model the process to system control structure without oversimplifying any possible influencing factors, and then examine the links an interaction among these factors to reveal what constraints need to be installed and are followed to ensure that the system performs in safe zone and deliver the expected outcomes. This approach can effectively reveal hidden defects and dangers in system that the traditional measures are not able to detect, and thus is very helpful to the high-stake industry such as medical device manufacturing to prevent potential serious adverse events and protect patients from injuries caused by accidents of quality hazards.
by Tieyu Li.
S.M. in Engineering and Management

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Eren, Ilke. "An Analysis Of Innovation And R&amp". Master's thesis, METU, 2010. http://etd.lib.metu.edu.tr/upload/12612851/index.pdf.

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This thesis aims to explore the challenges of Medical Devices sector in their innovative activities with the use of qualitative and quantitative methods. The specific subject of analysis is the Turkish Medical Device industry. Throughout the thesis the convergence of Medical Devices with pharmacy and its role in healthcare is mentioned in addition to the institutional regulations of the sector due to their effect on the firms innovative activities. The main focus of this thesis is the innovation in medical devices as vital components of healthcare supply with an important share in health expenditures. Even though Medical Devices are considered to be heterogeneous and classified in many other sectors such as chemicals, textiles and electronics, they have common features sufficient to be considered as a special product group and being an important part of the healthcare system, they are subject to common regulations. Sectoral Systems of Innovation approach is used to investigate Medical Devices Sector in Turkey. Medical devices sector also suffer from regulations that put cost on innovative activities, reimbursement policies that aim at cost containment, lower degrees of consumer support (in terms of user-producer relationship), high marketing costs due to the specific market they act in, in addition to the general obstacles such as scarce finance and human resources. Nonetheless, the ambiguity in entrance and allowance to reimbursement lists is also found to be a blocking factor on innovation.The studies on this aspect of the medical devices sector are limited and this thesis aims to fulfil the gap in this respect.

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Jow, Uei-Ming. "A multiband inductive wireless link for implantable medical devices and small freely behaving animal subjects". Diss., Georgia Institute of Technology, 2013. http://hdl.handle.net/1853/51930.

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The objective of this research is to introduce two state-of-the-art wireless biomedical systems: (1) a multiband transcutaneous communication system for implantable microelectronic devices (IMDs) and (2) a new wireless power delivery system, called the “EnerCage,” for experiments involving freely-behaving animals. The wireless multiband link for IMDs achieves power transmission via a pair of coils designed for maximum coupling efficiency. The data link is able to handle large communication bandwidth with minimum interference from the power-carrier thanks to its optimized geometry. Wireless data and power links have promising prospects for use in biomedical devices such as biosensors, neural recording, and neural stimulation devices. The EnerCage system includes a stationary unit with an array of coils for inductive power transmission and three-dimensional magnetic sensors for non-line-of-sight tracking of animal subjects. It aims to energize novel biological data-acquisition and stimulation instruments for long-term experiments, without interruption, on freely behaving small animal subjects in large experimental arenas. The EnerCage system has been tested in one-hour in vivo experiment for wireless power and data communication, and the results show the feasibility of this system. The contributions from this research work are summarized as follows: 1. Development of an inductive link model. 2. Development of an accurate PSC models, with parasitic effects for implantable devices. 3. Proposing the design procedure for the inductive link with optimal physical geometry to maximize the PTE. 4. Design of novel antenna and coil geometry for wireless multiband link: power carrier, forward data link, and back telemetry. 5. Development of a model of overlapping PSCs, which can create a homogenous magnetic in a large experimental area for wireless power transmission at a certain coupling distance. 6. Design and optimization for multi-coil link, which can provide optimal load matching for maximum PTE. 7. Design of the wireless power and data communication system for long-term animal experiments, without interruption, on freely behaving small animal subjects in any shape of experimental arenas.

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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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Quang, Tri T. "Development of Compact Multimodal Optical Imaging and Medical Assessment Systems". University of Akron / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=akron1452533192.

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Adeogun, Oluseun. "Informatics for devices within telehealth systems for monitoring chronic diseases". Thesis, Cranfield University, 2011. http://dspace.lib.cranfield.ac.uk/handle/1826/6493.

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Preliminary investigation at the beginning of this research showed that informatics on point-of-care (POC) devices was limited to basic data generation and processing. This thesis is based on publications of several studies during the course of the research. The aim of the research is to model and analyse information generation and exchange in telehealth systems and to identify and analyse the capabilities of these systems in managing chronic diseases which utilise point-of-care devices. The objectives to meet the aim are as follows: (i) to review the state-of-the-art in informatics and decision support on point-of-care devices. (ii) to assess the current level of servitization of POC devices used within the home environment. (iii) to identify current models of information generation and exchange for POC devices using a telehealth perspective. (iv) to identify the capabilities of telehealth systems. (v) to evaluate key components of telehealth systems (i.e. POC devices and intermediate devices). (vi) to analyse the capabilities of telehealth systems as enablers to a healthcare policy. The literature review showed that data transfer from devices is an important part of generating information. The implication of this is that future designs of devices should have efficient ways of transferring data to minimise the errors that may be introduced through manual data entry/transfer. The full impact of a servitized model for point-of-care devices is possible within a telehealth system, since capabilities of interpreting data for the patient will be offered as a service (c.f. NHS Direct). This research helped to deduce components of telehealth systems which are important in supporting informatics and decision making for actors of the system. These included actors and devices. Telehealth systems also help facilitate the exchange of data to help decision making to be faster for all actors concerned. This research has shown that a large number of capability categories existed for the patients and health professionals. There were no capabilities related to the caregiver that had a direct impact on the patient and health professional. This was not surprising since the numbers of caregivers in current telehealth systems was low. Two types of intermediate devices were identified in telehealth systems: generic and proprietary. Patients and caregivers used both types, while health professionals only used generic devices. However, there was a higher incidence of proprietary devices used by patients. Proprietary devices possess features to support patients better thus promoting their independence in managing their chronic condition. This research developed a six-step methodology for working from government objectives to appropriate telehealth capability categories. This helped to determine objectives for which a telehealth system is suitable.

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Tjhin, Poi Chung, i Rachita Pandey. "Inventory management strategy for the supply chain of a medical device company". Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/77474.

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Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 97-98).
In the medical device industry, many companies rely on a high inventory strategy in order to meet their customers' urgent requirements, sometimes leading to excessive inventory. This problem is compounded when it involves a long supply chain with several stages of activities and with long delivery and processing lead times. It is further exacerbated when high inventory leads to the frequent expiry of items with short shelf lives, which is typical of surgical items that have to be sterilized. Good supply chain strategies can potentially lead to a significant reduction of the supply chain cost. Through the use of relevant mathematical formulae and Strategic Inventory Placement optimization method, this paper examines the extent of the usefulness of a few possible strategies, such as kitting architecture change and continuous review system, for a family of medical emergency surgical kits across the whole supply chain for a medical device company. The result shows that reducing production lead time and review period, as well as adopting certain kitting architecture changes can reduce inventory value by more than 60% and operating cost by more than 20%. In addition, the paper shows that the Strategic Inventory Placement method can further reduce the total inventory value and operating cost by increasing the inventory of finished products and reducing the inventory of components in the supply chain.
by Poi Chung Tjhin and Rachita Pandey.
M.Eng.in Logistics

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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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O'Brien, Kathleen. "Inductively coupled radio frequency power transmission system for wireless systems and devices /". Aachen : Shaker, 2007. http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&doc_number=015959229&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA.

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AlEisa, Abdulaziz A. (Abdulaziz Asaad). "Production system improvement at a medical devices company : floor layout reduction and manpower analysis". Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/78160.

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Thesis (M. Eng. in Manufacturing)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2012.
"September 2012." Cataloged from PDF version of thesis.
Includes bibliographical references (p. 84).
Due to the low demand and the need to introduce other production lines in the floor, the medical devices company wants to optimize the utilization of space and manpower for the occlusion system product. This thesis shows the approaches and methodology used to reduce the occlusion system's floor area from 1528 ft² to 1052 ft². Also, it provides a detailed analysis of the manpower at the occlusion system assembly lines. The analysis includes different models that were developed and simulated using different number of available operators and batch sizes. The results show the maximum production rate for each subassembly using the existing production benches, tools, and equipment. Furthermore, a manpower model was recommended for each subassembly of the occlusion system along with the necessary cross training requirements based on the current average demand.
by Abdulaziz A. Aleisa.
M.Eng.in Manufacturing

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Moutinho, Luís Miguel da Conceição. "Studies on the NEXT experiment tracking system and development of medical devices with SiPMs". Doctoral thesis, Universidade de Aveiro, 2016. http://hdl.handle.net/10773/18637.

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Doutoramento em Física
Os recentes desenvolvimentos na área dos fotodetectores de estado sólido, nomeadamente os fotomulplicadores de silício (SiPM), permitiram a proliferação desta tecnologia num vasto número de aplicações em áreas distintas. Estes fotosensores robustos, versáteis e com um preço competitivo, tornaram-se uma das mais promissoras alternativas aos tubos fotomultiplicadores para deteção de baixo nível de luz, especialmente para aplicações onde é necessário um grande número de fotodetectores. Estes fotosensores multi-pixel, são capazes de deteção de fotão único, permitindo obter ao mesmo tempo informação sobre fotão de interação e energia. Os estudos realizados no âmbito deste programa doutoral e reportados neste documento dividem-se em três aplicações principais: colaboração no desenvolvimento do sistema de rastreamento (tracking system) da experiência NEXT na área da física de neutrinos e Neutrinoless Double Beta Decay (0⌫""), que comporta ⇠7.000 SIPMs para identificação da assinatura 0⌫"", um dosímetro para braquiterapia de próstata e um sistema PET didático - easyPET. Foram realizados vários estudos para caracterização da nova geração de SiPMS. Como verificado, estes dispositivos apresentam características melhoradas tais como uma maior eficiência quântica e menor crosstalk, afterpulsing e sensibilidade térmica. Esta nova geração de SiPMs adequa-se aos requisitos para aplicação no tracking system no NEXT. No entanto, uma maior eficiência quântica no ultravioleta de vazio (VUV) é desejável. Foi avaliada a aplicação de SiPMs em sensores de radiação para dosimetria médica. Foi desenvolvido um dosímetro com base em fibra ótica cintilante. O dispositivo foi caracterizado numa larga gama de energia e em regimes de baixa e de alta taxa de dose. O dosímetro foi avaliado em ambiente clínico recriando as condições de braquiterapia HDR, tratamento aplicado no tratamento de cancros da próstata e mama. Conforme verificado, os SiPM apresentam elevada dependência com a temperatura sendo portanto necessárias técnicas de compensação ou de estabilização. O protótipo do easyPET foi implementado com sucesso. A tecnologia foi licenciada e é esperada a sua comercialização até ao fim do ano de 2016. Dos estudos realizados nas várias aplicações, conclui-se que os SiPMs são fotodetectores muito versáteis devido à sua alta sensibilidade, elevado ganho, insensibilidade a campos magnéticos, de rápida resposta e de pequenas dimensões, abrindo a possibilidade de aplicação desta tecnologia em múltiplos campos permitindo uma infinidade de novos conceitos de detectores, tais como na física de alta energia e aplicações de imagiologia biomédica.
The recent developments of solid-state photodetectors, namely Silicon Photomultipliers (SiPMs), allowed a proliferation of this technology through numerous applications. These robust and versatile photosensors with an attractive price have become one of most promising alternatives for low light level detection, especially for applications where a large number of devices is required. These multi-pixel photosensors, capable of single photon detection, allow to obtain at the same time information on photon-interaction and energy. The Ph.D studies reported in this document cover three main applications: the NEXT experiment, a Neutrinoless Double Beta Decay (0⌫"" ) experiment using ⇠7000 SiPMs in the tracking system for topological signature identification, a dosimeter for prostate brachytherapy and a simple PET system for education purposes - the easyPET. Several studies were conducted envisaging the characterization of a new generation of SiPMs. As verified, these devices present improved features such as higher quantum e

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ANDRADE, Rony Marcolino de. ""Uma abordagem para construção de modelos de dispositivos médicos para testes de sistemas médicos físico-cibernéticos"". Universidade Federal de Campina Grande, 2016. http://dspace.sti.ufcg.edu.br:8080/jspui/handle/riufcg/1619.

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Submitted by Emanuel Varela Cardoso (emanuel.varela@ufcg.edu.br) on 2018-08-31T22:34:35Z No. of bitstreams: 1 RONY MARCOLINO DE ANDRADE – DISSERTAÇÃO (PPGCC) 2016.pdf: 3165388 bytes, checksum: e26452f5e3e73c3c717d633f0d6743b7 (MD5)
Made available in DSpace on 2018-08-31T22:34:35Z (GMT). No. of bitstreams: 1 RONY MARCOLINO DE ANDRADE – DISSERTAÇÃO (PPGCC) 2016.pdf: 3165388 bytes, checksum: e26452f5e3e73c3c717d633f0d6743b7 (MD5) Previous issue date: 2016-03-02
Os Sistemas Físico-Cibernéticos (SFC) são sistemas que surgiram da confluência da conectividade das redes, dos dispositivos embarcados e do controle computacional sobre processos físicos. Dessa forma os SFC se caracterizam como sistemas de controle, monitoramento e supervisão com componentes físicos e virtuais, que dependem de agentes humanos no processo. Nesse sentido, a combinação dos SFC à física dinâmica e complexa dos pacientes clínicos faz surgir uma classe distintas de sistemas médicos denominada de Sistemas Médicos Físico-Cibernéticos (SMFC). No domínio industrial há plantas que possuem sensores e atuadores que muitas vezes dependem de agentes humanos para manutenção e controle. Diferentemente, no domínio da saúde, o ser humano é o próprio processo a ser controlado, onde sensores e atuadores são os dispositivos médicos, e os agentes humanos são os cuidadores. Esse trabalho propõe uma abordagem para a construção de modelos de dispositivos médicos, como parte de um conjunto de artefatos para apoiar os testes de SMFC. Esta abordagem se baseia em modelos de referência que simulam o funcionamento de dispositivos médicos. Especificações técnicas fornecidas pelos fabricantes desses dispositivos, juntamente com diretrizes disponibilizadas por agências reguladoras, foram utilizadas para a definição da abordagem proposta. Além disso, um estudo de caso com três dispositivos médicos foi desenvolvido com o fim de validar a abordagem, criando artefatos e modelos de referência.
Cyber-Physical Systems (CPS) are systems that have emerged from the confluence of the connectivity of networks, embedded devices and computer control of physical processes. Thus, SFC are characterized as control, monitoring and supervision systems with physical and virtual components, which depend on human agents in the process. In this sense, the combination of SFC dynamic and complex physics of medical patients enable a distinct class of medical systems called Medical Cyber Physical Systems (MCPS). In the industrial area, there are plants with sensors and actuators that often rely on human agents for maintenance and control. On the other hand, in the field of health, human being is the process itself to be controlled, where sensors and actuators are medical devices and human agents are caregivers. MCPS perform monitoring and control of human health with high levels of security. This paper proposes an approach to build models of medical devices, as part of a set of artifacts to support MCPS testing. This approach is based on reference models which simulate the operation of medical devices. Technical specifications provide by manufacturers of these devices, along with guidelines provided by regulatory agencies, were used for the definition of the proposed approach. Moreover, a case study with three medical device was designed to validate the approach, creating some artifacts and reference models.

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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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Dicko, Ali Hamadi. "Construction of musculoskeletal systems for anatomical simulation". Thesis, Grenoble, 2014. http://www.theses.fr/2014GRENM084/document.

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L'usage d'humains virtuels s'est démocratisé à de nombreuses activités ces dernières années.Au-delà de la chirurgie virtuelle, les corps virtuels sont de plus en plus utilisés pour concevoir des dispositifs médicaux, des véhicules et des outils de notre quotidien plus généralement.Ils se sont avérés être également d'extraordinaires supports à l'apprentissage de l'anatomie.De récents films (Avatar, Le seigneur des anneaux, etc) ont démontré que l'anatomie et la biomécanique peuvent être utilisées pour concevoir des personnages d'une grande qualité.Cependant, reproduire le comportement des structures anatomiques demeure une tâche complexe, et de nombreuses connaissances variées sont nécéssaires à la mise en place de simulation de qualité de nos organes. Ceci fait de la modélisation pour la simulation d'humains une problématique non résolue, une tâche fastidieuse, mais également un sujet de recherche fascinant.À travers ces travaux de thèse, nous abordons cette problématique de la construction de systèmes musculo-squeletiques pour ces domaines variés : animation, biomécanique et aide à l'apprentissage.Notre objectif est de simplifier le processus entier de création en le rendant plus intuitif et plus rapide.Notre approche consiste à pallier à chacune des difficultés, à savoir : la représentation et la manipulation de connaissances anatomiques, la modélisation géométrique et la simulation efficace de systèmes musculosquelettiques grâce à trois principalescontributions introduites durant ces travaux de recherche.Notre première contribution se focalise sur la construction biomécanique d'un modèle hybride du rachis lombaire.Dans ces travaux, nous montrons que les approches hybrides combinant des systèmes de corps rigides et des modèles éléments finis permettent d'obtenir des simulations en temps intéractifs, précises, et respectant les principes de l'anatomie et de la mécanique.Notre seconde contribution s'intéresse aux problématiques liées à la complexité des connaissances anatomiques, physiologiques et fonctionnelles. En se basant sur une ontologie de l'anatomie et une ontologie inédite de la physiologie humaine, nous introduisonsun pipeline pour la construction automatique de modèles simulant les fonctions de nos organes.Celles-ci permettent d'exploiter les connaissances anatomiques complexes via des requêtes simples.Les sorties de ces requêtes sont utilisées pour créer des modèles simulables retranscrivant les aspects fonctionnels tels qu'ils ont été formalisés et décrits par les anatomistes.Enfin, notre troisième contribution : le transfert d'anatomie, permet d'adapter les modèles géométriques et mécaniques à la morphologie de patients spécifiques.Cette nouvelle méthode de recalage permet de reconstruire automatiquement l'anatomie interne d'un personnage défini par sa peau en transférant les organes d'un personnage de référence.Elle permet de pallier à la nécessité de re-construire ces géometries pour chaque nouvelle simulation, et contribue ainsi à accélérer la mise en place de simulations spécifiques à une grande variété d'individus de morphologie différente
The use of virtual humans has spread in various activities in recent years.Beyond virtual surgery, virtual bodies are increasingly used to design medical devices, vehicles, and daily life hardware more generally.They also turn out to be extraordinary supports to learn anatomy.Recent movies (Avatar, Lord of the Rings, etc) demonstrated that anatomy and biomechanics can be used to design high-quality characters.However, reproducing the behavior of anatomical structures remains a complex task, and a great amount and variety of knowledge is necessary for setting up high quality simulations.This makes the modeling of human body for simulation purposes an open problem, a tedious task, but also a fascinating research subject.Through this PhD, we address the problem of the construction of biomechanical models of the musculoskeletal systems for several domains : animation, biomechanics and teaching.Our goal is to simplify the entire process of model design by making it more intuitive and faster.Our approach is to address each difficulty : the representation and use of anatomical knowledge, the geometrical modeling and the efficient simulation of the musculoskeletal system thanks to three novel contributions introduced during these research works.Our first contribution focuses on the biomechanical construction of a hybrid model of lumbar spine.In this work, we show that hybrid approaches that combine both rigid body systems and finite element models allow interactive simulations, accurate, while respecting the principles of anatomy and mechanics.Our second contribution addresses the problem of the complexity of anatomical, physiological and functional knowledge.Based on a novel ontology of anatomical functions of the human body, we introduce a novel pipeline to automatically build models that simulate physiological functions of our bodies.The ontology allows us to extract detailed knowledge using simple queries.The outputs of these queries are used to set up simulation models of the functional aspects as they were formalized and described by anatomists.Finally our third contribution, the anatomy transfer, allows the mapping of available geometrical and mechanical models to the morphology of any specific individual.This novel registration method enables the automatic construction of the internal anatomy of any character defined by his skin, by transferring organs from a reference character.It allows to overcome the need to re-construct these geometries for each new simulation, and it contributes to accelerate the simulations setup for a range of people with different morph

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Broniatowski, David André 1982. "A method for analysis of expert committee decision-making applied to FDA medical device panels". Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/62617.

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Thesis (Ph. D.)--Massachusetts Institute of Technology, Engineering Systems Division, 2010.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from student submitted PDF version of thesis.
Includes bibliographical references (p. 254-263).
Committees of experts are critical for decision-making in engineering systems. This is because the complexity of these systems requires that information is pooled from across multiple specialties and domains of knowledge. The social elements of technical decision-making are not well understood, particularly among expert committees. This is largely due to a lack of methodology for directly studying such interactions in real-world situations. This thesis presents a method for the analysis of transcripts of expert committee meetings, with an eye towards understanding the process by which information is communicated in order to reach a decision. In particular, we focus on medical device advisory panels in the US Food and Drug Administration. The method is based upon natural language processing tools, and is designed to extract social networks in the form of directed graphs from the meeting transcripts which are representative of the flow of information and communication on the panel. Application of this method to a set of 37 meetings from the FDA's Circulatory Systems Devices Panel shows the presence of numerous effects. Prominent among these is the propensity for panel members from similar medical specialties to use similar language. Furthermore, panel members who use similar language tend to vote similarly. We find that these propensities are correlated - i.e., as panel members' language converges by medical specialty, panel members' votes also converge. This suggests that voting behavior is mediated by membership in a medical specialty and supports the notion that voting outcome is, to some extent, dependent on an interpretation of the data associated with training, particularly when a small number of interpretations of the data are possible. Furthermore, there is some preliminary evidence to suggest that as clinical trial data ambiguity and difficulty of decisionmaking increases, the strength of the mediating effect of medical specialty decreases. Assuming a common decision is reached, this might indicate that committee members are able to overcome their specialty perspective as the committee jointly deals with hard problems over longer periods of time. In cases where the panel's vote is split, a lack of linguistic coherence among members of the same medical specialty correlates with a lack of linguistic coherence among members who vote the same way. This could be due to the presence of multiple interpretations of the data, leading to idiosyncratic or value-based choice. We also find that voting outcome is associated with the order in which panel members ask questions - a sequence set by the committee chair. Members in the voting minority are more likely to ask questions later than are members in the voting majority. Voting minority members are also more likely to be graph sinks (i.e., nodes in a social network that have no outflow) than are voting majority members. This suggests an influence mechanism on these panels that might be associated with framing - i.e., later speakers seem to be less able to convince other panel members to discuss their topics of interest contributing to these members' minority status. These results may have some relation to FDA panel procedures and structure. Finally, we present a computational model that embodies a theory of panel voting procedures. Model results are compared to empirical results and implications are drawn for the design of expert committees and their associated procedures in engineering systems.
by David André Broniatowski.
Ph.D.

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32

Melli, Mauro. "Mechanical resonating devices and their applications in biomolecular studies". Doctoral thesis, SISSA, 2010. http://hdl.handle.net/20.500.11767/4646.

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To introduce the reader in the subjects of the thesis, Chapter 1 provides an overview on the different aspects of the mechanical sensors. After a brief introduction to NEMS/MEMS, the different approaches of mechanical sensing are provided and the main actuation and detection schemes are described. The chapter ends with an introduction to microfabrication. Chapter 2 deals with experimental details. In first paragraph the advantages of using a pillar instead of common horizontal cantilever are illustrated. Then, the fabrication procedures and the experimental setup for resonance frequencies measurement are described. The concluding paragraph illustrates the technique, known as dip and dry, I used for coupling mechanical detection with biological problems. In Chapter 3, DNA kinetics of adsorption and hybridization efficiency, measured by means of pillar approach, are reported. Chapter 4 gives an overview of the preliminary results of two novel applications of pillar approach. They are the development of a protein chip technology based on pillars and the second is the combination of pillars and nanografting, an AFM based nanolithography. Chapter 5 starts with an introduction about the twin cantilever approach and of the mechanically induced functionalization. Fabrication procedure is described in the second paragraph. Then the chemical functionalizations are described and proved. Cleaved surface analyses and the spectroscopic studies of the mechanically induced functionalization are reported. In Appendix A there is an overview of the physical models that are used in this thesis.

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BONFANTI, Silvia (ORCID:0000-0001-9679-4551). "Rigorous Model-based Development of Programmable Electronic Medical Systems (PEMS): from Requirements to Code". Doctoral thesis, Università degli studi di Bergamo, 2017. http://hdl.handle.net/10446/77230.

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Programmable Electronic Medical Systems (PEMS) are safety-critical system. They have effects on people health and, in case of malfunctions, they can seriously compromise human safety. For this reason, the software installed on these devices must be guaranteed through rigorous processes to assure safety and reliability. Moreover, correct operation of a medical device depends upon the controlling software, whose development should adhere to certification standards. The rigorous process presented in this thesis is based on the Abstract State Machines (ASMs) formal method, a mathematically based technique for the specification, analysis and development of software systems. The ASM formal approach proposes an incremental life cycle model for software development based on model refinement. It covers the main software engineering activities (specification, validation, verification, conformance checking), and it is supported by a wide range of tools which are part of the Asmeta (ASM mETAmodeling) framework. In this thesis, the ASM development approach and its supporting Asmeta framework are used to propose a rigorous development process for PEMS. The final goal is to provide a process able to guarantee the development of correct and controllable systems in a correct and controllable way. The definition of this process has leaded to some improvements of the method, mainly regarding the textual and graphical notations, and the automatic code generation from models. A new rigorous notation, Unified Syntax for Abstract State Machine (UASM), has been defined to provide a stable language kernel for ASMs. Formal models are not widely used in practice, since they are considered difficult to develop and understand. For this reason, we here make a proposal of a tool for a graphical representation of ASM models in order to increase the readability. Moreover, we have devised a methodology to generate the desired source code from ASM models. The tool automatically translates the formal specification into the target code (C++ for Arduino in the present case) and it keeps true the system behavior and the properties verified during validation and verification. The hemodialysis machine and the stereoacuity test are used as real case studies to show the applicability and effectiveness of the ASM-based development process in the area of PEMS.

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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.

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Antoine, Blandine. "Systems Theoretic Hazard Analysis (STPA) applied to the risk review of complex systems : an example from the medical device industry". Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/79424.

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Thesis (Ph. D.)--Massachusetts Institute of Technology, Engineering Systems Division, 2013.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from student-submitted PDF version of thesis.
Includes bibliographical references.
Traditional methods to identify and document hazards, and the corresponding safety constraints, are lacking in their ability to account for human, software and sub-system interactions in highly technical systems. STAMP, a systems-theoretic accident causality model, was created to overcome these limitations. The application of STAMP hazard analysis method STPA to five sub-systems of the Paul Scherrer Institute's experimental PROSCAN proton therapy system demonstrated how STPA can augment design and risk review of existing complex systems. Two of the five human controllers active in treatment delivery, two of the four process attributes controlled by the PROSCAN facility, and one of the four control loops that control the beam to target alignment attribute were analyzed. In doing so, the following contributions were made: - Analyzed the regulations currently in place in the US and Europe for the marketing of external beam radiotherapy devices and, more generally, medical devices that do not contain radioactive materials, concluding that STPA would be acceptable in both regulatory systems; - Provided experience in applying STPA to a complex device. Information on efficacy was derived by comparing STPA results with an existing safety assessment but a more formal counterpart is needed for stronger evidence. Information on learnability and usability was obtained when an informal workshop showed that system designers, in the course of one day, could be taught to use STPA to push their thinking about yet to be designed system elements; - Demonstrated the applicability of STPA to an experimental radiotherapy facility and, through this feasibility check, potentially influenced the state of the art in hazard analysis of medical devices and health care delivery; - Advanced the STPA methodology by creating notations and a process to document, query and visualize the possibly large number of hazardous scenarios identified by STPA analyses, with the goal of facilitating their review and use by their intended audience; Showed how STPA is complementary to more traditional hazard analysis techniques such as fault and event trees. Their respective strengths can be summoned when STPA is used to identify areas on which to focus the investigation lens of traditional hazard analysis techniques. Keywords: STAMP, STPA, hazard analysis, risk analysis, risk management, proton therapy, medical devices, safety, certification
by Blandine Antoine.
Ph.D.

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Dev, Nishanth K. (Nishanth Krishna). "Developing an Asia-Pacific manufacturing footprint strategy in the medical device industry". Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/80992.

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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Global Operations Program at MIT, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 125-126).
As medical device manufacturers operating in the Asia-Pacific region are planning for increased demand in the near future, they must evaluate their manufacturing footprint strategies to determine if they are getting the most value out of their supply chains given the various incentives and costs associated with regional manufacturing. Company X is investigating manufacturing expansion opportunities for medical devices due to the significant revenue growth rates expected for the Asia-Pacific region, especially in the emerging markets. This thesis deals with the development of a repeatable methodology that can be used to evaluate various medical device products and manufacturing capabilities for Asia-Pacific sourcing. The methodology was tested on a selected subsidiary to determine if a regional manufacturing opportunity exists. Furthermore, a business process, which includes insights into data collection, team formation, and implementation of footprint decisions, was developed for Company X to use in determining its overall network strategy for the sector. Other manufacturers can apply the methodology and the business process in the development of their manufacturing footprint strategies as well. Although the results from the decision analysis did not favor expansion of the manufacturing operations for the selected Product Line B in the Asia-Pacific region, they helped in identifying the key factors that would favor regional expansion. In addition, crucial factors that may be difficult to quantify, such as intellectual property rights, must be considered before making a expansion decision, even if it is the favored outcome based on the results of the decision analysis for other product lines or subsidiaries.
by Nishanth K. Dev.
S.M.
M.B.A.

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Björklund, Pernilla. "The curious case of artificial intelligence : An analysis of the relationship between the EU medical device regulations and algorithmic decision systems used within the medical domain". Thesis, Uppsala universitet, Juridiska institutionen, 2021. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-442122.

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The healthcare sector has become a key area for the development and application of new technology and, not least, Artificial Intelligence (AI). New reports are constantly being published about how this algorithm-based technology supports or performs various medical tasks. These illustrates the rapid development of AI that is taking place within healthcare and how algorithms are increasingly involved in systems and medical devices designed to support medical decision-making. The digital revolution and the advancement of AI technologies represent a step change in the way healthcare may be delivered, medical services coordinated and well-being supported. It could allow for easier and faster communication, earlier and more accurate diagnosing and better healthcare at lower costs. However, systems and devices relying on AI differs significantly from other, traditional, medical devices. AI algorithms are – by nature – complex and partly unpredictable. Additionally, varying levels of opacity has made it hard, sometimes impossible, to interpret and explain recommendations or decisions made by or with support from algorithmic decision systems. These characteristics of AI technology raise important technological, practical, ethical and regulatory issues. The objective of this thesis is to analyse the relationship between the EU regulation on medical devices (MDR) and algorithmic decision systems (ADS) used within the medical domain. The principal question is whether the MDR is enough to guarantee safe and robust ADS within the European healthcare sector or if complementary (or completely different) regulation is necessary. In essence, it will be argued that (i) while ADS are heavily reliant on the quality and representativeness of underlying datasets, there are no requirements with regard to the quality or composition of these datasets in the MDR, (ii) while it is believed that ADS will lead to historically unprecedented changes in healthcare , the regulation lacks guidance on how to manage novel risks and hazards, unique to ADS, and that (iii) as increasingly autonomous systems continue to challenge the existing perceptions of how safety and performance is best maintained, new mechanisms (for transparency, human control and accountability) must be incorporated in the systems. It will also be found that the ability of ADS to change after market certification, will eventually necessitate radical changes in the current regulation and a new regulatory paradigm might be needed.

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Leal, Michael J. "Effect of pixel size and scintillator on image quality of a CCD-based digital x-ray imaging system". Link to electronic thesis, 2001. http://www.wpi.edu/Pubs/ETD/Available/etd-0502101-123456.

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Benjamin, Valencia. "Experiences of professional nurses with regard to accessing information at the point-of-care via mobile-computing devices at a public hospital". Thesis, Nelson Mandela Metropolitan University, 2013. http://hdl.handle.net/10948/d1020193.

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Mobile computing devices are capable of changing how healthcare is delivered in the future, since they aim to merge and integrate all services into one device that is versatile, customisable, and portable. The aim of this study was to explore and describe the experiences of professional nurses with regard to accessing information at the point-of-care of the patient, in order to develop guidelines that could assist other professional nurses with implementing the mobile computing device for accessing information at the point-of-care of patients. To achieve the purpose of the study, a qualitative, explorative, descriptive, and contextual design was used to conduct this research – to gain an understanding of how the professional nurses experienced accessing information at the point-of-care via mobile computing devices. The study was conducted among the professional nurses employed at the public hospital, who were trained and provided with the mobile computing device for accessing information at the point-of-care for more than two years. In-depth interviewing was conducted to obtain the data. Data analysis was done using Tesch‘s method to make sense out of text and data. Four themes were identified, namely, the professional nurses‘ expression of various experiences regarding the training received; the need for support in implementing the mobile computing device; the accessing of information at the point-of-care as beneficial for educational purposes; and the accessing of information at the point-of-care as beneficial to patient care. Two main guidelines were developed. The study concludes with recommendations made with regard to the areas of nursing practice, education and research. Throughout the study, the researcher abided by the ethical considerations. The aspects of trustworthiness implemented in this study, included dependability, credibility, transferability and confirmability (Holloway & Wheeler, 2010:298).

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Hakemibarabadi, Amir. "Robust control of a wireless power transfer system for ventricular assist devices". Thesis, Queensland University of Technology, 2022. https://eprints.qut.edu.au/229219/1/Amir_Hakemibarabadi_Thesis.pdf.

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In recent times, wireless power transfer systems (WPTS) have been identified as a reliable option to supply power to heart pumps. When WPTS are used for heart pumps, they increase the number of required power converter stages and correspondingly hardware complexity. In addition, the existence of uncertainties in WPTS based medical implants such as load, and mutual inductance variations can lead to system instability or poor performance. To make a reliable closed-loop operation, a μ-synthesis robust controller is investigated for the medical implants to obtain a satisfactory performance which is critical for medical applications.

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Mykityshyn, Amy L. "Toward age-related training methodologies for sequence-based systems : an evaluation using a home medical device". Thesis, Georgia Institute of Technology, 2000. http://hdl.handle.net/1853/28746.

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Kativu, Tatenda Kevin. "A framework for the secure consumerisation of mobile, handheld devices in the healthcare institutional context". Thesis, Nelson Mandela Metropolitan University, 2017. http://hdl.handle.net/10948/18630.

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The advances in communication technologies have resulted in a significant shift in the workplace culture. Mobile computing devices are increasingly becoming an integral part of workplace culture. Mobility has several advantages to the organisation, one such example is the “always online” workforce resulting in increased productivity hours. As a result, organisations are increasingly providing mobile computing devices to the workforce to enable remote productivity at the organisations cost. A challenge associated with mobility is that these devices are likely to connect to a variety of networks, some which may insecure, and because of their smaller form factor and perceived value, are vulnerable to loss and theft amongst other information security challenges. Increased mobility has far reaching benefits for remote and rural communities, particularly in the healthcare domain where health workers are able to provide services to previously inaccessible populations. The adverse economic and infrastructure environment means institution provided devices make up the bulk of the mobile computing devices, and taking away the ownership, the usage patterns and the susceptibility of information to adversity are similar. It is for this reason that this study focuses on information security on institution provided devices in a rural healthcare setting. This study falls into the design science paradigm and is guided by the principles of design science proposed by Hevner et al. The research process incorporates literature reviews focusing on health information systems security and identifying theoretical constructs that support the low-resource based secure deployment of health information technologies. Thereafter, the artifact is developed and evaluated through an implementation case study and expert reviews. The outcomes from the feedback are integrated into the framework.

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Scandurra, Isabella. "Building Usability into Health Informatics : Development and Evaluation of Information Systems for Shared Homecare". Doctoral thesis, Uppsala : Acta universitatis Upsaliensis, 2007. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-8403.

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Garner, Robin S. "A Comparative Analysis of Data Collection Systems Used in Radiography Educational Programs and the Role Mobile Electronic Devices Play". Digital Commons @ East Tennessee State University, 2015. https://dc.etsu.edu/etd/2592.

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Each radiography program has a system to collect important data from didactic and clinical settings in order to accurately assess the progress and success of students, provide the needed student intervention, and provide accreditation agencies with appropriate documentation that demonstrates student success in reaching program learning outcomes. The purpose of this research study was to determine the method of data collection and documentation used by radiography programs to evaluate student progress and to examine if MEDs play a role in evaluating and documenting student skills at the point of care. The majority of radiography programs in this study were using paper methods for data collection and program directors reported value in using MEDs in clinical education but revealed that barriers still exist and will need to be addressed in order to increase their usage in clinical education.

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Khoury, Gregory Robert. "A strategic, system-based knowledge management approach to dealing with high error rates in the deployment of point-of-care devices". Thesis, Stellenbosch : Stellenbosch University, 2014. http://hdl.handle.net/10019.1/96206.

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Thesis (MBA)--Stellenbosch University, 2014.
There is a growing trend towards the use of point of care testing in resource poor settings, in particular in the diagnosis and treatment of infectious diseases such as Human Immunodeficiency Virus (HIV), Tuberculosis (TB) and Malaria. The Alere PIMA CD4 counter is widely used as a point of care device in the staging and management of HIV. While the instrument has been extensively validated and shown to be comparable to central laboratory testing, little is known about the error rates of these devices, as well as the factors that contribute to error rates. This research was a retrospective analysis of error rates from 61 PIMA point of care devices deployed in nine African countries belonging to Medisciens Sans Frontiers. The data was collected between January 2011 and June 2013. The objectives of the study were to determine the overall error rate and, where possible, determine the root cause. Thereafter the study aimed to determine the variables that contribute to the root causes and make recommendations to reduce the error rate. The overall error was determined to be 13.2 percent. The errors were further divided into four root causes and error rates assigned to each root cause based on the error codes generated by the instrument. These error rates were found to be operator error (48.4%), instrument error (2.0%), reagent/cartridge error (1%) and sample error (4.3%). It was found that a high percentage of the errors were ambiguous (44.3%), meaning that they had more than one possible root cause. A systems-based knowledge management approach was used to create a qualitative politicised influence diagram, which described the variables that affect each of the root causes. The influence diagram was subjected to loop analysis where individual loops were described in terms of the knowledge type (tacit or explicit), the knowing type (know-how, know-who, know-what and know-why), and the actors involved with each variable. Where possible, the variable was described as contributing to pre-analytical, analytical or post-analytical error. Recommendations to reduce the error rates for each of the variables were then made based on the findings.

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Danko, Charlott. "Traceability of Medical Devices Used During Surgeries : A Study of the Current Traceability System at the Karolinska University Hospital in Solna and Research of Improvement". Thesis, KTH, Medicinteknik och hälsosystem, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-279135.

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The last few decades' development of technology has greatly affected healthcare. The implementation of technology in healthcare has advanced and improved it immensely, but it has also brought a new level of complexity. One of the modern issues introduced to healthcare is the traceability of medical devices. The main reason why traceability is becoming a more important matter in regards to healthcare is because of patient safety. Patient safety is one of the greatest priorities in healthcare but is constantly challenged by new innovations. Enabling traceability of medical devices is a part of the process of ensuring patient safety. The aim of this master thesis project was to research how medical devices used in surgeries are traced and how the routine can be improved. The idea of this thesis was based on the application of two new regulations, Regulation (EU) 745/2017 and Regulation (EU) 746/2017, both with the purpose of improving traceability. Qualitative methods such as observations, surveys, and interviews were used for this project. To gain multiple perspectives on the issue, different target groups were defined for the collection of data. The qualitative data was then analysed and conclusions based on the data could be drawn. The results of this project showed that the current traceability routine is lacking and that there is a lot of potential for improvements. The computer systems that manages information regarding medical devices can enable proper traceability if combined with other systems. Improvements of features in the systems are suggested, as well as an idea of an integrated system that combines functionalities of other software. Some of the project's challenges are discussed and suggestions for how to further develop the research are presented.

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Hogaboam, Liliya Stepanivna. "Assessment of Technology Adoption Potential of Medical Devices: Case of Wearable Sensor Products for Pervasive Care in Neurosurgery and Orthopedics". PDXScholar, 2018. https://pdxscholar.library.pdx.edu/open_access_etds/4205.

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Information and communication technologies hope to revolutionize the healthcare industry with innovative and affordable solutions with a focus on pervasive care. Wearable sensors products can provide monitoring in a natural environment with a constant stream of information, enriching healthcare practices and enabling better pervasive care. Wearable sensor technologies could monitor patients' mobility, gait, tremor, daily activity and other health indicators in real time that could allow for simple, non-invasive, tracking of spine care that may lead to increased patient engagement, integration, feedback, post-surgery analysis, monitoring of patient's condition, patient's data extraction and analysis and possibly aiding in better diagnosis, intervention, adherence to treatment for the betterment of quality of care. This research focuses on the assessment of technology adoption potential of medical devices particular to tracking the mobility of patients of neurosurgery and orthopedics. Wearable medical devices that track the mobility of patients after spinal procedures could help surgeons in providing post-operative care, analysis of treatment outcomes and patient mobility. The assessment of those devices by physicians is a complex process associated with various perspectives and criteria. Therefore, the objective of this research is to assess the potential for technology adoption of those wearable medical devices through development of a hierarchical decision-making model (HDM) that incorporates the relevant perspectives and criteria encompassing the needs of hospital neurological surgery and orthopedics departments. The proposed research builds on an existing body of knowledge researched through literature review and background of the field and expands the health technology assessment field by implementation of a holistic, comprehensive and multi-perspective approach to technology assessment in wearable sensor products adoption for pervasive care in neurosurgery and orthopedics. The Hierarchical Decision Model (HDM) approach is used to break the problem down into hierarchical levels and then calculate the alternatives using pairwise comparison scales and a judgment quantification technique. Inconsistencies, disagreement, sensitivity and scenario analysis are performed as well. HDM research software is created with Ruby and R to facilitate the computation of some of these important model parameters to higher precision than is available in current statistical analysis software packages or extensions targeted for decision making. Patient perspective dominates as the main perspective for the technology adoption potential of wearable devices for pervasive care in neurosurgery and orthopedics, followed by technical and financial perspectives. Valedo, a wearable device aimed to relieve back pain through exercises, motivation and mobility tracking, received the highest ranking for adoption potential, while other devices also received high relative scores. The framework could serve as a supplementary technology assessment tool and could be tested in other settings: private, small clinic etc. with the experts and special needs of physicians in particular healthcare departments.

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Setiawan, Stanley. "Design and Tests of a Biofeedback Based Weight Bearing Rehabilitation Device". Thesis, KTH, Skolan för kemi, bioteknologi och hälsa (CBH), 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-262866.

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As upper-limb rehabilitation devices development continue to grow, lower limb rehabilitation devices have limited development. Thus a device that measures weight bearing of heel and forefoot during gait and also produces auditory feedback at certain thresholds were made in this project. The device was constructed based on an ARM-Core microcontroller and was supported by 5 force sensing resistor sensors for each foot. Communications between the modules and the computer as the GUI were established using an UART interface. For testing, sensors were placed beneath the foot using a stretchable cloth so each different subjects’ pressure points were correctly placed. The biofeedback used for this device was by enabling a buzzer and LED embedded to the designed board that turns on when heel strike or push off reached acertain threshold. Testing were divided into phase one and two. From phase one, it was concluded that both push off and heel strike event can have a reading exceeding 8.5% of the body weight. It was then used as a threshold for the biofeedback event. During the biofeedback tests, improvements in the subjects’ walking pattern and reading were noted. Results suggest that biofeedback can change the behavior of the subject.
I takt med att utvecklingen av rehabilitationsapparater i övre extremiteterna fortsätter att växa, har rehabiliteringsanordningar för nedre extremiteterna begränsad utveckling. Således gjordes en anordning som mäter viktbearbetning av häl och framfot under gång och också ger hörselåterkoppling vid vissa trösklar i detta projekt. Enheten var konstruerad baserad på en ARM-Core mikrokontroller och stöds av 5 kraftsavkännande motståndssensorer för varje fot. Kommunikation mellan modulerna och datorn som GUI upprättades medhjälp av ett UART-gränssnitt. För testning placerades sensorer under foten meden töjbar duk så att varje olika försöks tryckpunkter placerades korrekt. Den biofeedback som användes för den här enheten var genom att aktivera en summer och LED inbäddad i det konstruerade kortet som slås på när hälslaget eller skjutstoppet nådde en viss tröskel. Testningen delades in i fas en och två. Frånfas ett drogs slutsatsen att både push off och hälstreffhändelse kan ha en avläsningsom överstiger 8.5% av kroppsvikt. Den användes sedan som en tröskelför biofeedback-händelsen. Under biofeedback-testen noterades förbättringar i försökspersonernas gångmönster och läsning. Resultaten tyder på att biofeedback kan förändra beteendet hos ämnet.

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Germundsson, Frida, i Nicole Kvist. "MDR 2017/745 - New EU Regulation for Medical Devices: A Process Description for EHR Manufacturers on How to Fulfill the Regulation". Thesis, KTH, Medicinteknik och hälsosystem, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-279137.

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On the 26th of May 2021 the new regulation for medical devices, MDR 2017/745, will come into force. The underlying incentives to go from the medical device directive (MDD 93/42/EEC) to MDR are a series of adverse events involving medical devices. The main goal of MDR is to strengthen and improve the already existing legislation and thus will entail large changes for manufactures, one of them being manufacturers of Electronic Health Record (EHR) systems. For medical software, such as EHR systems, the new regulation will imply an upgrade in risk classification. This upgrade will bring additional requirements for EHR manufacturers. Furthermore, the released guidelines have been insufficient regarding the specific requirements for medical device software and thus EHR manufacturers are in need of tools and guidance to fulfill MDR. This thesis examines the new regulation for medical devices and thus identifies main requirements for EHR manufacturers. A qualitative approach was conducted comprising a literature study as well as a document study of the medical device regulation along with interviews with experts within the field of medtech regulatory affairs and quality assurance. The information gathered was analyzed to create a process description on how EHR manufacturers are to fulfill MDR. The process description is a general outline and presents the main steps on the route to be compliant with MDR in a recommended order of execution. The main steps are: divide the system into modules, qualify the modules, classify the modules, implement a quality management system, compile a technical documentation, compile the declaration of conformity, undergo a conformity assessment and finally, obtain the CE-mark. To each of the main steps additional documentation provides further information and clarification. The process description functions as a useful tool for EHR manufacturers towards regulatory fulfillment. Even though the process description is created for EHR manufacturers, it can be useful for other medical device software manufacturers. The process description provides an overview of the path to a CE mark and functions as a guidance. It can be used in educational purposes as well as to serve as a checklist for the experienced manufacturer to make sure everything is covered. However, it is not sufficient to rely solely on the process description in order to be in full compliance with MDR. Moreover, there is still a need for further clarifications from the European Commission regarding specific requirements on medical device software.

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Pashaei, Vida. "Flexible Body-Conformal Ultrasound Systems for Autonomous Image-Guided Neuromodulation". Case Western Reserve University School of Graduate Studies / OhioLINK, 2021. http://rave.ohiolink.edu/etdc/view?acc_num=case1621006180331273.

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