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1
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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Arredondo, Cecilia. "Imbued Medical Device Design." University of Cincinnati / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926108.
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Lang, Alexandra R. "Medical device design for adolescents." Thesis, University of Nottingham, 2012. http://eprints.nottingham.ac.uk/12501/.
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Adolescents have been identified as users of medical devices who are currently overlooked in the design and development of these products. This research presents a set of studies that investigate the non-clinical user requirements of adolescent medical device users. Interviews with a range of healthcare professionals provided guidance into chronic conditions and devices which are relevant to adolescent populations. Workshops involving healthy adolescents in schools were carried out to elicit adolescent perspectives of current medical device design. The results of this study showed that the range of medical devices presented did not satisfy adolescent user requirements and provided insight into factors which are important to this specific user group. The workshop also identified the acapella® physiotherapy device, used for chest and airway clearance in the treatment of cystic fibrosis, as a suitable case study for further evaluation with real adolescent users. Case study interviews were carried out with adolescents with cystic fibrosis: the users of the acapella®. The interviews identified a range of unmet requirements and expanded on the results from the workshops. In addition to the more general design factors, users of the acapella® highlighted the effect of device use on clinical effectiveness. The data from the workshops and case study interviews was used in a co-design project with an adolescent user of the device. A design specification was interpreted from the data to produce a visual representation of the adolescent requirements. The research has produced two outputs. The first is the development of a prototype tool for eliciting adolescent design priorities for medical devices - The Adolescent Medical Device Assessment Tool (AMDAT) The second deliverable is a set of guidelines which detail the specific requirements and goals of adolescent users of medical devices - Adolescent Medical Device Requirements. This guidance aims to facilitate the consideration of adolescent user requirements in the design and development of new medical devices. The research investigation has contributed new understanding to the fields of human factors and adolescent healthcare. The findings from these studies demonstrate how adolescent populations can be successfully engaged in research tasks. This research investigation has shown that adolescents have specific needs of medical devices and that meeting these needs through user-centred methods may lead to better adherence of use and improved health outcomes.
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Privitera, Mary B. "Collaborative Medical Device Design (cMDD)." Thesis, Loughborough University, 2016. https://dspace.lboro.ac.uk/2134/22524.
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The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights. The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.
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Glenn, J. V. "Propionibacterium acnes and medical device infection." Thesis, Queen's University Belfast, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.273034.
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Shefelbine, Sandra J. "Requirements capture for medical device design." Thesis, University of Cambridge, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.287242.
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Nair, Ganesh R. "Acquisition of medical device start-ups." Thesis, Massachusetts Institute of Technology, 2006. http://hdl.handle.net/1721.1/37978.
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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2006.Includes bibliographical references (leaf [39]).
Introduction: In the medical device space, a large proportion of the breakthrough inventions are developed by small firms that use private equity to bring their technologies from concept to varying stages of development. Medical Device companies spend a large proportion (11.4 % in 2002) of their sales on R&D, second only to Pharmaceutical companies. Smaller companies, in the meanwhile, spent 343 % of their sales in the same year'. [The Lewin Group (AdvaMed), 2004]. Private Equity financing is a critical factor that enables small start-ups to develop new technologies without a viable revenue stream to support the necessary R&D expenditure. In the medical device space, it has been noted that Venture Capital firms (VC's) use high risk capital to invest in early stage companies, and look for "exits" through either an Initial Public Offering (IPO) or through the sale of the start-up to an established firm. Corporations are also involved in varying degrees in early venture investments, through what is sometimes called Corporate Venture Capital (CVC), mainly for strategic reasons. Through CVC investments, some corporations hope, that as an insider, they would be able to judge better whether a particular company is a good target for acquisition. In this paper I review the exits through acquisition, from the perspective of venture backed start-ups, and hypothesize that factors related to the nature of investors, the type of investment, the impact of capital markets and the Intellectual Property of the company are associated with a higher exit valuation.
Ganesh R. Nair.
S.M.
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Bell, Rory Anthony. "Medical device coatings with enhanced functionality." Thesis, Queen's University Belfast, 2015. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.680887.
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Medical devices are an essential part of the human healthcare system. However, one of the major issues associated with their use is the development of medical device related infections (MDRIs) following bacterial colonisation and subsequent biofilm formation on the surface of the device. Different medical device coatings have been designed to help inhibit biofilm development. Antibacterial coatings include those that are contact active, antibacterial drug eluting or those with altered surface energies. The aim of this research was to develop strategies, which can be used to prevent the initial attachment and proliferation of microorganisms on biomaterial surfaces. Multiple linear regression (MLR) analysis was used to investigate the relationship between various drug physicochemical parameters and drug release from different hydrogel networks, which can be used alone or as a coating on medical devices such as urinary catheters. Models generated from this analysis were capable of accurately predicting the time for specific percentage release of drugs not used to derive the original models. An antibacterial quaternary ammonium compound (QAC) with thiol functionality was covalently immobilised on the surface of PVC. This created an anti-infective surface capable of preventing the adherence of two clinically important pathogens. A series of nature inspired slippery liquid infused porous surfaces were fabricated on the surface of PVC using textured silver coatings infused with different ionic liquids. As well as altering the PVC surface energy microbial adherence studies showed these materials were also capable of reducing, or in some cases preventing bacterial attachment and subsequent biofilm formation. The proposed techniques and materials developed in this thesis could be extremely useful in the fight against MDRIs.
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Wolf, Daniel W. (Daniel William). "Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration." Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/58093.
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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2010.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 99-102).
The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July 2009 under Chapter 305 of the Acts of 2008, An Act To Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care. The state law requires pharmaceutical and medical device manufacturers to comply with a marketing code of conduct, obey specific compliance activities, and disclose payments to Massachusetts-licensed healthcare providers with a value of $50 or more in connection with sales and marketing activities. This thesis qualitatively assessed the impact of 105 CMR 970.000 on physician-industry collaboration related to technology development and physician education in the Massachusetts medical device industry, as depicted by academic physicians and representatives of medical device companies during the first quarter of calendar year 2010. A pilot study comprising interviews and surveys of stakeholders in the Massachusetts medical device industry was conducted to summarize the initial impressions of the impact of 105 CMR 970.000 on medical device physician-industry collaboration, with the intention of creating a roadmap for future analysis. Informal interviews (36) included individuals at medical device manufacturers, distributors, academic medical centers, venture capital firms, law firms, consulting firms, MassMedic, and the DPH. Formal surveys (40) included academic physicians and medical device company representatives selling to Massachusetts licensed physicians. The hypothesis was confirmed that 105 CMR 970.000 has impaired medical device physician-industry collaboration related to technology development and physician education in Massachusetts. Our results may have state and federal regulatory implications for the medical device industry and can serve as a guide for future analysis.
by Daniel W. Wolf.
S.M.
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Ward, James R. "Design verification in the medical device industry." Thesis, University of Cambridge, 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.423867.
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Imani, Shabnam, and Elnaz Farzaneh. "Electromagnetic Compatibility Requirements for Medical Device Certification." Thesis, Högskolan i Borås, Akademin för textil, teknik och ekonomi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-13705.
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Until approximately 50 years ago, wireless electronics was confined to military purposes. With the advancement of technology, consumer electronics found widespread applications in almost every aspect of our lives and numerous devices were developed using electromagnetic waves to transfer different types of data. In light of such advancements, the electromagnetic compatibility (EMC) evolved from a military concept to regulate the radio frequency requirements of the battlefield equipment to a mature and essential part in manufacturing and employing electronic devices. Medical devices were no exception and largely benefited from the ease of connectivity and mobility provided by usage of wireless electronics. Due to the sensitive nature of medical devices and extreme consequences of their malfunction, EMC grew to a centric issue in design and production of such devices. This work examines the electromagnetic compatibility of a wearable biomedical measurement system used for the assessment of mental stress of combatants in real time. This system was developed as a part of the ARTEC project and supported by the Spanish Ministry of Defense through the Future Combatant program [1]. We focus on the EMC of the electrocardiogram of the system and aim to identify its EMC requirements of this system while assessing it against various standards and protocols. Throughout this study, we elucidate the fundamentals of electromagnetic compatibility with specific attention to medical devices. Furthermore, we present our results after conducting several EMC tests to measure the compatibility of the electrocardiogram device using the Intertek guidelines. The emission test was performed while essential counter measures such as appropriate shielding and anti-interference filters had been applied.
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Mays, Patricia Faye. "Seal strength models for medical device trays." [College Station, Tex. : Texas A&M University, 2008. http://hdl.handle.net/1969.1/ETD-TAMU-2756.
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Koivukangas, T. (Tapani). "The medical device industry market development analysis." Master's thesis, University of Oulu, 2014. http://urn.fi/URN:NBN:fi:oulu-201406241776.
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The basis and interest for this thesis is the global economic situation of especially the high technology industry. In the traditional fields of high technology and more recently, in the field of ICT, there is a clear transition of work and markets toward the continents with lower development and production costs and those that are in the need of new technologies. This transition has evidently hit the developed countries (i.e. Western Europe and the USA) the hardest.
Even though the other fields of technologies are clearly in transition, the statistics show that the medical device industry is in its highest growth in history. In fact, in 2012 the field grew at a pace of over 25 % annually in Finland and at double digits globally. In Finland, the medical device industry currently accounts for nearly 40 % of the total high technology market exports. This is remarkable to note, as this industry is relatively compact in size in comparison to the other high technologies.
The objective of this research was to define the medical device technologies, to analyze the medical device technology market and, finally, to analyze reasons for its predicted continuous growth. This thesis covers the driving factors of this field of technology that predict the current trend in its market growth. This thesis also covers the aspects of medical devices and the medical device development processes, including the main differentiating factors compared to other fields of high technology products, especially those in the consumer markets. Finally, this study estimates the future economic growth of the medical device industry globally with special reference to Finland.
The economic methods in this research are based on regression analysis of the medical device industry in the BRIC nations (Brazil, India, Russian Federation and P. R. China) and selected OECD countries. The variables used in the research include the trade balance, age structure, medical device technology status and GDP related factors, i.e. GDP in current USD and total health expenditure as percentage of GDP. Technology-wise, the research is based on the global trends in the medical device industry and the growing needs for new medical devices in general.
The results and analyses indicate that the driving factors behind the predicted market growth can be explained by the science-push and demand-pull models. The time series and panel analyses indicate that the medical device industry could also serve as a global market opening technology. Furthermore, the results show that the growth of this industry is highly affected by population growth and age structure that increase the demand for new technologies to prevent and treat illnesses. Also, it was found that the medical device industry is not so greatly affected by global financial disruptions. Finally, the results show that the increase of medical device technologies clearly shortens the length of hospital stay which has been previously found to be a major factor in the rise of healthcare costs especially in the developed countries. This industry is thus evidently both a technology-push and a demand-pull based industry which is expected to grow due to the demand for higher quality healthcare while being less affected by general economic situations.
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Gundimeda, Karthik. "Data logger for medical device coordination framework." Kansas State University, 2011. http://hdl.handle.net/2097/8718.
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Master of ScienceDepartment of Computing and Information Sciences
Daniel A. Andresen
A software application or a hardware device performs well under favorable conditions. Practically there can be many factors which effect the performance and functioning of the system. Scenarios where the system fails or performs better are needed to be determined. Logging is one of the best methodologies to determine such scenarios. Logging can be helpful in determining worst and effective performance. There is always an advantage of levels in logging which gives flexibility in logging different kinds of messages. Determining what messages to be logged is the key of logging. All the important events, state changes, messages are to be logged to know the higher level of progress of the system. Medical Device Coordination Framework (MDCF) deals with device connectivity with MDCF server. In this report, we propose a logging component to the existing MDCF. Logging component for MDCF is inspired from the flight data recorder, “black box”. Black box is a device used to log each and every message passing through the flight‟s system. In this way it is reliable and easy to investigate any failures in the system. We will also be able to simulate the replay of the scenarios. The important state changes in MDCF include device connection, scenario instantiation, initial state of MDCF server, destination creation. Logging in MDCF is implemented by wrapping Log4j logging framework. The interface provided by the logging component is used by MDCF in order to log. This implementation facilitates building more complex logging component for MDCF.
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Carbonneau, André 1952. "Conscientious objectors to a medical treatment - what are the rules?" Thesis, McGill University, 1999. http://digitool.Library.McGill.CA:80/R/?func=dbin-jump-full&object_id=30290.
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Patients who refuse a specific medical treatment for religious reasons must often overcome strongly entrenched presumptions held by physicians and judges, presumptions frequently based on personal values. A case in point is the refusal of blood transfusion therapy by Jehovah's Witnesses.This paper rests on the following theory: The sanctity of life principle is not necessarily violated by respecting the autonomous decision of a patient who, for religious or moral reasons, chooses one therapy over another that may be favored by the treating physician. Where a patient has decided for conscientious reasons against a certain treatment in any given medical situation, the need to be informed will shift from the patient to the physician. The physician must understand the nature of the religious or moral conviction, as well as his own moral and legal obligation to respect the patient's wishes by providing the best medical care under the circumstances.
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Carbonneau, André. "Conscientious objectors to a medical treatment, what are the rules?" Thesis, National Library of Canada = Bibliothèque nationale du Canada, 2000. http://www.collectionscanada.ca/obj/s4/f2/dsk2/ftp03/MQ64266.pdf.
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Medina, Melissa (Melissa M. ). "Modeling regulatory impacts on medical device supply chains." Thesis, Massachusetts Institute of Technology, 2018. http://hdl.handle.net/1721.1/117928.
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Thesis: M. Eng. in Supply Chain Management, Massachusetts Institute of Technology, Supply Chain Management Program, 2018.Cataloged from PDF version of thesis.
Includes bibliographical references (page 27).
Changing regulatory requirements continues to be an increasingly complex issue in the medical device industry. Regulations place stress on regional supply chains across the world. Most recently, the European Parliament issued the Medical Device Regulation (EU) 2017/745 instituting new compliance framework for all devices manufactured, sold, and/or distributed in the European Union. The new framework requires the implementation of unique device identifiers and more stringent conformity assessment procedures. In addition, many device classification types have changed, post-market clinical surveillance has been instituted, and traceability through a centralized IT database is now mandated. While the the act aims to improve patient safety and efficacy across the medical device industry, it poses huge impacts across both the physical and informational flows in supply chains. This research evaluates the regulatory impact across supply chain operations using predictive modeling and machine learning. The model determines how various activities and events in manufacturing and sourcing environments contribute to supply constraints when modified to accommodate new regulatory requirements. The model also determines how product attributes contribute to performance variability. By taking a proactive approach to assess the impacts of regulatory changes, firms can optimize supply chain flows to reduce cost, lead-time, and service level risks.
by Melissa Medina.
M. Eng. in Supply Chain Management
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Ohashi, Kevin Lee. "Mergers and acquisitions in the medical device industry." Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/39576.
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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2007.Includes bibliographical references (leaves 84-85).
Mergers and acquisitions in the Medical Device Industry are the primary mode of exit for early stage companies. The focus of this thesis is to examine factors which influence the value of these M&A transactions from the target and acquiring firm perspectives and to understand the value creation that occurs. Publicly available electronic and published data sources were used to build a database of 674 M&A transactions and 113 IPO events for deals with published deal values and terms between January 1996 and October 2006. In this work, we demonstrate that transaction deal value varies between various medical device industry sectors. Factors that were shown to significantly correlate with M&A transaction deal value included the Sales of the target company, Market Capitalization value of the acquiring company, type of regulatory approval, and whether the company had venture backing prior to acquisition. M&A transactions that involved targets that were Public companies had significantly higher deal values than those that were private. Using 3-day event window analysis, returns of acquiring companies were shown to be slightly negative and significantly less than the S&P composite index returns over the same period.
(cont.) Previous studies suggest that managers in larger firms tend to use overvalued stock and empire building behavior, resulting in overbidding or pay more for acquisitions. No significant difference in deal value was associated with financing terms between cash and stock transactions. The use of earn outs had no effect on the deal value or the acquirer stock returns. Markets that are developing will continue to have increasing deal value as firms attempt to establish market share and or acquire breakthrough technologies. We found that there were positive correlation of M&A or IPO transaction value for companies in less mature markets where companies have opportunities to leap frog other companies in market position and share. Conversely, there is negative correlation of M&A or IPO transaction value for companies in more mature markets. The results are discussed in terms of the specific factors that influence the transaction value and the degree to which target and acquiring firms benefit from M&A transactions.
by Kevin Lee Ohashi.
S.M.
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Johnson, Jonathan. "Managing technology feasibility within the medical device industry." Thesis, University of Cambridge, 2013. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.648198.
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Weflen, Mark R. "Technical Writing Internship at a Medical Device Company." Miami University / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=miami1323638856.
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Sorensen, Daniel David. "Dissimilar Metal Joining in the Medical Device Industry." The Ohio State University, 2017. http://rave.ohiolink.edu/etdc/view?acc_num=osu1494157928729494.
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Siregar, Azhar Fuadi. "Development of Medical Device : A Narrative Literature Review." Thesis, Uppsala universitet, Institutionen för samhällsbyggnad och industriell teknik, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-426920.
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The Stage-gate model has long been used in product development. Alternatives to Stage-gate such as Design Thinking and other models have been developed which are flexible and consider users’ needs early on and thus they could be more suitable for medical device development. This research aims to study and map how medical device development is treated in the existing research literature. This master thesis will focus on product development concerning medical devices. This research aims to conduct a narrative literature review. Data collection here is a set of articles which were collected through a database, which will be used for further analysis concerning how different approaches of models are being utilized in product development, with a specific focus on the healthcare sector. The goal of the literature review was to study what models have been utilized in the development has previously been utilized in the development of medical devices. Other possible alternatives besides conducting a narrative literature review are conducting one or several cases with interviews or surveys with companies. Data collection is limited approximately in the last 15 years (2005 – present), the lookup in the database was based on keywords applied in the research area. The database used for this research is Scopus. Articles chosen were selected also from the Scopus database. The ethical implications based on our findings here are identifying types of product development models that have been utilized by medical companies in the healthcare sector. Based on the review, we can identify several different product development models. Stage-gate and Design Thinking are not the most popular models utilized in the product development process. We classify the models based on elements, the element of the models here are divided into 3 categories which are based on requirements, they are; Regulatory Aspect, Process Workflow Aspect, and Collaboration Aspect. The regulatory aspect mainly concerns administrative affairs and how the system as an entity can control the regulation regarding medical device development. The Process Workflow Aspect, this element is based on a direct approach toward medical device development in terms of phases. The Collaboration aspect, this aspect addresses the stakeholders’ role in policy and decision-making regarding the production of medical devices. Stage-gate and Design Thinking are not the main models utilized in medical device development, other than that, various models are implemented in the healthcare sector, this means other models becoming alternatives and have been utilized and developed in the product development process. Other models besides Stage-gate and Design Thinking are alternatives which do not have significant changes and are just modified forms from the existing ones.
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Hamnede, Elisabet. "A new approach for medical device product documentation." Thesis, Mittuniversitetet, Avdelningen för informationssystem och -teknologi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:miun:diva-31055.
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Hardware and software developers rely on different tools for document management, product data management (PDM) and software configuration management (SCM). As more and more products include components of both types there is a growing demand for one collaborative system. This becomes even more critical in the medical sector, where a device is under regulatory demands for document management to even be allowed in to the market. Combined systems become more complex and are generally based on PDM-principles rather than SCM. Current development of SCM tends instead towards simpler systems focused on pure version control (VCS) that are easy to use and economically available to small- and medium sized enterprises (SME), which is not the case with generic PDM-systems or combined systems. This study explored the possibility to extend the usage of such a VCS and include hardware documentation as well as software. The aim was to further our understanding of the SME perspective on product documentation for the medical device field. The method was a case study, collaboration with a SME development company. The scope was to explore possible usage of a chosen VCS (GitLab) and to compare it with a generic PDM-system and with existing manual system. The results showed that for several of the hardware document types there are special made Git-solutions to find within the open source community. However, none of the ones tested in the study was deemed good enough with respect to functionality and reliability. Instead the case study used direct storage of the files in their binary format and focused on testing different VCS functions and on how to organize in order to best gain the advantages of using the system. The conclusions showed that hardware documents can be stored in the same iterative manner as software but with limited Git functionality. Compared with a PDM system GitLab can offer the same level of revision control and communication around the specifications but lacks classification of parts and detailed product structures. GitLab offers better iteration history than both a PDMsystem and the existing manual system does. But not being able to use full Git functionality the organization needs a collaboration strategy to handle the decentralized storage. If the collaboration strategy matches the organization development practices, GitLab is a useful alternative for medical device documentation.
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Shah, Anila. "User involvement in medical device development : an empirical study." Thesis, Brunel University, 2011. http://bura.brunel.ac.uk/handle/2438/5952.
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Changes in population, medical interventions and new technology opportunities, as well as public and political expectations, are all contributing factors to the pressure facing the healthcare system to change. Healthcare in the UK is beginning to move away from its traditional boundaries, for example hospitals and towards patient empowerment and collaboration. Consequently the target users for medical devices have also changed, with new users and user groups emerging. Further to this user involvement is emphatically becoming a part of healthcare delivery in the UK, recognised for bringing improvement in the quality, acceptance and in turn success of a medical device. The changing target market has given rise to the need to understand the newly created user groups and finding new ways to elicit their requirements has become vital for the success of medical devices. This research intends to draw upon and capture the importance of user requirements research, by investigating the early stages of Medical Device Development (MDD) giving particular attention to the conceptualisation of the user within this process. The research shall assess the possible links between user requirement elements, to benefit the healthcare system and investigate how user requirements methodologies that have been proven in other fields can be successfully deployed in the medical device development lifecycle. User requirements methodologies identified within the disciplines of information technology, ergonomics, psychology and design theories relating to medical device design, will be collectively assessed for their capacity to collaborate. The research methodology began with undertaking a systematic review of the literature, which facilitated the construction of a single theoretical conceptual framework of user involvement in medical device development, representative of a superior model of user requirements capture. To validate this framework empirical research followed. This was divided into exploratory, explanatory and interpretive data collection phases, with a view to extract; what the current process of MDD is in industry, why and how users are currently deployed in MDD, and the users perceived experience of involvement. The exploratory study showed that manufacturers were aware of their users and extracting the user requirements effectively was seen as the main competitive differentiator. However, manufacturers were not always aware of the best methods to capture user needs, especially with business objectives and obligatory requirements repeatedly taking precedence over optional user involvement methods. The explanatory study showed that not every department has an equal role to play in terms of user involvement in terms of methods to elicit requirements. However there was consensus across the departments to acknowledge their customers and their feedback to ensure they feel valued. Further to this communicating information to potential new devices users was carried out well in advance of the product coming to market. The customer focus was something not only addressed in the design of the device, but the service that followed. The interpretive study emphasised the importance of understanding the user’s needs and to understand that these needs do change over time. Educating users on disease and self-management was considered important, but realisation by patient user of their responsibility was vital in the successful use of a medical device. The original contributions of this study include its endeavour in taking a multidisciplinary approach to account for users and user involvement methods, and apply to specifically the early stages of the medical device development process. The research developed naturally to transcend and collaborate between these theories, as well as represent various voices within the research to really emphasise the multidisciplinary and multi-user approach it took. This research made a further innovative contribution by developing a framework to the problem of inadequate user involvement in the medical device development process. This could prove very beneficial for medical device manufacturers considering user involvement may become a regulatory requirement, meaning all medical device manufacturers would need to incorporate and document user involvement by law.
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BERGQVIST, KARL-FREDRIK, and TÖRBERG SOFIA WERNQUIS. "Developing a guide to regulations forthe Medical Device Industry." Thesis, KTH, Maskinkonstruktion (Inst.), 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-146630.
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All Medical devices are required to go through regulatory processes before they can be put onthe market. The regulatory processes differ depending on what market is the aim. To releasemedical devices within the European Economic Area (EEA) the devices need to have a CEmarking affixed. To release within the United States approval or clearance from the FederalFood and Drug Administration (FDA) is needed. Regulations and requirements for both thesemarkets differ depending on device types and risks that may be associated with the device.The biggest problem with regulations is the big amount of information and how it is presented.The regulatory processes are based on a vast number of regulations and requirements, manytimes with cross references that lead to confusion. Especially for smaller companies, where nospecific person is assigned to these types of tasks, the processes can be overwhelming and createaversion. Gathering information regarding the regulations and the approval process of a specificproduct type is hard and can be very time consuming.The Sister Kenny Research Center (SKRC) has a new medical device ready forcommercialization, meaning it needs to go through the regulatory processes. The SKRC haveever gone through any regulatory process before, which creates problems since the processes arecomplex. They experience problems due to lack of knowledge and understanding of theregulatory processes, as well as finding and interpreting information.The purpose for this thesis is to create understanding of the current problems in working with theregulatory processes for the American and the European market, and to create a way to help theSKRC go through these processes. The questions interesting in this thesis are: How doregulations pose a problem for release of medical devices, for small companies? How can thisproblem be aided?To assist the SKRC a guidebook to the regulatory processes has been created. The guidebook hasbeen viewed as a product, and to develop it different product development tools and techniqueshave been used. The guidebook gives an overall understanding of the regulatory processes,instructions on tasks and references to where more information can be found. Presenting thedifferent regulations in an understandable way in the guidebook will make the regulatoryprocesses more graspable and help the SKRC release their devices to market.All medicinteknisk utrustning behöver gå igenom regulatoriska processer innan de får lanseraspå marknaden. De regulatoriska processerna varierar beroende på vilken marknad produktenskall släppas på. När man lanserar inom europeiska ekonomiska samarbetsområdet (EES) måsteprodukten bära en CE-märkning. För lansering I USA måste produkten godkännas av the FederalFood and Drug Administration (FDA). Regleringarna och kraven för dessa marknader skiljer sigdessutom beroende på typ av produkt samt vilka risker som är associerade med produkten.Det största problemet med de regulatoriska processerna är den omfattande mängden informationsom finns tillhanda och hur den presenteras. Processerna baseras på flertalet regler och krav medinterna referenser som leder till förvirring. För små företag, där det oftast inte finns en specifikperson anställd för att hantera dessa ärenden, upplevs detta ofta väldigt överväldigande. Attsamla in all information om de regulatoriska processerna för en specifik produkt kan vara väldigtsvårt och tidskrävande.Sister Kenny Research Center (SKRC) har en ny medicinteknisk produkt som är redokommersialisering och behöver därför gå igenom dessa processer. SKRC har inte gåttprocesserna tidigare vilket skapar problem då erfarenhet inom det regulatoriska området och dessprocesser saknas.Syftet med detta arbete är att skapa en bättre förståelse för de befintliga problemen medregleringsprocesserna för både den den amerikanska och den europeiska marknaden. Syftet äräven att skapa ett hjälpmedel för SKRC att ta sig igenom processen. De frågeställningarna somär intressanta för detta projekt är: på vilket sätt är de regulatoriska processerna ett problem vidlansering av medicinteknisk utrustning för små företag? Hur kan detta problem underlättas?För att hjälpa SKRC så har en guidebok om de regulatoriska processerna skapats. Dennaguidebok har tagits fram med hjälp av olika produktframtagningsverktyg och metoder.Guideboken ger en övergripande insikt i processerna, instruktioner för olika delsteg ochreferenser till var läsaren kan hitta mer information inom området. Att informationen härpresenteras på ett förståligt sätt gör att den blir lättare att hantera och hjälper SKRC att få ut sinprodukt på marknaden.
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Kinley, Chad A. "Healthcare Technology: A Strategic Approach to Medical Device Management." Digital Commons @ East Tennessee State University, 2012. https://dc.etsu.edu/etd/1434.
Full textAbstract:
The constant evolution of medical technology has increased the demand for managing medical devices to ensure safety and effectiveness. In this paper I will investigate how biomedical engineering has addressed the issue of equipment management and identifies strategies to successfully maintain an inventory of medical devices. Through research, on-the-job experience, and in-depth discussions with various biomedical engineering managers, I have been able to document possible equipment strategies and best practices for managing medical devices. There is really no "one size fits all" to medical equipment management due to the various clinical environments, but there are many aspects that remain necessary to ensure proper equipment safety and function while meeting or exceeding various regulatory requirements.
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Bai, Xinye, and Yaniv Rosenberg. "Improving supply chain agility of a medical device Manufacturer." Thesis, Massachusetts Institute of Technology, 2015. http://hdl.handle.net/1721.1/99802.
Full textAbstract:
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.
Full textAbstract:
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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Berlin, David B. (David Benjamin). "Characteristics of disruptive innovation within the medical device industry." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/68462.
Full textAbstract:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 59-61).
Innovation within the medical device industry had led to tremendous advances in the provision of care for patients worldwide. Continued progress in the treatment of disease will require effective processes for managing and analyzing innovation within this industry. Popular models of innovation exist for many industries outside of the medical realm; however, an extensive literature search uncovered a limited body of work related to innovation within the medical device industry. Specifically, literature that examines the application of the principles of disruptive innovation to the medical device industry is limited in scope and in quantity. It is theorized that the medical device industry may have unique characteristics for disruptive innovation due to the unique economic and regulatory structures that exist within this industry. This thesis applies the principles of disruptive innovation that were popularized by Clayton Christenson's seminal work, "The Innovator's Dilemma", to the medical device industry. These characteristics are subsequently delineated and evaluated through examination of the prosthetic cardiac valve industry. This industry serves as an effective case study due to the long history of innovation and the emergence of new disruptive technology within this specialty. The categorization of a "disruptive" innovation was made when a given technology altered the value proposition for treating a disease, relative to incumbent technology. This case study was evaluated along metrics of performance characteristics, the perception of leading customers, the ability to prospectively analyze markets, and the profitability of disruptive innovation for the incumbent firm. Conclusions were reached based on an examination of relevant literature and primary research conducted with thought leaders in this area. This research supports the conclusion that the cardiac valve industry has experienced unique characteristics in the development and commercialization of disruptive innovations. Specifically, incentives appear to exist within this industry that support development and commercialization of disruptive innovations by industry incumbents. Furthermore, the importance of understanding what value proposition is being disrupted is paramount in effectively understanding the incentives of manufacturers to innovate. When a technology is developed that is disruptive to a procedure, then the manufacturer tends to behave similar to a "newentrant" within the Christenson framework. This appears to also be true when the innovation is disruptive to that manufacturer's legacy products. Additional research is warranted in extrapolating this finding to the broader medical device industry.
by David B. Berlin.
S.M.
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Haidar, Samer S. M. Massachusetts Institute of Technology. "Supply chain network strategy for consumer medical device introduction." Thesis, Massachusetts Institute of Technology, 2016. http://hdl.handle.net/1721.1/104310.
Full textAbstract:
Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2016. In conjunction with the Leaders for Global Operations Program at MIT.Thesis: S.M. in Engineering Systems, Massachusetts Institute of Technology, Department of Mechanical Engineering, 2016. In conjunction with the Leaders for Global Operations Program at MIT.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 97-99).
This thesis presents an optimization framework to model the trade-offs in strategic supply chain decision-making for a new product introduction in a real-world setting. The focus of the thesis is on a consumer medical device that Johnson & Johnson's Calibra business will launch in the future. As with any new product introduction, the launch exposes the J&J business to risk and uncertainty. We develop a mixed-integer optimization model to guide the optimal design of a global consumer medical device supply chain network comprising component suppliers, assembly facilities, sterilizers, and distribution centers. The model evaluates strategic decisions over a seven-year time horizon related to the location and capacities of various supply chain facilities and partners, transportation costs, and strategic inventory required to satisfy global demand. We developed a stochastic optimization extension of the model to protect the supply chain decision maker from demand uncertainty. Comparison of the output of the model assuming deterministic demand to a managerial heuristic resulted in total supply chain network cost reductions of 19% - 27%, amounting to hundreds of millions in present-value dollars. The stochastic optimization solution reduces infeasibility related to either not meeting the demand or transportation lead time constraints. The two models presented in this thesis enable J&J supply chain decision makers to gauge the additional costs and benefits of different network design concepts, develop a network strategy that can adapt to uncertain demand, and create a strong strategic foundation for future tactical and operational decisions.
by Samer Haidar.
M.B.A.
S.M. in Engineering Systems
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Wernquist, Örberg Sofia, and Karl-Fredrik Bergqvist. "Developing a guide to regulations forthe Medical Device Industry." Thesis, KTH, Industriell produktion, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-142032.
Full textAbstract:
All Medical devices are required to go through regulatory processes before they can be put on the market. The regulatory processes differ depending on what market is the aim. To release medical devices within the European Economic Area (EEA) the devices need to have a CE marking affixed. To release within the United States approval or clearance from the Federal Food and Drug Administration (FDA) is needed. Regulations and requirements for both these markets differ depending on device types and risks that may be associated with the device. The biggest problem with regulations is the big amount of information and how it is presented. The regulatory processes are based on a vast number of regulations and requirements, many times with cross references that lead to confusion. Especially for smaller companies, where nospecific person is assigned to these types of tasks, the processes can be overwhelming and create aversion. Gathering information regarding the regulations and the approval process of a specificproduct type is hard and can be very time consuming. The Sister Kenny Research Center (SKRC) has a new medical device ready for commercialization, meaning it needs to go through the regulatory processes. The SKRC have ever gone through any regulatory process before, which creates problems since the processes are complex. They experience problems due to lack of knowledge and understanding of the regulatory processes, as well as finding and interpreting information.The purpose for this thesis is to create understanding of the current problems in working with the regulatory processes for the American and the European market, and to create a way to help the SKRC go through these processes. The questions interesting in this thesis are: How do regulations pose a problem for release of medical devices, for small companies? How can this problem be aided? To assist the SKRC a guidebook to the regulatory processes has been created. The guidebook has been viewed as a product, and to develop it different product development tools and techniques have been used. The guidebook gives an overall understanding of the regulatory processes, instructions on tasks and references to where more information can be found. Presenting the different regulations in an understandable way in the guidebook will make the regulatory processes more graspable and help the SKRC release their devices to market.All medicinteknisk utrustning behöver gå igenom regulatoriska processer innan de får lanseras på marknaden. De regulatoriska processerna varierar beroende på vilken marknad produkten skall släppas på. När man lanserar inom europeiska ekonomiska samarbetsområdet (EES) måste produkten bära en CE-märkning. För lansering I USA måste produkten godkännas av the Federal Food and Drug Administration (FDA). Regleringarna och kraven för dessa marknader skiljer sig dessutom beroende på typ av produkt samt vilka risker som är associerade med produkten. Det största problemet med de regulatoriska processerna är den omfattande mängden information som finns tillhanda och hur den presenteras. Processerna baseras på flertalet regler och krav med interna referenser som leder till förvirring. För små företag, där det oftast inte finns en specifik person anställd för att hantera dessa ärenden, upplevs detta ofta väldigt överväldigande. Att samla in all information om de regulatoriska processerna för en specifik produkt kan vara väldigt svårt och tidskrävande. Sister Kenny Research Center (SKRC) har en ny medicinteknisk produkt som är redo kommersialisering och behöver därför gå igenom dessa processer. SKRC har inte gått processerna tidigare vilket skapar problem då erfarenhet inom det regulatoriska området och dess processer saknas. Syftet med detta arbete är att skapa en bättre förståelse för de befintliga problemen med regleringsprocesserna för både den den amerikanska och den europeiska marknaden. Syftet är även att skapa ett hjälpmedel för SKRC att ta sig igenom processen. De frågeställningarna som är intressanta för detta projekt är: på vilket sätt är de regulatoriska processerna ett problem vid lansering av medicinteknisk utrustning för små företag? Hur kan detta problem underlättas? För att hjälpa SKRC så har en guidebok om de regulatoriska processerna skapats. Denna guidebok har tagits fram med hjälp av olika produktframtagningsverktyg och metoder. Guideboken ger en övergripande insikt i processerna, instruktioner för olika delsteg och referenser till var läsaren kan hitta mer information inom området. Att informationen här presenteras på ett förståligt sätt gör att den blir lättare att hantera och hjälper SKRC att få ut sin produkt på marknaden.
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Dunn, Taylor B. "Development of an Improved Medical Transport Device: Stair Chair." Miami University Honors Theses / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=muhonors1303407927.
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Smith, Adam J. "Development of an Improved Medical Transport Device: Stair Chair." Miami University Honors Theses / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=muhonors1303485663.
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Machwirth, Mattias. "A Haptic Device Interface for Medical Simulations using OpenCL." Thesis, Örebro universitet, Institutionen för naturvetenskap och teknik, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-29980.
Full textAbstract:
The project evaluates how well a haptic device can be used to interact with a visualization of volumetric data. Since the interface to the haptic device require explicit surface descriptions, triangles had to be constructed from the volumetric data. The algorithm used to extract these triangles is marching cubes. The triangles produced by marching cubes are then transmitted to the haptic device to enable the force feedback. Marching cubes was suitable for parallelization and it was executed using OpenCL. Graphs in the report shows how this parallelization ran almost 70 times faster than the sequential CPU counterpart of the same algorithm. Further development of the project would give medical students the opportunity to practice difficult procedures on a simulation instead of a real patient. This would give a realistic and accurate simulation to practice on.Projektet går ut på att utvärdera hur väl en haptisk utrustning går att använda för att interagera med en visualisering av volumetrisk data. Eftersom haptikutrustningen krävde explicit beskrivna ytor, krävdes först en triangelgenerering utifrån den volymetriska datan. Algoritmen som används till detta är marching cubes. Trianglarna som producerades med hjälp av marching cubes skickas sedan vidare till den haptiska utrustningen för att kunna få gensvar i form av krafter för att utnyttja sig av känsel och inte bara syn. Eftersom marching cubes lämpas för en parallelisering användes OpenCL för att snabba upp algoritmen. Grafer i projektet visar hur denna algoritm exekveras upp emot 70 gånger snabbare när algoritmen körs som en kernel i OpenCL istället för ekvensiellt på CPUn. Tanken är att när vidareutveckling av projektet har gjorts i god mån, kan detta användas av läkarstuderande där övning av svåra snitt kan ske i en verklighetstrogen simulering innan samma ingrepp utförs på en individ.
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Jersenius, Ylva, and Erika Möller. "A medical device for spinal motion restriction : Development of a device for safe and efficient patient handling." Thesis, Luleå tekniska universitet, Institutionen för ekonomi, teknik och samhälle, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:ltu:diva-80042.
Full textAbstract:
Prehospital emergency care is facing a paradigm shift. Spinal motion restriction (SMR) is a way to treat trauma patients with symptoms of spinal injury. It was earlier entitled as ‘routine SMR’, and included spine board and cervical collar. During the 2000s, it has been noted that there is a lack of scientific evidence that proves the benefits with ‘routine SMR’. This led an expert group to the development of the national guidelines, that were published in 2019. The national guidelines can be described as ‘selective SMR’, where the cervical collar and spine board is excluded. It means that the SMR shall be adapted to the patient and not the equipment. Furthermore, the patient should be involved as much as possible in the treatment. This master thesis has been conducted at the Luleå University of Technology (LTU), in collaboration with AB Germa. The objective was to enable paramedics (the users in this project) to provide trauma patients with safe and efficient SMR by improving the usability of available or future products for SMR. Therefore, the project aim was to deliver a conceptual suggestion with feedback from the users. Furthermore, a mapping with experienced problems was delivered, and a review of the available medical devices with recommendations on how the future product development of medical devices for SMR could head in a user-centred direction. The theoretical framework included both ergonomics, including anthropometry and anatomy, and semiotics to involve both the physical and cognitive aspects of good usability, as a complement to the contextual immersion to be able to develop a thought through conceptual suggestion. The contextual immersion involved contact with Sweden’s 21 regions, and 16 paramedics. Through visits, interviews, and observations information was gathered about available medical devices for SMR, and challenges that paramedics are facing with them where mapped. This was compiled in a user need specification, which formed the basis for the idea generation. The ideation resulted in over 200 ideas. Iterative feedback sessions together with the users generated five concepts, that by further feedback, and iterative work converged into one final concept. The project delivers a vest with vacuum technology that enables paramedics to perform safe and efficient SMR of trauma patients with various anatomy. The concept has the flexibility of a KED and the adaptability of a vacuum mattress. It enables ’selective SMR’ in confined spaces, and facilitates the patient to be more involved in the treatment. The project has generated insights about ’selective SMR’, and the meaning of it for future product development. Generally, we are moving towards medical devices for SMR that does not restrict movement as strictly as before. Many products in ambulance care have not been updated for a long time, and there is no doubt that there is a need for it.Inom prehospital akutsjukvård pågår just nu ett paradigmskifte. Spinal rörelsebegränsning (SRB) är ett sätt att vårda patienter som varit utsatta för trauma och som uppvisar symtom på spinal skada. Det benämndes till en början som ’rutinmässig SRB’ och inkluderade användning av spineboard och nackkrage. Under 2000-talet visade det sig finnas en avsaknad av vetenskapliga bevis som talade för fördelarna med ’rutinmässig SRB’, vilket ledde till att nackkrage och spineboard exkluderades. Det här föranledde en expertgrupp att ta fram nya nationella riktlinjer som publicerades 2019. De nationella riktlinjerna kan beskrivas som ’selektiv SRB’, vilket handlar om att SRB ska anpassas utifrån patientens tillstånd och inte efter utrustningen. Patienten ska även involveras så mycket som möjligt i omhändertagandet. Det här examensarbetet har utförts vid Luleå Tekniska Universitet (LTU), tillsammans med AB Germa. Syftet var att underlätta för ambulanssjukvårdare (användarna i det här projektet) att utföra säker och effektiv SRB på traumapatienter, genom att förbättra användbarheten hos befintliga eller framtida produkter för SRB. Målet var därför att leverera ett konceptuellt förslag med feedback från användarna. Utöver detta skulle en kartläggning av dagens utrustning och problem med dessa undersökas, med rekommendationer om hur den framtida utvecklingen kan gå mot en mer användarcentrerad riktning. För att få med de fysiska såväl som de kognitiva aspekterna av en god användbarhet så inkluderades både ergonomi, inkluderande antropometri och anatomi, samt semiotik i den teoretiska referensramen. Det här användes som ett komplement till den kontextuella undersökningen för att försäkra sig om att det framtagna konceptet var väl genomtänkt. Den kontextuella undersökningen inkluderade kontakt med Sveriges 21 regioner och 16 ambulanssjukvårdare. Genom besök, intervjuer och observationer samlades information om dagens utrustning för SRB, som utgjorde underlag för en kartläggning av de upplevda problemen. Allt sammanställdes som användarbehov i en lista. Det här kom att ligga till grund för den kommande idégenereingen, som resulterade i över 200 idéer. Iterativa feedbacksessioner tillsammans med användarna resulterade i fem koncept, som genom ännu mer feedback och iterativt arbete resulterade i ett slutgiltigt koncept. Projektet levererar en väst med vakuumteknologi som möjliggör för användarna att utföra säker och effektiv SRB på traumapatienter med varierande anatomi. Konceptet har smidigheten av en KED och följsamheten av en vakuummadrass. Den möjliggör ’selektiv SRB’ i trånga utrymmen och underlättar för patienten att vara deltagande i omhändertagandet. Projektet har också levererat insikter om vad ’selektiv SRB’ kan innebära för framtida produktutveckling. Det har visat sig att trenden går mot att utrustningen inte ska rörelsebegränsa lika mycket som den gjort tidigare. Många produkter inom ambulansen har inte uppdaterats på länge och det finns inga tvivel om att det finns ett behov för detta.
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Sederholm, Thomas. "Measuring Lymphedema Symptoms : Continuing the Development of a Medical Device." Thesis, KTH, Maskinkonstruktion (Inst.), 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-99286.
Full textAbstract:
Denna rapport beskriver utvecklandet av ett medicinsktekniskt prototypverktyg för mätning av omkrets- och hårdhets-förändringar i armar och ben, för diagnostisering av lymfödem. Lymfödem är en bieffekt vid cancerbehandling som blir vanligare i och med att cancerbehandling blir allt mer effektiv. Lymfödem visar sig vanligtvis som svullnad av armar eller ben som kan bli bestående om den inte behandlas. Genom att följa omkretsen i armar och ben hos patienter som har strålbehandlats eller opererats för cancer kan en terapeut upptäcka tendenser till svullnad tidigt för att inleda behandling i god tid. Detta projekt baseras på ett tidigare projekt där ett verktyg för omkretsmätning tagits fram. Det är ett handhållet verktyg som matar en ring av måttband in och ut och sparar dess mått digitalt. Verktyget är tänkt att ersätta den nuvarande, manuella mätmetoden där måtten skrivs ner för hand och senare matas in i en dator. Fördelen med verktyget är att det ger en snabbare och mer pålitligt mätning. Resultatet från den manuella metoden kan variera mellan terapeuter medan verktyget är konsekvent i sina mått. En annan viktig del av diagnosen är palpering/känsel efter stelhet i patientens hud. Denna rapport beskriver också utvecklandet av en metod för att kvantifiera hudhårdhet i mänsklig vävnad på ett objektivt sätt – något som idag inte existerar. Genom att integrera styvhetsmåttet i mätverktyget kan diagnosprocessen göras mer tillförlitlig och effektiv. För att vara säker på att inte smittor sprids mellan patienter måste verktyget ha en ren gränsyta emot patienterna. För att möta detta krav har en engångsdel utvecklas som innehåller alla delar som kommer i kontakt med patienten och kan kastas efter bruk. Resultatet av projektet är ett mätverktyg som kan mäta omkrets med ett konfidensintervall på ± 3 mm. Samtidigt som omkretsmätningen utförs mäts också hudstyvheten genom att mäta hudens kompressabilitet. De viktiga egenskaper som uppnåtts hos styvhetsvärdet är förmågan att detektera skillnad i styvhet i olika material av samma omkrets samtidigt som värdet är oförändrat när samma material varierar i omkrets. Mätverktyget sparar minst 30 – 50 % av den tid som går åt till mätning. Verktyget minimerar också påverkan av den mänskliga faktorn under mätprocessen. 1This report describes project of developing of a medical device prototype for measuring changes in circumference and hardness in limbs, for diagnosing patients for lymphedema. Lymphedema is a side-effect of cancer treatment and it is becoming more common as cancer treatment is becoming more effective. Lymphedema presents itself as a swelling of the limbs, usually arms and legs, the swelling may become irreversible if left untreated. By tracking the circumference of the limbs of patients who have had cancer surgery or radiation treatment, therapists want to detect tendencies for swelling as soon as possible to be able to administer treatment as soon as possible. This project is based on a previous project; the development of a device for tracking the circumference of the limbs of patients. The device is a handheld tool which feeds a loop of tape measure in and out, storing its measurements digitally. It is intended to replace the current, manual measuring technique where measurements are written down by hand and later fed into a PC. The benefit of a device is that it is faster and more reliable. The manual measuring technique may differ from one therapist to the next, while the device is consistent in its measurements. Another important part of the diagnosis is palpating/feeling an approaching stiffening of the patient’s skin. This report also describes the development of a method for objectively quantifying the stiffness of human tissue – something that currently does not exist. By incorporating this into the device the process of diagnosing patients becomes more reliable. To make sure that contaminants are not transferred between patients the device needs to have a clean interface toward patients. To cater to this, a disposable part, containing all parts that come into contact with the patient, is developed too. The result is a device that can measure circumference with a confidence interval of ± 3 mm. As it measures the circumference it simultaneously assesses the stiffness of the skin by measuring its compressibility. The important properties achieved for the stiffness value are that the value will change for different materials of the same circumference while it remains the same for a specific material as it differs in circumference. The device will save at least 30 – 50 % of time spend measuring. It also reduces the influence of human error in the measuring process greatly. 3
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Zhang, Weifan. "The medical device market and its industrial evolution in China." Thesis, University of Sussex, 2016. http://sro.sussex.ac.uk/id/eprint/65893/.
Full textAbstract:
China has attracted increasing amounts of foreign investment since it opened its doors to the world and whilst many researchers have focused on foreign investment in popular areas, little has been written about medical device market. The medical device market is one of the most profitable areas in the global economy. With the development of China's economy, the Chinese medical device market is experiencing significant growth, and has become the second largest market in the world. The research in this thesis extracted foreign direct investment theory and summarized the current situation of the global medical device market and the Chinese medical device market. Analysis of the status of the Chinese medical device market from the perspective of the healthcare industry and its important market drivers, reveals that the medical device market has significant growth potential. The research methods such as: regression analysis; location quotient, which revealed the Chinese medical device market status, provides suggestions for investors who are interested in entering the Chinese market. Investors or companies who want to enter the Chinese market need to understand the regulatory environment, comparison of the medical device regulations with the US and EU regulations provide investors with a clear understanding of the Chinese medical device regulatory regime. The research in this thesis contributes to medical device market investment and regional economy in medical device industry, and make a clear statement of the changing medical device regulations in China, which came into force on 2014. The contribution of this thesis, bridges the research gap between investment theory and medical device market development.
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Gautreau, Leigh (Leigh Ann). "Green manufacturing in the medical device industry : a case study." Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/55209.
Full textAbstract:
Thesis (S.M.)--Massachusetts Institute of Technology, System Design and Management Program, 2009.Cataloged from PDF version of thesis.
Includes bibliographical references.
Introduction: Med Dev (name changed to protect confidentiality), is a medical device start-up using tissue engineering and drug delivery techniques to help combat the negative effects associated with secondary injury. Med Dev's first generation technology is a polymer scaffold that will be inserted into the injury site immediately post injury during a routine procedure. The scaffold prevents secondary injury (bruising and scarring) formation by filling the void space left by the injury, promoting cell growth over deleterious apoptosis (cell death), and slowly degrading away over the course of approximately one month. Med Dev's second generation technology is a photopolymerizable hydrogel which would function identically to the first generation, except that it would be injected into the injury rather than surgically inserted. Med Dev's first and second generation technologies, differ not only in their method of administration, but also in their manufacture. Commercially available polymers are mechanically processed for scaffold manufacture, whereas Med Dev must synthesize their own polymers for hydrogel manufacture. Polymer synthesis requires vast quantities of often toxic solvents to solubilize and later extract the polymer. In the first generation technology toxic solvent responsibilities lie with Med Dev's suppliers, whereas in the second generation technology Med Dev is directly responsible for their toxic solvents use. This is not to say Med Dev should not be aware of their supplier's use of toxic solvents when they are producing polymers for Med Dev's end-use, but rather to point out that Med Dev is more directly responsible for toxic solvent use when they produce their own polymers. In January, as Med Dev's director of operations I applied for a grant which required that I detail how Med Dev intended to build a green manufacturing facility. Understanding all the toxic solvents involved in a polymer synthesis, I thought while building a green manufacturing facility was a positive step toward becoming more environmentally sustainable, why stop there, why not incorporate green thinking into polymer synthesis process design. A thesis was born. The US EPA defines green chemistry as: "...the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. Green chemistry applies across the life cycle, including the design, manufacture, and use of a chemical product." ' Green chemistry is essentially a pollution prevention methodology, resulting in resource conservation, waste reduction, and enhanced product safety. Companies are beginning to realize that pursuing green chemistry is not only good for the environment, but also for their bottom line; they are becoming increasingly aware that continued competitiveness in the allied chemicals industry actually requires the implementation of green chemistry principles. Paul Anastas and John Warner published what have become the central tenets of green chemistry in their 1998 book entitled "Green Chemistry: Theory and Practice."
by Leigh Gautreau.
S.M.
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Song, Qingyang S. M. Massachusetts Institute of Technology. "A system theoretic approach to design safety into medical device." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76510.
Full textAbstract:
Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed.
by Qingyang Song.
S.M.in Engineering and Management
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Koert, Andrew J. (Andrew James). "Factors influencing FDA clearance time for medical device 510(k)." Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/62522.
Full textAbstract:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2010.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 173-174).
Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review times have varied dramatically for devices seeking clearance through the 510(k) pathway; devices that are by definition "substantially equivalent" to other devices previously cleared by the FDA and currently on the market. The goal of this thesis is to investigate the factors that impact the ability for a company to obtain a 510(k) clearance in a predictable timeframe and assess the most important factors that influence time to clearance. The Medical Device industry is a dynamic and rapidly evolving sector that presents complex challenges to regulatory oversight. The 510(k) program and larger device regulatory process has endured the test of time and is well structured to address these challenges. This research focuses on the 7,481 510(k) "substantially equivalent" clearances during the period from October 1, 2007 through June 30, 2010 (FY08 - Q3FY10) in order to analyze the variables that impact clearance times. By testing various hypotheses about the most important factors I aim to provide the device community with the data and suggestions for improving confidence around a particular 510(k) submission's likely approval time. I performed subset analyses on the dataset, segmenting clearances by the type of 510(k) (traditional, abbreviated, and special), clinical category, fiscal year of clearance, use of 3rd party review, submission volume, and product diversity according to clinical category. The results show a distinct increase in clearance time from FY08 to FY10 and suggest that recent scrutiny of the FDA premarket review process may be affecting the efficiency of the Agency FDA review process for medical devices. Further, the 3rd party review program is under-utilized with only 14%, on average, of eligible devices gaining clearance through this process. Through a discussion of two specific critiques of the 510(k) process, namely a recent Government Accountability Office study and an article by the Public Citizen (a public advocacy group), the potential implications of regulatory reform is explored from both a policy and industry perspective.
by Andrew J Koert.
S.M.
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Jafarbigloo, Azita. "Optimization and Simulation of the Medical Device Sterilization in Hospitals." Thesis, Université d'Ottawa / University of Ottawa, 2021. http://hdl.handle.net/10393/42415.
Full textAbstract:
There is no doubt Medical Devices have a crucial role in hospital processes such as surgeries and therapeutic procedures. Medical devices available in hospitals are of two types; reusable and non-resalable medical devices. Reusable medical devices are washed and sterilized after each use. The process of sterilizing medical devices is performed in the sterilization department. Each medical device travels through a cycle each time it is utilized. It is explicit that any part of the sterilization cycle that delays the process can cause serious problems for hospitals’ performance. The washing step of the sterilization process has been a bottleneck in the system. Thus, optimization approaches can be highly advantageous to improve this bottleneck. The data of the medical devices are usually unknown prior to the scheduling process since the finishing time of the surgeries are not known in advance. Thus, there is no information available on the ready time of medical devices to be sterilized. Due to this factor, to develop applicable solutions, it is critical to consider this problem as an online problem and develop online scheduling methods. In this thesis, we take advantage of mathematical programming and heuristic algorithms to solve both the offline and online settings of the problem. We model the washing step of the sterilization cycle as a scheduling problem. Batch scheduling and bin packing, two well-known optimization approaches, are used for this purpose. Medical devices are batched together first and then scheduled on machines to reduce the total washing time of all medical devices. First, a mathematical model for the offline problem is provided and tested to solve the problem. Then a series of heuristic algorithms are developed using the batch scheduling approach for solving both offline and online problems. Moreover, a special case with divisible job sizes and equal release dates is studied. It was proved that for the strongly divisible sequence the First Fit Increasing algorithm finds the optimal solution, also for the weakly divisible sequence a Dynamic Programming algorithm is developed. Finally, we couple optimization with simulation to test the impact of the optimization of the washing step on the entire sterilization system. Moreover, since the next step of the sterilization cycle, the sterilization step, is very similar to the washing step, we also implement the developed heuristics in this step to evaluate its performance and improve it further. The results show that as long as the washing step is optimized it does not differ which algorithm is used in the sterilization step, thus, the optimization of this step is not necessary.
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Kehne, Emily Templin. "Application of risk management frameworks to medical device production development." Thesis, Massachusetts Institute of Technology, 2019. https://hdl.handle.net/1721.1/122574.
Full textAbstract:
Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2019, In conjunction with the Leaders for Global Operations Program at MITThesis: S.M., Massachusetts Institute of Technology, Department of Mechanical Engineering, 2019, In conjunction with the Leaders for Global Operations Program at MIT
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 93-94).
Effective risk management is critical when manufacturing medical products to avoid any potential impact to patients due to supply disruptions or quality excursions. As Flex LTD, an end-to-end manufacturing solutions provider, continues to grow its medical device portfolio, they have a need to take a more proactive and systematic approach to managing project risks. This research applies several project risk management frameworks and interventions to one of Flex's medical device programs as a pilot study. First the current state of existing risk management practices is evaluated. The frameworks and interventions are then implemented over a period of 6 months and their effectiveness analyzed at the end of the study. The results found that the interventions and frameworks applied during the pilot study improved overall understanding of fundamental risk management concepts.
It also showed that key activities, such as training workshops and the intervention of a risk management "champion" impacted risk tracking activities and were effective for overcoming adoption barriers. In applying the Risk Driver framework to the data generated during the pilot study, it was determined that identifying commonalities and trends across risk drivers can be used to proactively inform risk management decision-making and establish new metrics. These results also show that useful insights can be derived from risk drivers without knowing the outcome of the risk event. The study concludes that while risk management has both cultural and structural components, changes to the structural aspects (tools and processes) enable cultural change. Additionally, it concludes that frameworks can be used facilitate proactive risk management if they are integrated into a robust overarching risk management process.
Recommendations for future work include improving training programs to educate team members about project risk management, as well as the development of simple frameworks that are integrated into the overall risk management process to enable more proactive risk management. Certain risk management interventions such as trainings and having an assigned "Champion" for risk management are effective in the near term, but further study is needed to evaluate their impact on long-term sustainability.
by Emily Templin Kehne.
M.B.A.
S.M.
M.B.A. Massachusetts Institute of Technology, Sloan School of Management
S.M. Massachusetts Institute of Technology, Department of Mechanical Engineering
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Shuja, Sana. "Formal Verification Techniques for Safety Critical Medical Device Software Control." Diss., North Dakota State University, 2016. http://hdl.handle.net/10365/25736.
Full textAbstract:
Safety-critical medical devices play an important role in improving patients health and
lifestyle. Faulty behaviors of such devices can cause harm or even death. Often these faulty
behaviors are caused due to bugs in software programs used for digital control of the device. We
present a formal veri cation methodology that can be used to check the correctness of object
code programs that implement the safety-critical control functions of these medical devices. Our
methodology is based on the theory of Well-Founded Equivalence Bisimulation (WEB) re nement,
where both formal speci cations and implementations are treated as transition systems. First, we
present formal speci cation model for the medical device. Second, we develop correctness proof
obligations that can be applied to validate object code programs used in these devices. Formal
methods are not widely employed for the veri cation of safety critical medical devices. However,
using our methodology we were able to bridge the gap between two very important phases of
software life cycle: speci cation and veri cation.
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Corzine, Moore Natalie L. "REPORT ON A MTSC INTERNSHIP AT A MEDICAL DEVICE COMPANY." Miami University / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=miami1366134338.
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Cagley, Laura Marie. "Report on a MTSC Internship at a Medical Device Company." Miami University / OhioLINK, 2009. http://rave.ohiolink.edu/etdc/view?acc_num=miami1259680980.
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Kleine, Klaus. "Micromachining with single mode fibre lasers for medical device production." Thesis, University of Liverpool, 2009. http://livrepository.liverpool.ac.uk/1295/.
Full textAbstract:
This Thesis is based on several research and development programs to implement the use of fibre lasers in the manufacturing of medical devices like stents and pacemakers. In general, the medical device manufacturing industry has a high demand for laser micromachining applications. The content of the thesis describes laser micromachining of metallic components with single mode fibre lasers. At the started of the research work for this thesis, most laser machining processes used flash-lamp pumped solid-state lasers for those applications. Reliable laser operation and low maintenance are required to meet the yields and up-time requirements for medical devices, such as stent cutting and pacemaker welding. Many lasers for micromachining applications are configured to operate near the diffraction limited beam performance to achieve very small feature sizes. It is challenging to maintain such a laser system performance in a production environment. The fibre laser provides a number of attractive features that could address the needs to maintain high up-time and high yields: • A single mode fibre laser does not require mirror alignment. • Diode pumped fibre lasers reduce maintenance due to eliminating the lamp change. • The compact air-cooled design helps to save expensive clean room space on the production floor. By 2000 the increases in average laser power extended the use of the fibre lasers into industrial applications such as cutting and welding.. The lasers investigated in this thesis generated 50 W to 200 W of laser power, representing the highest power levels commercially available at that time. For the microcutting of medical implants such as stents and guide wires, kerf width and sidewall surface quality are of special interest. Developing processes capable of achieving these criteria was the primary objective of the research described in this thesis. A secondary concern is the heat affected zone created by the laser machining process. Operation conditions to minimize this effect are also discussed in this thesis. Many microwelding applications in the electronics, telecom and medical device industry require smaller and smaller laser joining areas. The quality of a laser welded joint is very dependant on the temporal and spatial parameters of the laser beam. These parameters must be adjusted to match to the processing speed and the materials being welded. Switching continuous wave fibre lasers can achieve the parameters for processes requiring low average power. However the pulse-to-pulse stability can effect the process and has been investigated. Some welding applications require focus spot diameters in the order of 50 μm and pulse energy levels as low as 10 mJ. The fibre laser’s excellent single mode beam quality provides the desired spot size and laser power density. The research summarized in this thesis was performed to prove that fibre lasers are viable tools for micromachining. This thesis compares fibre laser machining results with those using legacy laser processes and describes ways to improve the quality of the fibre laser machining process.
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Surtees, Jennifer. "Interorganizational innovation and collaboration in the UK medical device sector." Thesis, Aston University, 2016. http://publications.aston.ac.uk/28864/.
Full textAbstract:
Interorganizational team research is a growing body of literature and research has started toexamine team related factors such as interorganizational trust (i.e. Stock, 2006) in theinterorganizational setting. This research applies insights from the intraorganizational teamfield into the interorganizational team setting in order to determine the team related factorspertaining to effective collaboration in medical device innovation projects. Interorganizational collaboration has been a persistent feature within the interorganizationalrelations literature, due to the added benefits that can come with working collaborativelytowards a common goal (Berg-Weger & Schnieder, 1998). While much research has exploredthe structures and performance outcomes of engaging in this cross-boundary working, theliterature is sparse with respect to interpersonal relationships, practices and processes leadingto effective collaboration (Bergenholtz & Waldstrom, 2011; Majchrzak, Jarvenpaa & Bargherz,2015). An interpretivist perspective has informed an exploratory mixed methods approach to datacollection, with contextual insights informing each phase of data collection. Three exploratoryphases of data collection have provided (1) qualitative ethnography data, (1i) qualitativeinterview data and (2) quantitative survey data. The NHS has recently set out agendas to increase innovative procurement (Department ofHealth, 2008), work more closely with industry and SMEs (Innovation and Procurement Plan:Department of Health, 2009) and to increase innovative practice (IHW: NHS, 2011). SMEsdeveloping novel medical devices require input from the NHS to ensure that their devices areclinically applicable and therefore will be adopted by the NHS. These contextual insightsprovide the backdrop for Studies 1i and 2. The findings suggest that the intraorganizational team literature can be extended into theinterorganizational collaboration literature, whilst also explaining the factors relating toeffectiveness and success of interorganizational team innovation.
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Wu, Kuo-wei, and 吳國偉. "Mode Selection Rules for Device-to-Device Communication with Probability Analysis." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/18125493521797282090.
Full textAbstract:
碩士國立中央大學
通訊工程學系
103
Device-to-device (D2D) communication underlaying a cellular network is a promising technology in future wireless networks to improve network capacity and reduce power consumption. Device to device communications enable mobile devices to directly communicate with each other when they are relatively close to each other. We consider the selection of direct or indirect communication path via the base station for D2D communications. Referring to this as the mode selection problem, in this paper we define mode selection rules based on channel capacity. Compare to traditional mode selection method, we add channel fading gain to calculate channel capacity and analysis mode selection with probability. Our results of the proposed method can improve the system sum-rate through mode selection rule for D2D communications. Keywords - Device to Device Communication, Mode Selection Rules, Channel Capacity
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Ho, Jui-Min, and 何瑞明. "The Study of Medical Device GMP and Medical Device Quality Assurance in Hospital." Thesis, 2000. http://ndltd.ncl.edu.tw/handle/46552416038076615512.
Full textAbstract:
碩士中原大學
醫學工程學系
88
Everybody has a close relationship with medication in his/her process of growth and fading. The medical device is a leading player in diagnosis & therapy of the process of medication. The quality of medical device projects direct influence on the users. The inferior quality of medical device affects the safety of consumers, even threatens the life. The consequence can be fatal. As the consequence of technological advancement, the varieties & functions of medical device are becoming more and more sophisticated. The utilization ratio increases, too. Without strict control in the process of production, the medical device will create permanent injuries. The ultimate goal of manufacturing medical device is for clinical application in diagnosis & therapy for human body’s health. However, the success of medical device’s development merely represents 1/3 of R&D. The subsequent clinical investigation & validation and the monitor & correction during post-market are the most important port in the overall research and development of medical devices. Pursuant to the regulation of Federal Register of U.S., the Food and Drug Administration (FDA) announced the enforcement of medical device GMP in 1978. Since then, all medical devices market into the United Stated are required to comply with the GMP requirements. The Department of Health (DOH) and the Ministry of Economic Affairs (MOEA) announced “Notice for Execution of Medical Device GMP” on August 10, 1998, effective from February 10, 1999. The Medical Device GMP signifies our country’s medical device management system’s movement toward global harmonization with International Standard ISO 13485: 1996 which was initiated based on FDA’s experience of current GMP inspection. Now ISO 9001/2 have become the minimum requirements of quality for all industries. On the other hand, the Medical Device GMP is a regulation initiated specifically for local and foreign manufacturers who market medical devices into R.O.C. The utilization of medical device affects patient’s lives directly. Therefore, the requirements for quality and safety are much higher than other industrial products. The specific requirements for the safety and functions of medical devices have reconciled the administration systems and products inspections of the United Stated and European countries. Now, the inspection of medical device entails product life-cycle management, including all phases of R&D, production, utilization and recycling. This research project is made with the hope that the quality of medical device and the clinical application can be warranted in line with the Medical Device GMP announced by government, thus provides the quality-assured medical services to the general public.
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Williams, Adepele Adeduntan. "Mining association rules in medical image data sets." 2003. http://hdl.handle.net/1993/20057.
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