Dissertations / Theses on the topic 'Medical device product documentation'

Thesis (S.B.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2010.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 43-44).<br>The objective of this paper is to describe the product design of a device that can be used to create medical supplies on-site in clinics in low-resource settings. The machine uses purely mechanical elements to cut and fold cardstock paper in order to fabricate aerosol masks for the treatment of asthma. The devices will be mass manufactured by larger firms and then distributed through the Ministry of Health to hospitals, clinics, and health posts across Nicaragua. An assessment of the market needs was conducted, and a target customer profile was developed. Alternative mask and device designs were explored and evaluated based on their financial costs, probability of user acceptance, and appropriateness to the design context. Feedback was obtained by doctors in Nicaragua as well as a few professionals working in the field of global health technologies. The use of this product will reduce dependency on imported medical supplies and solve some of the issues concerning lack of resources and incomplete healthcare coverage.<br>by Lisa Schlecht.<br>S.B.

Thesis (M.Eng. and S.B.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science, June 2003.<br>Includes bibliographical references (leaves 20-21).<br>This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.<br>Linux has become a viable alternative to Windows in recent years. This investigation looks at the feasibility of porting the software for a PC-based medical device to Linux. Using an open-source operating system frees developers from the constraints imposed by relying on a single company for the development platform. Several porting methods are considered. The port method chosen allows development on the Windows version to continue while simultaneously testing on Linux, without creating separate versions of the software. Differences in the way the software interacts with the operating system and with the hardware have to be addressed. A Linux environment was created in which to run the software and determine how to reconcile these differences. No major hurdles to using Linux exist, so it appears to be a viable platform on which to conduct future development.<br>by Steven B. Lustbader.<br>M.Eng.and S.B.

Healthcare information systems share records through common messaging standards and exchange information via universal network communications protocols. This interaction benefits hospitals by lowering administration costs and improving the accuracy of recorded information. This sharing and exchanging of information benefits patients by providing easier access to medical records, enabling point-of-care services, and simplifying retrieval of real-time patient data resulting in better patient care. Bedside medical device data complements the overall healthcare information system by providing a more complete understanding of a patient's health. This dissertation presents a simulation based on a standard network communications protocol for medical devices. This researcher addressed the problem that the use of the IEEE 1073 communications protocol to facilitate communication between legacy medical devices and hospital information systems is not adequately understood. The goal of this research was to further develop the understanding of such a system. The objective of this study was to develop a simulation model based on a reasonable approximation of a hypothetical system to identify the parameters involved and quantify its performance characteristics using real-world inputs. A model was developed using product-form queueing networks to model the steady-state behavior of a medical device communications system. The simulation model consisted of elements representing both physical and logical resources. Only the Physical and Data-Link Open Systems Interconnection (OSI) layers were considered. System configurations were limited to those defined by the IEEE 1073 communications protocol that support legacy medical devices. The inputs to the model consisted of real –world information compiled from vendor data specifications including physical communication mediums, microprocessors, medical devices, and representative software implementations. The results of the simulation suggest that a medical device communications network employing an IEEE 1073 communications protocol can support a limited number of legacy medical devices assuming a I -limited round-robin scheduling policy with a store and- forward data coherency strategy. However, under heavily loaded conditions, it is inadequate to deliver data generated from periodic multi -class work-loads in a timely manner. This conclusion demonstrates the need for an efficient medium access protocol schedule specification.

This Master's Thesis deals with the introduction of the new type of contact lenses ACUVUE to the Czech market. The thesis is divided into three parts. The first is focused on theoretical analysis of the standard procedure for introducing of new products to the market which is possible to find in professional publications. The practical part analyses the introduction procedure of new ACUVUE contact lenses in Vision Care Division of Johnson & Johnson company. Final part of this thesis includes evaluation of the Vision Care marketing strategy and recommendations which can improve the introducing procedure for the future. The required outcome of this work is the evaluation of the analysis and set a few recommendation for improvement of the introduction process for the future.

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

In assistive technology, there are mainly two different users that needs to be taken into account when developing products. The first, and most important, is the end-user who requires the product in order to function and live a normal life. The second is the support person who, for some products, needs to assist the end-user by preparing it to be used. This report presents the master thesis project conducted by Mattias Bygge and Sofie Strand at KTH Royal Institute of Technology in Stockholm. The client was Abilia, a company that research, develop, manufacture and sell assistive technology to people with impairments. This main goal of this project was to redesign a cognitive planning board. The product is used as a visual aid by people who has difficulties in planning daily activities and keeping track of time. In order to develop the product in a suitable way, a literature study and interviews with Abilia’s employees laid the foundation for the user studies that were conducted with end-users and support people. Several concepts were generated and five were evaluated against the original product and presented to the company. The two concepts that received the highest ranking, (1) Extra Hours and (2) Extra Hours Bistable, were further investigated and were eventually developed into one single hybrid concept. The final design proposal is Day Master, a flexible planning board intended for people with a cognitive impairment that impedes their ability to plan daily activities and keep track of time. The product visually displays time and weekdays by using coloured LED lights, which support people may program without difficulty to fit the end-user’s preference. The amount of hours is changeable with a range of 12-18 hours of daytime and with the remaining hours distributed to night-time. The accessories that have been developed for this products are a simple protective cover, and two holders, one for images and one for whiteboard markers. All accessories attaches to the planning board with magnets.<br>I hjälpmedelsteknologi är det fler än en användare som man måste ta hänsyn till när man utvecklar produkter. Den första och viktigaste är slutanvändaren som är den som behöver produkten i vardagen för att kunna leva ett någorlunda normalt liv. Den andra är stödpersonen som i många fall är den som förbereder produkten för användning av slutanvändaren. Denna rapport presenterar masterexamensarbetet utfört av Mattias Bygge och Sofie Strand på KTH Kungliga Tekniska Högskola i Stockholm. Kunden för projektet var Abilia, ett företag som utvecklar, tillverkar, och säljer hjälpmedel till personer med funktionsnedsättning. Målet med detta projekt var att omdesigna deras kognitiva planeringstavla. Produkten används som ett visuellt hjälpmedel av personer som har problem med tidsuppfattning och planering av aktiviteter. Projektet inleddes genom en literaturstudie och intervjuer med personal på Abilia. Detta lade grunden för användarstudierna där både slutanvändare och stödpersoner deltog. Utifrån användarstudierna så genererades ett flertal koncept varav fem stycken evaluerades mot original produkten och som presenterades för företaget under en delpresentation. De två koncept som erhöll högsta ranking i evalueringen var (1) Extra Hours och (2) Extra Hours Bistable. Koncepten undersöktes ytterligare och kom slutligen att kombineras till ett gemensamt koncept. Det slutgiltiga designförslaget är Day Master, en flexibel planeringstavla som riktar sig mot personer med en kognitiv funktionsnedsättning som försvårar för dem att hålla koll på tiden och planera aktiviteter. Produkten visar tid och veckodagar visuellt med hjälp av färgade LED lampor som stödpersonerna lätt och intuitivt kan programmera för att passa slutanvändarens individuella behov. Day Master ger möjligheten att själv bestämma antalet timmar som distribueras mellan dag och natt. Den har ett spann på 12-18 timmar för dagtid och återstående timmar läggs på natttid. Tillbehören som har utvecklats för denna produkt är ett enkelt magnetiskt plastskydd och två stycken olika ställ, ett för bilder och ett för whiteboardpennor. Alla tillbehör fästs på whiteboardtavlan med hjälp av magneter.

In assistive technology, there are mainly two different users that needs to be taken into account when developing products. The first, and most important, is the end-user who requires the product in order to function and live a normal life. The second is the support person who, for some products, needs to assist the end-user by preparing it to be used. This report presents the master thesis project conducted by Mattias Bygge and Sofie Strand at KTH Royal Institute of Technology in Stockholm. The client was Abilia, a company that research, develop, manufacture and sell assistive technology to people with impairments. This main goal of this project was to redesign a cognitive planning board. The product is used as a visual aid by people who has difficulties in planning daily activities and keeping track of time. In order to develop the product in a suitable way, a literature study and interviews with Abilia’s employees laid the foundation for the user studies that were conducted with end-users and support people. Several concepts were generated and five were evaluated against the original product and presented to the company. The two concepts that received the highest ranking, (1) Extra Hours and (2) Extra Hours Bistable, were further investigated and were eventually developed into one single hybrid concept. The final design proposal is Day Master, a flexible planning board intended for people with a cognitive impairment that impedes their ability to plan daily activities and keep track of time. The product visually displays time and weekdays by using coloured LED lights, which support people may program without difficulty to fit the end-user’s preference. The amount of hours is changeable with a range of 12-18 hours of daytime and with the remaining hours distributed to night-time. The accessories that have been developed for this products are a simple protective cover, and two holders, one for images and one for whiteboard markers. All accessories attaches to the planning board with magnets.<br>I hjälpmedelsteknologi är det fler än en användare som man måste ta hänsyn till när man utvecklar produkter. Den första och viktigaste är slutanvändaren som är den som behöver produkten i vardagen för att kunna leva ett någorlunda normalt liv. Den andra är stödpersonen som i många fall är den som förbereder produkten för användning av slutanvändaren. Denna rapport presenterar masterexamensarbetet utfört av Mattias Bygge och Sofie Strand på KTH Kungliga Tekniska Högskola i Stockholm. Kunden för projektet var Abilia, ett företag som utvecklar, tillverkar, och säljer hjälpmedel till personer med funktionsnedsättning. Målet med detta projekt var att omdesigna deras kognitiva planeringstavla. Produkten används som ett visuellt hjälpmedel av personer som har problem med tidsuppfattning och planering av aktiviteter. Projektet inleddes genom en literaturstudie och intervjuer med personal på Abilia. Detta lade grunden för användarstudierna där både slutanvändare och stödpersoner deltog. Utifrån användarstudierna så genererades ett flertal koncept varav fem stycken evaluerades mot original produkten och som presenterades för företaget under en delpresentation. De två koncept som erhöll högsta ranking i evalueringen var (1) Extra Hours och (2) Extra Hours Bistable. Koncepten undersöktes ytterligare och kom slutligen att kombineras till ett gemensamt koncept. Det slutgiltiga designförslaget är Day Master, en flexibel planeringstavla som riktar sig mot personer med en kognitiv funktionsnedsättning som försvårar för dem att hålla koll på tiden och planera aktiviteter. Produkten visar tid och veckodagar visuellt med hjälp av färgade LED lampor som stödpersonerna lätt och intuitivt kan programmera för att passa slutanvändarens individuella behov. Day Master ger möjligheten att själv bestämma antalet timmar som distribueras mellan dag och natt. Den har ett spann på 12-18 timmar för dagtid och återstående timmar läggs på natttid. Tillbehören som har utvecklats för denna produkt är ett enkelt magnetiskt plastskydd och två stycken olika ställ, ett för bilder och ett för whiteboardpennor. Alla tillbehör fästs på whiteboardtavlan med hjälp av magneter.

碩士<br>淡江大學<br>管理科學研究所企業經營碩士在職專班<br>94<br>The industry of medical device is always supposed stable and potential. But due to the financial worse of the National Health Insurance system, the overall profit of this industry is getting lower than before. Comparing to China, the market in Taiwan is small, the foreign supplier isn’t initiative now. The distributors in Taiwan have to be more aggressive to find the new product overseas directly. Under the situation, what is the product strategy of the distributor? What is the process of the decision making for new product? From the distributor situation, the study is to investigate the process of decision making for the product strategy by the distributor. The study selected the departments of General Surgery and Cardiovascular. Both were sorted into equipment and consumable products. So there were four distributors providing their valuable experience for the study. The purposes that distributor present product are to enhance the long term relationship with customers and the leading situation of the distributor in its field. There are five factors for these two purposes, they are the product integration, the competitive ability of the product, the sources of the products, the customer’s benefit, and the company’s benefit. What are the roles of the five factors in the decision making? From the result of the study, to enhance the long term relationship with customers, the ranking of the five factors are the competitive ability of the product, the product integration, company’s benefit, customer’s benefit and the source of the product. It’s the same ranking by the two distributors for consumable products. It’s different between the two distributors for equipment. To enhance the leading situation of the distributor in its field, the ranking is the same to the previous group. The process of decision making is something to do with the property of the products, it’s nothing to do with the department. The process of the decision making is on the basis of the ranking of the five factors, the competitive ability of the product, the product integration, company’s benefit, customer’s benefit and the source of the product.

碩士<br>國立臺灣科技大學<br>管理研究所<br>106<br>This is a case study of a medium-sized manufacturer of medical device that manufactures and sells disposable accessories used with “Electrosurgical Pencils” and disposable accessories used in the manufacture of AEDs. And these products are mainly marketed in the European and the US markets. After 30 years dedicated in this field, the development of “Electrosurgical Pencils” has been well-accomplished and has been produced with implementation of automation. However, some bottlenecks have been encountered in the process of product development for different electrosurgical products. The “Electrosurgical Pencils” is a very basic surgical instrument in surgical operation. Although it is commonly used in surgery to provide cutting and coagulating function, the price of this commodity type of instrument keeps approaching to a lower range due to the policy of reduce of medical waste and reduce of cost. This has led to continuous decline in profitability for this company. What the owner of this company considers are it is needed to develop new products in response to the development of new technology so the company can continuously grow and enable to make stable profits. Through the sharing and discussion of this case, it helps all partners from medical device field in Taiwan are able to speak up in global medical device industry and then stand in a favorable market position. In this business process, it is very important to know how to integrate the company's resources and technologies with the changing trends of the medical device regulations in the world's most developed countries in order to achieve the rapid development of the company's sustainable business opportunities.

碩士<br>國立中央大學<br>工業管理研究所碩士在職專班<br>96<br>Nowadays, companies must confront high levels of competition and extensive globalization. New product development (NPD) is a way to boost up enterprises and achieve optimum benefits. In the medical device industry, there have been rapid advancements in technology and medical practices, as well as ageing of the population, increases in the number of diseased individuals, and increasing respect for health-care management. The medical device industry is now faced with stiff competition in the development of novel medical devices. In Taiwan, the design of new medical devices is just starting to be competitive. However, designing new medical devices requires diversification, complexity and consistency. The basic theories and technical applications of medical devices span the fields of medical science, biotechnology, physiology, material science, mechanical engineering, electronics engineering and electrical engineering. Also, medical devices help in the diagnosis, treatment and prevention of human disease, and/or affect the structure and function of the human body. As a result, this dissertation attempts to provide a method by which one can figure out the problem as such as (1) failure to address customer wants and needs; (2) Unstable product definition; (3) Poor quality execution of key NPD tasks; (4) A poorly-structured, ineffectual project team and (5) Premature product launches. This dissertation applies concurrent engineering (CE) methodology by attribute-driven design (ADS). Then, the method combines new product development (NPD) and integrated computer-aided manufacturing (ICAM) DEFinition (IDEF3). The proposed method first defines product attributes in an NPD project for ODM or OEM medical device manufacturers. The study addresses the difficult scenario that occurs when the NPD team faces problems during the NPD process, like problems with resource management, target inconsistencies, and uncertainties in the development schedule. The dissertation also utilizes the proposed method to integrate and monitor the NPD team, as it strives to fulfill goals, like meeting customer requirements and reducing the time to market. Finally, this dissertation applies the model to a specific new device case, so as to verify that the method is both effective and efficient.

碩士<br>國立臺灣師範大學<br>工業教育學系在職進修碩士班<br>100<br>The purpose of this study is investigating the effects of Market Orientation, Product Innovation, Marketing Capability, Industrial Environment and Business Performance. Samples are drawing from Taiwan Medical And Biotech Industry Association. A total of 350 questionnaires are distributed, and the valid respondents are 98. The model is verified by factor analysis and multiple regression. Finally, the conclusions are listed as follows: 1. Market orientation has significantly influence on product innovation. 2. Market orientation has significantly influence on marketing capability. 3. Market orientation has significantly influence on performance. 4. Product innovation has significantly influence on performance. 5. Marketing capability has significantly influence on performance. 6. Industrial environment has significantly influence on performance. 7. Marketing Capability has a significant mediating effect between the influence of market orientation on performance. 8. Product innovation has no significant mediating effect between the influence of market orientation on performance.