Master of Science / Department of Computing and Information Sciences / Eugene Vasserman / The Medical Device Coordination Framework (MDCF) is an open source Medical Application Platform (MAP) that facilitates interoperability between heterogeneous medical devices. The MDCF is designed to be an open test bed for the conceptual architecture described by the Integrated Clinical Environment (ICE) interoperability standard. In contrast to existing medical device connectivity features that only provide data logging and display capabilities, a MAP such as the MDCF also allows medical devices to be controlled by apps. MAPs are predicted to enable many improvements to health care, however they also create new risks to patient safety and privacy that need to be addressed. As a result, MAPs such as the MDCF and other ICE-like systems require the integration of security features. This thesis lays the groundwork for a comprehensive security architecture within the MDCF. Specifically, we address the need for access control, device certification, communication security, and device authentication. We begin by describing a system for ensuring the trustworthiness of medical devices connecting to the MDCF. To demonstrate trustworthiness of a device, we use a chain of cryptographic certificates which uniquely identify that device and may also serve as non- forgeable proof of regulatory approval, safety testing, or compliance testing. Next, we cover the creation and integration of a pluggable, flexible authentication system into the MDCF, and evaluate the performance of proof-of-concept device authentication providers. We also discuss the design and implementation of a communication security system in the MDCF, which enables the creation and use of communication security providers which can provide data confidentiality, integrity, and authenticity. We conclude this work by presenting the requirements and a high level design for a Role-Based Access Control (RBAC) system within the MDCF.

Information technology (IT) is empowering consumers, service providers, and inventor teams with superior services. Various IT innovations are enabling diverse groups of people to search, exchange, and learn from information. In healthcare services, the context of the three essays of this dissertation, information resources are often not equally accessible to consumers, not transparent between patients and physicians, and hard to locate across technological domains that may be relevant to the development of breakthrough innovations. Focusing on empowering roles of IT in healthcare services, I develop a three-essay dissertation to study how IT can enable information access to (i) address health inequalities in developing regions of the world, (ii) strengthen the physician-patient relationship where patient trust in the physician has atrophied, and (iii) energize inventor teams in the development of medical device innovations. Essay 1 examines consumers’ awareness and use of mobile health that can empower consumers to access health advice information. Essay 2 investigates how online health consultation communities can empower physicians to build trust with patients, and gain social and economic advantages in competitive healthcare services. Essay 3 studies the role of digital capabilities to empower inventor teams in medical device companies by converting expertise of inventor teams into broad and deep knowledge capital and expanding knowledge production regarding medical device innovations. I adopt a pluralistic approach to collect data (surveys administered in multiple languages for Essay 1, scraping web data from online communities for Essay 2, and constructing a multisource archival panel dataset for Essay 3) and analyze data (multivariate analysis for Essay 1, multilevel modeling and econometrics for Essay 2 and Essay 3). The essays contribute to our understanding about the acceptance of empowering IT innovations, the empowering role of user-generated content in online communities for providers of credence services, and the empowering role of IT for inventor teams of healthcare innovations.

The prevalence and use of medical devices in the home environment continues to grow in the United Kingdom (UK) and Worldwide. It is recognised that such devices offer significant benefits to both patients and the National Health Service in the UK. The design of home use medical devices however represents a considerable challenge to designers and manufacturers alike. Developing devices that are usable and understandable by inexperienced, lay or dexterity impaired users requires an understanding across a breadth of disciplines. Previous research in this field has explored these challenges in attempt to offer support for developers of home use medical devices. There have been very few studies however that have explored whether the design community actually need, want or use such guidance, before considering whether this literature is adopted correctly. Through case studies, an online survey and in depth interviews this thesis suggests that industry practitioners are sceptical of the value of design guidance towards user involvement in home use medical device design. Consequently the practitioners in this research make little or no use of the formal design methods and supportive guidance documents available to them. More typically, practitioners in the home use medical device field use their own personal experiences and knowledge from working in the industry to adapt their own approaches to design. This thesis reports that the greatest challenge to involving users in the design of home use medical devices are the internal corporate and traditionally hierarchical barriers between stakeholders within the design process. In contrast to previous research offering support for designers and developers of home use medical devices this thesis calls for a wider change in design practice to facilitate the application of usability principles. As a conclusion to this thesis, recommendations for further research to address these changes in practice are proposed to industry professionals in the medical device industry. This thesis is submitted as part of the requirement for the Degree of Doctor of Philosophy at Loughborough University.

L'émergence de l'ophtalmologie en tant que spécialité pointue est récente, contemporaine de l'aire de la révolution technologique. Cette discipline ne s'exerce qu'en présence de dispositifs médicaux et ses spécificités sont aussi liées aux particularités de l'organe responsable de la fonction visuelle. Mais justifient-elles un traitement particulier de la responsabilité de l'ophtalmologiste ? Médicale, chirurgicale et fonctionnelle cette discipline embrasse de nombreux champs de la responsabilité médicale. Les réponses en vue de la réparation du dommage produit, sont examinées au regard de la causalité qu'une perte de chance relativise fréquemment. Le fait originel obéit aux qualifications habituelles, mais l'incidence du défaut des produits prend un relief particulier au côté de la faute, de l'aléa et de l'infection nosocomiale. Les frontières des qualifications évoluent dans le temps et participent outre une certaine ambiguïté, à alimenter les procédures. Le contexte d'exercice et le développement du consumérisme modifient la jurisprudence. Ils sont à l'origine de la loi du 4 mars 2002, tournant de la relation médecin malade, qui assoie les récents revirements de jurisprudence, notamment sur le plan de l'information. Elle créé les commissions de conciliation et d'indemnisation qui transcendent les voies judiciaires et administratives sans les supprimer. Ouvertes aux préjudices visuels, les critères de gravité liés tant à leur accès et qu'à la solidarité nationale renforcent les tensions autour de l'oeil par un seul fait arithmétique. En fait, ces différentes instances ne tiennent pas compte du particularisme de l'exercice mais intègrent leur raisonnement en droit commun. / The ophtalmology has very old history; it's recently appeared like a speciality because of the technological revolution. The specificities of the discipline are applied only with medical devices and are connected with the peculiarities of this organ ; the eye is manager of the visual function. But do they justify a particular treatment of the ophtalmologist responsibility? It's a medical, surgical and functional discipline which opens so many medical responsibilities. Answers to repair the ophthalmologist intervention damage are examined face to causality, the loose of lucky often reduce it. The original fact obeys to the usual qualifications, but the incidence of the default product is particular next to the fault, the hazard and the hospital-borne infection. Qualifications limit differ with the time and play with a certain ambiguity to create so many process for the ophthalmologist. The practicing context and the consumer society development m odify the case law which doesn't miss and are of the origin of an Act. The recent cases laws completes changes, particular for patient information, are to the origin of the Act of 4 March 2002 and show a modification of the patient doctor relation. The Act creates reconciliation and compensation board which transcend judicial and administrative ways without deleting them. Those last one are open to the visual damages. The seriousness criteria linked to access and national solidarity increase problems around the eye by a only arithmetical fact. In my opinion, these different authorities don't take care about the particularism of exercise but integrate their arguments into common law.

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.

No intuito de simplificar a gastrostomia endoscópica percutânea (GEP) suprimindo- se a utilização de um endoscópio ou métodos de imagem, a gastrostomia magnética percutânea (GMP) foi concebida como nova opção técnica. Objetivo: investigar factibilidade de nova técnica para GMP por estudo experimental controlado, comparada à técnica GEP. Método: quatorze porcos foram submetidos a GEP (grupo ENDO, 7 animais) ou a GMP (grupo MAG), e submetidos a eutanásia 7 dias após o procedimento. Foram avaliados sucesso técnico, peso, tempo de procedimento e número de ocorrências/complicações (complicação menor – sem necessidade de nova intervenção). Para análise estatística foram aplicados o teste não paramétrico de Mann-Whitney e o teste exato de Fisher. Valores de p<0.05 indicaram significância estatística. Resultados: Todos os procedimentos realizados foram tecnicamente bem-sucedidos. Doze animais apresentaram evolução pós-operatória favorável. Dois animais (um de cada grupo) foram a óbito precocemente, não atribuível ao acesso gástrico. Houve no total 5 ocorrências/ complicações menores (4 no grupo MAG), sendo 3 dessas relacionadas ao tubo de gastrostomia. Houve maior perda de peso no grupo MAG comparado ao grupo ENDO, com significância estatística (peso médio em gramas 115±131(desvio-padrão) e -83±128, respectivamente, p=0,04). O tempo de procedimento foi maior para o grupo MAG comparado ao grupo ENDO, com significância estatística (tempo médio em segundos 471±140 e 882±239, respectivamente, p=0,001). Conclusão: a gastrostomia percutânea magnética é tecnicamente factível, porém necessita de melhorias no dispositivo devido a complicações relacionadas ao tubo de gastrostomia. Comparado ao método tradicional endoscópico, a gastrostomia magnética apresentou maior tempo de procedimento e maior perda de peso. / In order to simplify a Percutaneus Endoscopic Gastrostomy (PEG) procedure and obviate the need of imaging methods, a Percutaneous Magneticallyguided Gastrostomy (PMG) has been conceived. OBJECTIVE to investigate preclinical application of a novel magnetic device for PMG through an experimental controlled trial compared to PEG. METHODS fourteen domestic pigs were assigned for ENDO group (undergoing PEG, 7 animals), and MAG group (undergoing PMG). All animals were euthanized 7 days after procedure. Aspects related to technical success, procedure duration and clinical outcome (weight changes, event/complication rate) were evaluated. These were statisctically evaluated using Mann-Whitney (non-parametric) and Fisher’s exact test. Values of p<0.05 were considered statistically significant. RESULTS technical success was achieved for all animals undergoing the procedures. Of these, 12 had a favorable clinical outcome. Two animals died in less than 24 hours (one from each group), not directly related to gastric access. There were 4 minor complications (4 of them for group MAG), and 3 of these were tube-related. Weight loss was statistically significantly higher for group MAG (mean weight in grams 115±131(standard-deviation) e - 83±128, respectively, p=0.04). The procedural time was statistically significant higher for group MAG compared to ENDO (mean time in seconds 471±140 e 882±239, respectively, p=0.001). CONCLUSION a magnetically-guided percutaneous gastrostomy without imaging is technically feasible, however a device improvement is needed because of tube-related complications. Compared to percutaneous endoscopic gastrostomy, the magnetically-guided percutaneous gastrostomy technique is more time-consuming and had more weight loss.

In recent years, due to the combination of technological advances in the fields ofmeasurement instrumentation, communications, home-health care and textile-technology thedevelopment of medical devices has shifted towards applications of personal healthcare.There are well known the available solutions for heart rate monitoring successfully providedby Polar and Numetrex. Furthermore new monitoring applications are also investigated. Amongthese non-invasive monitoring applications, it is possible to find several ones enable bymeasurements of Electrical Bioimpedance.Analog Devices has developed the AD5933 Impedance Network Analyzer which facilitatesto a large extent the design and implementation of Electrical Bioimpedance Spectrometers in amuch reduced space. Such small size allows the development of a fully wearable bioimpedancemeasurement.With the development of a Electrical Bioimpedance-enable wearable medical device in focusfor personal healthcare monitoring, in this project, the issue of power management has beentargeted and a battery-driven Electrical Bioimpedance Spectrometer based in the AD5933 hasbeen implemented. The resulting system has the possibility to operate with a Li-Po battery with apower autonomy over 17 hours.

The purpose of this research was to investigate the application of design processes to the development of novel self-use molecular diagnostic devices for sexually transmitted infections. The argument proposed in this thesis is that the application of design methods at the earliest research stages into miniaturised, low cost, molecular diagnostic technologies will accelerate and improve the process of translating proof of concept diagnostic technologies into usable devices. Concept development requirements and potential issues and barriers to development were identified through interviews with expert stakeholders. These requirements were further refined through a survey of a multidisciplinary diagnostic medical device research group. An action research method was applied to develop a proof of concept prototype to the preclinical trial stage. Through these research studies, a design process model was formulated for use in a research environment. The application of design methods to the proof of concept prototype described in the thesis have resulted in a preclinical trial prototype that exhibits the necessary features for development into a self-use molecular diagnostic device. Issues and barriers were identified and discussed, design guidelines for further development beyond preclinical trial were defined and a generalised design process model for self-use molecular diagnostic devices for sexually transmitted infections was proposed. This research highlights the need for design methods to be applied at the earliest possible stages of the development of novel molecular diagnostic devices.

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.

Guidewires have been used in many operating rooms by vascular surgeons to assist them in positioning and maneuvering through a tortuous stenosis or lesion to a desired location, and to be used as a guide for the implantation of a catheter. Surgeons are tasked with having to insert a guidewire inside a small cavity, which requires a high level of skill and patience. The insertion of the guide wire is controlled by a torque device, which allows a surgeon to advance, rotate and grip the wet hydrophilic coating of the guidewire. Despite its many advantages, the torque device does, in fact, give rise to many time consuming issues that results in delays to the surgical procedure. One main problem in the use of the torque device is that it is introduced through the proximal end of the guidewire. Therefore, it requires the assistance of another individual, the surgical technician, to advance the torque device from the furthest point away from the patient. Once the torque device is in position, it is up to the surgeon to attempt to control the tightening, advancing and loosening of the device all with one hand. The other, free hand is used as a placement hand to secure the positioning of the guidewire within the patient. Another issue arises in the removal of the torque device, which must be loosened with one hand and slid off the same end it was introduced, often resulting in the unwanted ejection of the guide wire tip from within the patient's body. The process must then commence from the start, resulting in loss of valuable time, and be repeated until the distal tip of the guidewire is secure in the desired location and the catheter can now be introduced. The main purpose of this research is to investigate, design, and develop a new guidewire torque device to facilitate in a more controlled manipulation of a guidewire by vascular surgeons. Through in-depth interviews with both surgeons and surgical residents alike, direct observational time in the vascular surgery OR (operating room), and I obtained knowledge used as a design basis for the development of the product. For example, observations of relevant medical procedures were also accomplished at Tampa General Hospital to establish a basis for the design,and to assess current vascular surgery medical procedures. Initial design concepts where created using SolidWorks CAD software. After a period of researching and understanding user needs, an assortment of non-slip adhesives where found to be a viable solution to the problem. A characterization analysis was done on the highest rated non-slip adhesive to further define design parameters, and pave the way for FDA approval and product commercialization.