This record of study details the experience and the knowledge applied by an engineering doctoral candidate during two internships with two separate organizations in the cardiovascular device industry. The first internship was with an early startup company with a large focus in early research and design. The second was in a more mature organization with a focus in process control and increasing efficiencies. The startup company provided the appropriate dynamic for applying engineering design methods such as generating customer requirements, generating product functional requirements, building a quality function deployment, and proposing a basic high level design approach. With the mature company the focus was on investigating procedural inefficiencies through root cause analysis and mitigating the inefficiencies through integrated software solutions. The detailed accounts of these experiences provide a broad overview of the many challenges facing the cardiovascular device industry and the organizations involved. These accounts also illustrate the importance and value of engineering design principles and systems based engineering management in the industry.

The purchase of medical devices involves engaging various stakeholders as well as balancing clinical, technical and financial requirements. Failure to consider these requirements can lead to wider consequences in the delivery of care. This study first builds a general knowledge base of current purchasing practice in a sample of NHS Trusts, which confirms the direction and guidance given by policy documents and literature as to the extent of the challenges faced by purchasing stakeholders. This then leads to an analysis to identify inefficiencies in the purchasing process, and how such practice can lead to risks in the delivery of care. These risks range from injury to individuals, impacts to the healthcare delivery service, and financial and litigation risks. Finally, a framework that highlights these potential risks in the life-cycle of medical devices in hospitals is presented. Key policy guidance has encouraged both researchers and implementers of healthcare services to approach patient safety from a systems perspective, acknowledging that medical device errors are not only directly related to device design, but to the design of the healthcare delivery service system in which the device operates. Little evidence exists of successfully applying systems approaches specifically to medical device purchasing practice. Medical device purchasing, because of its implications to patient safety on the one hand, and the uniqueness of the healthcare context, requires a unique approach. By demonstrating the influence of purchasing practice to service delivery and patient care, the thesis made is that taking a holistic systems approach is one method to improve device purchasing practice, and hence influence better care.

This licentiate thesis uses descriptive, mainly official,Swedish statistics to analyse industrial structure, productionand foreign trade in an industry that is traditionallydifficult to describe in numbers, that of medical devices. Forthe purposes of the thesis, the Swedish Medical Device industryis defined as companies classified in the SE-SIC manufacturingcodes 33101 (medical equipment and instruments, etc), 33102(dental products) and 35430 (invalid vehicles). Also otherbranches contribute, notably parts of SIC 51460 (wholesale inmedical equipment and pharmaceutical goods) and 73103 (medicalresearch and development) although their medical device volumecannot be specified. Additional items have been identified interms of specific product groups rather than as "belonging" toa specific SIC industrial code. Taken together, this is considered to correspond reasonablywell to the scope of the field as defined by the Global MedicalDevice Nomenclature (GMDN), a new European standard forclassifying medical devices in a more generic way than do theEuropean Medical Device Directives (or other pieces oflegislation). No quantification according to GMDN can be madeas yet, however, as that requires changing reporting habits inindustry as well as in official statistical classification andnomenclature regimes. With the manufacturing code SE-SIC 33101 as main object, thestudy for the first time presents data on the regionaldistribution, size classes of employment, company starting timeand company dynamics, in the form of entries to and exits fromthe code, over a six-year period. The latter analysis includesa follow-up of the "exits", some firms reappearing in otherparts of industry and others disappearing–surprisinglyfew among them being limited companies. Although this industryis comparatively mature, considerable mobility among themid-sized companies is indicated for reasons of real changes or(to some degree) factors inherent in the industrialclassification system. Some structural changes in companies inthe ≥50 employees bracket are identified. It is notedthat American actors, directly or indirectly, are increasinglyinvolved with the medical device industry in Sweden, and that anumber of technology-based companies that were started mostlyin the early eighties have recently reached the 50+ employeelevel. The analysis of identifiable production and internationaltrade in medical devices spans a period of 17 years based onofficial statistics following the HS/CN nomenclatures. Adatabase has been built, bottom-up, from the 8-digit CN levelwith production, exports and imports values for close to 100items collected in 12 product groups, for presentation purposesgrouped under three main headings. Compound annual growth ratesfor the latter are presented for three five-year periods1985-2000, showing that Swedish production and exports have hadan overall growth of 10 per cent p.a. This has kept Swedenahead of the international overall growth of 6- 7 per cent p.a.in recent years, products in the main group "Aids&Implants" growing more than 20 per cent p.a. Growth rates inthe most recent five-year period are lower, however. Healthynet exports figures are presented, the figure for 2002nominally representing 40 per cent of the production value incurrent as well as constant prices. Production figures are given at industry (local unit) levelas well as at product group level. The product-based figuresidentified for Production 2001 are estimated to SEK 13,3billion, Exports to SEK 13,7 billion and Imports to SEK 9,7billion. Figures for the Apparent Domestic Market arecalculated for the corresponding entities. It is obvious,however, that the statistics do not capture the real productionvalue as exports exceed production both at overall level and inmajor product groups, particularly those on a high systemstechnology level. The situation is not uncommon for a number ofreasons; further, cases in the statistics methodologyliterature confirm that medical instrument-related codes areliable to this phenomenon. Corrections, including adjustmentsof both production and exports values, are possible butdemanding already at one individual 4-digit HS/CN level. This,therefore, must be considered outside the scope of an academicstudy. The basic tablework developed for this thesis will be madefreely available to external parties for their own use providedthe author, with contact details, is named as the source.(Processing for commercial purposes is not expected, however.)Any suggestions for improvements are welcomed. / NR 20140805

This work investigates flow measurement capabilities within meso- and micro-scaled medically relevant devices using particle image velocimetry (PIV). Medical devices can be particularly challenging to validate due to small length scales and complex geometries, which can reduce measurement accuracy by introducing noise and reducing available signal. Although the sources of such problems are often device specific, the effective outcome is a reduction in the signal-to-noise ratios (SNRs) of PIV images and correlations. This effort utilizes advanced PIV processing and post-processing techniques to establish protocols for achieving high accuracy PIV measurements in challenging flow environments. This investigation takes place within three wide-ranging medically related devices. First, channel flow in a microfluidic device is investigated to evaluate improvements in measurement accuracy gained using phase correlations in comparison to confocal microscopy. This work found substantial improvements in error with respect to the ensemble field for phase correlations while only moderate improvements were observed for confocal imaging with standard processing techniques. Secondly, an evaluation of stenting procedures was executed resulting in the first published PIV and computational fluid dynamics (CFD) joint study on bifurcating stents. This work analyzes steady flow in three bifurcation angles and four different single- and double-stenting procedures, which are clinically used in coronary bifurcations. Finally, a medical device analog was evaluated to develop a comprehensive CFD validation dataset, including a full uncertainty analysis for velocity and wall shear stress as well as estimates for pressure fields and relevant flow statistics including Reynolds stresses and dissipation. / Ph. D.

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The public relations field is rapidly adopting two-way symmetrical communications as a way to achieve excellence and win-win solutions for multiple publics. This paper focuses on activism and industry public relations approaches involving a group of expert physicians in Houston and the medical devices industry. After exploring two-way symmetrical communications and the Excellence Theory of Public Relations, the paper explores these physicians’ viewpoints and provides an overview of the medical device industry. The discussion then provides public relations suggestions for the physicians to symmetrically approach the industry to create change. Next, the paper recommends how the medical device industry can respond to work with the physicians and to prevent possible public relations damage and crisis. The paper concludes by expressing the importance of applying symmetrical communications methods to solve challenges and create win-win solutions. / text

As the world population ages, the healthcare system is facing new challenges in treating more patients at a lower cost than today. One trend in addressing this problem is to increase the opportunities of in-home care. To achieve this there is a need for safe and cost-effective monitoring systems. Biosignal PI is an ongoing open-source project created to develop a flexible and affordable platform for development of stand-alone devices able to measure and process physiological signals. This master thesis project, performed at the department of Medical Sensors, Signals and System at the School of Technology and Health, aimed at further develop the Biosignal PI software by constructing a new flexible software framework architecture that could be used for measurement and processing of different types of biosignals. The project also aimed at implementing features for Heart Rate Variability(HRV) Analysis in the Biosignal PI software as well as developing a graphical user interface(GUI) for the Raspberry PI hardware module PiFace Control and Display. The project developed a new flexible abstract software framework for the Biosignal PI. The new framework was constructed to abstract all hardware specifics into smaller interchangeable modules, with the idea of the modules being independent in handling their specific task making it possible to make changes in the Biosignal PI software without having to rewrite all of the core. The new developed Biosignal PI software framework was implemented into the existing hardware setup consisting of an Raspberry PI, a small and affordable single-board computer, connected to ADAS1000, a low power analog front end capable of recording an Electrocardiography(ECG). To control the Biosignal PI software two different GUIs were implemented. One GUI extending the original software GUI with the added feature of making it able to perform HRV-Analysis on the Raspberry PI. This GUI requires a mouse and computer screen to function. To be able to control the Biosignal PI without mouse the project also created a GUI for the PiFace Control and Display. The PiFace GUI enables the user to collect and store ECG signals without the need of an big computer screen, increasing the mobility of the Biosignal PI device.   To help with the development process and also to make the project more compliant with the Medical Device Directive a couple of development tools were implemented such as a CMake build system, integrating the project with the Googletest testing framework for automated testing and the implementation of the document generator software Doxygen to be able to create an Software Documentation.    The Biosignal PI software developed in this thesis is available through Github at https://github.com/biosignalpi/Version-A1-Rapsberry-PI / Allt eftersom världens befolkning åldras, ställs sjukvården inför nya utmaningar i att behandla fler patienter till en lägre kostnad än idag. En trend för att lösa detta problem är att utöka möjligheterna till vård i hemmet.För att kunna göra detta finns det ett ökande behov av säkra och kostnadseffektiva patientövervakningssystem. Biosignal PI är ett pågående projekt med öppen källkod som skapats för att utveckla en flexibel och prisvärd plattform för utveckling av fristående enheter som kan mäta och bearbeta olika fysiologiska signaler. Detta examensarbete genomfördes vid institutionen för medicinska sensorer, signaler och system vid Skolan för Teknik och Hälsa. Projektet syftade till att vidareutveckla den befintliga mjukvaran för Biosignal PI genom att skapa ett nytt flexibelt mjukvaruramverk som kan användas för mätning och bearbetning av olika typer av biosignaler.Projektet syftade också till att utvidga mjukvaran och lägga till funktioner för att kunna genomföra hjärtfrekvensvariabilitets(HRV) analys i Biosignal PIs mjukvara, samt att utveckla ett grafiskt användargränssnitt(GUI) för hårdvarumodulen PiFace Control and Display. Projektet har utvecklat ett nytt flexibelt mjukvaruramverk för Biosignal PI. Det nya ramverket konstruerades för att abstrahera alla hårdvaruspecifika delar in i mindre utbytbara moduler, med tanken att modulerna ska vara oberoende i hur de hanterar sin specifika uppgift. På så sätt ska det vara möjligt att göra ändringar i Biosignal PIs programvara utan att behöva skriva om hela mjukvaran.Det nyutvecklade Biosignal PI ramverket implementerades i det befintliga hårdvaru systemet, som består av en Raspberry PI, liten och prisvärd enkortsdator, ansluten till ADAS1000, en analog hårdvarumodul med möjlighet att registrera ett elektrokardiografi(EKG/ECG). För att kontrollera Biosignal PI programmet har två olika grafiska användargränssnitt skapats.Det ena gränssnitt är en utvidgning av original programvaran med tillagd funktionalitet för att kunna göra HRV-Analys på Raspberry PI, detta gränssnitt kräver dock mus och dataskärm för att kunna användas.För att kunna styra Biosignal PI utan mus och skärm skapades det även ett gränssnitt för PiFace Control and Display. PiFace gränssnittet gör det möjligt för användaren att samla in och lagra EKG-signaler utan att behöva en stor datorskärm, på så sätt kan man öka Biosignal PI systemets mobilitet. För att underlätta utvecklingsprocessen, samt göra projektet mer förenligt med det medicintekniska regelverket, har ett par utvecklingsverktyg integrerats till Biosignal PI projektet såsom CMake för kontroll av kompileringsprocessen, test ramverket Googletest för automatiserad testning samt integrering med dokumentations generatorn Doxygen för att kunna skapa en dokumentation av mjukvaran.

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.