Svenska medicintekniska företag kan inte konkurrera med de globala företagen med stordrift och låga priser, de måste därför anpassa sina produkter efter de specifika behoven i den svenska vården. Syftet med studien är att analysera och utvärdera svenska medicintekniska företags marknadsföringsstrategier med avseende på sambandet mellan samarbetsformer och produkters anpassning till specifika behov.

<p>Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.</p><p>The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.</p>

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union. The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

I rapporten presenteras en lågkostnads, portabel och bärbar design av ett nytt system med reflekterande teknik för pulsoximetri. Arbetet har utförts som ett projekt, inkluderande elektronikkonstruktion, mjukvaruutveckling, design av inkapsling för prototypen samt fortlöpande tester av både hård- och mjukvara under arbetets gång. Resultatet av arbetet är ett egenkonstruerat system för pulsoximetri. Med hjälp av bluetooth-teknik kan systemet kommunicera trådlöst med en PC, laptop eller mobiltelefon som stöder bluetooth 4.0. Mätvärden visas i realtid på PC/laptop/mobiltelefon. Programvaran är skriven i mbed med programspråket C++ för mikroprocessorn. Projektet kräver olika tekniska färdigheter såsom signalbehandling, programmering, kretskortskonstruktion och mikroprocessorer. Totalt sett är projektet en bra introduktion till medicintekniska enheter och en grund för elektronikingenjörer. Syftet och målet med examensarbetet har till större delen uppnåtts och vidare tester samt utveckling av produkten är möjlig. / In this report a low-cost, portable and wearable design of a new system with reflective technologyfor pulse oximetry is presented. The work has been executed as a project, including electronics construction, software development, a design of the embedding for the prototype and continuous tests of both the hardware and software during the work in progress. The result of this work is a prototype system for pulse oximetry. The system can communicate through Bluetooth wireless interface with a PC, laptop or smartphone which supports Bluetooth 4.0. The measurements are shown in real time on a PC/laptop/smartphone. The software is written in mbed with the language C++ for the microprocessor. The project demands different technical skills like signal processing, programming, electronic design and microprocessors. Over all the project is a good introduction for medical technology and a basis for electronic engineers. The purpose and goal with the thesis is considered to be reached for the most part and further testing and development of the product is possible.

State-of-the-art reconstruction algorithms for medical helical cone-beam Computed Tomography (CT) are of type non-exact Filtered Backprojection (FBP). They are attractive because of their simplicity and low computational cost, but they produce sub-optimal images with respect to artifacts, resolution, and noise. This thesis deals with possibilities to improve the image quality by means of iterative techniques. The first algorithm, Regularized Iterative Weighted Filtered Backprojection (RIWFBP), is an iterative algorithm employing the non-exact Weighted FilteredBackprojection (WFBP) algorithm [Stierstorfer et al., Phys. Med. Biol. 49, 2209-2218, 2004] in the update step. We have measured and compared artifact reduction as well as resolution and noise properties for RIWFBP and WFBP. The results show that artifacts originating in the non-exactness of the WFBP algorithm are suppressed within five iterations without notable degradation in terms of resolution versus noise. Our experiments also indicate that the number of required iterations can be reduced by employing a technique known as ordered subsets. A small modification of RIWFBP leads to a new algorithm, the Weighted Least Squares Iterative Filtered Backprojection (WLS-IFBP). This algorithm has a slightly lower rate of convergence than RIWFBP, but in return it has the attractive property of converging to a solution of a certain least squares minimization problem. Hereby, theory and algorithms from optimization theory become applicable. Besides linear regularization, we have examined edge-preserving non-linear regularization.In this case, resolution becomes contrast dependent, a fact that can be utilized for improving high contrast resolution without degrading the signal-to-noise ratio in low contrast regions. Resolution measurements at different contrast levels and anthropomorphic phantom studies confirm this property. Furthermore, an even morepronounced suppression of artifacts is observed. Iterative reconstruction opens for more realistic modeling of the input data acquisition process than what is possible with FBP. We have examined the possibility to improve the forward projection model by (i) multiple ray models, and (ii) calculating strip integrals instead of line integrals. In both cases, for linearregularization, the experiments indicate a trade off: the resolution is improved atthe price of increased noise levels. With non-linear regularization on the other hand, the degraded signal-to-noise ratio in low contrast regions can be avoided. Huge input data sizes make experiments on real medical CT data very demanding. To alleviate this problem, we have implemented the most time consuming parts of the algorithms on a Graphics Processing Unit (GPU). These implementations are described in some detail, and some specific problems regarding parallelism and memory access are discussed.

Radio frequency (RF) lesioning and deep brain stimulation (DBS) are the two prevailing surgical treatments for movement disorders within the field of stereotactic and functional neurosurgery. For RF-lesioning, a small volume of brain tissue is coagulated and knowledge of the lesion size and growth is of great importance for the safety and outcome of the procedure. This thesis deals with adapting the laser Doppler perfusion monitoring (LDPM) technique for measurements in brain tissue during RF-lesioning. The relation between LDPM signal changes and developed lesion size was investigated. LDPM measurements were evaluated both in vitro (albumin protein solution) and in vivo in the porcine brain during RF-lesioning corresponding to a bilateral thalamotomy in man. The investigated signals from the LDPI measurements can be used for following the lesioning time course and to detect if a lesion was created, both in vitro and in the animal model. For the albumin model, both the total backscattered light intensity and the perfusion signal can be used as markers for estimating the final coagulation size, while in the animal model this conclusion was not statistical verified. Independent on surgical method, RF-lesioning or DBS, intracerebral guidance is an important aspect within stereotactic and functional neurosurgery. To increase the accuracy and precision of reaching the correct target, different methods for intracerebral guidance exist, such as microelectrode recording and impedance methods. In this thesis, the possibility of developing an optical intracerebral guidance method has been investigated. Diffuse reflectance spectroscopy served as technology and all measurements were performed stereotactically in both porcine and human brain. Measurements of white and gray matter showed large differences, with higher reflectivity for white brain matter, both in porcine and in human brain. For the human measurements during DBS-implants, large differences between white matter and functional targets were found. Additionally, differences between native and lesioned porcine brain matter were detected. Both studies support the idea of using diffuse reflectance spectroscopy for developing an intracerebral guidance method.

Coronary artery bypass graft (CABG) surgery is a common treatment for patients with coronary artery disease. A potential complication of CABG is myocardial ischemia or infarction. In this thesis, a method - based on laser Doppler flowmetry (LDF) - for detection of intra- and postoperative ischemia by myocardial perfusion monitoring is evaluated. LDF is sensitive to motion artifacts. In previous studies, a method for reduction of motion artifacts when measuring on the beating heart has been developed. By using the ECG as a reference, the perfusion signal is measured in intervals during the cardiac cycle where the cardiac motion is at a minimum, thus minimizing the artifacts in the perfusion signal. The aim of this thesis was to investigate the possibilities to use the ECG-triggered laser Doppler system for continuous monitoring of myocardial perfusion in humans during and after CABG surgery. Two studies were performed. In the first study, changes in myocardial perfusion during CABG surgery were investigated (n = 13), while the second study focused on postoperative measurements (n = 13). In addition, an ECG-triggering method was implemented and evaluated. It was found that the large variations in myocardial perfusion during CABG surgery could be monitored with the ECG-triggered laser Doppler system. Furthermore, a perfusion signal of good quality could be registered postoperatively from the closed chest in ten out of thirteen patients. In eight out of ten patients, a proper signal was obtained also the following morning, i.e., about 20 hours after probe insertion. The results show that respiration and blood pressure can have an influence on the perfusion signal. In conclusion, the results indicate that the method is able to detect fluctuations in myocardial perfusion under favourable circumstances. However, high heart rate, abnormal cardiac motion, improper probe attachment and limitations in the ECG-triggering method may result in variations in the perfusion signal that are not related to tissue perfusion. / Varje år utförs omkring 4500 kranskärlsoperationer i Sverige. En allvarlig komplikation som kan uppstå efter operationen är otillräcklig blodförsörjning till hjärtmuskeln. Den här licentiatavhandlingen handlar om utveckling och utvärdering av en metod, baserad på laserdopplerteknik, för att kunna upptäcka nedsatt blodperfusion i hjärtmuskeln på ett tidigt stadium. Laserdopplertekniken är känslig för rörelsestörningar. I tidigare studier har en metod för reducering av rörelsestörningar vid mätning på slående hjärta tagits fram. Med EKG:t som referens mäts blodperfusionen i de faser under hjärtcykeln då hjärtats rörelse är som minst, vilket minskar bidraget av rörelsestörningar i blodperfusionssignalen. I den här avhandlingen undersöks om metoden kan användas för kontinuerlig övervakning av hjärtmuskelns blodperfusion på patienter under och efter hjärtoperationer. Två studier har genomförts: en där hjärtmuskelns perfusion mättes i olika faser under kranskärlsoperationer och en där mätproben lades in i hjärtmuskeln under operationen och mätningar gjordes under det första dygnet efter operationen. Det visade sig vara möjligt att följa förändringar i hjärtmuskelns blodperfusion under operation. Det var även möjligt att registrera en perfusionssignal av god kvalitet efter operationen då bröstkorgen var stängd. Hos åtta av tio patienter erhölls en bra signal även morgonen efter operationen, dvs. ca 20 timmar efter att proben lades in. Resultaten visar också att andning och blodtryck kan ha en påverkan på blodperfusionssignalen. Slutsatsen av arbetet är att det går att se variationer i hjärtmuskelns blodperfusion med EKG-triggad laserdoppler under vissa förutsättningar. Signalen är dock i många fall svårtolkad på grund av att t ex hög hjärtfrekvens, onormal hjärtväggsrörelse eller ändrad probposition sannolikt kan ge variationer i perfusionssignalen som inte är relaterade till blodflödesförändringar. / Report code: LIU-TEK-LIC-2007:35.

Risk, risk analysis and decision-making are essential aspects of health care andmedicine, for patients as well as for physicians and for society as a whole, andthe concept of risk and risk analysis in decision-making has a long history. Theword risk has many different interpretations and has no commonly accepteddefinition. In this thesis, we shall let risk stand for the combination of randomor uncertain events with negative consequences for human health, life and/orwelfare and/or the environment together with some measures of the likelihoodof such events. We believe this is the dominant concept and understanding ofrisk, the risk being the likelihood or probability of an event followed by somenegative consequences or activities of that event. In this doctoral thesis, we focus on biostatistics, risks and risk analysis in thefield of medicine, a science which has been using methods from the area of riskanalysis for a long time. The seven papers (paper I - paper VII) presented inthis thesis, together with a general introduction to risk, risk analysis anddecision-making, will be used to illustrate and discuss risk analysis as a tool fordecision-making in the field of medicine. From my point a view, risk analysisin the field of medicine aims to reduce pain, raise the quality of life, reduce therisk of adverse events, compare cost efficiency between different treatmentregimes and prolong a healthy life. Based on results presented in the thesis, weconclude that biostatistics, risks and risk analysis used in the field of medicineare valuable methods for evaluation of hypotheses within the health care areaand a good basis for decision-making. / <p>QC 20100901</p>

<p>Currently film is being replaced by electronic detectors for portal imaging in radiation therapy. This development offers obvious advantages such as on-line quality assurance and digital images that can easily be accessed, processed and communicated. In spite of the improvements, the image quality has not been significantly enhanced, partly since the quantum efficiency compared to film is essentially the same, and the new electronic devices also suffer from sensitivity to the harsh radiation environment. In this thesis we propose a third generation electronic portal imaging device with increased quantum efficiency and potentially higher image quality.</p><p>Due to the parallel readout capability it is much faster than current devices, providing at least 200 frames per second (fps), and would even allow for a quality assurance and adaptive actions after each accelerator pulse. The new detector is also sensitive over a broader range of energies (10 keV - 50 MeV) and can be used to obtain diagnostic images immediately prior to the treatment without repositioning the patient. The imaging could be in the form of portal imaging or computed tomography. The new detector is based on a sandwich design containing several layers of Gas Electron Multipliers (GEMs) in combination with, or integrated with, perforated converter plates. The charge created by the ionizing radiation is drifted to the bottom of the assembly where a tailored readout system collects and digitizes the charge. The new readout system is further designed in such a way that no sensitive electronics is placed in the radiation beam and the detector is expected to be radiation resistant since it consists mainly of kapton, copper and gas.</p><p>A single GEM detector was responding linearly when tested with a 50 MV photon beam at a fluence rate of ~10¹⁰ photons mm^-2 s^-1 during 3-5 μs long pulses, but also with x-ray energies of 10-50 keV at a fluence rate of up to ~10⁸ photons mm^-2 s^-1. The electron transmission of a 100 μm thick Cu plate with an optical transparency of ~46% was found to be ~15.4%, i.e. the effective hole transmission for the electrons was about one third of the hole area. A low effective GEM gain is enough to compensate for the losses in converters of this dimension. A prototype for the dedicated electronic readout system was designed with 50 x 100 pixels at a pitch of 1.27 mm x 1.27 mm. X-ray images were achieved with a single GEM layer and also in a double GEM setup with a converter plate interleaved. To verify the readout speed a Newton pendulum was imaged at a frame rate of 70 fps and alpha particles were imaged in 188 fps. The experimental studies indicates that the existing prototype can be developed as a competitive alternative for imaging in radiation therapy.</p>

<p>Part 1: The bandwidth of the ultrasound Doppler signal is proposed as a classification function of blood and tissue signal in transthoracial echocardiography of the left ventricle. The new echocardiographic mode, Bandwidth Imaging, utilizes the difference in motion between tissue and blood. Specifically, Bandwidth Imaging is the absolute value of the normalized autocorrelation function with lag one. Bandwidth Imaging is therefore linearly dependent on the the square of the bandwidth estimated from the Doppler spectrum. A 2-tap Finite Impulse Response high-pass filter is used prior to autocorrelation calculation to account for the high level of DC clutter noise in the apical regions. Reasonable pulse strategies are discussed and several images of Bandwidth Imaging are included. An in vivo experiment is presented, where the apparent error rate of Bandwidth Imaging is compared with apparent error rate of Second-Harmonic Imaging on 15 healthy men. The apparent error rate is calculated from signal from all myocardial wall segments defined in \cite{Cer02}. The ground truth of the position of the myocardial wall segments is determined by manual tracing of endocardium in Second-Harmonic Imaging. A hypotheses test of Bandwidth Imaging having lower apparent error rate than</p><p>Second-Harmonic Imaging is proved for a p-value of 0.94 in 3 segments of end diastole and 1 segment in end systole on non averaged data. When data is averaged by a structural element of 5 radial, 3 lateral and 4 temporal samples, the numbers of segments are increased to 9 in end diastole and to 6 in end systole. These segments are mostly located in apical and anterior wall regions. Further, a global measure GM is defined as the proportion of misclassified area in the regions close to endocardium in an image. The hypothesis test of Second-Harmonic Imaging having lower GM than Bandwidth Imaging is proved for a p-value of 0.94 in the four-chamber view in end systole in any type of averaging. On the other side, the hypothesis test of Bandwidth Imaging having lower GM than Second-Harmonic Imaging is proved for a p-value of 0.94 in long-axis view in end diastole in any type of averaging. Moreover, if images are averaged by the above structural element the test indicates that Bandwidth Imaging has a lower apparent error rate than Second-Harmonic Imaging in all views and times (end diastole or end systole), except in four-chamber view in end systole. This experiment indicates that Bandwidth Imaging can supply additional information for automatic border detection routines on endocardium.</p><p>Part 2: Knowledge Based Imaging is suggested as a method to distinguish blood from tissue signal in transthoracial echocardiography. This method utilizes the maximum likelihood function to classify blood and tissue signal. Knowledge Based Imaging uses the same pulse strategy as Bandwidth Imaging, but is significantly more difficult to implement. Therefore, Knowledge Based Imaging and Bandwidth Imaging are compared with Fundamental Imaging by a computer simulation based on a parametric model of the signal. The rate apparent error rate is calculated in any reasonable tissue to blood signal ratio, tissue to white noise ratio and clutter to white noise ratio. Fundamental Imaging classifies well when tissue to blood signal ratio is high and tissue to white noise ratio is higher than clutter to white noise ratio. Knowledge Based Imaging classifies also well in this environment. In addition, Knowledge Based Imaging classifies well whenever blood to white noise ratio is above 30 dB. This is the case, even when clutter to white noise ratio is higher than tissue to white noise ratio and tissue to blood signal ratio is zero. Bandwidth Imaging performs similar to Knowledge Based Imaging, but blood to white noise ratio has to be 20 dB higher for a reasonable classification. Also the highpass filter coefficient prior to Bandwidth Imaging calculation is discussed by the simulations. Some images of different parameter settings of Knowledge Based Imaging are visually compared with Second-Harmonic Imaging, Fundamental Imaging and Bandwidth Imaging. Changing parameters of Knowledge Based Imaging can make the image look similar to both Bandwidth Imaging and Fundamental Imaging.</p>