Introduction In order to foster innovation of medical devices within the healthcare sector, a collaboration project, PUSH, has been initiated including the hospitals managed by the Stockholm County Council. The collaboration aims to capture ideas from employees and turn them into so called “high-practice” products as well as facilitate the possibilities for medical device companies to try out their products in the settings of healthcare. Collaborations for innovation, comparable to the PUSH project, can be found in both Swedish and foreign regions, but some of them fail to survive due to obstacles affecting the progress of each collaboration. Avoiding the same destiny will be a challenge to the PUSH project. Purpose The purpose is to search for factors affecting organizational collaboration concerning innovation systems for medical device development. The study is focusing on ”high-practice” products within the PUSH project. Theoretical approach In order to emphasize factors affecting innovation, theories regarding innovation systems, clusters and networks has been studied hence they  all concern organizational collaboration. Method The study’s qualitative approach is based on a semi deductive method. The analysis derives from a deductive outlook consistent with chosen theories, whereas collected data is used inductively to stress and enlarge part of the theoretical framework. Semi structured interviews, earlier research and evaluations constitutes most of the collected data. Results and analysis Experience from collaborations for innovation shows that some affecting factors can’t be influenced by collaborators, as political decisions and medical device directives. Collaborators can however affect circumstances such as connections and networking, which is significant to manage the innovation process; from idea to commercialization. An explicit focus on commercialization is important to the collaboration project’s surviving opportunities. A central cause why innovation projects don’t last is lack of funding, both for commercializing certain products as well as for retaining and developing existing innovation structures. Conclusion Collaborating projects should utilize existing structures and complement their networks to involve extensive competency. Decision makers need to decide whether innovation ventures shall be part of the County Council’s assignment. To fulfil the visions of the collaboration project, a policy common to all participants in the forthcoming innovation project needs to be stated, regarding ownership relations, risk sharing, funding and sharing of profits. / Bakgrund För att främja medicinteknisk innovation inom vården har ett utvecklingsprojekt för samverkan mellan Stockholms landstingsstyrda sjukhus påbörjats, under namnet PUSH (Produktutveckling inom Stockholms hälso- och sjukvård). Syftet med samverkan är att ta vara på landstingspersonalens idéer och utveckla s.k. high-practice-produkter samt att underlätta för medicintekniska företag att testa produkter i vårdmiljö. Liknande innovationssatsningar finns på olika håll i Sverige och utomlands, men det har varit problematiskt att få flera av dessa att överleva, då olika omständigheter påverkar utvecklingen av satsningarna. Samverkansprojektet mellan sjukhusen står således inför en rad utmaningar om de inte ska gå samma öde till mötes. Syfte Syftet är att undersöka omständigheter som är centrala för organisatorisk samverkan inom innovationssystem för utveckling av medicinteknik. Utgångspunkten är utveckling av ”high-practice-produkter” inom projektet PUSH. Teoretisk ansats För att belysa innovationspåverkande omständigheter i studien, har teorier om innovationssystem, kluster och nätverk studerats, utifrån att de behandlar organisatorisk samverkan. Metod Studiens kvalitativa upplägg bygger på ett semideduktivt tillvägagångssätt. Utifrån ett deduktivt synsätt utgår analysen från befintliga teorier medan empirin på ett induktivt sätt ligger till grund för att framhålla och vidga delar av teorierna. Insamlad data utgörs till stor del av semistrukturerade intervjuer och tidigare undersökningar och utvärderingar. Resultat och analys Erfarenheter från samverkansprojekt för innovationer visar att projekten påverkas delvis av omständigheter som ligger utanför projektens kontroll, som innovationspolitiska beslut och medicintekniskt regelverk. Påverkningsbara omständigheter är exempelvis att innovationsprojekt är beroende av ett välutvecklat kontaktnät som sträcker sig över hela innovationsprocessen, från utveckling av idén till kommersialisering. För långsiktig överlevnad är ett uttalat kommersialiseringsfokus av största vikt för projekten. En central orsak till att innovationsprojekt inte överlever på lång sikt är att det saknas finansiering, dels för kommersialisering av enskilda produkter och dels för att behålla och utveckla befintliga innovationsstrukturer. Slutdiskussion För samverkansprojekt bör befintliga strukturer utnyttjas och kompletteras med en utvidgning av nätverket för att involvera en bredare kompetens. Beslutsfattare måste ta ställning till om huruvida innovationssatsningar ingår i landstingets uppdrag. En gemensam policy för ägarförhållanden och risktagande, finansiering och fördelning av eventuella vinster måste utarbetas om samverkansprojektets visioner ska kunna uppnås.

Regelverket för medicintekniska produkter är omfattande och medicintekniska företag lägger idag stora resurser på att säkerställa att deras produkter uppfyller de lagar och krav som finns. Detta arbete beskriver författarnas bidrag till CE-märkningsprocessen på det nystartade företaget LARA Diagnostics första produkt, en handhållen enhet för utvärdering av perifer neuropati samt hur processen att CE-märka en medicinteknisk produkt generellt går till för ett mindre eller nystartat företag. Arbetet syftar till att visa vilka utmaningar mindre bolag har i synnerhet vid processen att CE-märka sin första produkt samt vad företag kan göra för att effektivisera sin process. I arbetet visas att mindre företag kan effektivisera sin process genom att: Tidigt lägga grunden till CE-märkningen. Se till att rätt kompetens finns eller införskaffas utifrån Redan i produktutvecklingen säkerställa att väsentliga krav uppfylls, gärna genom att följa harmoniserade standarder. Arbetet visar även att kraven inom det regulatoriska området för medicintekniska produkter blir hårdare med tiden och att den utvecklingen förväntas fortsätta. / The regulatory framework for medical devices is extensive and the medical device industry spends considerable resources on ensuring that their products comply with existing laws and requirements. This paper describes the authors’ contribution to the CE marking process of the very first product from the startup company LARA Diagnostics, a handheld device for the evaluation of peripheral neuropathy, as well as how the process of CE marking a medical device is carried out in general for a small or startup business. The work aims to point out the challenges for smaller companies in particular to get their first product certified, but also what can be done to streamline that process. The paper shows that small companies can improve the process by: Laying the foundation for CE marking early in the process. Ensure that the right skills exist internally or are acquired externally. Making sure that essential requirements are met early in the product development life cycle, preferably by adhering to harmonized standards. The paper also shows that the requirements within the regulatory framework for medical devices are becoming stricter over time and that this trend is expected to continue.

Space weather is the field within the space sciences that studies how the Earths magnetosphere is influenced by the Sun. The Sun is constantly emitting dangerous radiation and plasma which in some cases can affect or damage the systems on Earth. Scientists have an interest in studying this interaction and therefore visualizations of space weather data are useful. OpenSpace is an interactive software that visualizes the entire known universe with real-time data. OpenSpace supports a range of different visualization methods and techniques, for this work, the relevant visualization tools are field lines and cut planes. GAMERA is a simulation model that simulates a wide range of situations where plasma is subjected to the influence of magnetic fields, the simulations are based on curvilinear grids. This project focuses on implementing data from GAMERA into OpenSpace. OpenSpace already supports a variety of different simulation models, although none that uses curvilinear grids for the data. The curvilinear grid can adapt to the specific shape and geometry of the data, allowing for more accurate data representation. The project aims to create a pipeline for reading data files from simulation runs and visualize it as field lines and cut planes. The files used in this project contain data suitable for volumes and field lines. The method was to first develop a reader to extract and manage desired data from HDF5 files in which the simulation data is stored. The data used to visualize field lines is rendered with an already existing component in OpenSpace. Secondly, a slice operation was developed to extract cut planes from the files containing data for volume visualization, these are then visualized with the help of a component for rendering cut planes which was developed during this work. The work led to a pipeline that reads and manages simulation data from GAMERA and the data is successfully visualized. However, there is room for improvement in color rendering, robustness and level of user interaction during runtime. / <p>Examensarbetet är utfört vid Institutionen för teknik och naturvetenskap (ITN) vid Tekniska fakulteten, Linköpings universitet</p>

<p>Ett problem med elektroniska patientjournalsystem är att arkitekturen för patientjournalerna inte är gemensam vilket försvårar automatiskt utbyte av patientdata. En arkitektur har skapats inom ett projekt som heter openEHR. Förhoppningen är att denna arkitektur ska klara av automatiskt utbyte av patientdata mellan elektroniska patientjournalsystem.</p><p>I openEHRs arkitektur används något som kallas arketyper. Arketyper är återanvändbara modeller för att begränsa, strukturera och förklara vad som lagras i elektroniska patientjournaler som bygger på denna arkitektur. Istället för att områdesspecifik information, som vad ett blodtryck är, skapas i systemet flyttas den och annan liknande kunskap ut från systemarkitekturen och in i arketyperna. Arketyper kan skapas och redan existerande arketyper förändras utan att några ändringar i systemarkitekturen behöver göras.</p><p>Huvudproblemet i examensarbetet har varit att hitta en metod för att generera ett grafiskt gränssnitt utifrån en elektronisk patientjournal som är konstruerad med hjälp av arketyper. För att lösa detta behövdes det först skapas arketyper och ett system för att generera journaler utifrån dessa. Därefter har en webbportal utvecklats där det går att logga in och läsa de skapade patientjournalerna. Metoden för att generera gränssnittet i webbsidorna använder sig av en rekursiv funktion för att samla in information ur patientjournalerna. Funktionen lagrar den insamlade information i en objektstruktur som följer designmönstret Composite. Utifrån denna struktur går det sedan att generera ett grafiskt gränssnitt.</p><p>Webbportalen kan användas för att demonstrera hur ett system kan se ut där både patienter och behörig personal får tillgång till och möjlighet att läsa inlagda journaler som bygger på openEHRs arkitektur.</p> / <p>One problem with electronic health record systems is that the health records are not built on a common architecture. This makes automatic exchange of patient data difficult. openEHR is a project that has developed an architecture that tries to solve this problem.</p><p>The openEHR architecture uses something called archetypes. Archetypes are reusable models that limit, structure and explain what will be stored in the electronic health record that is built on this architecture.</p><p>The main goal of this master thesis has been to find a method to generate a graphical user interface from an electronic health record created using archetypes. To solve this problem first archetypes and a system that generates health records from these had to be created. Then a Web portal has been developed that displays the generated health records.</p><p>The Web portal can be used to demonstrate the graphical user interface of a system where both patients and authorized personnel can read patient records that are bases on the openEHR architecture.</p>

<p>The technique of volume rendering can be a powerful tool when visualizing 3D medical data sets. Its characteristic of capturing 3D internal structures within a 2D rendered image makes it attractive in the analysis. However, the applications that implement this technique fail to reach out to most of the supposed end-users at the clinics and radiology departments of today. This is primarily due to problems centered on the design of the Transfer Function (TF), the tool that makes tissues visually appear in the rendered image. The interaction with the TF is too complex for a supposed end-user and its capability of separating tissues is often insufficient. This thesis presents methods for detecting the regions in the image volume where tissues are contained. The tissues that are of interest can furthermore be identified among these regions. This processing and classification is possible thanks to the use of a priori knowledge, i.e. what is known about the data set and its domain in advance. The identified regions can finally be visualized using tissue adapted TFs that can create cleaner renderings of tissues where a normal TF would fail to separate them. In addition an intuitive user control is presented that allows the user to easily interact with the detection and the visualization.</p>

The aim of this thesis work has been to develop signal analysis methods for a computerized cardiac auscultation system, the intelligent stethoscope. In particular, the work focuses on classification and interpretation of features derived from the phonocardiographic (PCG) signal by using advanced signal processing techniques. The PCG signal is traditionally analyzed and characterized by morphological properties in the time domain, by spectral properties in the frequency domain or by nonstationary properties in a joint time-frequency domain. The main contribution of this thesis has been to introduce nonlinear analysis techniques based on dynamical systems theory to extract more information from the PCG signal. Especially, Takens' delay embedding theorem has been used to reconstruct the underlying system's state space based on the measured PCG signal. This processing step provides a geometrical interpretation of the dynamics of the signal, whose structure can be utilized for both system characterization and classification as well as for signal processing tasks such as detection and prediction. In this thesis, the PCG signal's structure in state space has been exploited in several applications. Change detection based on recurrence time statistics was used in combination with nonlinear prediction to remove obscuring heart sounds from lung sound recordings in healthy test subjects. Sample entropy and mutual information were used to assess the severity of aortic stenosis (AS) as well as mitral insufficiency (MI) in dogs. A large number of, partly nonlinear, features was extracted and used for distinguishing innocent murmurs from murmurs caused by AS or MI in patients with probable valve disease. Finally, novel work related to very accurate localization of the first heart sound by means of ECG-gated ensemble averaging was conducted. In general, the presented nonlinear processing techniques have shown considerably improved results in comparison with other PCG based techniques. In modern health care, auscultation has found its main role in primary or in home health care, when deciding if special care and more extensive examinations are required. Making a decision based on auscultation is however difficult, why a simple tool able to screen and assess murmurs would be both time- and cost-saving while relieving many patients from needless anxiety. In the emerging field of telemedicine and home care, an intelligent stethoscope with decision support abilities would be of great value.

The technique of volume rendering can be a powerful tool when visualizing 3D medical data sets. Its characteristic of capturing 3D internal structures within a 2D rendered image makes it attractive in the analysis. However, the applications that implement this technique fail to reach out to most of the supposed end-users at the clinics and radiology departments of today. This is primarily due to problems centered on the design of the Transfer Function (TF), the tool that makes tissues visually appear in the rendered image. The interaction with the TF is too complex for a supposed end-user and its capability of separating tissues is often insufficient. This thesis presents methods for detecting the regions in the image volume where tissues are contained. The tissues that are of interest can furthermore be identified among these regions. This processing and classification is possible thanks to the use of a priori knowledge, i.e. what is known about the data set and its domain in advance. The identified regions can finally be visualized using tissue adapted TFs that can create cleaner renderings of tissues where a normal TF would fail to separate them. In addition an intuitive user control is presented that allows the user to easily interact with the detection and the visualization.

Ett problem med elektroniska patientjournalsystem är att arkitekturen för patientjournalerna inte är gemensam vilket försvårar automatiskt utbyte av patientdata. En arkitektur har skapats inom ett projekt som heter openEHR. Förhoppningen är att denna arkitektur ska klara av automatiskt utbyte av patientdata mellan elektroniska patientjournalsystem. I openEHRs arkitektur används något som kallas arketyper. Arketyper är återanvändbara modeller för att begränsa, strukturera och förklara vad som lagras i elektroniska patientjournaler som bygger på denna arkitektur. Istället för att områdesspecifik information, som vad ett blodtryck är, skapas i systemet flyttas den och annan liknande kunskap ut från systemarkitekturen och in i arketyperna. Arketyper kan skapas och redan existerande arketyper förändras utan att några ändringar i systemarkitekturen behöver göras. Huvudproblemet i examensarbetet har varit att hitta en metod för att generera ett grafiskt gränssnitt utifrån en elektronisk patientjournal som är konstruerad med hjälp av arketyper. För att lösa detta behövdes det först skapas arketyper och ett system för att generera journaler utifrån dessa. Därefter har en webbportal utvecklats där det går att logga in och läsa de skapade patientjournalerna. Metoden för att generera gränssnittet i webbsidorna använder sig av en rekursiv funktion för att samla in information ur patientjournalerna. Funktionen lagrar den insamlade information i en objektstruktur som följer designmönstret Composite. Utifrån denna struktur går det sedan att generera ett grafiskt gränssnitt. Webbportalen kan användas för att demonstrera hur ett system kan se ut där både patienter och behörig personal får tillgång till och möjlighet att läsa inlagda journaler som bygger på openEHRs arkitektur. / One problem with electronic health record systems is that the health records are not built on a common architecture. This makes automatic exchange of patient data difficult. openEHR is a project that has developed an architecture that tries to solve this problem. The openEHR architecture uses something called archetypes. Archetypes are reusable models that limit, structure and explain what will be stored in the electronic health record that is built on this architecture. The main goal of this master thesis has been to find a method to generate a graphical user interface from an electronic health record created using archetypes. To solve this problem first archetypes and a system that generates health records from these had to be created. Then a Web portal has been developed that displays the generated health records. The Web portal can be used to demonstrate the graphical user interface of a system where both patients and authorized personnel can read patient records that are bases on the openEHR architecture.

<p>A prototype of a haptic and virtual reality simulator has been developed for simulation of the bone milling and material removal process occurring in several operations, e.g. temporal bone surgery or dental milling. The milling phase of an operation is difficult, safety critical and very time consuming. Reduction of operation time by only a few percent would in the long run save society large expenses. In order to reduce operation time and to provide surgeons with an invaluable practicing environment, this licentiate thesis discusses the introduction of a simulator system to be used in both surgeon curriculum and in close connection to the actual operations.</p><p>The virtual reality and haptic feedback topics still constitute a young and unexplored area. It has only been active for about 10-15 years for medical applications. High risk training on real patients and the change from open surgery to endoscopic procedures have enforced the introduction of haptic and virtual reality simulators for training of surgeons. Increased computer power and the similarity to the successful aviation simulators also motivate to start using simulators for training of surgical skills.</p><p>The research focus has been twofold: 1) To develop a well working VR-system for realistic graphical representation of the skull itself including the changes resulting from milling, and 2) to find an efficient algorithm for haptic feedback to mimic the milling procedure using the volumetric Computer Tomography (CT) data of the skull. The developed haptic algorithm has been verified and tested in the simulator. The visualization of the milling process is rendered at a graphical frame rate of 30 Hz and the haptic rendering loop is updated at 1000 Hz. Test results show that the real-time demands are fulfilled. The visual and haptic implementations have been the two major steps to reach the over all goal with this research project.</p><p>A survey study is also included where the use of VR and haptic simulators in the surgical curriculum is investigated. The study starts with a historical perspective of the VR and haptic topics and is built up by answering different questions related to this topic and the implementation of simulators at the medical centres. The questions are of general concern for those developing surgical VR and haptic simulators.</p><p>Suggested future work includes modelling, development and validation of the haptic forces occurring in the milling process and, based on this, implementation in the simulator system. Also, further development of the simulator should be done in close cooperation with surgeons in order to get appropriate feedback for further improvements of the functionality and performance of the simulator.</p>

Prostate cancer is the most frequent type of cancer in men in Europe and the USA. The methods presently used to detect and diagnose prostate cancer are inexact, and new techniques are needed. Prostate tumours can be regarded as harder than the surrounding normal healthy glandular tissue, and therefore it is of interest to be able to reliably measure prostate tissue stiffness. In this dissertation the approach was to evaluate tactile resonance sensor technology and its ability to measure mechanical properties and to detect cancer in human prostate tissue. The tactile resonance sensor is based on a piezoelectric transducer element vibrating at its resonance frequency through a feedback circuit. A change in the resonance frequency is observed when the sensor contacts an object. This feature has been utilized to measure tissue stiffness variations due to various pathophysiological conditions. An impression-controlled tactile resonance sensor system was first used to quantify stiffness and evaluate performance on silicone. Then the sensor system was used on fresh human prostate tissue in vitro to measure stiffness using a combination of frequency change and force measurements. Significant differences in measured stiffness between malignant and healthy normal tissue were found, but there were large variations within the groups. Some of the variability was explained by prostate tissue histology using a tissue stiffness model. The tissue content was quantified at four depths in the tissue specimens with a microscope-image-based morphometrical method involving a circular grid. Numerical weights were assigned to the tissue data from the four depths, and the weighted tissue proportions were related to the measured stiffness through a linear model which was solved with a least-squares method. An increase in the proportion of prostate stones, stroma, or cancer in relation to healthy glandular tissue increased the measured stiffness. Stroma and cancer had the greatest effect and accounted for 90 % of the measured stiffness (45% and 45%, respectively). The deeper the sensor was pressed, the greater, i.e., deeper, volume it sensed. A sensing depth was extrapolated from the numerical weights for the measurements performed at different impression depths. Horizontal surface tissue variations were studied by altering the circular grid size relative to the contact area between the sensor tip and the tissue. The results indicated that the sensing area was greater than the contact area. The sensor registered spatial tissue variations. Tissue density-related variations, as measured by the frequency change, were weakly significant or non-significant. The measured force registered elastic-related tissue variations, to which stroma and cancer were the most important variables. A theoretical material-dependent linear relation was found between frequency change and force from theoretical models of frequency change and force. Tactile resonance sensor measurements on prostate tissue verified this at small impression depths. From this model, a physical interpretation was given to the parameters used to describe stiffness. These results indicate that tactile resonance sensor technology is promising for assessing soft tissue mechanical properties and especially for prostate tissue stiffness measurement with the goal of detecting prostate cancer. However, further studies and development of the sensor design must be performed to determine the full potential of the method and its diagnostic power. Preferably, measurements of tissue mechanical properties should be used in combination with other methods, such as optical methods, to increase the diagnostic power.