MedTech firms experience barriers when entering the healthcare sector, although their solutions could solve healthcare challenges. The study provides a conceptual framework for MedTech firms' business environment including institutional alignments and misalignments. These insights support MedTech firms' business model development when aiming for successful commercialization. The research is conducted with a multiple case study analyzing MedTech firms' and healthcare organizations' perspective regarding the business environment and relationship dynamics. The study generated three main findings. Firstly, an organizational and institutional logic analysis outlined essential problem areas where MedTech firms and healthcare organizations align differently. Secondly, suggestions on how the MedTech firm can respond to the identified problem areas through their business model are presented. Thirdly, the study provides an example of how social- and business literature can be connected to understand complex business environments. In contrast to a majority of prior research, the study is designed for the MedTech firm's perspective where the final result answering how the business model can be improved based on healthcare organizational and business insights.

The concept of integrated sensors in the Biotage® Extrahera™ system to perform live-monitoring of pressure inside SPE-columns is investigated. A test-rig containing the components necessary to simulate the pressure-cycle in the system is constructed and a printed-circuit board assembly is designed and implemented into its 24-column format. Liquid samples with varying viscosity are then synthesized using water and glycerol, which are used in a simplified 2-step SPE-process during which the pressure inside the columns is logged. The results obtained showed that the concept is viable and methods for clog detection as well as state assessment are discussed. However, it was established that the solution needs further testing involving complete SPE-processes with real samples before any detailed algorithms can be presented. A pre-study is finally done regarding solutions for minimizing the design to allow for implementation into the system's more spatially restricted 96-column format.

Health technology assessment (HTA) is a process that evaluates the value and effects of health technology during its life cycle and provides scientific information to decision makers. However, the chasm between healthcare and innovation has been highlighted in several research areas. HTA as a bridge connecting the research and decision-making demands, achieving more transparent processes and high quality of evidence to enable more effective and safer MedTech innovations to reach and benefit healthcare and patients. This thesis aims to examine the current status of HTA across different countries compared to Sweden to identify the major hurdles and enablers in this process and any opportunities for learning across systems. Germany, the United Kingdom, and Finland are three countries being compared to Sweden in the thesis. A literature review combined with interviews were the main methodologies used for this project. Peer-reviewed literature, government documents, and official websites gave an overview of the HTA systems in selected countries and laid a solid foundation for the more in-depth interviews. Eight interviews (nine interviewees) with HTA agencies and companies were performed via Zoom, along with an email communication(one interviewee) with Fimea. The interviews were used as a support tool to gain a better understanding of the whole HTA system. Some personal opinions were also helpful to gain a view of the system from an alternative, more practical perspective. The results show the different HTA processes and the evidence generation paths in four countries. Views from MedTech companies are also given. The HTA in Sweden has two main pathways: SBU and TLV. These two agencies have particular traits that work differently with distinct purposes. In terms of the evidence generation and assessment methods, they also share different points of view. It is difficult to simply compare these systems in parallel due to the system's complexity and different healthcare conditions in every country. But all countries, including Sweden, should realize the challenges ofthe existing HTA systems, and try to reduce the evidence generation gap between expectation and reality. This would create more opportunities for small MedTech companies to be involved in the process, and actively participate in international HTA cooperation. / Hälsoteknikutvärdering (HTA) är en process som utvärderar värdet och effekterna avhälsoteknik i dess livscykel och ger vetenskaplig information till beslutsfattare. Klyftanmellan hälso- och sjukvård och innovation har dock lyfts fram inom fleraforskningsområden. HTA länkar forskning och beslutsfattande genom att möjliggöramer transparenta processer och hög kvalitet på bevis för effektivare och säkrareMedTech-innovationer att nå och gynna sjukvård och patienter. Denna uppsats syftartill att undersöka HTA:s nuvarande status i olika länder jämfört med Sverige för attidentifiera de största hindren och möjliggörare i denna process och eventuellamöjligheter till lärande i olika system. Tyskland, Storbritannien och Finland är treländer som jämförs med Sverige i avhandlingen. Litteraturöversikt och intervjuer är de huvudsakliga metoderna som används för dettaprojekt. Forskargransakad litteratur, regeringsdokument och officiella webbplatser gaven översikt över HTA-systemen i utvalda länder och lade en solid grund för följandeintervjuer. Åtta intervjuer (nio intervjuade) med HTA-byråer och MedTech-företaggenomfördes via Zoom, tillsammans med en e-postkommunikation med Fimea.Intervjuerna användes som ett stödverktyg för att ge en bättre förståelse för hela HTAsystemet.Vissa personliga åsikter gav tillfälle att förstå HTA från ett alternativtperspektiv jämfört med dess beskrivning i litteraturen. Resultaten visar olika HTA-processer och bevisgenereringsvägar i fyra länder, samtsynpunkter från MedTech-företag. HTA i Sverige har två huvudvägar: SBU (viaregionala HTA centra) och TLV. Dessa två vägar har speciella egenskaper som fungerarannorlunda och med olika syften. När det gäller bevisgenerering ochbedömningsmetoder skiljs de även åt. Det är utmanande att jämföra dessa systemparallellt på grund av systemets komplexitet och olika sjukvårdsförhållanden i varjeland. Men alla länder, inklusive Sverige, bör inse brister i befintlig HTA och försökaminska bevisgenereringsgapet mellan förväntan och verkligheten. Under tiden skapasfler möjligheter för små MedTech-företag att delta i processen och delta aktivt iinternationella HTA-samarbeten.

Imagine a power wheelchair that can step over obstacles, step up on sidewalks and drive on lateral slopes whilst the user is still seated upright. Previously these features were impossible, but thanks to Elumo this is no longer the case. Elumo is a six-wheeled base to be used on electric wheelchairs. The base has been developed by Malin Svensson and Johan Olsson during their bachelor’s thesis at the Innovation Engineering Program at Halmstad University. The project took place between autumn 2021 and spring 2022.   The development of Elumo started with several user studies conducted by the students, where over 70 wheelchair users responded to a survey concerning the everyday life of a person using wheelchairs. These users were later invited to a user workshop where they could list everyday complaints and possible improvements concerning existing power wheelchairs. One of the most common complaints was getting up on sidewalks and driving on uneven terrain.   Both of these problems will be solved with the base Elumo. The technology that makes the stepping-feature and improved suspension possible, is patented by the company EMTW and the students have had a close cooperation with them during the development. Our goal is for “Elumo to become a new product that will focus on the user and will deliver innovative power wheelchairs that provide safety, independence and improve quality of life for people using wheelchairs.”