Medicinteknisk utrustning (MT) har en stor och avgörande roll i dagens samhälle för att kunna utföra en patientsäker sjukvård. De senaste tekniska framstegen har försett sjukvården med otaliga skräddarsydda MT-produkter för olika behov som uppstår vid behandling av patienterna. Trots detta har vissa hälso- och sjukvårdssektorer särskilda behov som inte kan tillgodoses genom marknadens utbud. När en sådan situation uppstår, tillåter regelverket sjukvårdsverksamheter att utveckla egentillverkade produkter eller modifiera befintlig MT-utrustning för att lösa det specifika sjukvårdsproblemet. Egentillverkning av en MT-produkt är en reglerad process i enlighet med EU-förordning om MT-produkter MDR (EU 2017/745) artikel 5.5. Detta regelverk säkerställer en patientsäker och kvalitetssäkrad MT-utrustning för intern användning inom sjukvårdsverksamheten.  Karolinska Universitetssjukhuset (Karolinska) som är Nordens största sjukhus har, i enlighet med regelverket, tagit fram egna interna riktlinjer för egentillverkning av MT-produkter. Covid-19-pandemin har aktualiserat att tillämpa dessa rutiner i praktiken. Karolinska har vårdat ett stort antal Covid-19-patienter med svåra respiratoriska symptom som har krävt ett särskilt omhändertagande bland annat på intensivvårdsavdelningen (IVA).  Ett av de mest förekommande kirurgiska ingreppen på IVA-patienter under denna period har varit trakeotomi. På grund av de stora svårigheter som uppstår med att flytta patienten till vanlig operationssal har öron-näsa-halsenheten (ÖNH) på Karolinska, som ansvarar för alla kirurgiska trakeotomier på sjukhuset, behövt utföra operationen på patienten i IVA-sängen. För att utföra en mer patientsäker på-plats-operation och förbättra denna ohållbara arbetsmiljö har ÖNH-kirurger önskat och sökt ett mobilt operationsbord som kan dockas till de olika IVA-sängtyperna som finns på sjukhuset. Eftersom detta operationsbord inte fanns att köpa på marknaden har MT-mekaniska verkstaden på Karolinska utvecklat en prototyp av trakeotomibordet som uppfyller ÖNH-kirurgernas specifika behov.  I detta arbete undersöktes egentillverkning av MT-produkter inom Karolinska i samband med utveckling av trakeotomibordet. I detta avseende studerades hela processen som krävs av regelverket och Karolinskas interna föreskrifter, från behovsanalys och definition av MT-produkten till kvalitetssäkring och riskhanteringen som garanterar en godkänd MT-utrustning för intern användning inom Karolinska Universitetssjukhuset. / Medical devices have a crucial role in performing a high-quality healthcare with patient safety in focus. Recent technological advances have provided healthcare systems with countless customized medical products for the various needs that arise in the treatment of patients. Despite this, some health care sectors have special needs that cannot be met by the market supply. In such circumstances, the regulations allow healthcare providers to develop in-house production or modify existing medical equipment to solve the specific need of the medical staff. In-house production of a medical device is a detailed regulated process defined in accordance with MDR (EU 2017/745) Article 5 (5). This regulatory framework ensures a patient-safe and quality-assured medical equipment for internal use within the healthcare.  Karolinska University Hospital (Karolinska), which is the Nordic region's largest hospital, follows the regulatory praxis for in-house production of medical devices. These praxes were put into use during the Covid-19 pandemic. Karolinska had to take care of many Covid-19 patients with severe respiratory symptoms who required special care, including intensive care unit (ICU).  One of the most common surgical procedures on ICU patients during this period was tracheotomy. Due to the complications that occur in moving patients to regular operating theatre, the ear-nose-throat unit (ENT) at Karolinska, which is responsible for all surgical tracheotomies at the hospital, has had to perform operations directly on ICU beds.  To improve the quality of the operations and the surgeon's work condition, the Karolinska ENT have sought a mobile operating table with ability to be docked to various ICU beds, available at the hospital. Since this medical equipment was not available on the market, the medical engineering workshop at Karolinska has developed a prototype of the tracheotomy table that meets the specific needs of ENT surgeons. This project studies the in-house production of a medical device at Karolinska through examining the development of tracheostomy table’s prototype by medical engineering workshop. In this respect, the regulatory requirements that approve the tracheostomy table for internal use within Karolinska University Hospital, are studied.

<p dir="ltr">Digital Health technologies have revolutionized healthcare delivery, offering innovative solutions that enhance access, improve patient outcomes, and optimize the use of resources. Despite this advancement, health outcomes remain disparate across different social groups, with underprivileged populations at an increased risk of poor health outcomes due to inadequate access to care. Digital Health technologies serve as a critical intervention in mitigating these disparities, particularly for groups affected by geographical, economic, and infrastructural barriers.<br><br>The purpose of this study was to conduct a review of the current state of Digital Health technologies, including Software as a Medical Device (SaMD), Wearable Health, Portable Diagnostic Devices, and remote care platforms, and their impact on healthcare accessibility. Employing qualitative methodology, this metasynthesis emphasized an important discovery: the need for a paradigm shift among stakeholders in healthcare towards integrated and digitally-driven patient care. This shift requires more than just an understanding of new technologies. It demands a fundamental re-evaluation of patient care methods and the orchestration of the entire healthcare system towards integrated digital practices. Importantly, this study found that the pace of digitalization must be carefully managed and cultural factors must be considered and signals the urgency for a balanced approach to digital integration in healthcare.</p>

<p dir="ltr">Ultra-scaled, always-on, smart, wearable and implantable (WI) therapeutic platforms define the research frontier of modern personalized medicine. The WI platform integrates real-time sensing with on-demand therapy and is ideally suited for real-time management of chronic diseases like diabetes. Traditional blood tracking methods, such as glucometers, are insufficient due to their once-in-a-while measurements and the imprecision of insulin injections, which can lead to severe complications. To address these challenges, researchers have been developing smart and minimally invasive microneedle (MN) components for pain-free glucose detection and drug delivery, potentially functioning as an "artificial pancreas". Inspired by natural body homeostasis, these platforms must be accurate and responsive for immediate corrective interventions. However, artificial MN patches often have slow readings due to factors like MN morphology and composition that remain poorly understood, hindering their optimization and integration into real-time monitoring devices. Despite extensive, iterative experimental efforts worldwide, a holistic framework incorporating the interaction between MN sensing and therapy with fluctuating natural body functions is missing. In this thesis, we propose a generalized framework for glycemic management based on the interaction between biological processes and MN-based operations. The results, incorporating theoretical insights from the 1960s and recent advancements in MN technology, are platform-agnostic. This generality offers a unique template to interpret experimental observations, justify the recent introduction of drugs like GLP-1 cocktails, and optimize platforms for accurate and fast disease management. </p>

<p>There are no commercially available wearable shoe in-sole sensors that are capable of measuring and distinguishing between shear and compression forces. Companies have already developed shoe sensors that simply measure pressure and make general inferences on the collected data with elaborate software [2, 3, 4, 5]. Researchers have also attempted making sensors that are capable of measuring shear forces, but they are not well suited for biomedical applications [61, 62, 63, 64]. This work focuses on the development of a novel wearable sensor system that is capable of identifying and measuring shear and compression forces through the use of capacitive sensing. Custom hardware and software tools such as materials test systems and capacitive measurement systems were developed during this work. Numerous sensor prototypes were developed, characterized, and optimized during the scope of this project. Upon analysis of the data, the best capacitive measurement system developed in this work utilized the CAV444 IC chip, whereas the use of the Arduino-derived measurement system required data filtering using median and Butterworth zero phase low pass filters. The highest dielectric constant reported from optimization experiments yielded 9.7034 (+/- 0.0801 STD) through the use of 60.2% by weight calcium copper titanate and ReoFlex-60 silicone. The experiments suggest certain sensors developed in this work feasibly measure and distinguish between shear and compressional forces. Applications for such technology focus on improving quality of life in areas such as managing diabetic ulcer formation, preventing injuries, optimizing performance for athletes and military personnel, and augmenting the scope of motion capture in biomechanical studies.</p>

Diploma thesis designs a barrier free new building of medical devices – policlinic (health center) with 14 medical workplaces. Object has three floors and basement. The building is covered by a vegetation flat roof. Building of policlinic is based on strip foundations and load-bearing walls are made from sand-lime blocks. Horizontal systém is created like reinforced concrete ceiling and in the same way internal staircase. The building is design at passive architecture – have compact form, thick layer of insulation and airtight cover. The main glass facade is oriented to the sout. There is used heat recovery air conditioning and heat pumping for heating in building. Health center satisfy currently legislation.

<p>The last two decades have shown a boom in the field of wearable sensing technology. Particularly in the consumer industry, growing trends towards personalized health have pushed new devices to report many vital signs, with a demand for high accuracy and reliability. The most common technique used to gather these vitals is photoplethysmography or PPG. PPG devices are ideal for wearable applications as they are simple, power-efficient, and can be implemented on almost any area of the body. Traditionally PPGs were utilized for capturing just heart rate, however, recent advancements in hardware and digital processing have led to other metrics including respiratory rate (RR) and peripheral oxygen saturation (SpO2), to be reported as well. Our research investigates the potential for wearable devices to be used for outpatient apnea monitoring, and particularly the ability to detect opioid misuse resulting in respiratory depression. Ultimately, the long-term goal of this work is to develop a wearable device that can be used in the rehabilitation process to ensure both accountability and safety of the wearer. This document details contributions towards this goal through the design, development, and evaluation of a device called “Kick Ring”. Primarily, we investigate the ability of Kick Ring to record heartrate (HR), RR, and SpO2. Moreover, we show that the device can calculate RR in real time and can provide an immediate indication of abnormal events such as respiratory depression. Finally, we explore a novel method for reporting apnea events through the use of several PPG characteristics. Kick Ring reliably gathers respiratory metrics and offers a combination of features that does not exist in the current wearables space. These advancements will help to move the field forward, and eventually aid in early detection of life-threatening events.</p>

<p>Sudden unexpected death in epilepsy (SUDEP) is a fatal complication of epilepsy that kills 1̃2 of every 10,000 epileptic patients every year. SUDEP has proven difficult to study because it frequently occurs unobserved and cannot be predicted. What limited clinical data exists suggests that SUDEP occurs as a cardiorespiratory collapse immediately following a seizure. In this work, I explore how a group of autonomic reflexes termed collectively as “oxygen‐conserving reflexes (OCRs)” lead to sudden death when activated during seizures. I also demonstrate multiple physiological parallels between the OCR‐mediated deaths that I report and the clinical data on cases of human SUDEP. Additionally, I explore the neural pathway underlying OCRs, identify the carotid body as a potential target for intervention, and demonstrate the efficacy of electroceutical intervention in reducing the mortality risk of OCR activation during seizures. This work seeks to both offer a neural explanation for SUDEP as well as present a promising target and means for potential intervention.</p>