The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. This study aims to elaborate on a practical and objective situation of this latest shift and picture out a predictable scenario for the implementation of future technology like Additive Manufacturing (AM) in healthcare. These two objectives are addressed from the perspective of the core role in this system, Notified Bodies (NBs). Specifically, it answers the following questions: What is the impact of the MDR on the NBs’ operations? What is the impact of the MDR on the device building on AM from NBs’ perspective? A literature review is conducted on existing researches in the relevant fields mentioned in the research questions of this study. Then a self-completion questionnaire is generated and sent to NBs who offer the CE marking granting service for the medical devices around the EU. The eight responses for the survey indicate that the MDR influences NBs and the device building on AM from several perspectives. For the NBs, the number of NBs will decrease while the workload and new recruitment will increase. Also, the independence and competences of NBs will be improved by MDR. In the case of AM-relevant medical devices, MDR will pose specific issues on them while the market will be developed by ensuring the product quality and raising public awareness. These findings are valuable practical evidence to examine the application of MDR and the implementation of technology like AM in healthcare under MDR. Overall, it found that the MDR will cause a tough situation in the short term. At the same time, the far-reaching influence for the regulatory system, as well as the medical device market, is affirmative and expectable worthy.

Sedan 2021 regleras medicintekniska produkter inom EU av förordningen MDR (EU 2017/745). Det primära syftet med regelverket är att säkerställa ändamålsenliga produkter med hög säkerhet. Det nya regelverket ställer högre krav på företag som tillverkar medicintekniska produkter samt andra aktörer inom den medicintekniska industrin. De mer omfattande kraven innebär att det blir mer utmanande att uppfylla samtliga kriterier som krävs för att kunna lansera medicintekniska produkter på unionsmarknaden. Detta examensarbete har undersökt hur företag som tillverkar specifika medicintekniska produkter som rullstolar och personlyftar upplever förutsättningarna för att nå marknaden. För att undersöka tidigare studier kring ämnet har en litteraturstudie genomförts och sedan utformades intervjufrågor med hjälp av samtliga handledare. Frågorna besvarades av företag som tillverkar rullstolar eller personlyftar. Som komplement till de semistrukturerade intervjuerna har upphandlingar undersökts med syfte att kartlägga vilka standarder som refereras till som skall-krav vid inköp av rullstolar och personlyftar. Resultatet visar att de ökade kraven påverkar större medicintekniska företag, men att mindre företag påverkas i högre utsträckning enligt intervjuobjekten. Dessutom noteras att standarder nämns mindre frekvent i upphandlingar än vad de intervjuade personerna hävdar. Slutligen anser intervjuobjekten att det är värdefullt att följa standarder vid utveckling och marknadsföring av personlyftar och rullstolar. / Since 2021, the Medical Device Regulation (MDR) has regulated medical devices within the EU (EU2017/745). The regulation’s primary purpose is to ensure fit-for-purpose products with high safety standards. The new regulatory framework imposes strict requirements on companies manufacturing medical devices and other actors within the medical device industry. The more extensive requirements make meeting all the criteria necessary for launching medical devices on the European Union market more challenging. This thesis has examined how companies that manufacture medical devices, especially wheelchairs and patient lifts, perceive the conditions for reaching the market. A literature review was conducted to examine previous studies on the subject. Then, interview questions were formulated with the assistance of supervisors to participate by companies manufacturing wheelchairs or patient lifts. Procurements were examined to complement the semi-structured interviews and map out which standards are mandatory requirements in procuring wheelchairs and patient lifts. The results indicate that the increased requirements affect larger medical device companies, but the interviewees say smaller companies are more affected.  Additionally, standards are mentioned less frequently in procurements than what the interviewed individuals claim. Finally, the semi-structured interviews revealed that the interviewees consider it valuable to adhere to standards in developing and marketing wheelchairs and patient lifts.

The New Medical Device Regulations (MDR) will become affective on 26 May, 2021. The new regulation entails higher requirements for companies that develop medical devices, but also for all parties involved in the medical device industry. The strengthened requirements mean that it will be more difficult to meet all the criteria for placing medical devices on the market. This thesis has been carried out on behalf of the Swedish Institute for Standards (SIS) and examines companies' transition to MDR and how companies can get support from SIS, but also by other organizations and authorities. A qualitative literature study and document study has been carried out to ponder interview questions, which have then been answered by companies, authorities and organizations who are in one way or another affected by the transition to MDR. Part of the work was also to find out how the companies, depending on size, differ from each other to comply with the new regulation. The results showed that the transition to MDR differs significantly between all the interviewed parties, but that everyone agrees that standardization is important. / Den nya förordningen om medicintekniska produkter (MDR) kommer att träda i kraft den 26 maj, 2021. Den nya förordningen innebär högre krav på företag som utvecklar medicintekniska produkter, men även på alla inblandade parter i den medicintekniska industrin. De stärkta kraven innebär att det kommer vara svårare att uppfylla alla kriterier för att kunna placera medicintekniska produkter på marknaden. Detta examensarbete har utförts på uppdrag av Svenska Institutet för Standarder (SIS) och undersöker företagens övergång till MDR och hur företag kan få stöd, bland annat av SIS, men också av andra organisationer och myndigheter. Det har genomförts en kvalitativ litteraturstudie och dokumentstudie för att formulera intervjufrågor som sedan har besvarats av företag, myndigheter och organisationer som på ett eller annat sätt blir påverkade vid övergången till MDR. En del av arbetet var även att ta reda på hur företagen, beroende på storlek, skiljer sig mellan varandra vad gälleratt uppfylla det nya regelverket. Resultatet visade att övergången till MDR skiljer sig markant mellan alla de intervjuade parterna, men att alla är eniga om att standardisering är viktigt.

Additive manufacturing (AM) has enabled the possibility for the hospitals to become their own implant producers developing implants that are tailored to patient’s anatomy. Despite the enormous potential of custom-made implants there are challenges that complicate the implementation of them into clinical practice. The aim of this research is to (1) identify the main driving forces and barriers for the delivery of custom-made implants; (2) explore staff stakeholder views and practices related to the implementation of AM in surgery for the development of custom-made implants; (3) formulate recommendations on how to cope with the implementation challenges. The research method was an explorative qualitative study consisted of a literature review on the challenges of custom-made implants in clinical applications coupled with the collection and inductive analysis of empirical data. The empirical study was based on ten semi-structured interviews conducted among both domestic and international hospital managers medical doctors and research engineers. The consolidated framework for implementation research (CFIR) was utilized for data collection. Using the five domains of CFIR, the following results were obtained: (1) Characteristics of individuals: Most research participants indicated a positive attitude towards the innovation expressing self-efficacy to its use; (2) Intervention characteristics: Custom-made implants were perceived to have a relative advantage in surgical practice due to their high degree of observability and geometrical adaptability providing increased surgical quality, perfect patient fit and better understanding of pathologies. However, high implementation costs, low degree of trialability and high degree of complexity in the development process were regarded as drawbacks of the innovation; (3) Outer setting: the regulatory uncertainty and lack of reimbursement limit the accessibility of custom-made implants to low income populations; (4) Inner setting: scarcity of resources, staff resistance to change, insufficient management support, communication difficulties, limited access to educational materials and training opportunities as well as lack of time and innovative capacity were regarded by the majority of participants as implementation barriers; (5) Process: central for the success of implementation is the need for a coherent implementation plan and evaluation process as well as the engagement of key stakeholders such as hospital managers, payers, regulatory and implementation advisors. This dissertation proffers a deeper understanding of the implementation issues related to custom-made implants and offers preliminary recommendations on how to cope with implementation impediments through the use of Rogers diffusion of innovation coupled with concepts from the field of organizational change and innovation management including Clayton’s disruptive innovation.

Global rise in life expectancy has resulted in an increased demand for affordable healthcare and monitoring services. The advent of miniature and low–power sensor technologies coupled with the emergence of the Internet–of–Things has paved the way towards affordable health monitoring tools in wearable platforms. However, ensuring power–efficient operation, data accuracy and user comfort are critical for such wearable systems. This thesis focuses on the development of accurate and computationally efficient algorithms and low–cost, unobtrusive devices with potential predictive capability for monitoring mobility and cardiac health in a wearable platform. A three–stage complementary filter–based approach is developed to realize a computationally efficient method to estimate sensor orientation in real–time. A gradient descent–based approach is used to estimate the gyroscope integration drift, which is subsequently subtracted from the integrated gyroscope data to get the sensor orientation. This predominantly gyroscope–based orientation estimation approach is least affected by external acceleration and magnetic disturbances. A two–stage complementary filter–based efficient sensor fusion algorithm is developed for real–time monitoring of lower–limb joints that estimates the IMU inclinations in the first stage and uses a gradient descent–based approach in the second stage to estimate the joint angles. The proposed method estimates joint angles primarily from the gyroscope measurements without incorporating the magnetic field measurement, rendering the estimated angles least affected by any external acceleration and insensitive to magnetic disturbances. An IMU–based simple, low–cost and computationally efficient gait–analyzer is developed to track the course of an individual's gait health in a continuous fashion. Continuous monitoring of gait patterns can potentially enable detecting musculoskeletal or neurodegenerative diseases at the early onset. The proposed gait analyzer identifies an anomalous gait with moderate to high accuracy by evaluating the gait features with respect to the baseline clusters corresponding to an individual’s healthy peer group. The adoption of a computationally efficient signal analysis technique renders the analyzer suitable for systems with limited processing capabilities. A flexible dry capacitive electrode and a wireless ECG monitoring system with automatic anomaly detection capability are developed. The flexible capacitive electrode reduces motion artifacts and enables sensing bio–potential over a dielectric material such as cotton cloth. The virtual ground of the electrode allows for obtaining single–lead ECG using two electrodes only. ECG measurements obtained over different types of textile materials and in presence of body movements show comparable performance to other reported ECG monitoring systems. An algorithm is developed separately as a potential extension of the software to realize automatic identification of Atrial Fibrillation from short single–lead ECGs. The association between human gait and cardiac activities is studied. The gait is measured using wearable IMUs and the cardiac activity is measured with a single–lead handheld ECG monitor. Some key cardiac parameters, such as heart rate and heart rate variability and physical parameters, such as age and BMI show good association with gait asymmetry and gait variation. These associations between gait and heart can be useful in realizing low–cost in–home personal monitoring tool for early detecting CVD–related changes in gait features before the CVD symptoms are manifested. / Thesis / Doctor of Philosophy (PhD) / Wearable health monitoring systems can be a viable solution to meet the increased demand for affordable healthcare and monitoring services. However, such systems need to be energy–efficient, accurate and ergonomic to enable long–term monitoring of health reliably while preserving user comfort. In this thesis, we develop efficient algorithms to obtain real–time estimates of on–body sensors' orientation, gait parameters such as stride length, and gait velocity and lower–limb joint angles. Furthermore, we develop a simple, low–cost and computationally efficient gait–analyzer using miniature and low–power inertial motion units to track the health of human gait in a continuous fashion. In addition, we design flexible, dry capacitive electrodes and use them to develop a portable single–lead electrocardiogram (ECG) device. The flexible design ensures better conformity of the electrode to the skin, resulting in better signal quality. The capacitive nature allows for obtaining ECG signals over insulating materials such as cloth, thereby potentially enabling a comfortable means of long–term cardiac health monitoring at home. Besides, we implement an automatic anomaly detection algorithm that detects Atrial Fibrillation with good accuracy from short single–lead ECGs. Finally, we investigate the association between gait and cardiac activities. We observe that some important cardiac signs, such as heart rate and heart rate variability and physical parameters, such as age and BMI show good association with gait asymmetry and gait variation.