The topic of this thesis is the design of dental X-ray. User problems were identified based on the design and technical analysis for which solutions are presented in the work. The innovative shape and design solution shows a new approach to dental X-rays. The main benefit of the design is the solution to real ergonomic problems that can occur during the interaction of the operator or patient and the device. The design corresponds to current trends in the evolving design field of medical design.

No description available.

The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. The first de-facto platform for re-certification is delivered by AMASS project. This thesis is expected to fill the specific gap: evaluate the compliance re-certification efficiency of the platform in the medical domain during the re-certification effort required as a consequence of a change in the normative space. Due to the lack of demonstrations in this safety-critical domain, the standard for medical devices, ISO 14971 with its versions and the Notified Bodies Recommendation Group (NBRG) Consensus paper are considered. There are several differences among them, in terms of the normative part and the fact whether they are international or only applicable in Europe. The evaluation will be conducted on acase study and the research has followed best practicing in case study design/execution. The focus is on two changes. The first change in the normative space is represented by the introduction of the EU directives (EU Medical Device Directives (MDDs): 90/385/EEC, 93/42/EEC, and 98/79/EC.) in relation to ISO 14971:2007, which required the introduction of ISO 14971:2012 (which applies only to manufacturers placing devices on the market in Europe). The second change is represented by the introduction of ISO 14971:2019, an international standard. Through the tool-chain (EPF Composer-BVR Tool), the families of standards and processes are modeled. The reuse of components is assessed through the application of selected metrics creating the measurement framework.The aim is to increase evidence according to the usefulness of the tool-chain in other domains. This master thesis will contribute with a case study evaluation of the tool-chain (a subset of the platform), considering cross-jurisdictional challenges. This work could represent the starting point for an evaluation where not only reference-processes are considered, but also the processes actually modelled in industrial settings.

Paper-fluidic devices are a popular platform for point-of-care diagnostics due to their low cost, ease of use, and equipment-free detection of target molecules. The most common example is the lateral flow assay, in which samples are added to a paper membrane and a colorimetric indicator provides a binary signal indicating whether the molecule of interest is present. A novel lateral flow assay was developed to detect a protein biomarker for early stage cervical cancer. Cervical cancer can be cured if detected and treated at an early stage, but approximately 90% of cervical cancer deaths occur in low and middle-income countries due to lack of accessible testing. Methods for detecting the biomarker, valosin-containing protein (VCP), were optimized using enzymatic and gold nanoparticle dot blots, then lateral flow assays were developed and validated using purified VCP and cervical cancer HeLa cells. Future validation with patient tissue samples will permit translation of this device to testing clinics in low-resource areas. Despite advantages for use in resource limited settings, lateral flow assays are limited by their inability to perform more complex or multi-step processes, such as nucleic acid amplification or enzymatic signal enhancement. Thermally actuated wax valves are one mechanism that provides complete control over fluid obstruction and release. To better understand how wax valves can be used in fully automated, self-contained lateral flow assays, different sizes and geometries of valves were tested to investigate their effects on actuation time, flow rate, and flow pattern. Another limitation in the understanding of lateral flow assays is the lack of experimental data describing the microscale flow within the pores of the paper membrane that drives the biophysical reactions in the assay. Mathematical models can be designed to explain macroscopic phenomena, but so far, no literature has compared microfluidic models to microfluidic data. To quantify microfluidic properties within lateral flow assays, fluorescent nanoparticles were imaged flowing through different areas of the membrane and their velocity was quantified using micro-particle image velocimetry (µPIV). Scanning electron microscope images were used to verify that this experimental model was reasonable for describing microfluidic properties of the lateral flow assay. Altogether, this document investigates how developing lateral flow assays for cervical cancer detection can save lives by improving the accessibility of an early diagnosis, and how more robust lateral flow assay characterization can expand their applicability to a broad range of detection processes.

Für die Zulassung von Medizinprodukten ist eine geprüfte mechanische und elektrische Sicherheit und eine validierte Gebrauchstauglichkeit gesetzlich vorgeschrieben. Für den Erfolg eines Medizinproduktes ist die Umsetzung dieser Anforderungen allein nicht ausreichend. Mit dem Ziel, sowohl Anwender als auch Patienten nachhaltig zu begeistern, ist es mittlerweile notwendig, Usability Engineers und Produktdesigner in die Entwicklung einzubeziehen. Je frühzeitiger dies gelingt, umso größer ist das Potential des nutzerzentrierten Designs und damit die Wahrscheinlichkeit des Markterfolges. Aufgrund der zunehmenden Komplexität und der immer kürzer werdenden Entwicklungszeiten erfordert dies ein tiefgreifendes Verständnis der relevanten Normen und Regularien bei den beteiligten Partnern. [... aus der Zusammenfassung]

<p>In the year of 2020, an international pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has afflicted tens of millions of people’s life also disrupting global economics. Diagnostic testing is an important part of ensuring public health until a vaccine that has been shown to be safe and effective is made available to the general public. Most tests for detecting COVID-19 utilize quantitative polymerase chain reaction (qPCR) assays, which is a specific and relatively simple quantitative assay that could provide adequate sensitivity for diagnosing early infection. Although powerful, these lab-based molecular assays have a significant lag time, usually several days before receiving results. To satisfy the needs of different purposes (diagnostics, screening, and surveillance), a unified approach is impractical. This thesis presents an alternative testing method supporting the current procedure of point of care (POC) testing and in community testing. This paper-based test overcomes the limitations of current testing methods by utilizing reverse-transcription loop-mediated isothermal amplification (RT-LAMP) and receiving the result on-site by a color change in the presence of the virus within 60 minutes. The test utilizes untreated freshly collected saliva, a less invasive specimen, as the sample and possesses a limit of detection (LoD) of 200 copies of virus per microliter of whole saliva with an analytical sensitivity of 97% and analytical specificity of 100%. The test requires minimal operator training and could be fabricated on a large-scale using roll-to-roll methods. Since the test is based on nucleic acids, the testing platform itself lends to further applications <a>including food safety monitoring, animal diagnostic, etc. simply by changing the specific primers</a>. </p>

Una de las principales causas del crecimiento económico del Perú es la integración comercial con el mundo, lo que ha originado la firma de 20 acuerdos comerciales, entre ellos el TLC con China, que ha permitido el incremento de las importaciones de dispositivos médicos provenientes de ese país, impulsados por su bajo costo y la reducción de los aranceles de importación. Sin embargo, la oferta es insuficiente para atender al mercado nacional. A pesar de haber grandes importadores como 3M Perú, Laboratorios Americanos o Utilitarios Médicos, ninguno asume una posición de dominio de mercado, no tienen mayor influencia en los precios, por lo que podemos deducir que estamos ante un mercado competitivo. Esto es una oportunidad para las Mypes, que al 2017 representaban el 99.4% del total de empresas en el Perú. La mayor concentración está en Lima, siendo la zona Centro la principal ubicación de estas empresas. Esta tesis ha sido realizada debido a la necesidad de descubrir el impacto de los factores internos y externos que influyen en las micro y pequeñas empresas, ubicadas en Lima Cercado, que importan dispositivos médicos desde China, puesto que, al tener un conocimiento profundo de estos factores, permitirá guiar a aquellos emprendedores que deseen invertir, dándoles herramientas que ahonde su conocimiento en el sector y a los actuales empresarios que buscan la reducción de riesgos en sus procesos de importación, a efectos de volverse más competitivos. Además, deseamos que nuestra tesis sirva como antecedente para próximas investigaciones vinculadas al sector. / One of the main reasons of Peru's economic growth is trade integration with the world, which has led to the signing of 20 trade agreements, including the FTA with China, which has allowed the increase in medical device’s imports from that country, driven by its low cost and the reduction of import tariffs. However, the offer is insufficient to serve the national market. Despite having large importers such as 3M Peru, American Laboratories or Medical Utilities, none assumes a position of market dominance, they do not have a greater influence on prices, so we can deduce that we are facing a competitive market. This is an opportunity to Mypes, which as of 2017 represented 99.4% of all companies in Peru. The highest concentration is in Lima, with the Central area being the main location for these companies. This thesis has been realized due to the need to discover the impact of internal and external factors influences micro and small companies, located in Lima Cercado, which imports medical devices from China, since, having a deep knowledge of these factors, it will allow to guide those entrepreneurs who wish to invest, giving them tools to deep their knowledge in the sector and current entrepreneurs who seek to reduce risks in their import processes, to become more competitive. In addition, we want our thesis to serve as an antecedent for future research related to the sector. / Tesis

<p>  </p> <p>Cavitation, liquid slosh, and splashes are ubiquitous in science and engineering. However, these phenomena are not fully understood. Yet to date, we do not understand when or why sometimes the splash seals, and other times does not. Regarding cavitation, a high temporal resolution method is needed to characterize this phenomenon. The low temporal resolution of experimental data suggests a model-based analysis of this problem. However, high-fidelity models are not always available, and even for these models, the sensitivity of the model outputs to the initial input parameters makes this method less reliable since some initial inputs are not experimentally measurable. As for sloshing, the air-liquid interface area and hydrodynamic stress for the liquid slosh inside a confined accelerating cylinder have not been experimentally measured due to the challenges for direct measurement.</p>

No description available.

<p>Glaucoma is the leading cause of irreversible blindness worldwide. While current therapies aim to lower elevated intraocular pressure (IOP) to prevent blindness, they often do not provide the desired long-term efficacy, can fail over time, and have systemic side effects. Electroceutical stimulation can be a solution to many of these current issues with glaucoma treatment, as it is believed to have fewer systemic side effects and quicker response times. The goal of this work is to develop and demonstrate a novel system using electrical stimulation to lower intraocular pressure. I present data from a human clinical study and an ongoing clinical trial of the IOPTx™ system, a wearable electroceutical for treating glaucoma, that provides preliminary evidence of efficacy and safety. <a>Furthermore, no current glaucoma treatments allow for closed-loop, continuous monitoring of IOP, requiring more frequent doctor visits or forcing patients and clinicians to operate in the dark. Using an electroceutical therapeutic device with closed-loop feedback and continuous IOP recording can improve glaucoma management. I combined a pressure sensor with this electroceutical therapy, implanted the sensor and stimulation coils in rabbits, and stimulated the eyes. However, to better understand the optimal stimulation parameters, long-term effects, and mechanisms of action, an integrated circuit is designed as part of a fully implantable, closed-loop device. The chip was fabricated in 0.18 </a>µm CMOS process and validated on the benchtop and <i>in vivo</i>. In the future, this electroceutical device has the potential to be a novel treatment for patients suffering from glaucoma.</p>