Physikingenieurwesen (PHY)
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Faculty
The extended quasiparticle picture is adapted to non-Fermi systems by suggesting a Pad´e approximation which interpolates between the known small scattering-rate expansion and the deviation from the Fermi energy. The first two energy-weighted sum rules are shown to be fulfilled independent of the interpolating function for any selfenergy. For various models of one-dimensional Fermions scattering with impurities the quality of the Pad´e approximation for the spectral function is demonstrated and the reduced density matrix or momentum distribution is reproduced not possessing a jump at the Fermi energy. Though the two-fold expansion is necessary to realize the spectral function and reduced density, the extended quasiparticle approximation itself is sufficient for the description of transport properties due to cancellation of divergent terms under integration.
The T-matrix approximation leads to the delay time as the time two particles spend in a correlated state. This contributes to the reduced density matrix and to an additional part in the conductivity which is presented at zero and finite temperatures. Besides a localization at certain impurity concentrations, the conductivity shows a maximum at small temperatures interpreted as onset of superconducting behaviour triggered by impurities. The Tan contact reveals the same universal behaviour as known from electron-electron scattering.
Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for an exemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not all jurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM.
Im Mittelpunkt der Medizintechnikbranche stand in den letzten Jahren fast ausschließlich ein Thema: die Medical Device Regulation, kurz MDR. Mit Inkrafttreten der MDR steigen die regulatorischen Anforderungen für alle Akteure der Medizintechnikbranche in ganz Europa. Vor allem kleine und mittelständische Unternehmen werden durch die Implementierung der MDR vor Herausforderungen gestellt. Das Ziel der durchgeführten Online-Befragung war es, ein umfassendes Erfahrungs- und Meinungsbild hinsichtlich der Akzeptanz und Umsetzbarkeit der MDR zu gewinnen. Hierfür wurden Händler und Hersteller orthopädischer Hilfsmittel im Januar und Februar 2021 deutschlandweit anonymisiert befragt. In diesem Artikel werden die Ergebnisse der Umfrage ausführlich dargestellt und diskutiert.
Die computergestützte Modellierung und Simulation (CMS) ist in vielen Bereichen der Industrie gängige Praxis und hat das Potenzial die Medizintechnikbranche zu revolutionieren. Die Markteinführung neuer Produkte kann erheblich beschleunigt und entstehende Kosten können reduziert werden, ohne die Patientensicherheit negativ zu beeinflussen. Dennoch beruhen die Entwicklungs- und Zulassungsprozesse in der Medizintechnik bis dato überwiegend auf experimentell ermittelten Daten, was in Europa unter anderem auf die bestehenden regulatorischen Unsicherheiten zurückzuführen ist. Verglichen mit der FDA hat die EU-Kommission die Möglichkeiten der CMS bisher nicht erkannt – es fehlt an rechtlichen Vorgaben. Der folgende Artikel soll daher eine Übersicht der aktuellen regulatorischen Situation bieten.
Objectives: In recent years, the European Union has revised its regulatory framework for medical devices, primarily to improve patient safety and public health. The Medical Device Regulation (MDR) is fully applicable since May 2021, strengthening the requirements for all stakeholders. As a result, many companies are facing enormous challenges. The aim of this study was to assess the impact of the MDR on the orthopaedic aids industry.
Methods: Two surveys were conducted: one shortly before the MDR became applicable (146 respondents) and a second survey almost two years later (233 respondents).
Results: Both surveys revealed that all businesses in the orthopaedic aids sector, regardless of size, have difficulty implementing the MDR. Key challenges include additional workload for technical documentation, increased resource expenditure and cost, and lack of clarity regarding the new requirements. Many companies are downsizing their product portfolio, resulting in potential supply shortages and a loss of competitive advantage and innovation for the medical device industry in Europe.
Conclusions: The full extent of the MDR’s impact on clinical practice is still unclear. However, many companies lack the necessary resources. The MDR can potentially be a bottleneck in the availability of medical devices.