07.2022 – 09.2022 Clinical Outcome, Patient Care and Solid Fusion: Method Collection Spinal Fusion Technologies
Zweck: Method Collection & kritische Literaturreview der Studienendpunkte in Spinal Fusion Applications, um erfolgreiche Fusion und die zufriedenstellende Patientenversorgung nach erfolgter „Spinal Fusion Technologien“ zu belegen. Ein weiteres Ziel ist die vergleichende Darstellung zeitlicher Unterschiede hinsichtlich „time to fuse“ bei cervicalen und lumbalen Indikationen und Operationstechnologien. Damit einhergehend die Dokumentation möglicher Unterschiede, resultierend aus den eingesetzten Implantatmaterialien und der durchgeführten Operationstechnik.
Überblick über die Literatur: In zahlreichen Studien wird über erfolgreiche Fusion und zufriedenstellende Patient Care berichtet. Fusionsraten innerhalb „cervicaler interbody fusion“ und „lumbaler interbody fusion“ weisen dabei aber eine erhebliche zeitliche Varianz auf. Ein Vergleich „cervicaler fusion“ mit „lumbaler fusion“ macht diese Varianz noch deutlicher.
Während Faktoren wie Implantattyp, Implantatmaterial, OP-Technik Einfluss auf die Fusionsrate haben, kann ein weiterer Unterschied auch in der „Definition von Fusion“ liegen und in der Tatsache, dass herkömmliche festgelegte Beobachtungszeitpunkte überdacht, neu bewertet und vereinheitlicht werden müssen. Dazu soll der „klinische Outcome“ (fusion) wie auch den „Patienten-spezifischen Outcome“ (sufficient patient care) in der „Method Collection Spinal Fusion“ analysiert werden.
Methoden: Es wird eine umfassende englische PubmedMedline- und Google Scholar Literaturrecherche unter Verwendung einschlägiger Schlüsselwörter durchgeführt. Es werden „Legal Manufacturer“ von Spinal Fusion Implants“ zu deren PMS/PMCFu Erfahrungen befragt.
Wir teilten die Ergebnisse in zwei Hauptgruppen [a] „reported clinical outcome“ und [b] „reported sufficient patient care“ mit jeweils mehreren Untergruppen [a1] „cervical“ und [a2] „lumbar“ sowie [b1] „cervical“ und [b2] „lumbar“ ein.
Die eingeschlossene Literatur und die Resultate der PMS / PMCFu werden anschliessend hinsichtlich der Anzahl der Patienten, der Nachbeobachtungszeit, des Implantatyps, Implantatmaterials und Instrumentalisierung sowie OP-Technik analysiert. Außerdem wird die Literatur daraufhin untersucht, ob eine (einheitliche) Definition von Fusion und Fusionsrate vorliegt.
Hintergrund: Recherchen im Vorfeld der „Method Collection Spinal Fusion“ zeigen, dass ein erheblicher Prozentsatz der veröffentlichten Studien Fusion beschreibt, ohne einheitliche Fusionskriterien oder Zeitpunkte zu definieren. Wir konnten auch feststellen, dass zu unterschiedlichen Beobachtungszeitpunkten keine deutliche Veränderungen der zu beobachtenden Parameter mehr stattgefunden haben.
Schlussfolgerungen: Wir schlagen vor, innerhalb der „Method Collection Spinal Fusion“ einheitliche Fusionskriterien zu definieren und mit PMS / PMCFu Daten zu belegen: „Fusion ist das Vorhandensein von überbrückendem Knochen (Bone Bridge / BB1) und die beginnende Einschränkung der Bewegung in Flexion und Extension (FE1) zu bestimmten Beobachtungszeitpunkte (T1/T2).“
Companies that already have applied:
Nexon Medical AG
7S AG
stimOS GmbH
Universitätsklinikum Leiden, Holland
Regulatory Experts ETH Zürich
dTIP
surgeSupply GmbH
30.06.2022 – 01.10.2022. Future Technologies in Precision Medicine and Patient Centricity. Apply now to contribute: You are a researcher or legal manufacturer? You are working with emerging technologies for the benefit of the patient? You have the patient in the center of your work? Contribute to this method collection and share with us your projects. This method collection is open for: POC Technologies, SaMDs, IVDs, Finishing Technologies, Medical Devices, Borderline Concepts
Companies that already have applied:
orion medical GmbH
S2B GmbH
Odilia Vision GmbH
Leila/Levy
stimOS GmbH
27.09.2021 – 31.03.2022, Polymer Science-2021: The aim of the Polymer Science-2021 is to promote quality research and real-world impact in an atmosphere of true international cooperation between scientists and engineers by bringing together the world class researchers, International Communities and Industrial heads to discuss the latest developments and innovations in the fields of Polymer and Material Science.
>> You can find the conference program here.
>> You can see the lecture of AG PolyMORE here.
We are looking forward to seeing you at Polymer Science-2021 in Lyon, France.
Zurich, 21.09.2021:
Hosted by RegulatoryExperts@ETHzürich:
AG PolyMORE – Opening meeting
21.09.2021: Opening meeting
Expert-Panel AG PolyMORE,
hosted by RegulatoryExperts@ETHzürich
Call for ABSTRACTS
Method Collection PolyMORE
Intelligent solutions in medical technology:
AG PolyMORE – Consortium and expert panel founded
Berlin, Constance, Zurich – 2021-09-07. The advances made in healthcare over the last decade in manufacturing, optimization and delivery of medical products within a shortened supply chain bring both benefits for patients and further challenges for manufacturers and users of these types of products. In recent years, the high-performance polymer polyetheretherketone (PEEK) has become increasingly popular in medical applications due to its good mechanical properties, making it an excellent alternative to metallic materials for load-bearing applications.
Click here to read the Press Release
The healthcare industry is undergoing a profound transformation: one of the key enablers of this transformation is the proliferation of point-of-care (POC) technologies that can improve clinical outcomes and reduce costs through better access. POC technologies have the potential to improve the management and treatment of various diseases and conditions, especially in resource-limited settings where healthcare infrastructure is weak and access to quality and timely care is challenging.
Polymers versus Metals
While personalized or functionalized implants or medical devices made from metals have been reentering the market for years and in some cases define the golden standard in orthopedic applications, polymer materials are hardly used in this field.
PEEK products with sophisticated shapes and controlled architecture can currently be manufactured using various 3D printing technologies. However, the mechanical properties, surface functionalities, and biocompatibility of 3D-printed PEEK and its composites are still unclear and partly only explored in an academic-experimental set-up.
Therefore, representatives from industry and academia have now joined forces to make the use of polymers in personalized medical technology available to users – surgeons and orthopedic surgeons from a wide range of disciplines – in a way that is (a) industrially scalable, (b) fundable by patients and insurance companies and (c) certifiable by regulators: “Together we are planning a consortium of highly specialized polymer experts. Our goal is to reach and integrate in this project as many researchers and experts as possible, from industry, academia, and the authorities. This is exactly the right time to discuss smart polymers, smart manufacturing methods and smart regulatory strategies”, explains Dietmar Schaffarczyk A1, I3, Expert for Regulatory Strategies and Surface Functionalization.
High Five PolyMORE
“We will report continuously on our work”, explains Christoph Koslowski, co-initiator of the consortium. “As a partner for our initiative, we were able to win MedDEV News (www.meddev.news), which will support us with the possibility of open-source publishing.”1. PolyMORE: More Freedom in Design and Geometry
1. PolyMORE: More Freedom in Design and Geometry
2. PolyMORE: More Functionalities for Medical Surfaces
3. PolyMORE: More High-tech Filaments on the Market
4. PolyMORE: More Manufacturing Technologies
5. PolyMORE: Less Metal Medical Devices
Starting members of the consortium AG PolyMORE
Advisors
A1. Dipl. Auditor, Lead Technical Assessor Dietmar Schaffarczyk, ETH Zurich: Regulatory Experts @ ETH / digital Trial Intervention Platform (dTIP) focus on a human centric regulatory approach and guide academia and industry in defining regulatory strategies and certification pathways to drive forward health-related research and to transfer academic research into industrial applications. dTIP has been created to guide researchers and spin-offs in implementing clinical trials. Our mission is to support generation of human evidence for new medical solutions at ETH. The platform will collaborate with a network of clinical partners. In addition, there will be systematic research to establish new types of clinical research modes, including remote, decentralized trials and to utilize digital technology to characterize physiological function under real-world conditions. These activities are embedded in current global initiatives to advance clinical trials like the Clinical Trial Transformation Initiative (CTTI) and the EU Innovative Medicines Initiative (IMI). Regulatory Experts @ ETH will systematically investigate new regulatory strategies. This will lead to new standards, common specifications, and structures.
A2. Priv.-Doz. Dr. Andreas Schwitalla, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Aßmannshauser Str. 4-6, 14197 Berlin, Germany.
A3. Sebastian Spintzyk , Carinthia University of Applied Sciences, Europastraße 4, 9524 Villach, Austria. Research interests: Additive and subtractive manufacturing in dentistry and biomedical engineering; digital workflow (CAD/CAM); scanning; rapid prototyping; rapid manufacturing
Industries
I1. IPC – Innovative Polymer Compounds is a specialist ISO 13485:2016-approved compounder of medical grade engineering polymers for a wide range of medical devices including long-term implantable, short-term implantable and external devices. IPC produces pellets from a mixture of pellets, pigments and powders through a process called compounding, a form of blending. Our customers use these pellets to make their medical devices. Our compounds are used in long- and short-term implantable applications such as: vascular tubing, neurological tubing, female health, orthopedics, gastric, ophthalmic, dental. Our latest investments are a filament maker (3Devo) for medical 3D printing applications and an additional smaller compounder (20mm) which improves material distribution and minimizes waste, making it ideal for medical 3D printing applications.
I2. Orion Additive Manufacturing is a privately held company focused on scientific research and the development of additive manufacturing technologies to solve today’s complex problems and create innovative solutions for tomorrow. Originally focused on developing highly regulated aerospace solutions, Orion AM developed the A150 series printers using patented Thermal Radiation Heating (TRH) technology. With knowledge of highly regulated environments and very complex parts using high performance polymers, Orion AM translated its knowledge into the development of the first medical printer, the M150 series. The Orion Medical System is designed and structured to easily adapt to any clinical scenario. It can create 3D prints based on patient-specific anatomy. In this way, surgeons can plan, visualize, simulate, and develop a better understanding of possible solutions for congenital or acquired pathologies.
I3. stimOS GmbH, a research company and 13485:2016-certified legal manufacturer, was founded in 2015. stimOS develops innovative technologies and processes for the refinement, functionalization, and activation of implant materials. As a supplier and service provider, stimOS makes this technology available to implant manufacturers. In addition, the company offers services in product development and certification and develops implants for spinal fusion surgery with its spineFuse MBT product line. stimOS products for surface functionalization of implants under the MBT label are available in different categories: MBT osseo, MBT biocid, MBT dental, MBT active and MBT protect. All stimOS surface functionalization technologies show superiority in terms of bone cell growth. Comparative data from the Universities of Constance, Zurich and Charité Berlin show excellent results for all stimOS MBT surface treatments compared to currently available implant materials.
zyk@stimos.net >> Read the Press Release HERE.
MedDEV News 