AG PolyMORE combines a broad spectrum of expertise in the fields of medical technology, implantology, additive manufacturing, polymer materials, surface functionalization and regulatory strategies. The vision of the expert group and the goal of the joint efforts can be described with the following statement: “For the benefit of the patient, we pursue the transfer of pioneering, medical technology concepts into industrial application. The aim is to comply with all regulatory requirements or to "redefine" them in the sense of MDR (EU) 2017/745 and all applicable laws.”
Regulatory Thinking and a Human Centric Regulatory Approach
A methodological thinking approach called “Human Centric Regulatory” (HCR), defined by RegulatoryExperts@ETHzürich will be applied to the research and development efforts of the expert group members to ensure that the most promising research results can be translated into industrial applications. HCR is a regulatory strategy in the sense of “Regulatory Thinking” (RT) that considers the interests of the various stakeholders in medical technology. Stakeholders identified are patients, physicians and healthcare professionals, operators of medical centers and hospitals, insurance companies and health insurers, certification authorities and notified bodies.
In addition to efforts in research, design, and development, it is important for the members of the consortium to consider the various needs of the different stakeholders: safety, performance and efficacy of the products, verification and validation of the technologies, transparency in documentation, proof of positive healthcare effect, as well as compliance with regulatory requirements (MDR (EU) 2017/745) and legal requirements such as -e.g.- the MPBetreibV (Medical Devices Operator Ordinance) in Germany. During product or technology development the group will follow the S.P.E.L. (Safety and Performance Evidence Level) requirements.
The next consortium meeting is planned to be held in Berlin, November 2021, hosted by Priv. Doz. Dr. Andreas Schwitalla, Charité Universitätsmedizin Berlin.
Information about AG PolyMORE: www.meddev.news
in cooperation with:
Stiftung für Medizin-Innovationen
Medical Innovations Incubator GmbH
MedDEV News ISSN 2673-7663
Founding members AG PolyMORE
A1. Dipl. Auditor, Lead Technical Assessor Dietmar Schaffarczyk, RegulatoryExperts@ETHzürich. Our regulatory experts 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
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 spineFuseMBT 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.
I4. QS – QS Schaffhausen AG is an accredited Certification Body. QS understands "Regulatory Thinking" and "Human Centric Regulatory" as a “certification culture” that transfers scope for action to the business of the customers, insofar as the applicable regulations permit this. QS Schaffhausen AG is accredited by the Swiss Accreditation Service (SAS). Partner companies and firms that are also committed to the QS performance standard contribute further accreditations and notifications of their own, which QS can arrange for the needs of its customers.
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