@inproceedings{CarlHochmann2021,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {Regulatory Framework for 3D Printed Custom-Made Devices in Europe},
  series = {Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz},
  booktitle = {Beitrag zur 3. Additive Manufacturing Meets Medicine (AMMM) Konferenz},
  issn      = {2699-1977},
  doi       = {10.18416/AMMM.2021.2109542},
  year      = {2021},
  abstract  = {Additive manufacturing (AM) has been growing continuously over the past 20 years, enabling unprecedented tailoring to the anatomy of each patient. In Europe, custom-made devices qualify for an exemption and pass a simplified approval process. New technologies, like AM, provoke questions about the adequacy of the current regulatory framework for custom-made devices. This article addresses the regulatory requirements for such devices in Europe and discusses the implications for AM. It concludes that the legal framework for custom-made devices entails uncertainties which need to be resolved to guide manufacturers through the regulatory requirements, highlighting the specific areas of focus for AM.},
  language  = {en}
}
@article{CarlHochmann2022,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {Comparison of the regulatory requirements for custom-made medical devices using 3D printing in Europe, the United States, and Australia},
  series = {Biomedical Engineering / Biomedizinische Technik},
  volume    = {67},
  journal   = {Biomedical Engineering / Biomedizinische Technik},
  number    = {6},
  issn      = {1862-278X},
  doi       = {10.1515/bmt-2021-0266},
  pages     = {61 -- 69},
  year      = {2022},
  abstract  = {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.},
  language  = {en}
}
@incollection{CarlHochmann2022,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {In-silico Methoden im Zulassungsprozess. Regulatorische Anforderungen an computergest{\"u}tzte Modellierung und Simulation},
  series = {Medizinprodukte planen, entwickeln, realisieren. Der CE-Routenplaner},
  booktitle = {Medizinprodukte planen, entwickeln, realisieren. Der CE-Routenplaner},
  publisher = {T{\"U}V Media GmbH T{\"U}V Rheinland Group},
  address   = {K{\"o}ln},
  isbn      = {978-3-7406-0716-6},
  publisher      = {FH M{\"u}nster - University of Applied Sciences},
  pages     = {1 -- 15},
  year      = {2022},
  abstract  = {Die computergest{\"u}tzte Modellierung und Simulation (CMS) ist in vielen Bereichen der Industrie g{\"a}ngige Praxis und hat das Potenzial, die Medizintechnikbranche zu revolutionieren. Die Markteinf{\"u}hrung neuer Produkte kann erheblich beschleunigt und entstehende Kosten k{\"o}nnen reduziert werden, ohne die Patientensicherheit negativ zu beeinflussen. Dennoch beruhen die Entwicklungs- und Zulassungsprozesse in der Medizintechnik bis dato {\"u}berwiegend auf experimentell ermittelten Daten, was in Europa unter anderem auf die bestehenden regulatorischen Unsicherheiten zur{\"u}ckzuf{\"u}hren ist. Verglichen mit der FDA hat die EU-Kommission die M{\"o}glichkeiten der CMS bisher nicht erkannt - es fehlt an rechtlichen Vorgaben. Der folgende Artikel soll daher eine {\"U}bersicht der aktuellen regulatorischen Situation bieten.},
  language  = {de}
}
@inproceedings{CarlHochmann2022,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {Aktueller Stand der regulatorischen Vorgaben f{\"u}r 3D-gedruckte Sonderanfertigungen in Europa},
  series = {Beitrag zur OTWorld 2022},
  booktitle = {Beitrag zur OTWorld 2022},
  year      = {2022},
  language  = {de}
}
@article{CarlHochmann2021,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {MDR - Wie gut vorbereitet ist die Hilfsmittelbranche?},
  series = {mt-medizintechnik},
  volume    = {141},
  journal   = {mt-medizintechnik},
  number    = {2},
  issn      = {0344-9416},
  pages     = {34 -- 39},
  year      = {2021},
  abstract  = {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 f{\"u}r alle Akteure der Medizintechnikbranche in ganz Europa. Vor allem kleine und mittelst{\"a}ndische Unternehmen werden durch die Implementierung der MDR vor Herausforderungen gestellt. Das Ziel der durchgef{\"u}hrten Online-Befragung war es, ein umfassendes Erfahrungs- und Meinungsbild hinsichtlich der Akzeptanz und Umsetzbarkeit der MDR zu gewinnen. Hierf{\"u}r wurden H{\"a}ndler und Hersteller orthop{\"a}discher Hilfsmittel im Januar und Februar 2021 deutschlandweit anonymisiert befragt. In diesem Artikel werden die Ergebnisse der Umfrage ausf{\"u}hrlich dargestellt und diskutiert.},
  language  = {de}
}
@article{CarlHochmann2022,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {Regulatorische Anforderungen an Computergest{\"u}tzte Modellierung und Simulation},
  series = {mt-medizintechnik},
  volume    = {142},
  journal   = {mt-medizintechnik},
  number    = {4},
  issn      = {0344-9416},
  pages     = {14 -- 18},
  year      = {2022},
  abstract  = {Die computergest{\"u}tzte Modellierung und Simulation (CMS) ist in vielen Bereichen der Industrie g{\"a}ngige Praxis und hat das Potenzial die Medizintechnikbranche zu revolutionieren. Die Markteinf{\"u}hrung neuer Produkte kann erheblich beschleunigt und entstehende Kosten k{\"o}nnen reduziert werden, ohne die Patientensicherheit negativ zu beeinflussen. Dennoch beruhen die Entwicklungs- und Zulassungsprozesse in der Medizintechnik bis dato {\"u}berwiegend auf experimentell ermittelten Daten, was in Europa unter anderem auf die bestehenden regulatorischen Unsicherheiten zur{\"u}ckzuf{\"u}hren ist. Verglichen mit der FDA hat die EU-Kommission die M{\"o}glichkeiten der CMS bisher nicht erkannt - es fehlt an rechtlichen Vorgaben. Der folgende Artikel soll daher eine {\"U}bersicht der aktuellen regulatorischen Situation bieten.},
  language  = {de}
}
@inproceedings{CarlKirillovHochmannetal.2023,
  author    = {Carl, Ann-Kathrin and Kirillov, Maxim and Hochmann, David and Quadrat, Eric},
  title     = {Towards credible computational models: Application of a risk-based framework for establishing credibility},
  series = {Transactions on Additive Manufacturing Meets Medicine},
  booktitle = {Transactions on Additive Manufacturing Meets Medicine},
  issn      = {2699-1977},
  doi       = {10.25974/fhms-17382},
  url       = {http://nbn-resolving.de/urn:nbn:de:hbz:836-opus-173821},
  year      = {2023},
  abstract  = {The use of computational modeling and simulation (CMS) as a tool for gaining insight into the technical performance and safety of medical devices has emerged continuously over the past years. However, to rely on information and decisions derived from model predictions, it is essential to establish model credibility for the specific context of use. Limited regulatory requirements and lack of consensus on the level of verification and validation activities required result in rare use of CMS as a source of evidence in the medical device approval process. The American Society of Mechanical Engineers (ASME) developed a risk-informed framework to establish appropriate credibility requirements of a computational model: the ASME V\&V 40?2018 standard. This paper aims to outline the concepts of this standard and to demonstrate its application using an example from the orthotics field. The necessary steps to establish model credibility for a custom?made 3D printed wrist hand orthosis (WHO) are presented. It is shown that the credibility requirements of each verification and validation activity depend on model risk by applying two different contexts of use to the same computational model.},
  language  = {en}
}
@article{CarlHochmann2023,
  author    = {Carl, Ann-Kathrin and Hochmann, David},
  title     = {Impact of the new European medical device regulation: a two-year comparison},
  series = {Biomedical Engineering / Biomedizinische Technik},
  journal   = {Biomedical Engineering / Biomedizinische Technik},
  issn      = {1862-278X},
  doi       = {10.25974/fhms-17381},
  url       = {http://nbn-resolving.de/urn:nbn:de:hbz:836-opus-173816},
  year      = {2023},
  abstract  = {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.},
  language  = {en}
}
@article{Hochmann2019,
  author    = {Hochmann, David},
  title     = {3D-Printing in Zechnical Orthopedics - Current Status and Oulook},
  series = {How To Treat},
  volume    = {2019},
  journal   = {How To Treat},
  number    = {1},
  pages     = {45 -- 49},
  year      = {2019},
  language  = {en}
}
@article{Hochmann2019,
  author    = {Hochmann, David},
  title     = {3D-Druck in der Technischen Orthop{\"a}die - Stand und Perspektiven},
  series = {Orthop{\"a}die-Technik},
  volume    = {70},
  journal   = {Orthop{\"a}die-Technik},
  number    = {5},
  issn      = {0340-5591},
  pages     = {18 -- 23},
  year      = {2019},
  language  = {de}
}