TY  - CHAP
A1  - Carl, Ann-Kathrin
A1  - Kirillov, Maxim
A1  - Hochmann, David
A1  - Quadrat, Eric
T1  - Towards credible computational models: Application of a risk-based framework for establishing credibility
T2  - Transactions on Additive Manufacturing Meets Medicine
N2  - 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.
KW  - computational modeling and simulation
KW  - CMS
KW  - validation
KW  - V&V 40
KW  - model credibility
Y1  - 2023
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:hbz:836-opus-173821
SN  - 2699-1977
ER  - 
TY  - JOUR
A1  - Carl, Ann-Kathrin
A1  - Hochmann, David
T1  - Impact of the new European medical device regulation: a two-year comparison
JF  - Biomedical Engineering / Biomedizinische Technik
N2  - 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.
KW  - orthopaedic aids
KW  - medical device regulation
KW  - MDR
KW  - survey
Y1  - 2023
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:hbz:836-opus-173816
SN  - 1862-278X
ER  -