TY  - JOUR
A1  - Carl, Ann-Kathrin
A1  - Hochmann, David
T1  - Comparison of the regulatory requirements for custom-made medical devices using 3D printing in Europe, the United States, and Australia
JF  - Biomedical Engineering / Biomedizinische Technik
N2  - 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.
KW  - additive manufacturing
KW  - AM
KW  - personalized medical devices
KW  - regulation
Y1  - 2022
U6  - http://dx.doi.org/10.1515/bmt-2021-0266
SN  - 1862-278X
VL  - 67
IS  - 6
SP  - 61
EP  - 69
ER  - 
TY  - CHAP
A1  - Feldmann, Carsten
A1  - Delke, Vincent
A1  - Wasserman, Michael E.
T1  - Strategically Aligning Additive Manufacturing Supply Chains for Sustainability and Effectiveness
T2  - International Federation of Automatic Control (IFAC): Intelligent Manufacturing Systems (IMS 2019) Proceedings
N2  - This paper builds on a previously developed framework that integrated additive manufacturing, life-cycle analysis, and value creation (Feldmann & Kirsch, 2019) by exploring conditions related to the life-cycle approach that would require alignment among suppliers, additive manufacturing firms, and customers. This extension creates a bridge to aid implementation of taking a sustainability approach to additive manufacturing. In order to develop this extension, we distinguish between direct/indirect customers and internal/external customers and then create a matrix of incentives and cognitive frames that we believe will help companies interested in large-scale AM improve both the speed and the effectiveness of AM adoption. We provide an organizing framework that managers can use to create a supply chain that is aligned around closed-loop principles that will help speed adoption and move closer to sustainable goals that exist for AM technologies. These include reduced raw material use, reduced scrap and material overage, and reduced rework, and lower transportation costs. The goal is to attain often-conflicting goals of lower long-term costs and decreased environmental footprint. Using our extension, we believe we can provide a useful framework to help managers implementing advanced manufacturing technologies to achieve lower costs and greater environmental sustainability by creating a common supply chain framework around customized, on-demand products.
KW  - supply chain
KW  - additive manufacturing
Y1  - 2019
SN  - 2405-8963
SP  - 260
EP  - 264
CY  - Oshawa, Ontario, Canada
ER  -