On May 16, 2019, representatives of the Chinese medical device industry and leading universities convened for the first Sim4Life Workshop at CMEF Spring 2019 in Shanghai, China. The event was hosted by Michael Oberle of ZMT and Selena Hsu from Auden Technology.
“RF safety of Ultrahigh field MRI”, was the title of the outstanding first presentation given by Ye Li from the Chinese Academy of Sciences, Shenzhen Institutes of Advanced Technology, China. He introduced the audience to ultrahigh field (UHF) magnetic resonance imaging (MRI) and the advantages of this technology for neuroscience and brain research, and provided some insights into the new and exciting “Pre-14T Human MRI” project. Ye Li also addressed the two key challenges of UHF MRI, namely the transmit B1+ inhomogeneities in large body cross-sections, and the radiofrequency (RF) power deposition in tissue (i.e., specific absorption rate). He then described how computational modeling and simulation with e.g., Sim4Life as well as experimental validation techniques such as a flexible and high-precision near-field scanner from ZMT’s sister company Schmid & Partner Engineering AG (SPEAG), or the torso phantom from the IT’IS Foundation (IT’IS) with built-in sensors for measurement of MRI-induced fields can contribute to solve these problems.
Wolfgang Kainz, Senior Principal Scientist at the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA), outlined why computational modeling and simulation has become an essential part of FDA’s required safety and effectiveness evaluation of medical devices, especially in the context of MRI safety R&D, as well as of the related total product life cycle (TPLC) management. He also explained how these processes are regulated by FDA guidelines. By sharing practical examples from real device applications to the FDA, he was able to demonstrate both the key advantages and the potential pitfalls of the methodology. The presentation concluded with helpful insights on verification and validation procedures and the importance of a sound uncertainty analysis.
Niels Kuster of IT’IS introduced the audience to the Z43 Strategic Alliance, which consists of the tree partner organizations IT’IS, ZMT, and SPEAG. Habib Bousleiman provided an in-depth introduction of the IT’IS Virtual Population as well as ZMT’s flagship product Sim4Life. Hands-on examples showed a variety of successful applications for the design, optimization, and safety evaluation of wireless body area networks, MRI systems, and neurostimulation devices. Finally, Aiping Yao of IT’IS presented her work on “MRI RF Safety Evaluations for Active and Passive Implantable Devices”, showing how ZMT’s IMAnalytics and the MRIxViP field exposure database as well as the Medical Implant Test Systems (MITS) help customers worldwide to successfully perform safety evaluations following IEC/ISO 10974 or ASTM F2182 standards.
The dense but very constructive workshop ended with a light networking aperitif where participants had the chance to discuss remaining questions and share their experiences with each other.
Once again, many thanks to everyone who contributed to the success of the event and see you again at CMEF Spring 2020!