Application of risk management for it-networks incorporating medical devices

2015 ◽  
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.


Author(s):  
Karolina Jagiello ◽  
Anita Sosnowska ◽  
Alicja Mikolajczyk ◽  
Tomasz Puzyn

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.


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