Embracing Cybersecurity Risk Management in the Industry of Medical Devices

2018 ◽  
pp. 177-197 ◽  
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong
Keyword(s):  
Risk Management ◽  
Local Government ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Life Cycles ◽  
Shared Responsibility ◽  
Operating Environments ◽  
Set Up ◽  
Industry Needs

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.

Embracing Cybersecurity Risk Management in the Industry of Medical Devices

2021 ◽  
pp. 2044-2064
Author(s):  
Maria Lai-Ling Lam ◽  
Kei Wing Wong
Keyword(s):  
Risk Management ◽  
Local Government ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Life Cycles ◽  
Shared Responsibility ◽  
Operating Environments ◽  
Set Up ◽  
Industry Needs

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.

scholarly journals EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

2021 ◽  
Vol 9 (4) ◽  
pp. 33-36
Author(s):  
Vidya Sagar ◽  
Piyush Patel ◽  
Avni Rana ◽  
Bhavin Trivedi ◽  
Deepak Patel ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Management Plan ◽  
European Database ◽  
Periodic Safety ◽  
Post Market ◽  
Periodic Safety Update Report ◽  
Medical Device Regulation

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

scholarly journals Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products

Materials ◽  
2020 ◽  
Vol 13 (20) ◽  
pp. 4532 ◽  
Author(s):  
Elisa Giubilato ◽  
Virginia Cazzagon ◽  
Mónica J. B. Amorim ◽  
Magda Blosi ◽  
Jacques Bouillard ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Devices ◽  
Medical Diagnostics ◽  
Life Cycles ◽  
Environmental Risks ◽  
Medicinal Products ◽  
Management Framework ◽  
Advanced Therapy Medicinal Products ◽  
Risk Management Framework ◽  
Advanced Therapy

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Implementation of Industry 4.0 in Transformation of Medical Device Maintenance Systems

2020 ◽  
pp. 512-532 ◽  
Author(s):  
Lejla Gurbeta Pokvic ◽  
Lemana Spahic ◽  
Almir Badnjevic
Keyword(s):  
Artificial Intelligence ◽  
Medical Device ◽  
Medical Devices ◽  
Industry 4.0 ◽  
Traditional Approach ◽  
Clinical Engineering ◽  
Device Management ◽  
Real Time Analysis ◽  
Maintenance Systems

Due to the development of information communication technologies (ICT), the number of medical devices (MDs) with telemetric possibilities is rising, so the concept of homecare is gaining importance. Also, new generation medical devices are equipped with artificial intelligence that is able to perform real-time analysis of measurement result and provide diagnosis prediction. This is the Industry 4.0 happening now. However, there is still traditional approach in management of medical devices. As medical devices have been sophisticated, management systems should improve so they can encompass all the important aspects regarding safety of patients and quality of care. This chapter presents how the technology of Industry 4.0 can be used to improve medical device maintenance systems by application of artificial intelligence (AI). Clinical engineering and health technology management departments benefit from such systems in terms of increase of safety and quality of patient diagnosis and treatments, and cost optimization in medical device management.

scholarly journals Medical device risk management and its economic impact

2013 ◽  
Vol 59 ◽  
pp. 49-60 ◽  
Author(s):  
Katerina Krsteva Jakimovska ◽  
Marija Glavas-Dodov ◽  
Jasmina Tonic-Ribarska ◽  
Suzana Trajkovic-Jolevska
Keyword(s):  
Risk Management ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Economic Losses ◽  
Serious Adverse Events ◽  
Safety Level ◽  
Management Standards ◽  
Medical Device Manufacturers ◽  
Potential Risks

The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses

Equipment in anaesthesia

2017 ◽  
Author(s):  
Antony R. Wilkes
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Healthcare Workers ◽  
Small Children ◽  
Management Procedures ◽  
Different Types ◽  
First Time ◽  
Work First ◽  
Subsequent Patient

The anaesthetist will routinely use many different types of medical devices during normal working practice, and will have access to many other devices for more challenging use in emergency and other difficult scenarios. The anaesthetist will expect and rely on each medical device to work first time and not to compromise the safety of the user, the patient, their relatives, or other healthcare workers in the vicinity. The equipment will also be expected to be effective, that is, that it will perform as expected when used in a defined population of patients (e.g. small children). Manufacturers and users of equipment use risk management procedures to reduce the risk to patients and others of using the equipment. Following use, the equipment will need to be reprocessed to make it safe for use for a subsequent patient, or disposed of safely.

scholarly journals Risk management for medical devices in research projects

2015 ◽  
Vol 1 (1) ◽  
pp. 543-546
Author(s):  
Christian Sauter ◽  
Marion Heinloth ◽  
Andreas Tobola ◽  
Nadine Pensky ◽  
Christian Weigand
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Applied Research ◽  
Relevant Aspect ◽  
Research Projects ◽  
Technical Documentation ◽  
Commercial Products ◽  
Research Teams

AbstractIn applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.

THE CONCEPT OF AUTONOMOUS SYSTEMS IN INDUSTRY 4.0

2019 ◽  
Vol 12 (1) ◽  
pp. 77-87
Author(s):  
György Kovács ◽  
Rabab Benotsmane ◽  
László Dudás
Keyword(s):  
Industry 4.0 ◽  
Intelligent Systems ◽  
Autonomous Systems ◽  
Essential Element ◽  
Industrial Sector ◽  
Life Cycles ◽  
Multi Agent Systems ◽  
New Paradigm ◽  
Intelligent Machines ◽  
Digital Network

Recent tendencies – such as the life-cycles of products are shorter while consumers require more complex and more unique final products – poses many challenges to the production. The industrial sector is going through a paradigm shift. The traditional centrally controlled production processes will be replaced by decentralized control, which is built on the self-regulating ability of intelligent machines, products and workpieces that communicate with each other continuously. This new paradigm known as Industry 4.0. This conception is the introduction of digital network-linked intelligent systems, in which machines and products will communicate to one another in order to establish smart factories in which self-regulating production will be established. In this article, at first the essence, main goals and basic elements of Industry 4.0 conception is described. After it the autonomous systems are introduced which are based on multi agent systems. These systems include the collaborating robots via artificial intelligence which is an essential element of Industry 4.0.

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