The issues related to cybersecurity is becoming a concern for the medical device manufacturers due to which they are trying to increase the efficiency operation data management system.
FREMONT, CA: The medical device market offers a wide range of products starting from something simple like a bandage to a complicated item like ultra-high-tech pacemakers.
A few years back, the industry of medical device manufacturing witnessed the importance of simple designs boosted by technologies and software. This innovation created a massive shift as the pharmaceutical industry's power was transferred to the medical device industry. With time the demand for technology and intuitive devices is increasing in the market than it has ever before. Furthermore, medical device manufacturers are also under pressure to develop efficient, innovative, secure, and cost-effective devices from medical facilities, hospitals, and other markets.
Technology and Security
Industry 4.0 is also known as the fourth industrial revolution. Industry 4.0 presented the manufacturing sector with highly advanced digital technologies like robotics, artificial intelligence, and IoT. However, with such innovative digitalized technologies, cybersecurity concerns also increased for the medical device industry.
In medical devices, cybersecurity became a significant concern when, in 2017, there was an attack on the National Healthcare Service due to which the healthcare computer systems got paralyzed. Moreover, there were also occasions when the FDA had to remove two healthcare defibrillator models when they saw the possibility of a security breach in the systems. It will become easy for hackers to access the tools, exhaust the battery, or even create spontaneous cardia command with such vulnerabilities in the machine.
It is not possible to eliminate threats and vulnerabilities. Due to such security threats, the FDA has issued necessary reporting tools that will monitor the devices' performance and identify any potential problems.
Regulations and Government
The medical device manufacturers have to report specific complicated events or issues related to the pharmaceutical products to the FDA according to the Medical Device Reporting (MDR) regulations. The MDR makes sure that the devices utilized for public health maintains standards and follow the rules for patient safety.
The manufacturers need to take opportunities of the situation and ensure that they increase the efficiency of the operations and enhance data management. An enhanced system will help to develop a robust and collaborative relationship in the supply chain. But it will also generate efficient response during crucial situations. The medical device manufacturers, health facilities, pharmaceuticals, and hospitals must work together to identify and manage the risks to improve the quality and offer enhanced service to the patients.