The fourth industrial revolution, Industry 4.0, successfully exposed manufacturing practitioners to the world of state-of-the-art digitalization, such as artificial intelligence, robotics, and more.
Fremont, CA: Today's medical device manufacturing industry is struggling with disruptions to their businesses because of several reasons. The coronavirus outbreak has created an severe effect on financial expectations, operations, and supply chain, as well as crisis response plans. The requirement for an adequate volume of products has put manufacturers in trouble as they have to balance between keeping their families and employees safe.
In addition, this moment of crisis has also provided them with a huge opportunity that is left unexplored in different instances. Some of the challenges facing today's medical device manufacturing industry are described below.
Cybersecurity
The fourth industrial revolution, Industry 4.0, successfully exposed manufacturing practitioners to the world of state-of-the-art digitalization, such as artificial intelligence, robotics, and more. In addition, there has also been a pressing concern about cybersecurity, particularly following the attack on the National Health Service in 2017 and the paralyzed UK Computer networks for health care.
The vulnerabilities and possible security breaches in the systems make it easy for the hacker to access any medical device and deplete the battery or issue random cardiac commands. This rise in technical safety risks is known to have an effect on the quality of the product, to generate high recall rates, and to result in the possibility of harm to the patient.
Complex Regulatory Requirements
Medical device manufacturers are compelled to follow specific regulations and government guidelines. For example, as per the Medical Device Reporting (MDR) regulation, the manufacturing professionals are asked to report adverse events or medical product issues to the FDA as early as possible. The MDR in Europe also needs them to make sure a high level of public health and patient safety standards.
