Fremont, CA: The medical equipment market is booming at the moment, and innovation has contributed to the shift in power from pharmaceutical to the medical device industry.
One of the largest medical equipment markets is in the U.S., encompassing large items as simple as bandages via ultra-high-tech pacemakers. The medical device manufacturing industry has been witnessing an increasing emphasis on design and simplicity, driven by software and technologies. Presently, there is a high demand for technological, intuitive devices that has a faster time-to-market than ever before. Hospitals, medical facilities, and other markets are pushing the medical device manufacturers to be more secure, innovative, cost-effective, and efficient.
Product Design Processes and Development
Continuous innovation gives rise to new product design and development; the added impact of regulations on the manufacturing sector has lead to more straightforward administrative tasks and increased legal certainty and credibility of the overall medical device system. With medical device regulations and technological advancements evolving consistently, manufacturers must implement a data management strategy that gives a complete view of data to help with ongoing compliance and regulations. In doing so, data-driven decision-making would be more impactful to inspections and the supply chain, and many processes can also be automated with digital transformation solutions.
Technology and Security
The fourth industrial revolution brought manufacturing to a world of state-of-the-art digitalization, such as IoT, artificial intelligence, and robotics. It also brought to light a pressing concern for cybersecurity in the healthcare computer system. The FDA has put a mandatory reporting tool in place to oversee device performance and detect potential issues due to the increase in technological security threats affecting product quality, contributing to high recall rates, and introducing the likelihood of patient harm. There is a range of pre and post-market cybersecurity guidance that has to be addressed by the manufacturers. The manufacturers have to test a product before releasing it and implement patches after product release too. Manufacturers must be able to demonstrate their products are safe and reliable throughout its lifecycle, so continuous and efficient monitoring is imperative.