The medical device market in the United States is the largest in the world and offers a wide range of simple products such as high-tech bandages and accelerators. More than a decade ago, the medical device industry placed greater emphasis on design and simplicity, powered by software and technology. And innovation has helped shift power from the pharmaceutical industry to the medical device industry.

Technology and Security

The fourth industrial revolution, widely known as Industry 4.0, ushered manufacturing into a cutting-edge digital world like, robotics and artificial intelligence. Urgent cyber security concerns have also been introduced.

Today, intuitive technology and devices are still in high demand such as ear light scope is most demanding, with time-to-market faster than ever. Hospitals, medical facilities and other markets are putting pressure on medical device manufacturers to be safer, more innovative, cheaper and more efficient.

Cybersecurity of medical devices

Cyber ​​security of medical devices became a major concern following the attack by the UK NHS and cryptographic health systems in 2020. In 2021, the FDA recalled two health defibrillator models after discovering a potential security breach in systems. The vulnerabilities could allow a hacker to access the device, drain the battery, or issue impromptu basic commands.

Threats and vulnerabilities in any business

Threats and vulnerabilities cannot be completely ruled out in a business situation. With increasing technological security threats impacting product quality, contributing to high recall rates and the risk of patient harm, the FDA has put in place mandatory reporting tools to monitor device performance and identify potential problems. .

There are pre-market and post-market cybersecurity guidelines that manufacturers need to follow. This means that it is the manufacturer’s responsibility to test the product before it is released and to apply patches after the product is released. Manufacturers need to be able to easily demonstrate that their products are safe and reliable throughout their life cycle. Continuous and effective monitoring is therefore essential.

Regulations and Government

According to the Medical Device Reporting guideline, manufacturers must report certain adverse events or product problems related to medical devices to the FDA. MDR was also created in Europe to ensure high levels of public health and patient safety standards. For example, manufacturers need to collect data on their performance to improve transparency.

Analysis by critiques of the medical device regulations

In particular, the criticism of the regulations for medical devices by the FDA and the EU is contradictory: the legal requirements are so complex that they hinder the availability of the device to the public, but the legal requirements that citizens are sufficiently strong enough to endanger. As we have seen in the COVID-19 pandemic, the healthcare environment is complex and supply chain logistics in the medical and pharmaceutical industries are critical to any health emergency.

Manufacturers must seize the opportunity to streamline operations and improve data management, not only to build closer and more collaborative relationships throughout the supply chain, but also to respond effectively in times of need. Pharmaceuticals, medical equipment manufacturers, hospitals and healthcare facilities must work together to drive regulation and manage risk at all stages of the lifestyle and product quality control process.

For example, healthcare organizations and manufacturers must work closely together to communicate necessary changes to devices, such as new patches or network updates; It is not a special responsibility of one party to another, but a shared responsibility.

Product Design Processes and Development – An Opportunity

While nonstop novelty supports the design and development of new products, the additional impact of regulations on manufacturing leads to simpler administrative tasks and greater legal certainty and credibility throughout the medical device system.

Manufacturers should see this as an opportunity to improve their processes and stay one step ahead of their competitors. A major medical device company reported annual cost savings of $ 1.2 million in the two years after implementing an electronic master proof system (eTMF) that translates documentation from paper to electronics.

Final Thought…

Regulations for medical devices and technological advances are continuously developing. Manufacturers must implement a data management strategy that offers a comprehensive view of data to upkeep ongoing regulatory and agreement. Data-driven decision-making would have a greater impact on reviews and the supply chain, and many processes could even be automated with digital transformation solutions.