Key Challenges in Medical Device Manufacturing

By CIO Applications| Wednesday, March 10, 2021

Threats and vulnerabilities can never be fully removed in any business scenario. However, the FDA has put mandatory reporting tools in place to track system output and identify potential problems with an increase in technical security risks impacting product quality, leading to high recall rates and introducing the probability of patient injury.

Fremont, CA: The US medical device market is the largest in the world, encompassing large products as basic as bandages all the way through to ultra-high-tech pacemakers.

Protection and Technology

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The fourth industrial revolution, largely known as Industry 4.0, brought manufacturing, such as robotics, IoT, and artificial intelligence, to a world of state-of-the-art digitalization. It also raised a pressing cybersecurity issue.

After an assault on the National Healthcare Service in 2017, the cybersecurity of medical devices became more of a problem and crippled UK healthcare computer systems. The FDA recalled two healthcare defibrillator models in 2018 after discovering a possible device security breach. The vulnerabilities may cause the system to be accessed by a hacker and could deplete the battery or issue impromptu cardiac orders.

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Threats and vulnerabilities can never be fully removed in any business scenario. However, the FDA has put mandatory reporting tools in place to track system output and identify potential problems with an increase in technical security risks impacting product quality, leading to high recall rates and introducing the probability of patient injury. Pre and post-market cybersecurity requirements must be addressed by manufacturers, meaning it is the manufacturer's duty to test the product before shipping it and also to incorporate fixes after product release. Manufacturers clearly need to be able to show that their goods over their life cycle are healthy and secure, so consistent and successful monitoring is crucial.

Government and Regulations

Under the Medical Device Reporting (MDR) law, manufacturers are required to report medical devices to the FDA for any adverse effects or product issues. In Europe, the MDR has also grown to maintain a consistently high degree of public health and patient safety quality, such as the need for manufacturers to collect performance data in an attempt to increase transparency.

Notably, there are contradictory criticisms of the FDA and EU medical device regulations that regulatory requirements are so confusing that they obstruct public availability of devices, and yet regulatory requirements that are not strong enough put people at risk. The healthcare environment is dynamic, and the supply chain logistics in the medical and pharmaceutical industry are vital to any emergency health scenario, as we have seen with the COVID-19 pandemic.