Three Key Challenges Faced by Medical Device Manufacturers

Three Key Challenges Faced by Medical Device Manufacturers

Laura Davis, Manufacturing Technology Insights | Friday, January 07, 2022

Medical device manufacturers face a labor shortage capable of handling complex electronics and enabling data collecting, analysis, and remote communication for a given device.

FREMONT, CA: The medical device manufacturing industry is now experiencing commercial interruptions because of many factors. The coronavirus outbreak, in particular, has hurt financial expectations, supply chain, and operations, and crisis response strategies. The necessity for a sufficient volume of products has put manufacturers in a difficult position, as they must strike a balance between protecting their employees and their families.

Here are three challenges faced by medical device manufacturing industries:

Complex Regulatory Requirements

Medical device producers are required to adhere to strict regulatory laws and norms. However, it should be emphasized that the EU and FDA’s assessments of medical device rules are highly inconsistent. Furthermore, the regulatory restrictions are so complex that they prevent the public from accessing devices. The healthcare setting is complicated, as we saw with the COVID-19, and supply chain logistics in this area are crucial to emergency health.

As a result, medical device companies must use the chance to streamline operations. They must improve data management while also forming a stronger, more cooperative link across the supply chain and developing effective responses in times of need. Pharmaceuticals, hospitals, and healthcare facilities must manage hazards at every stage of the quality control process and product lifestyle among other medical specialists and institutions.

Remote Connectivity Through IoT

Because it allows for self-monitoring, rationalizes data collecting, and promotes a seamless connection between patients and clinicians, the Internet of Things (IoT) has shown to be an appropriate answer for healthcare concerns. Although medical device manufacturers intend to implement this new business model, they face a labor shortage capable of handling complex electronics and enabling data collecting, analysis, and remote communication for a given device.

For medical device manufacturers, IoT applications frequently cause technical issues. For example, numerous technologies are used to communicate, handle, and evaluate the vast amount of data collected by IoT-enabled sensors. Furthermore, the confidentiality of patient data complicates the method, as it necessitates expertise in secure broadcast and storage in the cloud or another repository.

Concern for Cybersecurity

Hackers can easily access any medical equipment and deplete the battery or deliver spontaneous cardiac orders due to system vulnerabilities and potential security breaches. This increase in technical security concerns has been shown to influence product quality, result in high recall rates, and increase the risk of patient injury.

Even though threats and vulnerabilities in such a setting cannot be eliminated entirely, the FDA is attempting to do so to some extent by implementing obligatory reporting mechanisms to track device performance and uncover latent dangers. Furthermore, manufacturers must adhere to pre-and post-market cybersecurity recommendations, which require them to test the product before its release to the market and apply fixes after the device has been released.

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