Medical device manufacturers are leaning towards artificial intelligence (AI) for their product innovations. These devices have shown that AI can be beneficial to improve patient diagnosis and care. It can help make patient assessment faster and provide a more accurate diagnosis through data-driven medical decisions.

But some are afraid that having AI devices may reduce the demand for clinical medical experts and workers. They are worried that these devices may soon replace the work usually intended for people in the medical field.

It seems that will be far from reality because AI medical devices will just act as a support to improve medical performance and decisions. Ultimately, medical experts are still best positioned to conclude diagnosis and suggest the best treatment planning.

A medical device with AI integration first needs to undergo stringent testing and risk management assessment. The European Medical Device Regulation (EU MDR) requires applying risk management before getting medical devices approved for clinical use to safeguard patients. Qualified MPEs can perform device assessment and safety testing to meet the standards of EU MDR.

The New European Medical Device Regulation (EU MDR)

The EU MDR is a relatively new set of regulatory requirements imposed on the manufacturing and sale of medical devices. These rules became effective on May 26, 2021, intending to ensure a high-quality standard for all medical devices for patient safety.

The new EU MDR replaced the old European Medical Device Directive (EU MDD) for two reasons. One is that it needs to have new rules that will cover new technology such as AI software tools. Two, it needs to impose new requirements that push transparency of medical device technical information to be open to the public.

All medical devices manufacturers, importers, distributors, authorized representatives, and quality management professionals must comply with the mandatory EU MDR rules. Even health institutions that develop their in-house medical device software must now also comply with EU MDR rules.

Why Manufacturers Need Qualified Medical Physicists

Medical physicist experts (MPE) play a significant role in getting medical devices approved for clinical practice. They can assess a device’s safety performance from the start of the manufacturing process up to the integration into clinical practice.

Before getting these medical devices approved for clinical use, manufacturers will need the help of MPEs by applying their knowledge of physics to develop these medical devices properly. They have a working knowledge of the regulatory aspects of medical physics, which makes them the most qualified to lead quality assurance programs.

Manufacturers can hire MPEs in-house as part of their development team. Some medical devices will be using AI technology to drive medical decisions, so medical physicists need to ensure that the results are accurate and based on updated medical findings and clinical standards.

Because MPEs now have a new and vital role in the healthcare industry, they must be updated and knowledgeable of EU MDR requirements. They need to gain perspective of the EU MDR’s effects on incoming medical devices with AI technology and how important it is that MPEs properly guide manufacturers to ensure that these medical devices will meet quality and safety standards for the sake of the patients.

Takeaway

As the landscape of the medical industry shifts towards modernization, the healthcare system can be overwhelmed with information and data sets. Artificial intelligence in medical devices will assist workers in reducing repetitive administrative work and focusing on patient care.

Doctors can help make data-driven medical decisions faster and apply the appropriate treatment immediately, which can be very helpful during emergency cases. Doctors can make the entire patient assessment process from consultation to prognosis quicker, accommodating more patients and providing better care.