What is state of the art?
“state of the art” means “of the latest technology, most advanced”.
ISO 14971:2019 “Medical devices – Application of risk management to medical devices” includes definitions for the following terms
3.28 State of the art
The stage of technological competence with respect to products, processes, and services based on the combined scientific, technical, and empirical knowledge at a given point in time
In other words, the latest state of the art embodies what is currently generally accepted as good practice in technology and medicine.
The design and development of medical devices must be based on the latest state of the art.
The regulators’ expectations are to constantly improve the quality system with the latest information and to review the product design, manufacturing process, risk analysis, etc.
In other words, “state of the art” includes the following findings
- Latest regulatory requirements
- Latest international standards (ISO, IEC, etc.)
- Latest safety information (adverse events, accident reports, etc.)
- Latest information on other companies (e.g., collection reports)
- Latest treatment methods (e.g., other therapies)
- State-of-the-art technology (structural equipment, analytical instruments, etc.)
Collecting Safety Information
When developing new medical devices, many of them will refer to prior or similar models.
In Japan, safety information is collected by the Safety Information Management Division based on the GVP ordinance.
When developing improved medical devices, it is basically necessary to incorporate safety information such as failures in prior or similar models.
This is because in an application for an improved medical device, it must be proven that the efficacy and safety of the device are equivalent to those of the prior model being compared.
What must not be mistaken here is not the result of risk management at the time of the prior model application. It must be the result of risk management that has been updated based on feedback from the market after the model has been shipped to the market.
Naturally, risk management has been implemented throughout the life cycle in prior models.
In order to claim in the application materials that the safety of the product is equivalent to that of the preceding model, it is necessary to incorporate the latest safety information.
Not the most technologically advanced solution
However, the latest technological standards do not necessarily mean the most technologically advanced solutions.
The latest technological level is “the generally accepted state-of-the-art.” For example, it does not mean the most advanced technology being researched in academia, such as universities.
Reassessment of benefit/risk ratio
If unacceptable residual risk exists during the design and development phase, a benefit/risk assessment would be conducted.
If the benefits outweigh the risks, the product may be placed on the market even if the risks are unacceptable.
However, the benefit/risk ratio may worsen after a medical device is launched.
Because the risks are increasing and the benefits are decreasing.
The reason for the increased risk is that new hazards may be exposed that were not foreseen during the design and development phase.
The causes of the decline in benefits include the development of better-performing medical devices, the invention of new treatment methods such as the availability of pharmaceuticals for treatment, and the development of new technologies.
Thus, even if the benefit/risk ratio was considered good during the design and development phase, the value may have deteriorated and is no longer acceptable after the product is launched.
Therefore, the collection of state of the art is required to re-evaluate the benefit/risk ratio after the product is launched.
Post-launch risk management.
Once a company completes development and enters the manufacturing phase, it rarely revisits design (process design), manufacturing, risk analysis, etc. from the ground up.
However, there is much more information that needs to be incorporated, such as better methods, examples of other companies’ failures, and the latest risks. In the future, companies will be asked how they monitor the “state of the art” and feed it back into their own processes.
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