State Of The Art FAQ

Q: What does "state of the art" mean in the context of medical devices?

A: In the context of medical devices, “state of the art” refers to the current accepted standard of care and good practice in technology and medicine. It represents what is generally acknowledged as the current level of development or advancement in a particular field. However, the interpretation of “state of the art” can vary depending on the context and can be influenced by regional medical guidance, regulatory frameworks, and industry standards.

Q: Why is considering the state of the art important in the medical device industry?

A: Considering the state of the art is important in the medical device industry because it helps determine the level of innovation, safety, and effectiveness of a device. It ensures that devices meet the current accepted standards and practices, and it plays a crucial role in evaluating the benefit-risk ratio of a device. Understanding the state of the art helps manufacturers demonstrate compliance with regulatory requirements, such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and supports successful CE submissions.

Q: How does risk management relate to the state of the art in medical devices?

A: Risk management in medical devices should take into account the state of the art. Manufacturers must establish and maintain a risk management system that aligns with the current accepted practices and risk control measures. State-of-the-art risk controls should be used to minimize risks associated with the device. The state of the art is dynamic and can influence the risk management approach by considering the latest advancements, technology, and clinical practices. Manufacturers should conduct a thorough analysis of the state of the art when assessing risks and developing risk mitigation strategies.

Q: How does the state of the art relate to clinical data in medical devices?

A: The state of the art is important when evaluating clinical data for medical devices. Manufacturers must consider the current accepted standards of care and best practices in medicine when assessing the performance and safety of their devices. They need to consider all the patient populations that the device is being used in, considering the condition treated and potential vulnerable groups. The clinical data should demonstrate that the device achieves a clinical benefit and is safe compared to alternative treatments or similar devices across the full spectrum of patients (or users), where it differs it should be highlighted. The state of the art provides the benchmark for evaluating the clinical evidence of the target device and helps determine the amount and quality of clinical data is sufficient against the SoTA range to demonstrate conformity with regulatory requirements.

Q: Are SOTA literature reviews easy to do?

A: Some common challenges when conducting
a literature review to establish the state of the art in medical devices
include:

Ensuring comprehensive search results to include all relevant articles
Providing proof of the literature review process and participation
Maintaining accuracy and consistency in data entry
Managing the workload efficiently, especially when multiple literature reviews are required.

Q: Who should conduct a SOTA literature review?

A: Using proper tools, such as correct literature databases, correct literature search syntax and keywords ensures suitable articles are identified. The MEDDEV 2.7.1rev4 and EU MDR requires personnel who conduct the literature reviews and medical writing is suitable qualified and experienced to undertake Clinical Evaluations (SoTA write-up).