Lesson 1 – Systematic Literature Review Course: Search Protocol Key Sections

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Identifying the State of the Art (SoTA) in Medical Device Literature Reviews

When it comes to systematic literature reviews for medical devices, identifying the State of the Art (SoTA) is a critical step. Understanding SoTA not only ensures compliance with regulations but also demonstrates how your device compares to the current standard of care. In this blog post, we’ll guide you through the essential aspects of identifying SoTA and creating a comprehensive review protocol.

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What is SoTA?

SoTA refers to the most commonly recognized approach for diagnosing, treating, or managing a specific medical condition or procedure. This could be a widely used medical device, a standard drug treatment, or even a specific clinical procedure. Understanding SoTA helps position your device against current industry benchmarks and provides critical data to support safety and performance claims.

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Prerequisites for Identifying SoTA

1. Understand Your Device:
   • Familiarize yourself with your device’s primary function. For instance, a dual-lumen catheter is designed to facilitate blood flow during hemodialysis. Knowing its purpose helps narrow down relevant comparisons.
2. Focus on Common Procedures:
   • Identify the most commonly used procedures associated with your device rather than focusing solely on technically advanced options.
3. Consider Software as a Medical Device (SaMD):
   • While traditional methods may involve in-person evaluations by professionals, modern SaMD options like pre-assessment apps can enhance the process. However, these technologies don’t claim to replace traditional methods but rather streamline them.

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How to Determine the Standard of Care

1. Search for Similar Devices:
   • Look for devices with similar indications and functions.
2. Compile References:
   • Gather a list of standard practices, treatments, or devices from the search results.
3. Include Drug Comparisons if Relevant:
   • Sometimes, the standard of care may involve drug treatments rather than devices. Ensure you consider all relevant options.

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The Importance of a Robust Literature Review Protocol

A well-structured literature review protocol is essential for ensuring your review is organized, reproducible, and compliant with MDR/IVDR requirements. Your protocol should:

• Outline the search design (databases, terms, date ranges, inclusion/exclusion criteria).
• Include the device description, indications for use, and comparable devices.
• Address safety and performance claims, ensuring they align with marketing materials and regulatory requirements.

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Building a Strong Protocol: Key Components

Device Description and Background

• Copy these directly from the Instruction for Use (IFU) document. This includes:
  • Device function and description.
  • Indications for use.
  • Similar and comparable devices.

Safety and Performance Claims

• Clearly state claims from the IFU, supported by clinical data from the literature review.
• Align these claims with marketing materials to maintain consistency.

Search Methodology

• Include details such as:
  • Databases and search terms.
  • Date ranges for data collection.
  • Inclusion and exclusion criteria.
  • Duplicates handling process.

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Identifying SoTA for Devices

When identifying SoTA, you need to consider devices or treatments widely recognized as the standard of care. For example:

• Class I Device (e.g., Disposable Scalpel): The standard of care might involve traditional scalpels or advanced lasers, depending on the context.
• Class IIa Device (e.g., Dual-Lumen Catheter): Focus on commonly used hemodialysis devices.
• Class IIa Software (e.g., Skin Tracker App): Compare with similar apps or traditional diagnostic methods.
• Class III Device (e.g., Suture Anchor): Analyze competing devices used in surgical procedures.

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Conclusion

Identifying the State of the Art is a cornerstone of any effective literature review for medical devices. By understanding your device’s role in the current standard of care and building a robust, reproducible protocol, you can ensure compliance, clarity, and credibility in your review. Remember, aligning safety and performance claims with supportive literature data is key to regulatory success.

For more insights on conducting systematic literature reviews, stay tuned for the next post in our series!