Lesson 4 – Systematic Literature Review Course: Understanding the State of the Art (SoTA) for Medical Devices

Missed last week? Read our Past Lesson: Literature Search Terms and PICO. Be sure to check it out if you haven’t already!”

Why State of the Art (SoTA) Matters in Medical Device Certification

Navigating the regulatory landscape of medical devices, particularly under the EU MDR, requires a clear understanding of the State of the Art (SoTA). Establishing SoTA isn’t just a formality—it’s the foundation for demonstrating the safety and performance of your device and ensuring compliance with regulatory standards.

In this post, we’ll break down the essentials of SoTA and guide you through building a robust strategy to integrate into your Clinical Evaluation Report (CER).

What is SoTA?

SoTA refers to the current standard treatments and devices for a specific medical indication. It includes clinical data on medical alternatives, equivalent devices, similar technologies, and treatment options. Essentially, SoTA provides a benchmark for assessing your device’s safety and performance.

For example:

• Blood Pressure Devices: The SoTA is manual BP readings performed by a professional using a sphygmomanometer.
• Catheters: SoTA includes venous catheters used for blood transfusions or similar procedures.

Why SoTA is Crucial

A strong SoTA search supports your submission by:

• Defining the clinical background.
• Identifying potential risks and feeding them back into risk management.
• Justifying equivalence criteria (if applicable).
• Providing benchmarks for safety and performance.
• Highlighting gaps requiring further studies.

SoTA vs. Equivalence: What’s the Difference?

Under the old MDD regulations, equivalence was a popular route for demonstrating compliance. However, MDR has made equivalence significantly more stringent. Proving equivalence now requires access to design and engineering data from the equivalent device—often feasible only if the device is manufactured by your company or you have a legal agreement with its manufacturer.

Without such access, establishing SoTA becomes the primary route to demonstrate your device’s safety and performance.

Steps to Conduct a Robust SoTA Search

1. Start with Broad Literature Searches

• Use general terms like “venous catheters” or “dermatology diagnostics.”
• Gradually narrow your focus based on initial findings, e.g., “venous catheter adults.”

2. Include Medical Guidelines

• Refer to clinical guidelines to identify standard practices and commonly accepted devices.

3. Focus on Safety and Performance

• Search for articles that address your product’s safety and performance claims.
• Include competitor products to capture a comprehensive view of the current standards.

4. Extract Key Metrics

• Look for safety metrics like infection rates or failure rates.
• Identify performance metrics like device precision or longevity.

Examples of SoTA for Different Devices

1. Surgical Scalpels

• SoTA: Disposable scalpels with precise cutting and minimized tissue trauma.
• Metrics: Sterility under standard conditions, durability.

2. Two-Lumen Hemodialysis Catheters

• SoTA: Commonly used dual-lumen catheters or AV fistulas.
• Metrics: Reduced thrombosis rates, long-term patency.

3. Dermatology AI Diagnostic Software

• SoTA: Traditional dermatologist diagnoses and biopsies.
• Metrics: Diagnostic accuracy, sensitivity, and specificity.

4. Suture Anchors

• SoTA: Anchors used in similar orthopedic procedures.
• Metrics: High stability, low adverse material reactions.

Turning Your SoTA Research Into Action

After completing your SoTA search:

1. Compile Your Findings: Create a detailed review of current treatments and devices.
2. Draw Conclusions: Summarize safety and performance benchmarks relevant to your device.
3. Integrate Into Your CER: Use SoTA insights to justify your device’s design and highlight its benefits and risks.

SoTA and the Clinical Evaluation Report (CER)

The CER is your opportunity to showcase your device’s safety and performance relative to current standards. A thorough SoTA review supports:

• Establishing Benchmarks: Demonstrate how your device compares to current best practices.
• Justifying Design Choices: Show how your device improves upon existing technologies.
• Proving Benefit-Risk Performance: Define endpoints and metrics for safety and performance comparisons.

By following these steps, you can build a SoTA strategy that not only ensures compliance but also strengthens your device’s market positioning. Want to dive deeper into this topic? Watch our video lesson for detailed insights!