When Should MedTech Companies Engage a Medical Device Testing and Validation Lab? Blog Post by Dr. Anas Aljabo

February 27, 2025

Ensuring that a medical device can be effectively cleaned, disinfected, and sterilized is a critical step in its development and regulatory approval process. However, many MedTech companies struggle to determine the optimal time to engage a medical device testing and validation laboratory for these essential evaluations. A common misconception is that cleaning, disinfection, and sterilization validation should be addressed only toward the end of product development—when, in reality, considering these factors earlier can significantly reduce costs, streamline regulatory approvals, and improve patient safety.

Why Early Consideration of Cleaning, Disinfection, and Sterilization Matters

Medical device manufacturers often focus their early efforts on product design, functionality, and biocompatibility. While these are undoubtedly critical, overlooking reprocessing considerations (i.e., cleaning, disinfection, and sterilization) until later phases can lead to significant design and regulatory challenges. The effectiveness of cleaning and sterilization is heavily influenced by the materials, surface characteristics, and complexity of the device. Failing to optimize these features early in development can result in unexpected validation failures, necessitating costly design modifications.

Key Stages to Engage a Validation Lab

1. Concept Development & Early Prototyping

At the concept stage, MedTech companies should begin assessing whether their device will be reusable, how it will be cleaned, and which sterilization method will be suitable. Even if full validation is not required at this phase, consulting with a testing and validation lab can help manufacturers identify potential risks associated with material compatibility, cleaning challenges, and biofilm formation.

• Key Considerations:

  • Will the chosen materials withstand repeated exposure to sterilants or high temperatures?

  • Are there design features (e.g., lumens, hinges, porous surfaces) that may trap contaminants and complicate cleaning?

  • Are there established industry standards (ISO 17664, AAMI TIR12, etc.) applicable to the device type?

2. Design Freeze & Pre-Validation Feasibility Testing

Before finalizing the design, manufacturers should conduct feasibility studies to assess cleaning, disinfection, and sterilization effectiveness. This stage is critical in avoiding costly failures during full-scale validation.

• Recommended Actions:

  • Perform initial soil accumulation and cleaning efficiency studies.

  • Conduct material compatibility testing to ensure device longevity.

  • Evaluate various sterilization modalities to determine optimal parameters.

Engaging a validation lab at this stage ensures that the selected cleaning and sterilization processes align with regulatory expectations and practical usability in clinical settings.

3. Full Validation Studies Before Regulatory Submission

Once the design is finalized, full validation studies must be conducted to provide regulatory bodies with comprehensive data on cleaning, disinfection, and sterilization efficacy. The validation lab will conduct standardized tests to demonstrate compliance with FDA, Health Canada, and EU MDR requirements.

• Validation Scope Includes:

  • Cleaning validation: Residual protein, hemoglobin, carbohydrate, and total organic carbon (TOC) testing.

  • Disinfection validation: Efficacy testing against clinically relevant microorganisms.

  • Sterilization validation: Sterility assurance level (SAL) determination and cycle optimization.

By this stage, engaging a qualified ISO 17025-accredited lab is essential to ensure the data is robust, reproducible, and meets regulatory scrutiny.

The Risks of Delaying Engagement

Companies that delay engaging a validation lab until the regulatory submission phase often encounter significant setbacks, such as:

• Design Incompatibility: Late-stage redesigns due to failed cleaning or sterilization tests can result in production delays and additional costs.

• Regulatory Rejections: Inadequate or non-compliant validation studies can lead to non-approvals, necessitating rework and resubmission.

• Increased Costs: Revalidating an entire cleaning and sterilization process after design changes is more expensive than addressing these factors in early development.

Conclusion: A Proactive Approach to Reprocessing Validation

MedTech companies should not treat cleaning, disinfection, and sterilization validation as an afterthought. Instead, these considerations should be integrated into the earliest stages of product design to ensure regulatory success and patient safety. Engaging a qualified medical device testing and validation lab early can help manufacturers optimize reprocessing strategies, mitigate risks, and accelerate time-to-market.

At SteriLabs, we specialize in supporting MedTech companies through every phase of reprocessing validation. Whether you need early feasibility studies, design input, or full-scale validation testing, our team of experts is ready to help you navigate the complexities of medical device compliance.

Contact us today to discuss how we can support your medical device validation needs.

About the Author

Dr. Anas Aljabo, Co-Founder & Director of Operations

Dr. Anas Aljabo is the co-founder and Director of Operations at SteriLabs, specializing in medical device testing and regulatory compliance. With over a decade of experience, he has led validation projects for major MedTech companies, ensuring compliance with FDA, Health Canada, and EU MDR standards. He actively contributes to industry standards through AAMI and ASTM committees.