Design and Efficacy Validation

Exposure

Design and efficacy are important considerations when evaluating a medical product. The Code of Federal Regulations outlines requirements validating the safety and effectiveness of a product. Additionally, drug or device applicants must provide documentation of "adequate and well-controlled" studies validating the health benefit and safety of the proposed product. 

Additional considerations for a company's product development include:

  • Drug interactions

  • Ease of use

  • Compatibility (bio, electrical, mechanical, consumables, interoperability, etc.) 

  • Administration and dosage

  • Advantages of the product over the standard care

  • Clinical trial validation (review protocol and patient consent form, CRO

What Can Happen

Failure to adequately prove the safety and effectiveness of a product during the approval process may result in the serious injury, death, and/or delay the delivery of product to market. 

How to Reduce Risk

  • Document controls

  • Conduct clinical research collaboration (IRB, CRO, etc.)

  • Product testing and validation

  • Development of specific quality metrics for commercial-scale production

  • Conduct human clinical trials where appropriate

  • Product-prototyping where appropriate

Contact us to learn more about how we can help protect your organization.

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