Design and Efficacy Validation

Exposure

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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. 

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Additional considerations for a company's product development include:

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• 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

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What Can Happen

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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. 

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How to Reduce Risk

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• 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.