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:
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Drug interactions
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Ease of use
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Compatibility (bio, electrical, mechanical, consumables, interoperability, etc.)
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Administration and dosage
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Advantages of the product over the standard care
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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
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Document controls
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Conduct clinical research collaboration (IRB, CRO, etc.)
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Product testing and validation
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Development of specific quality metrics for commercial-scale production
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Conduct human clinical trials where appropriate
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Product-prototyping where appropriate
Contact us to learn more about how we can help protect your organization.