How Long Does It Take to Develop and Bring a Medical Device to Market?

How Long Does It Take to Develop and Bring a Medical Device to Market?

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Developing and commercializing a medical device involves multiple stages to ensure safety, effectiveness, and regulatory compliance. On average, the process takes 3-7 years, depending on the device's complexity.

At Bioana, we accelerate development timelines. Our state-of-the-art facilities enable rapid, cost-effective prototyping at every stage. We deliver functional prototypes for proof-of-concept testing, customer feedback, material selection, and validation, helping your device reach the market faster.‍

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Key Stages and Timelines

• Design and Prototype (3 a 12 months): Clinical needs are identified, and Early concepts are developed into functional prototypes.
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• Verification y validation testing (3 a 9 months): Safety and performance are evaluated through Bench, mechanical and biocompatibility testing.

• Clinical Trials (6 months–5 years): Higher-risk devices are tested on patients for safety and effectiveness.
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• Regulatory Approval (6 months–2 years): Depending on the regulatory pathway (e. g. FDA 510 k, PMA CE marking) the review process can vary significantly. 
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• Production and Launch (3 months–1 year): Production scale- up, packaging, labeling, and distribution are prepared for commercialization. 

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Influencing Factors

• Low-risk devices (e.g., gloves, bandages): 1–2 years.
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Why Does It Take So Long?
Strict safety standards ensure medical devices are reliable and protect patient health, making the process rigorous but essential.

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