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    Fogarty Innovation

    Non-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Fogarty Innovation (formerly Fogarty Institute) is a non-profit MedTech incubator that mentors early-stage device founders through technology development, regulatory strategy, and clinical trial planning, with strong ties to Stanford and El Camino Hospital.
    What the regulation says
    While not a regulatory body itself, Fogarty Innovation supports MedTech startups in navigating regulatory requirements set by authorities like the FDA (e.g., 21 CFR Part 807 for premarket submissions) and understanding quality system regulations (e.g., 21 CFR Part 820). Their mentorship includes guidance on developing regulatory strategies and planning clinical trials in accordance with standards such as ISO 14155 for good clinical practice.

    What this means in practice

    Reflects Dr. Fogarty's tradition of physician-led device innovation. Programs span structural heart, neurovascular, and surgical specialties.

    Examples

    • A startup developing a novel cardiovascular device works with Fogarty Innovation mentors to draft their pre-submission package for the FDA, ensuring it addresses key regulatory concerns.
    • A team planning a clinical trial for a neurovascular stent receives guidance from Fogarty Innovation on developing a study protocol that aligns with good clinical practice principles.
    • A MedTech entrepreneur utilizes Fogarty Innovation's network to connect with regulatory experts who can provide specific advice on achieving compliance with ISO 13485 for their quality management system.
    Common pitfalls
    • •Confusing Fogarty Innovation's guidance with official regulatory agency directives is a common mistake.
    • •Assuming their programs guarantee regulatory clearance or approval will lead to unmet expectations.
    • •Failing to conduct independent due diligence on regulatory pathways, despite their mentorship, can result in significant delays.
    • •Overlooking the importance of quality management system implementation from the earliest stages of device development is a frequent pitfall.
    • •Relying solely on their clinical trial planning without deep understanding of relevant regulatory requirements for human subject protection is a risk.

    Frequently asked questions

    No, Fogarty Innovation is an incubator providing mentorship and support; it does not have the authority to approve MedTech devices, which is the role of regulatory bodies like the FDA.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    Fogarty·1RAPS·1AAMI·1
    1. 1
      Fogarty Innovation
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      Fogartyfogartyinnovation.org
    2. 2
      RAPS
      Verified
      RAPSraps.org
    3. 3
      AAMI
      Verified
      AAMIaami.org

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