--- title: "Fogarty Innovation, Definition | MedTech Terms" description: "Non-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty. Plain-English Industry Bodies definition for MedTech teams, with examples and related" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/fogarty-innovation#term", "name": "Fogarty Innovation", "description": "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.", "url": "https://medtechterms.com/terms/fogarty-innovation", "termCode": "fogarty-innovation", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/fogarty-innovation#article", "headline": "Fogarty Innovation", "description": "Non-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty.", "url": "https://medtechterms.com/terms/fogarty-innovation", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/fogarty-innovation" }, "about": { "@id": "https://medtechterms.com/terms/fogarty-innovation#term" }, "articleSection": "Industry Bodies", "inLanguage": "en", "keywords": "Fogarty Innovation, Industry Bodies, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "Fogarty Innovation", "url": "https://www.fogartyinnovation.org/", "publisher": { "@type": "Organization", "name": "Fogarty" } }, { "@type": "CreativeWork", "name": "RAPS", "url": "https://www.raps.org/", "publisher": { "@type": "Organization", "name": "RAPS" } }, { "@type": "CreativeWork", "name": "AAMI", "url": "https://www.aami.org/", "publisher": { "@type": "Organization", "name": "AAMI" } } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Industry Bodies", "item": "https://medtechterms.com/terms?cat=Industry%20Bodies" }, { "@type": "ListItem", "position": 4, "name": "Fogarty Innovation", "item": "https://medtechterms.com/terms/fogarty-innovation" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/fogarty-innovation#faq", "mainEntity": [ { "@type": "Question", "name": "Does Fogarty Innovation approve MedTech devices?", "acceptedAnswer": { "@type": "Answer", "text": "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." } }, { "@type": "Question", "name": "Is participation in Fogarty Innovation's programs a substitute for a robust quality management system?", "acceptedAnswer": { "@type": "Answer", "text": "No, their programs offer guidance, but each startup must establish and maintain its own quality management system in compliance with regulations such as 21 CFR Part 820 or ISO 13485." } }, { "@type": "Question", "name": "Does Fogarty Innovation help with EU MDR compliance?", "acceptedAnswer": { "@type": "Answer", "text": "While their focus is often on FDA pathways due to their location and ties, their mentorship in regulatory strategy can be broadly applicable, but specific EU MDR compliance efforts remain the responsibility of the device manufacturer." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Industry Bodies](/terms?cat=Industry%20Bodies) 6. / 7. Fogarty Innovation [All terms](/terms) Industry Bodies [Strategic Landscape](/ecosystems/strategic-landscape) # Fogarty Innovation Non-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/iso-14155) for [good clinical practice](/terms/gcp). ## What this means in practice Reflects Dr. Fogarty's tradition of physician-led device innovation. Programs span [structural heart](/terms/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 Does Fogarty Innovation approve MedTech devices? 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. Is participation in Fogarty Innovation's programs a substitute for a robust quality management system? Does Fogarty Innovation help with EU MDR compliance? ## Related terms Grouped by theme ### More in Industry Bodies · Same category [ Industry Bodies AAMI(AAMI) Standards body for medical instrumentation; co-publisher of ISO/IEC adoptions. ](/terms/aami)[ Industry Bodies AdvaMed U.S. trade association for the medical device and diagnostics industry. ](/terms/advamed)[ Industry Bodies AdvaMedDx Diagnostics-focused division of AdvaMed. ](/terms/advameddx)[ Industry Bodies Contract Research Organization(CRO) Service organization providing clinical trial management and supporting services to sponsors. ](/terms/cro) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 Fogarty· 1 RAPS· 1 AAMI· 1 1. [1 Fogarty Innovation Verified Fogarty · fogartyinnovation.org ](https://www.fogartyinnovation.org/) 2. [2 RAPS Verified RAPS · raps.org ](https://www.raps.org/) 3. [3 AAMI Verified AAMI · aami.org ](https://www.aami.org/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Aligning your program with industry guidance? We help MedTech teams operationalize cybersecurity guidance from IMDRF, HSCC, AAMI, and other industry bodies. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Industry Bodies Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=fogarty-innovation) Learn in 60 seconds Card Lesson Quiz Non-profit MedTech incubator carrying on the legacy of Dr. Thomas Fogarty. - · Reflects Dr. - · Fogarty's tradition of physician-led device innovation. - · Programs span structural heart, neurovascular, and surgical specialties. Remember this Watch out: Confusing Fogarty Innovation's guidance with official regulatory agency directives is a common mistake. You may also need Auto-suggested from Industry Bodies and shared keywords. - [Specialty MedTech Venture Capital ](/terms/specialty-medtech-vc) - [Contract Research Organization(CRO) ](/terms/cro) - [Corporate Venture Capital(CVC) ](/terms/corporate-venture) - [Medical Device Innovation Consortium(MDIC) ](/terms/mdic) - [MedTech Accelerators and Incubators ](/terms/accelerator-MedTech) - [Texas Medical Center Innovation(TMC Innovation) ](/terms/texas-medical-center) [All Industry Bodies terms](/terms?cat=Industry%20Bodies) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)