Center for Rapid Device Translation Brochure

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The Center for Rapid Device Translation is ready to support you in moving your medical device toward commercialization. We can help you:

• C onnect with clinical experts for input on your project • Create a prototype of your medical device • Conduct a preclinical study • Prepare for an early phase clinical trial

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Houston Methodist

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Research Institute

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CENTER FOR RAPID DEVICE TRANSLATION

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Texas Children’s Neurological Research Institute

D. Texas Children’s Texas Hospital Heart St. Luke’s Institute Hospital

M.D. Anderson Cancer Center

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E BLVD. We offer a full suite of services, centralized in the HOLCOMB extensive research facilities of our research institute, enabling efficient workflow without leaving Houston Methodist. We are located in the heart of the Texas Medical Center, the world’s largest medical complex, with eight academic and research institutions and 21 hospitals serving over 7 million visitors each year.

Center for Rapid Device Translation 6670 Bertner Avenue Houston, TX 77030 713.363.9931

rapiddevicetranslation.org HMRI Communications & External Relations | RICORE-026 | LC | DH | 500 | 07.2018

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UNIVERSITY OF HOUSTON

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CENTER FOR RAPID DEVICE TRANSLATION Homer Quintana, MCTM Program Project Manager Preclinical Translation Comparative Medicine Program Houston Methodist Research Institute Email: hquintana@houstonmethodist.org 713.363.9931

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HOUSTON METHODIST RESEARCH INSTITUTE

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Jones Tower

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M.D. ANDERSON BLVD.

As industry innovators, our clients have access to entrepreneurs and scientists with invaluable expertise and insight during the foundational planning and first phases of product development and testing.

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Center for

Rapid Device Translation The Center for Rapid Device Translation guides clients through preclinical studies and regulatory approval pathways to bring new medical devices to market. We provide full service expertise and study execution to achieve preclinical device validation, opening the door for early-phase clinical testing if required by a regulatory agency.

Our Center offers industry innovators a multi-faceted range of services and expertise. Our leaders have first-hand experience in entrepreneurial endeavors.

Our clients enjoy access to clinicians, researchers and experts with laboratory and regulatory experience who, daily, carry out best practices within one of the nation’s top-ranked hospitals.

We connect our clients to core services that move innovative medical devices and biologic therapies from bench to bedside with safety, accuracy and efficiency. Some of our collaborations with key industry leaders include JLABS @ TMC, Siemens Healthineers and Automobili Lamborghini.

PRECLINICAL TESTING & VALIDATION The Center for Rapid Device Translation is committed to collaborating with clients to navigate effective regulatory pathways through preclinical device testing. We assist with preparing the technologies, tools and facilities for applying Good Laboratory Practice (GLP), conducting successful safety studies, and achieving robust data for regulatory agency approval.

We collaborate with clients to leverage these Houston Methodist resources in both GLP and non-GLP environments:

• Comparative Medicine Program • Houston Methodist Debakey Heart & Vascular Center • Preclinical Catheterization Core • cGMP Core • Translational Imaging Core • Houston Methodist Institute for Technology, Innovation & Education (MITIESM) • Machine Shop Core

Upon achieving preclinical validation, clients gain access to our resources for moving forward with early phase clinical trials when necessary.

CLINICAL RESEARCH SERVICES CORE Our Clinical Research Services Core delivers excellence in standards of care and research integrity for client-sponsored clinical trials, focused on yielding patient data for regulatory agency review.

We offer three distinct facilities to fulfill the data requirements of clinical trials needing approval by a regulatory agency: • Academic Office of Clinical Trials • C ockrell Center for Advanced Therapeutics (CCAT) • CCAT Phase 1 Unit