CREATING MODELS FOR EVERY STAGE OF THE PRODUCT DEVELOPMENT LIFECYCLE
LEARNING
Research & Development
Design, test and clinically evaluate devices; identify the root cause of device malfunctions; navigate the regulatory process by identifying risks
TEACHING
Physician Training
Increased use and complexity of medical devices requires increased physician training. Models with accurate pathology and anatomy are created using human or animal cells, organs or full donors
UNDERSTANDING
Tissue Response
Understand how to coax cell growth over implantable devices; the response of excitable cells to an implant; cellular responses to different scaffoldings, materials, and coatings
QUESTION
Experimental Design
Models demonstrating accurate anatomy and physiology allow for improved experimental design in defining the questions that show device efficacy
EVALUATE
Risk Analysis
Anticipate and manage device failures and medical issues that may arise during the course of clinical studies
PLAN
Usability & Workflow
Usability data and physician feedback allow for relevant IFU creation and clinical preparation. Procedure development and imaging workflow set the script for a successful clinical experience
Ex vivo hearts with working valves, explanted hearts that maintain electrical properties, perfused human or animal donors to evaluate device delivery, and cardiac and nervous system tissue culture to determine the cellular response to an implantable device are all examples of models that we design to provide invaluable information about devices that treat heart, vascular and neurological disease