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