Accelerate your device development process by testing your devices in clinically relevant anatomical models. Our process goes beyond simple geometric accuracy; we can tune model compliance, puncture force, vessel straightening, and other properties to meet your testing needs. In close collaboration with physicians, we select, analyze, design, validate, and manufacture anatomical models, all under one roof.
Design starts with the patients. We facilitate medical record reviews for both retrospective and prospective evaluations, securing the appropriate Institutional Review Board (IRB) approvals as required.
Specific anatomical features, disease states, and populations of interest can be specified to drive design decisions and specifications, identify relevant anatomy for testing, and provide the foundation for formal justification of design and testing targets chosen.
We employ 510(k) cleared segmentation workflows to transform patient imaging into editable 3D files, ensuring an accurate and streamlined process. We conduct anatomical segmentation using imaging provided by the client or the JI.
If needed, we provide comprehensive anatomical analysis on vascular or related features using segmented patient imaging. This analysis is documented in a formal design justification report which serves as a statistical justification for the model design’s clinical relevance and degree of clinical challenge.
This analysis often includes:
We can customize model geometry based on a single patient scan or incorporate engineered features and anatomical sections combined from multiple patient scans. Customization does not end at geometry. We can tune the material properties to achieve realistic vessel compliance or reproduce feature hardness from subcutaneous fat to bone.
These capabilities can be employed to simulate various disease states, such as vessel calcifications, chronic total occlusions, and tumors; providing appropriate and relevant challenges for device design and testing.
We design and manufacture all models within our Quality Management System. We also offer a comprehensive qualification report justifying the clinical relevance of the model to support device testing and regulatory submissions.
Justification reports may include:
The JI produces anatomical models using technologies including Polyjet multimaterial, SLA, Glass, and Silicone. We’re here to help you navigate the selection process to address your unique testing needs.
Review our model manufacturing facilities and equipment.
The Jacobs Institute is focused on accelerating the research, design, development and manufacture of innovative high-quality, clinically relevant engineering solutions and products to impact the treatment of vascular, neurological, and related diseases.
We are registered to ISO 13495:2016 by SRI Quality System Registrar. Learn more about our quality management system