LEARNING
Research & Development
Design, test and clinically evaluate devices; identify the root cause of device malfunctions; navigate the regulatory process by identifying risks

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

EVALUATE
Risk Analysis
Anticipate and manage device failures and medical issues that may arise during the course of clinical studies

QUESTION
Experimental Design
Models demonstrating accurate anatomy and physiology allow for improved experimental design in defining the questions that show device efficacy
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TEACHING
Physician Training
Increased use and complexity of medical devices require increased physician training. Models with accurate pathology and anatomy are created using human or animal cells, organs, or full donors
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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
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About Our Mission
Our team serves patients and clients through a comprehensive preclinical partnership that involves device development and testing, offering custom and standardized in-vitro laboratory services, and creating new test models and test systems. Our commitment is to the patients who will receive the therapies that pass through our laboratories & the clients who are involved in their development, testing, and training.
Where Did We Start?
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2020
Founded BioSim Innovations, LLC, and began creating biosimulation models.

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2024
Moved into 42,000 sq ft facility to expand capabilities, facilities, advanced imaging, and expertise.
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2019
Observed a need for better translational models to evaluate medical devices and therapies that focus on human clinical relevance and animal in vivo alternatives (NAM- New Alternative Methodologies).

2022
Expanded physical footprint with procedure room and in vitro lab.
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2026
Hub for physician & engineering engagement. Full Wheel of Services implemented with synergistic biosimulation, in-vitro, histopathology, in vivo, and product development services, returned product decontamination, supported by AAALAC, GLP, and forecasted end-of-2026 ISO 17025 and ISO 13485 compliance.
