Human Tissue, Organ & Full Donor Studies

BioSim Innovations offers you a wide range of resources for development and testing. Here are a few reasons why we can help your team:

Models do not exist that address both anatomy and physiology in the same model (human specimens provide anatomical information and animal models provide non-human physiological information). Healthy and pathological models are needed for testing.
The increased quantity and sophistication of medical devices being invented requires more sophisticated models than current bench-top models.
Engineers are going into expensive animal studies prematurely resulting in the unnecessary sacrifice of animals. Biosimulators can reduce the numbers of animals sacrificed.
Models allow for improved experimental design in defining the questions being asked and in experiment execution compared to the unpredictability associated with acute animal studies.
Increased use and complexity of medical devices requires increased physician training. Physician training requires sacrifice of animals, high cost, and a location other than the site of the physician’s clinical practice.
Better models result in better device risk determination resulting in lower risk in device development, first in man, physician training and the end user.

User needs - anatomical AND physiological models:

The FDA's Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.

Past & Current Status of Device Design & Development, Pre-clinical Data, and Training
- Human Donors
  - Lack of physiology data
  - Lack of blood flow
- Current Biosimulators
  - Heart only (lack vascular circuit)
  - Pig heart dissimilar to human heart
- Animal Studies
  - Lack of human anatomy data
  - Unpredictable and expensive
  - Real time- little time to make adjustments during short testing window
  - Anatomy does not mimic human pathways, size and proximity
  - Sacrificing large quantities of animals- using animals too soon in design and development process

Future of Device Design & Development, Pre-clinical Data, and Training
- Clinical Relevance
  - Model provides accurate anatomy AND physiology
  - 3D print pathology to create accurate model of pathology repair
  - Accurate pressure, flow, blood analog
  - Repeatable data/experiment design
  - Reduce risk in device development
  - Utilize animals only in last stage of pre-clinical, not before
  - Computer modeling to translate healthy and pathological clinical states into models
- Organ and Full Donor
  - Fresh, preserved, partially preserved
  - Reanimated human heart
  - Expand simulator beyond heart
  - Perfusion model of organ and torso
  - Provide accurate anatomy AND physiology
- Target Vasculature
  - Heart
  - Systemic and Respiratory Circuit
  - Neurovascular
- Living Cellular Component to Model
  - Provide accurate anatomy AND physiology
  - Decellularized / recellularized vessels
  - Micro-organs, cell culture
  - Seeded cells on scaffolding