Design Validation
SynDaver™ brand synthetic human body parts and SynTissue™ brand synthetic human tissues were originally designed for use in the medical device design verification and validation process. Such studies are sometimes called simulated use tests because they involve the evaluation of device function, safety, and efficacy in a simulation of the actual use (human) environment. Live animals are often employed in these tests because they have traditionally been the best model available for simulating the complexity of human anatomy and physiology. However, SynDaver™ and SynTissue™ brand products possess a unique feature set allowing them to be substituted for live animals, cadavers, and other models in these tests.

Synthetic Human Tissues
SynDaver™ Labs' products may be substituted for traditional models in these tests because they closely resemble the actual use environment. This resemblance is characterized by a similarity of mechanical, physical, and chemical properties, geometry, and organ-to-organ interaction. On the simplest level, individual tissue components (rectus femoris muscle, small intestine, abdominal aorta, etc) are constructed so that they replicate the geometry (general shape, length, diameter, etc) of a particular portion of the target anatomy. In addition, the individual synthetic tissue analogs used to fabricate these components are formulated so that they exhibit chemical and physical properties (water, fiber, and salt content, strength or modulus in shear, coefficient of static or dynamic friction, surface energy, dielectric properties, heat capacity, porosity, etc) that mimic the properties of the target tissue. Finally, the model components are assembled in such a way that the interaction between adjacent components is similar to that expected in the target tissue. That is, the model is designed so that interfacial properties such as the coefficient of dynamic friction (inter-organ) mimic those exhibited in the target anatomy.

In order to design such synthetic body parts, the anatomy to be simulated must be conceptually divided into discrete sections that will form the basis of the model components. For example, a very simple model of the thoracic aorta might be conceptually divided into two parts; the first consisting of the artery itself and the second of the surrounding tissues. At least two (and possibly many more) tissue analogs would then be designed for the fabrication of this model. In this case, one tissue analog would be required for the artery component and the other would be used to construct