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, human cadavers, and other models in these tests.

Synthetic Human Tissues
SynDaver™ Labs' products may be substituted for traditional models in such tests by nature of their similarity to the actual use environment. This resemblance is characterized by a matching of mechanical, physical, and chemical properties, geometry, and organ-to-organ interaction. On the simplest level, individual synthetic organs (rectus femoris muscle, small intestine, abdominal aorta, etc) are constructed so that they replicate the geometry (shape, diameter, wall thickness 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 body part is designed so that interfacial properties such as the coefficient of dynamic friction (inter-organ) and mechanical attachments mimic those exhibited in the target anatomy.

In order to design these synthetic body parts, the anatomy to be simulated must be conceptually divided into discrete sections that will form the basis of the model. For example, a very simple model of the thoracic aorta might be separated 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 the supporting tissue component. Of course, in practice models require more than two tissue components to accurately simulate the response of the target anatomy, and each of these components would typically employ three or more tissue analogs. SynDaver™ elastic arteries, for example, employ separate tissue analogs for intima, media, and adventitia, and each of these layers are individually comprised of multiple materials.

Synthetic Tissue Analogs
SynDaver™ Labs' synthetic human tissues are designed to mimic one or more properties of a specific target tissue, and in order to develop each analog two sets of design inputs (modeled properties and data source) must be defined. The modeled properties are determined by prioritizing the chemical, physical, mechanical,and other properties that the analog must mimic, and strictly speaking these may vary depending on the type of device being tested or procedure being simulated, the target anatomy, and the objective of the exercise. For example, if one objective is to determine the intimal damage caused by a device tracking through the femoral artery, abrasion resistance would be included in the target list for the tissue analog. In addition, if it was also