Biotextile Product Development

Catalog description

Overview of the product development process for medical textiles and implantable biotextile devices. FDA classification system for medical and healthcare products. Review steps in identification of healthcare needs, market size and demand, product specifications and design, prototype fabrication and sterilization, in vitro testing of mechanical, chemical, surface and biological properties, in vivo animal testing, regulatory issues, consumer and clinical trials and explant analysis. Examples of medical textiles for personal hygiene, wound care, external support, orthopedic, general surgery, dental and tissue engineering applications. The student will be introduced to the process of new product development as it applies to medical textiles and biotextiles.