This chapter describes how the behavior of biomaterials under different operating conditions is assessed for safety and efficacy during the medical device design process. The intrinsic properties of biomaterials are evaluated for various requirements such as their mechanical integrity and their reactions to their immediate environment. A selection of standard testing methods to predict the behavior of materials under different conditions are discussed in this chapter.

This chapter discusses the fundamentals of tissue engineering and the different cell types that are pertinent to this field. Typical scaffold fabrication techniques as well as common methods used to evaluate scaffolds, cell growing on scaffolds, and neo-tissue are also presented.

Metals used for medical devices and their properties are discussed in this chapter. Phase diagrams for each metal are also included to help students understand the importance of temperature and its role in determining a specific phase and structure.

Factors affecting protein structures and properties, formation of monolayers, forces influencing protein interactions and how proteins are adsorbed on different biomaterial surfaces are presented in this chapter. In addition, some of the commonly used methods to understand the behavior of adsorbed proteins are briefly discussed.

The chapter presents the fundamentals and importance of sterilization. Different methods used to sterilize medical implants are discussed, together with the principles behind determining the type of sterilization method suitable for an application.

Different types of biocompatibility testing such as cytotoxicity; sensitization; irritation acute, subacute, subchronic, and chronic systemic toxicity; pyrogenicity; genotoxicity; implantation; hemocompatibility; carcinogenicity; reproductive and developmental toxicity are discussed in this chapter.

This introductory chapter provides a brief history of biomaterials, and the emphasis over the years on ensuring the viability of implants for the desired time and their interaction with the biology of the body. It discusses the importance of first understanding the type of chemical bonds that hold atoms together and how these bonds impart physical, chemical, and mechanical properties to the materials. These properties render biomaterials more or less appropriate for different medical applications as well as determine the body’s response to them.

Different surface modification techniques to modify surfaces of medical devices including principles underlying these surface modification techniques and advantages and limitations of each technique are discussed in this chapter.

Key components of the extracellular space together with the principal proteins and pathways that cells utilize to interact, different adhesion mechanisms, and the role of cell material environment are discussed in this chapter.

This chapter presents the cellular environment and encompasses a diverse population of control systems that range from biomolecular phenomena to a remarkably complex coordination of signaling pathways. Discussions include the principal functions of the plasma membrane, major classes and operation of cell junctions, cell signaling pathways, and secondary messengers. In addition, common biological testing techniques in biology–biomaterial interactions are also discussed.

In this chapter, thrombus formation on biomaterial surfaces and other biological responses are presented. Information discussed includes details on platelets structure and function, platelet–material interactions, contact activation, and pathways of blood coagulation. In addition, the complement system and its activation through different pathways, including activation in the presence of biomaterials, are discussed. The occurrence of acute and chronic inflammation, the role of biomaterials in causing inflammation as well as foreign body reactions, and the formation of fibrous encapsulation around a biomaterial are also covered in this chapter.

The fundamentals and importance of different drug delivery systems – such as diffusion-controlled drug delivery systems, water penetration-controlled drug delivery systems, chemcially controlled drug delivery systems, responsive drug delivery systems, and particulate systems – are discussed in this chapter.

Basic polymeric chemistry discussed in this chapter includes polymerization processes as well as understanding that the molecular weight of polymers is determined using different ways of calculating averages. Factors influencing polymeric properties, such as chemical elements, structure, and their physical states are also discussed. Polymers most often used as biomaterials are similar to those widely used in everyday life, and this chapter includes various types of non-degradable and degradable polymers that have been explored for a variety of applications in biomedicine.

This chapter provides the definition of a general ceramic as well as the classification and properties of various ceramics. Ceramics discussed include biodegradable, surface reactive, and nano-sized ceramics used in biomedical applications.

Different natural polymers that have applications in medicine are discussed in this chapter. Classified as protein-based or polysaccharide-based, these natural materials perform diverse functions in their natural environments such as intracellular communications, providing structure, storage, and acting as catalysts. In addition to natural polymers, other natural materials such as corals are also discussed.

This chapter provides an array of different characterization techniques that are used to determine the surface and bulk properties of biomaterials. Principles underlying the various instruments that are typically used for characterization of biomaterials and their limitations are presented.