Assessing the triad of biocompatibility, medical device functionality and biological safety

Abstract

Biomaterials, defined as 'materials designed to take a form that can direct, through interactions with living systems, the course of any therapeutic or diagnostic procedure' (Zhang & Williams, 2019), are used in an increasing number of medical applications (Williams, 2014a). From both engineering and regulatory perspectives, the 'form' that the biomaterials take is usually referred to as a 'device'; the interaction with living systems may occur in vivo or ex vivo. The devices have functions that range from mechanical (joint replacements, heart valves), optical (intra-ocular lenses) and electrical (cardiac pacemakers, deep brain stimulators) to those of complex systems that may incorporate the delivery of molecules to the body (prolonged release of drugs) or involve diagnostic character (imaging contrast agents, continuous glucose measurement).Of all the required properties of the biomaterials and devices, two are of profound importance. These are biocompatibility and functionality. Biocompatibility, defined as 'the ability of a material to perform with an appropriate host response in a specific application', (Zhang & Williams, 2019) encompasses all types of interaction that can occur between the material / device and the host. These interactions can be considered negatively in the sense that they may inhibit the appropriate host response, for example being responsible for blood clots forming within intravascular devices, or positively if they promote superior host responses, for example enhanced bonding with bone in orthopaedic devices. The full spectrum of potential mechanisms of biocompatibility has not yet been identified, but much progress has been made in recent years (Williams 2008;Williams 2017a;Villanueva-Flores et al. 2020). It is difficult to itemize the required functionality characteristics of medical devices since they vary from one applications to another,

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“…These alloys are used because they have suitable mechanical properties for bone tissue replacement and their biocompatibility with the body environment is good. According to the International Union of Pure and Applied Chemistry (IUPAC), biocompatibility is the ability of a material to be in contact with a biological system without producing an adverse effect [23][24][25]. Although these alloys are biocompatible with the body environment, their biological interaction with the bone tissues is very low.…”

Recent Advances in Two-Dimensional Nanomaterials for Healthcare Monitoring

“…The biocompatibility of a material depends upon several factors including its chemical composition, surface properties, size, and specific biological application. Extensive experimentation is used to ensure that 2D nanomaterials intended for biomedical applications meet the necessary biocompatibility standards. − Several strategies are used to enhance the biocompatibility of 2D nanomaterials; this is a vital aspect of developing novel materials for biomedical applications. One fundamental approach for biocompatibility enhancement is surface functionalization, wherein the surface of a material is modified with biocompatible molecules or polymers to reduce its cytotoxicity and facilitate interactions with biological moieties. − …”

Biocompatibility pathways and mechanisms for bioactive materials: The bioactivity zone

“… In this context, a biomaterial is “ a material designed to take a form that can direct, through interactions with living systems, the course of any therapeutic or diagnostic procedure ” [ 2 ]. From engineering and regulatory perspectives, the ‘form’ that the biomaterials take is referred to as a device [ 3 ]; this needs to have appropriate qualities of biocompatibility and functionality. Biocompatibility has, for 40 years, been defined as “ the ability of a material to perform with an appropriate host response in a specific application ” [ 2 ].…”

“…From engineering and regulatory perspectives, the ‘form’ that the biomaterials take is referred to as a device [ 3 ]; this needs to have appropriate qualities of biocompatibility and functionality.…”