Biocompatibility of interactions that occur between implanted biomaterials and the host living tissue

Jun 21 2004

Researchers across the world are working toward biocompatibility by optimizing interactions that occur between implanted biomaterials and the host living tissue. Overcoming this significant technical challenge is likely to broaden the scope of biomaterials' applications.

"Thrombosis involving blood coagulation and adhesion of blood platelets to biomaterial surfaces as well as fibrous-tissue encapsulation of biomaterials that are implanted in soft tissues are two challenging issues for researchers in quest of biocompatibility," says Technical Insights Analyst Dr. James Smith.

Biocompatibility assumes greater significance as surgeons are increasingly focusing on treatment of chronic diseases.

For instance, spinal surgeons are turning their attention to technologies that can treat chronic back pain rather than focusing on achieving spinal stability, as fusion technology such as cages, bone grafts, and fixation devices attain maturity in terms of providing positive clinical benefits.

Growing understanding of complex biological materials and development of novel biomaterials designed at the molecular level to meet specific medical applications are likely to mark future advancements toward biocompatibility.

One such development is tailor-made, designer polymers from a beaker by programming the modular polymer scaffolds to attract building blocks of small molecules. This 'one-beaker' process aims at simplifying the synthesis of designer polymers through self-assembly using combinatorial chemistry.

Researchers have used the same 'one-beaker' principle to build copolymers and modify properties of polymers by changing certain variables such as temperature, pH factor, ultraviolet light, and solvents.

Other exciting research prospects include the development of customized organic polymers that can be used to regenerate damaged nerves. Research on visual prostheses promises to restore vision for blind individuals by way of retinal implants.

However, researchers may have to face long periods of product testing, product cycle, and clinician acceptance while countering reimbursement issues before successful commercialization.

"The efforts of researchers are hampered by the current liability laws and stringent functioning of the Food and Drug Administration (FDA) in certifying the safety and effectiveness of the medical devices based on the results of clinical trials," informs Smith.

However, the FDA's conservative policy and demand for comprehensive documentation is understandable, as medical device manufacturers can be subject to liability lawsuits even after obtaining governmental approval.