Biomedical materials (BiomedicalMaterials) are materials used to diagnose, treat, repair, or replace damaged tissues, organs, or enhance the functions of organisms. As a basis for the study of artificial organs and medical devices, biomedical materials have now become an important branch of contemporary materials disciplines. Especially with the vigorous development and major breakthroughs of biotechnology, biomedical materials have become the research field of scientists from all over the world. In recent years, there have been endless reports on medical materials and application research of medical materials in the field of high-tech medical technology.

 

Biomedical materials are classified according to their uses. They can be classified into bone-muscle system repair materials such as bones, teeth, joints, and tendons, soft tissue materials such as skin, breasts, esophagus, bladder and respiratory tract, artificial heart valves, blood vessels, and intravascular catheters. Vascular system materials, blood purification membranes and separation membranes, gas selective permeation membranes, contact lenses and other medical membrane materials, tissue adhesives and suture materials, drug release carrier materials, clinical and biosensor materials, etc.

 

Biomedical materials are not drugs, and their effects do not need to be achieved through pharmacological, immunological or metabolic means. They cannot be replaced by drugs. They are necessary to protect human health, but they can be combined with them to promote the realization of their functions. In June of this year, representatives of the European Parliament and the European Council of Ministers reached a compromise resolution on the revision of the European Union's medical device and in vitro diagnostic guidelines. The resolution requires the restriction of the use of substances that can cause cancer, cause organic mutations, toxic regeneration, or interfere with hormone functions. This resolution is of great benefit to strengthening the market supervision of medical materials implanted in the human body. The research and development of biomedical materials must have clear application goals. Even materials with the same chemical composition have different application purposes, not only the structure and property requirements are different, but the manufacturing process is also different. Therefore, biomedical materials science and engineering are always inseparable from their end-application products (generally referred to as medical implants). Usually, when talking about biomedical materials, it refers to both the material itself and the medical implantation device.

 

According to international practice, the management of medical biological materials belongs to the category of medical devices, with a market share of >40%. As an important part of high technology, biomedical materials have entered a new stage of rapid development. Its market sales are increasing at an annual rate of 16%. It is expected that in the next 20 years, the share of biomedical materials will catch up with drugs. The market has become a pillar industry.

 

Biomedical materials are a wide range of multidisciplinary interdisciplinary fields in contemporary science and technology, involving materials, biology and medicine and other related disciplines. They are the important foundation of the two pillars of modern medicine-biotechnology and biomedical engineering. Due to the progress of contemporary materials science and technology, cell biology and molecular biology, the understanding of the interaction between materials and the body has been deepened at the molecular level, coupled with the advancement of modern medicine and the huge clinical demand, contemporary biomaterials science and industry Revolutionary changes are taking place, and are on the verge of achieving a significant breakthrough-regenerating human tissues, and further, the entire human organs, opening the door to the transformation of inanimate materials into living tissues. Under the situation that my country's conventional high-tech biomedical materials market is basically monopolized by foreign investors, seize the favorable opportunity of revolutionary changes in biomaterial science and engineering, look forward to the world biomaterial science and industry in the next 20-30 years, and deliberately improve Innovative ability can not only win a rare opportunity to revitalize my country's biomaterial science and industry, and catch up with the world's advanced level, but also make great contributions to the development of human science.

 

Although the application of biomedical materials has achieved great success, the long-term clinical application has also exposed many problems, which are prominent in that the functionality, immunity, and service life cannot meet the requirements of clinical application. For example, the mortality rate of human heart valve after 12 years is 58%, the rate of vascular restenosis after vascular stent implantation is ≈10%, the validity period of artificial joint is 12-15 years in the elderly group, and only ≈5 years in the young and middle-aged group. It is the material or implant that basically exists in the body as a foreign body. The repair of tissues and organs in contemporary medicine has been developed in the direction of regeneration and reconstruction of human tissues or organs, or restoration and enhancement of their biological functions, personalization and micro-traumatic treatment, and traditional biomedical materials have been difficult to meet clinical requirements. Endow materials with biological structure and biological functions, fully mobilize the human body’s self-healing ability, regenerate and reconstruct damaged human tissues or organs, or restore and enhance its biological functions, and realize the rehabilitation of damaged tissues or organs. It has become contemporary biomedicine. The development direction of materials. The main frontier areas focus on: materials and implanted devices (including tissue engineering products) that can induce the regeneration of damaged tissues or organs; and drugs and biological activities used to treat incurable diseases, restore and enhance the biological functions of tissues or organs Substances (vaccines, proteins, genes, etc.) targeted and controlled release vectors and systems, etc. The cutting-edge research of biomedical materials and implanted devices is continuously making significant progress. The US FDA has approved 7 tissue-engineered products to market, and the Chinese SFDA has approved the marketing of osteoinductive artificial bone and tissue-engineered skin that can induce bone regeneration, and issued Seven tissue-engineered product standards have been established, and a large number of implantable devices for reproducible tissue are in clinical trials at home and abroad. Frontier research is facing the verge of achieving a major breakthrough-designing and manufacturing living human tissues, and furthering the entire human body. Its development and application have given birth to a new discipline-regenerative medicine. It is expected that the development of regenerative medicine will give birth to a new industry of regenerative medicine products, and its market sales will exceed US billion in the next 20 years. Regenerative medicine products are mainly composed of stem cells, tissue engineered tissues and organs with biological materials as scaffolds, and biological tissues and organs that can be transplanted. Biomedical materials are the basis for their development.