The era of medical surgery is rapidly changing. It is part of the world driven by technology and powered by increased understanding and improved knowledge of the body. Nowhere is this more evident than in spinal surgery. The current technological boom is driving comprehensive changes including implants. Spinal implant manufacturers are working overtime to remain competitive in this field of medicine.
Standards and Medical Devices
In the United States, two major bodies are in charge of recommending and implementing standards for medical devices, including spinal implants. These are:
- The American National Standards Institute (ANSI): They are a representative to the International Organization for Standardization (ISO). It is the American representative to the ISO. However, while ANSI may adopt a standard, the other large American regulatory authority need not recognize it.
- The Food and Drug Administration (FDA): The FDA has its own list of recognized standards. Among the major standards are those for medical devices ANSI/AAMI/ISO 14971:2007 (R2010) but not ISO 13485 the quality management system. The FDA has its own
When dealing with such medical devices as a spinal implant, manufacturers have to adhere to the standards accepted by the FDA for sale and use in the USA.
Emerging Trends
The emerging trends for producing spinal devices have to work within the parameters of two major factors: FDA standards and demands of the medical device community. The race is on to produce technologically advanced devices for minimally invasive surgical spinal implants. However, the ongoing demands by hospitals and ambulatory surgery centers (ASC) to reduce costs while producing quickly the latest and highest-quality medical technology is also behind the move.
Spinal Implant Manufacturers
In the medical industry, manufacturing expertise is central to success. An Expert Spinal implant manufacturers work closely with surgeons and other invested parties to produce an effective product. In a competitive market, it is important to produce quickly, efficiently and effectively.
