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Semi-finished goods (ortho implants)
The market for orthopedic implants is in heady days, despite a recent downturn. Manufacturers have seen double-digit growth in recent years, and some forecasters anticipate that the growth will continue for the next ten to fifteen years. The industry was stagnant from the early to mid-1990s, but is now booming, and it has a number of reasons for its success. However, prolonged periods of rapid growth can pose unique challenges for smaller firms. Finding qualified employees and adding production capacity to keep up with the demand is a time-consuming and energy-consuming process.
The FDA requires strict verification and validation procedures for medical devices, ensuring that the implant confers the desired performance specifications and is safe for use in the human body. Most manufacturing shops follow itemized procedures and individualized labeling practices to ensure that the metal implants meet blueprint requirements. Listed below are some of the common manufacturing practices followed by these companies. To find out whether your company offers a similar service, contact the manufacturers directly.
The process for manufacturing medical devices begins with identifying the right metal alloy. The metals used to make surgical devices must be appropriate for the anatomic site. Corrosion is a consequence of minute changes in pH, which can turn a stable construct into a disastrous one. Titanium is commonly used for orthopedic hip stems. Its high fatigue strength and light weight help reduce stress shielding, a factor that contributes to localized bone loss. As titanium forms an outer oxide layer, it resists corrosion and prevents stress shielding.
Product development involves complex computer modeling and prototyping procedures. Finite element analysis (FEA) is a popular method for this, providing quantitative simulations of complex biomechanics of the implant. Moreover, this process also provides valuable information about the methods of failure, which is important for implant development. If your goal is to produce an effective orthopedic device, a solid material like stainless steel will help. In addition to plastic, stainless steel is a popular choice for surgical materials.
In addition to testing, the development process also incorporates a highly detailed computer modeling process. This process is called finite element analysis, and it is used to simulate the biomechanics of a device. It provides valuable information on possible failure methods of an implant. This technology is vital for the development of a high-quality implant. Once the final product is completed, the manufacturer is free to market it. It is vital for a surgeon and the patient to receive the best possible outcome from the surgery.
While the FDA have no universal standards, there are several acceptable practices that can be followed. The first is sterilization, while the other is the process of sterilization. The latter is essential for a surgical procedure, especially if it is performed on a patient who has suffered a fracture. Then, the process of replanting is important. In case the implant is not sterilized, the implant manufacturer can simply use it.