CNC Machine Shop Medical Device Manufacturing
Medical device manufacturing is an intensely iterative process. Even if a product makes it through the initial development and design stage, it still needs to pass compliance standards before making it to the market.
To do this, companies must follow strict ISO and FDA guidelines. These often include specialized technologies and processes, such as plastic welding or 3D printing of medical-grade polymers.
CNC Machine Shop
Medical device manufacturing creates state-of-the-art tools and implants for monitoring, diagnostics, and therapeutics. As a vital industry, it requires precision, safety, and compliance with regulatory guidelines. Often, this involves partnering with contract CNC manufacturers like Bates Machine nad Manufacturing in Farmersville, Texas who specialize in a wide range of high-precision manufacturing processes.
When engineers look at a bill of materials for any given medical device, they often find components with names like “bracket,” “stand,” or “adapter.” These types of parts typically require sheet metal fabrication processes and/or welding. Moreover, their design must adhere to the medical grade specifications for each of the metals used. For example, springs and wire form material must be made from a special type of metal alloy known as Elgiloy.
Injection molding is ideal for many medical devices because it provides a cost-effective alternative to fabrication and machining. However, injection molds can be expensive to produce, especially if they are required for a high volume of production. To avoid this, some companies opt to use 3D printing for low-volume, customized parts.
Plastic Injection Molding
Injection molding involves heating plastic materials until they liquefy, then injecting them into a pre-designed mold. The molten plastic takes on the shape of the mold, creating a finished product. Injection molding is a simple and cost-effective method of shaping raw materials into complex parts, and it can be used for both large and small production runs.
The medical industry uses injection molding for electronics that need to be durable and able to withstand sterilization procedures. Many medical devices also require specialized plastics that resist contaminants and can stand up to radiation, chemical exposure, and other harsh environmental conditions.
Injection molding is used for plastic components of electronic devices, such as housings that protect and insulate the internal parts. It is also often used to create the plastics that comprise medical instruments and parts for implantable devices. Plastic injection molding services can provide products in a variety of shapes, sizes, and colors. They can also handle high press tonnage and provide prototyping and low to high-volume production runs.
Assembly
Medical devices need to be manufactured with precision and quality, as well as a high degree of safety. They also need to comply with regulatory standards, which can add a significant amount of cost and time to the manufacturing process.
Depending on the device being developed, there may be a number of different assembly processes required to bring it to market. Whether it’s a tongue depressor or an MRI machine, it is important that design engineers understand the various production methods and how they can be used for each specific device in order to optimize the manufacturing process.
Medical device contract assembly services can help companies focus on their core competency of designing life-saving medical devices while outsourcing the assembly aspect to a trusted partner. This can help reduce risk, lower costs and reduce the time it takes to get medical devices to market. It is also an effective way to test prototypes and develop new models with the help of a trusted partner.
Testing
A manufacturer that is in the business of assembling and testing medical devices uses a wide range of test equipment. Some tests are highly specialized, while others are more standard in nature. The method of manufacturing for a new device needs to be considered early on in the design phase.
This can help the engineering team understand the impact their design decisions will have on production cost. While actual cost modeling may not be possible until the prototype is complete, it’s a good idea to begin putting some numbers down so that the design process can be better focused.
The manufacturing process can quickly put the product team over budget if it’s not managed efficiently. An effective test strategy can reduce costs without sacrificing quality and help engineers get their devices to market at speed. LSI’s MES solutions are designed specifically to meet the needs of the medical device industry. They enable manufacturers to simultaneously increase revenues and decrease costs — boosting profit margins.