XavierIntroduction to the Basics of Medical Device Machining
Medical device machining involves the use of different procedures to manufacture medical devices. They must be manufactured or machined in the right way to meet the standards set by the relevant associations.
The industry has witnessed increasing public scrutiny and costly recalls. The US health agency FDA (Food and Drug Administration) classifies these devices based on the risks they pose. These risks include medical device machining procedures and the introduction of new products to the market.
1.Precision CNC Machining for Medical Device Machining
First, you need to choose the right medical device machining procedure that will help you manufacture a high-quality product. One of the most precise methods that can be used is CNC machining.
In this manufacturing procedure, the already programmed computer software will determine the operation of the machine. Coming up with the right design and choosing the right manufacturing equipment will also help you manufacture a high-quality device.
Medical device prototyping is often fundamental to your design and production process. At Xavier, we offer 5-axis CNC milling and turning to manufacture a wide range of medical devices.
Rapid development of health product samples will give you the opportunity to evaluate the concept and make further improvements. The company you choose can help you develop and validate your ideas.
Most ideas fail to materialize because the inventor does not know where to start or how to build a model. One can use medical rapid prototyping techniques to create more accurate models.
2.Developing Device Prototypes
Researchers will first develop a device prototype, or an initial model of a specific medical device. At this stage, medical device prototypes are not available to the public. The models that are built are then tested in a supervised laboratory environment.
Corrective prototypes provide researchers with some important information about the potential use of a specific product by consumers. The entire process is designed to minimize the risk of harm to different users. However, it is impossible to eliminate all risks in the medical prototyping process.
Working prototypes are an important part of a product. This critical step in the design process gives you a chance to get some feedback and evaluate your concept before the product goes to market. Prototypes also give people a chance to look for flaws in the design, operational adjustments, and proper performance before the product goes into manufacturing.
Prototypes can be anything from a simple cutting board to a complex 3D printed design, giving you the opportunity to make your product with fewer risks. When it comes to the production of medical devices, building, designing, and operating test prototypes is essential for future product development.
Chances are, some cost-effective programs will get functional prototypes into the hands of clinicians for evaluation, and some manufacturers can help you figure out which prototyping method is right for your product requirements on time and within budget.
Some common medical devices include biopsy tubes, cannulas, surgical scissors, and saw guides for bone surgery.
Medical device companies can also use a variety of materials to produce clinical prototypes. These include titanium, steel, nylon, and polyurethane. While the type of material to be used depends largely on the specific device, there are a few basic questions to consider when selecting and describing the material.
At some point, licensing your device prototype is essential. When copyrighting your device, it is crucial to protect any alternatives that may be used to replace the original material. Some of the most common processes used when processing medical devices include injection molding, EDM, and extrusion.
1) Extrusion
This is an uninterrupted production process where silicone rubber is stretched through a mold to achieve the perfect shape and then cured. The basic pressure is generated by the screw, and the material is standardized, compacted, and discharged.
Tubes for pharmaceutical and medical purposes are manufactured using this method. After these processes, the tubes are packaged in the correct manner, which means that customers can rest assured that the device will not change color before it reaches the clean room.
2) Injection Molding
Injection molding is currently the most popular and effective process for producing large quantities of high-quality silicone. Silicone rubber from different manufacturers can be used to produce valves, seals and diaphragms. The entire process is fully computerized and requires no post-processing, even for those with the most complex geometries.
3) Electrospark Machining
Electrospark machining, commonly known as EDM, is a process for producing parts and other elements from conductive materials that cannot be processed by other machining processes due to factors such as material hardness, required cutting accuracy, etc.
The process is used in different fields, but it is most useful in making molds, prototypes and dies as it can cut very precise parts and can also cut hard materials such as carbide, titanium, Inconel, Kovar and hardened steel tools.
The medical industry relies heavily on this process when machining medical devices. EDM can also be used to remove drill bits and other broken pieces from the cavity.
3.Choosing the Right Medical Device Machining
You need to choose the right medical machining equipment to get high-quality devices. The machining equipment you choose depends largely on its purpose and material.
The first thing you should look out for is a machine that can produce a large number of devices. Using a CNC machine is very advantageous because it can replicate the same design after a period of time, which requires little human intervention.
You should also consider the type of technology used by the processing equipment you want to choose. Laser technology is vital in the production of medical device processing because it gives users the opportunity to make multiple adjustments that can help improve the accuracy of a specific device. Water jet technology is also vital in cutting, drilling, and device surface development.