The rise of the manufacture of medical parts, medical equipment parts, and precision medical components stems from the rapid growth of computer and industrial outsource back in the early 1990s. Although the market of consumer electronics was growing at the time, outsourcing in the medical device sector remained stagnant due to the regulatory nature of the market as well as the potential risks embodied within medical products. Only a small base of the manufacturers was equipped with the skills to not lose ground in the related field.
Later, however, the outsourcing of medical equipment parts and the relative supply chain began to emerge, which started to bring products into the medical equipment manufacturing sector over the subsequent years and in turn facilitated the manufacturing of device parts. Now this notable trend is still shaping the market we have today.
Medical equipment parts are often made from metals and metal alloys, most notably for implanted medical equipment or other devices that are sometimes in contact with parts of the body for an extended period of time. The safety and effectiveness of these devices involving the metals and materials by which they are made are evaluated by the FDA to protect the users from the inherent risks of medical products.
Before one looks into a specific part of medical equipment, it is advisable to have a fundamental understanding of the industry sector to which the part belongs. The medical equipment industry can be broken into several areas of expertise including implants, instruments, and equipment intended for therapeutic, diagnostics and monitoring. These embody reconstructive equipment like knee and hip replacements, and implantable monitors for cardiac and diabetic care. The relative industry sectors pertaining to the manufacturing of medical equipment and parts are outlined below:
● Orthopedics: This has been one of the most prominent sectors in the manufacturing of medical devices and parts. This includes the components of spinal implants, reconstructive devices, arthroscopy, hip implants and keen placement. The manufacturing processes utilized in this sector include machining, casting, grinding, polishing, rapid manufacturing, and metal injection molding.
● Diagnostic Apparatus: This is the one relevant sector that involves technologies like IT, imaging, and micro-manufacturing of endoscopic devices.
● Surgical Instrument: This must just be the second-largest sector following orthopedics which involves the manufacturing of dilators, sutures, surgical robotics, etc.
● Cardiovascular Devices: This includes the manufacturing of medical devices like pacemakers, defibrillators, and so on. Key technologies used in producing the parts including power sources, micro-molding, and assembly.
● Diabetes Devices: This sector is primarily characterized by technologies revolving around continuous glucose monitoring (GCM), such as nanotechnology, sensors, and assembly.
● Dental Instrument: This includes implants, drills, and imaging equipment. Core technologies include additive manufacturing, machining, and 3D imaging.
Following the above, the related technologies and processes used to manufacture medical devices and parts are as follows:
● 3D Imaging: This process involves the collection of 3D digital data from physical objects.
● Quality systems: This is an extremely important component to ensure the consistency of quality of production, especially for precision medical components.
● Measurement & Inspection: This has to do with maintaining consistency and reliability through measurement and inspection methods.
● Additive Manufacturing: This process capitalizes on 3D imagining to reduce development time.
● Assembly: This is perhaps one of the most common manufacturing methods that is especially ideal for producing micron-sized medical components.
● Lasers: Precision medical components require laser cutting to produce intricate details with maximum accuracy.
Having touched base on the various technologies above, we want to specifically address the precision manufacturing process – the manufacture of small, individual pieces with maximum accuracies which is widely used in the medical equipment part manufacturing industry.
Precision manufacturing is especially useful for creating small, identical medical parts in large quantities. To ensure extreme precision and control, the machines that are used to manufacture these parts are often equipped with CNC capability. This includes highly precise machines like the CNC milling machines or CNC turning centers which are capable of done-in-one production.
Last but not least, utilizing the right tooling is also very crucial for making small, detailed medical device parts. Micro-machining tooling is generally preferred for these lines of operations. Tapping extremely small pieces on a lathe machine can be difficult, so having the right tool is critical.
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