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What is Medical Device Manufacturing?

The global market for medical devices is expected to reach $543.9B in revenue by 2020. With the move toward minimally invasive surgery and micro-machined parts, medical device manufacturing is expected to experience growth for years to come. The medical technology industry invests heavily in research and development to keep up with the innovation and constant pressure for improvement.

About Medical Device Manufacturing

Medical devices are essential in countries with aging populations like the United States and Japan. In addition to demographics, the industry’s growth is driven by the increasing costs of healthcare and technology advancements. Medical device manufacturing includes orthopedics, cardiovascular devices, surgical instruments and robots, and dental. Their component parts are produced by technologies such as machining, grinding, polishing, micro-machining, and surface treatment. 

Medical Devices

Medical devices improve surgical outcomes with advanced technologies and make a tangible difference in people’s lives. The United States is the world’s largest medical device market, representing 40% of the global market in 2017. As the market for health care grows, manufacturers are continually striving to improve product features, customer service, and business models. However, they are challenged to advance technologically while reducing cost. 

Precision Medical Machining

Precision medical machining is both a job and a definition. It involves machining medical parts with absolute precision and accuracy. CNC (computer numerical control) machines produce the extremely intricate parts needed for manufacturing medical devices. They handle routine processes such as drilling, turning, milling, boring, and knurling along with special processes such as broaching, deep hole drilling, hobbing, threading, and slotting without multiple set-ups. The most advanced machinery available features 11 axis, automatic bar loading and CNC control. CNC machines are capable of producing sophisticated surgical instruments, tiny screws and everything in between.  Medical machined parts for the most complex devices require tight tolerances. The pressure is on to make these parts smaller and smaller, which means that manufacturers need to stay on top of developments such as miniaturization and micro-machining. Multi-tool and multi-axis machines, such as CNC Swiss Turning Centers, improve the manufacturing of medical parts with shorter cycle times and because all features are produced on one machine.

Medical Component Parts

Machined components for medical devices are highly sophisticated, complex pieces that are critical to the safe operation of the unit. It requires ingenuity to design and produce component parts that make advances in medical device technology possible. Medical devices include parts such as surgical needles, grippers, screws, and lock plates. It’s important for the device manufacturer to consult with their component part suppliers early in development. Medical component specialists are experts in high precision machined parts and can identify when tighter than necessary tolerances have been specified. They can also work to design production processes that will save the OEM both time and money. 

Minimally Invasive Surgery

One of the benefits of minimally invasive surgery is that it can be accomplished with very small incisions. Medical device manufacturers want to provide doctors with the surgical tools they envision for minimally invasive procedures. For example, a surgeon may require smaller tubes or tinier cameras for minimally invasive cardiac surgery. What they can imagine in their minds sometimes doesn’t yet exist. That’s where workable prototypes and test quantities come in. Engineers at the OEM and the precision machining company get their heads together and it’s not too much longer before the newly envisioned improvement has gone from prototype to acceptance to manufacturing.

Robotic Surgery

Minimally invasive surgery is accomplished with robotic technology. Robotically-assisted surgical (RAS) devices are changing the experience of surgery for both doctors and patients. Robotic surgical systems allow surgeons to work with tiny instruments and precise motion control inside the patient’s body. There is no room for error. Every part of the surgical robot must be perfect. The benefits of robotic surgery are generally shorter hospital stays and fewer complications, which means that it will continue to be in demand from both patients and insurers. 
 
One of the ways the industry works to ensure perfection is with ISO 13485 certification. ISO is the world’s largest developer of voluntary international standards. ISO 13485 is an internationally agreed upon quality management system standard for the design, development, production, and sale of products for the medical device industry.
An ISO 13485 certification is absolutely essential for a machining company working with surgical robot manufacturers. It means that the quality and precision of their manufactured products is assured. It requires a robust system for component part manufacturing and testing and it includes a stringent audit and inspection process.
Medical device manufacturing is constantly evolving and developing new technologies. Those new technologies require expertise in the science of precision medical components for medical equipment and robotic surgical systems. Consistently manufactured, reliable component parts are critical to the safe operation of medical devices. At SPM, we are a manufacturer of precision parts for the medical industry. We help our customers innovate and work with them to develop a solution that works at a competitive price.