634 Glenn Ave., Wheeling, Illinois 60090

Planning and Engineering Medical Machined Parts

Medical device design and manufacturing requires expertise in three engineering disciplines: mechanical, electrical, and software. As a provider of medical machined parts, we operate within the mechanical engineering discipline. The planning stages of medical device design include research and discovery, specification development, prototyping, and documented testing. We work with our customers throughout all phases of the design and production process to ensure that the end product is safe, effective, innovative, and successful.

Developing precision parts for medical devices is one of our toughest and most exciting challenges. Medical device companies compete to deliver the best, most effective products in today’s demanding market. In order to succeed in planning and engineering medical parts, we need to excel in precision and safety — all within the framework of strict regulatory standards. 

Precision

The number one requirement for medical machined parts is precision and accuracy because precision affects the operation of the medical device, and thus the safety of the patient. During research and discovery, the development team must ask how precise each of the parts needs to be. For example, devices that are used during minimally invasive procedures are complex and require very tight tolerances. Engineers and machinists must also take into consideration the consequences if a part is less precise. This conversation addresses the tradeoff between cost and tolerances. We have the ability to produce parts with strict tolerances at competitive prices because we are always looking for ways to simplify without a loss of performance. We know that if we can eliminate unnecessary specifications, we can offer significant savings over the long term.

Safety

Medical devices are generally required to be single-failure safe. For example, the da Vinci surgical robot “incorporates multiple redundant safety features designed to minimize opportunities for human error when compared with traditional approaches.” Machinists must ensure that parts are free of contamination and debris, and so they plan for the removal of metal pieces, dust, oil, and other contaminants through processes such as deburring and passivation. They must also know and comply with special regulations such as ASTM A967 for passivation.

Regulatory Standards

The primary regulatory agency in the United States for medical devices is the Food and Drug Administration (FDA). In 2018, the FDA published its 5-point Medical Devices Safety Action Plan. It outlines a vision to assure the safety of medical devices and advance innovative technologies. It focuses on how the FDA can:
  1. Establish a robust medical device patient safety net in the United States 
  2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations 
  3. Spur innovation towards safer medical devices 
  4. Advance medical device cybersecurity
  5. Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a TPLC approach to device safety

This is important to medical component part manufacturers because the “US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.” The most important regulatory standards for medical parts machining are addressed with ISO 13485:2016. ISO is the world’s largest developer of voluntary international standards. ISO 13485:2016 is an internationally agreed upon quality management system standard for the design, development, production, and sale of products for the medical device industry. When a manufacturer achieves ISO 13485:2016 certification, it communicates to their customers that they are a trustworthy manufacturer of precision parts for medical devices.

In addition to the above, medical device manufacturers may need to comply with environmental requirements or to conform to regulations for chemicals and other controlled substances. 

Success with Medical Machined Parts 

“Producing a successful part requires a process that transforms raw materials into a final product that satisfies design requirements while taking into account both technological and geometric constraints. But, more than that, a truly successful process will also be cost effective for the business.”

Component parts for medical devices should be planned and engineered with the same care and attention to detail that is applied to the finished medical device. Medical machined parts must be precise and accurate. They must ensure that the device is safe for use in or on the human body. They must conform to complex safety regulations. At SPM, we have been accomplishing this, on time and on budget, for more than 40 years.