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Precision is the cornerstone of success within the industrial and medical device arenas. And with medical devices being used to save lives in hospitals and surgery centers across the globe, the importance of accuracy during the design process is critical. Examples of medical devices whose life-saving capability hinges upon the precise industrial product design and engineering of plastic components include the following:

  • Defibrillators
  • Anesthesia machines
  • Respiratory ventilators
  • Patient vital signs monitors

Even the slightest deviation in the design of a plastic part or component can result in the failure of a device, resulting in life-altering consequences. The manufacture of these key device components is best undertaken by a company with proven expertise in the engineering of plastic parts.

The Importance of Precision in the Device Manufacturing Industry

With plastic parts being used every day to manufacture aerospace devices, medical equipment, and other life-saving tools, it is crucial that manufacturers choose a reputable injection molding company to produce the components that are critical to the functionality of their products.

Factors to consider when choosing an injection molding company include expertise, precision tolerance, and the presence of professional certifications. Original equipment manufacturers (OEMs) in the medical device arena should be particularly concerned with precision, given the stringency of device regulations set forth by the FDA.

How a Tiny Part in a Medical Device can Have a Huge Impact on a Life

The role that a single plastic part plays in the functionality of a medical device cannot be understated. For instance, if a plastic fitting for an anesthesia machine or flow meter is just a fraction of an inch too large, the resulting gap could cause a gas leak. The end result could be an insufficient delivery of oxygen or nitrous to an ailing patient. If a button for a defibrillator is slightly over or undersized, health care providers may have difficulty depressing the button to operate the device to save a patient. Accuracy in the engineering of device components can literally be a matter of life or death.

Ensuring Precision in Devices with Components from a Certified Company

One of the best ways to ensure precision with medical and industrial devices is to utilize components that are designed in accordance with the most stringent quality and safety standards. Device companies should consider parts manufacturers that are ISO (International Organization for Standardization) and ITAR (International Traffic in Arms Regulations) compliant.

ISO standards were established to make sure that devices are reliable, safe to use, and of high quality. ITAR compliance is achieved by adhering to laws that govern the export of technology. Parts designed in accordance with these standards must adhere to the most rigorous design regulations.

The Significance of Production Capabilities

Production capabilities are as important as precision in the device industry. When evaluating a company’s ability to provide plastics processing and design services, manufacturers should consider the company’s competency and expertise in the following areas:

  • Injection molding
  • Rapid prototyping
  • Plastic dip molding
  • Assembly

Additionally, a manufacturer should seek the services of a company that can handle the receipt of large orders. OEMs of medical devices should pay particularly close attention to this variable because of the time-sensitive nature of life-saving devices.

Choosing a Trusted Expert in Product Design and Component Engineering

With the wide array of component suppliers for medical and industrial device manufacturers, it is important to choose a company with proven expertise and a focus on quality and accuracy. With over 50 years of engineering and molding experience in virtually every industry, Molded Devices, Inc. (MDI) is committed to the design of precision device components.