The medical product design & engineering cycle must progress through many steps before a functioning prototype is created that meets all the expectations of process design feasibility and product functionality.

Yet often, device manufacturers neglect to engage in early planning for the final phases of medical device manufacture, such as adhering to federal process record keeping regulations, simplifying or combining secondary operations, incorporating medical assembly techniques, and the final clean room packaging facilities.

The duties of a quality medical device manufacturer include limiting the contact between non-sterile surfaces and the medical device during production, secondary operations, and packaging and labeling.

The distribution of medical products can be global, which is why the product integrity, its protection in packaging containment, and the presentation provided by labeling and package inserts are key factors in providing life-saving products that are transparent to the end user. It is for this reason that post production operations should be weighed heavily and integrated early in the product development cycle.

Process Validation Records

It is crucial to partner with a manufacturing facility that adheres to the U.S. Food and Drug Administration (FDA) quality system, which regulates the process design and control of production. Not only must process parameters be controlled, but they must also be monitored and recorded, according to Title 21 CFR QSR, 820.75.

Evidence must be gathered and recorded that proves the intended design has been properly translated throughout the manufacturing process, and that all the requirements are being met.

Accurate process records will reflect that both machine and operator have followed established procedures, and any deviations which may have produced a product out of conformity are vital information that can be used to improve procedures and methods. A high degree of validation through product inspection and testing is critical to prevent failure to meet governmental quality standards.

Secondary Operations and Assembly

Early planning of secondary operations goes beyond the injection molding or extrusion process and involves those processes that result in a final, completed medical device that functions properly. Select a component manufacturer that can handle a full range of secondary operations, such as pad printing, sonic welding, heat staking, laser engraving, and more.

Secondary operations can acquire a significant portion of production time and costs; strategies that are mapped out early can incorporate multiple operations into one process cycle.

In the field of medical device manufacturing, secondary operations and assembly take precision and care, and often must be accomplished within a cleanroom environment. Seek a contract manufacturer that is capable of meeting airborne particulate cleanliness according to ISO 14644, with modern, automated technology for post-production processes.

Additionally, in-process testing is considered a secondary operation and should be accounted for throughout the design process to prevent a higher cost per piece or additional production time.

Labeling and Packaging Requirements

Good Manufacturing Practice (GMP), as mandated by the federal government, requires incorporating a quality assurance program in the packaging and labeling of medical devices.

Product testing and flexible or rigid packaging should be conducted within a Class 7 clean room environment using automated equipment to minimize handling, and is often integrated seamlessly within the production cycle. Clean rooms are regularly monitored for particle count, temperature, and humidity to ensure the integrity of the product.

While there is flexibility in labeling procedures, laws require that the labels applied to devices or printed onto plastic products must remain in place and legible during storage and use. Also, devices that are sterile in the fluid path after manufacture, or those devices that must undergo sterilization processes, must have the proper labeling of precautions and instructions prior to shipping.

FDA compliant contract manufacturers can offer a range of services, from fabrication to testing, packaging, labeling, appropriate process validation record-keeping, clean room procedures, and trained personnel to get your medical device to market. For more information on how to get help with your device manufacturing, contact us today.