News & Blog

Injection molding has allowed many life-enhancing and life-saving medical devices to be within reach of millions of people, by making it possible to produce plastic medical products in large volumes and at competitive cost.

As we have discussed before on this blog, design for manufacturing (DFM) is important for getting the most value out of your injection molding production. DFM is most successful when the contract manufacturer and OEM combine their design and engineering expertise in order to find the optimal choices of tooling material, thermoplastic resin,  placement and size of core outs, number of cavities per tool, runner type (hot or cold), and the right gating structure. By focusing on key aspects like draft, wall thickness, coring, thin and fragile steel conditions, undercuts, and drawing tolerances, effective DFM can reap significant savings.

The MD&M West expo has remained the most significant educational event on more levels than are easily realized. It is traditionally attended by engineers, executives, manufacturing and operations personnel, and R&D engineers looking for suppliers, new technologies and inspiration.

Parting lines and weld lines are important subjects for product designers and mold designers.   An awareness of both is a good first step.    

Only after, you fully comprehend all of the nuances of launching a new injection molding project, can you confidently begin analyzing and developing the processes that will deliver consistent product quality.  Use these tips to help navigate your new injection molding project.

Quality Management System Standards and Certifications

The Quality Management System is a program for the systematic monitoring, evaluation and documentation of the various aspects of a project to ensure critical standards for quality are being met.    

This means that quality standards like FDA registration ensure the injection molder complies with the rules established under FDA quality system regulation as established under the 21 code of Federal Regulation (CFR) Part 820 (Medical Devices). This means certification and government compliance can help validate the highest quality processes by establishing clear standards.

ISO 13845 certification is a manufacturing certification in line with the Food and Drug Administration’s QSR standards and are globally recognized for conforming to the medical device regulatory requirements.

A good quality management system incorporates quality process validations.  Process validation is the process in which objective evidence is established that a process consistently produces a result or product meeting its predetermined specifications. This helps to diminish the risk of product failure

Product/Process Failure Mode and Effect Analysis; this refers to a quality engineering tool used to quantify and evaluate the process variables used in the injection molding process.  Using a structured PFMEA approach to identify, estimate, evaluate and prioritize risk delivers a higher level of product quality.  Process mode and analysis also helps to identify critical input and process variables that can affect product quality while evaluating the risk associated with product defects in order to mitigate that risk.

RPN is used to calculate the relative risk with the defects. This must be calculated for the entire process or design.  After the RPN is calculated, the failure modes with the highest RPN are assigned to the highest priority, and then corrective action is considered.