Streamlining FDA Approval

FDA Approval | Medical Manufacturer | Metal Injection Molding

Staying ahead of production roadblocks like FDA validation is essential to getting to market before your competition. Since FDA validation can take anywhere from six months to two years to get the product fully surveyed, approved, and into the marketplace, it’s important to choose a superior process that reduces risk, variance, and part failure to make FDA approval easier.

With OptiMIM’s value-added process, complex capabilities, and engineering expertise, you can reduce the need for secondary assembly, single-source your components, and streamline your supply chain to shorten your design and process validation processes. And you can do it all to scale.

Working with FDA approval requirements in mind

When considering manufacturing processes for your medical components, whether in the prototyping or mass production stage, you want to factor in FDA approval processes and requirements into your decision. The product must pass both process and design validation to guarantee its function and quality.

Section 820.3(z) of the Code of Federal Regulations Title 21 states that validation entails an “examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled,” presenting in both process and design validation.


FDA Approval | Medical Manufacturer | Metal Injection Molding

During the course of approval, your chosen manufacturing process will be subject to scrutiny in process validation. You need a manufacturing process that is reliable, repeatable, and produces parts with guaranteed composition and geometries.

OptiMIM process guarantee

With our proprietary MIM process, custom feedstock, and enhanced strength and elongation capabilities, our process is built to make FDA approval smooth sailing. Since we make our feedstock in-house, we can guarantee its exact composition each time. And our proprietary furnace recipes make for higher strength and elongation properties in our components—especially components of stainless steel. With OptiMIM, our superior process means that you’re reducing risk, variance, and part failure, making it easier for the process to be validated by the FDA.

In addition to having an impact on the length of your process validation, your chosen manufacturing process and the supplier also have a potential impact on the length of your component’s design validation. With these high stakes, it’s important to choose a partner who helps to streamline FDA validation.

With OptiMIM, you can achieve complexity without compromise. Learn more about our complex design capabilities for the medical industry here.

Early supplier involvement to streamline design validation

The MIM process is designed to produce extremely complex geometries, and you can achieve your net-shape component with minimal up-front investments as compared to other processes. With years of experience in the medical industry under our belt, OptiMIM knows the ins and outs of the design validation requirements for medical components. And with early supplier involvement, you can take advantage of our many combined years of engineering expertise to move your component quickly from concept to production with all of your desired part features—without supply chain hiccups.

Have you considered the benefits of part consolidation? Or thought it to be impossible with your current process? Not with OptiMIM. Our value engineering and greater design freedom means that you can reduce the need for secondary assembly, single-source your components, and streamline your supply chain to shorten your design validation process and get to market sooner than your competitors. And OptiMIM enables you to do it at scale.

Interested in learning more about our part consolidation capabilities? Check out our blog post!

FDA Approval | Medical Manufacturer | Metal Injection Molding

Eliminate scalability setbacks with OptiMIM

We’ve seen several medical manufacturers stumbling into the trap of using a “shortcut” manufacturing process like machining from bar stock to validate their prototype and get to market as fast as possible. While these processes may create a functional prototype, they are not scalable over the life of the program. So when these medical manufacturers move to a new process to scale for mass production, they must start the process validation over again from scratch, setting them back several months. On top of that, different processes for prototype and final component might mean different design considerations, depending on the capabilities of each process.

With OptiMIM, we can produce fully functional prototypes to validate your design in a way that is scalable throughout the life of the product. Rather than having to pivot from another process and suffer the re-validation and potential re-designs, OptiMIM engineers can help guide your program all the way from conception to mass production so that you can take advantage of the full suite of benefits of the MIM process. The earlier we’re involved, the more value we can engineer into your component.

Streamline FDA approval at scale

If you’re looking for a supplier with experience in the medical industry and process and design validation for the FDA, look no further than OptiMIM. Contact our engineering team today to learn more about how OptiMIM can lend value to your medical component program.

Check out some of the medical equipment and devices we’ve worked on in the past:


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Last updated 12.09.2021