Streamlining FDA approval with OptiMIM

Staying ahead of production roadblocks such as FDA validation is essential to getting to market before your competitors. Since FDA validation can take anywhere from six months to two years for the product to be fully assessed, approved and brought to market, it is important to choose a superior process that reduces risk, variation 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, source your components from a single supplier and streamline your supply chain to shorten your design and process validation activities. And you can do it all at scale.

Working with FDA approval requirements in mind

When considering manufacturing processes for your medical components, whether at the prototyping or mass-production stage, you should factor 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 Title 21 of the Code of Federal Regulations states that validation entails an "examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled", applying to both process and design validation.

During the approval process, 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 assured composition and geometries.

OptiMIM process guarantee

With our proprietary metal injection moulding process, custom feedstock, and enhanced strength and elongation capabilities, our process is designed to facilitate FDA approval. Since we make our feedstock in-house, we can guarantee its exact composition every time. Our proprietary furnace programmes also provide greater strength and elongation properties in our components—especially stainless-steel components. With OptiMIM, our superior process means you reduce risk, variation and part failure, making the process easier for the FDA to validate.

In addition to affecting the duration of your process validation, your chosen manufacturing process and supplier can also affect the duration of your component's design validation. With so much at stake, it is important to choose a partner that helps streamline FDA validation.

Early supplier involvement to streamline design validation

The MIM process is designed to produce extremely complex geometries, and you can produce your net-shape component with minimal upfront investment compared with other processes. With years of experience in the medical industry, OptiMIM understands the design validation requirements for medical components. With early supplier involvement, you can benefit from our combined years of engineering expertise to move your component quickly from concept to production with all your required part features—without supply chain disruptions.

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

Eliminate scalability setbacks with OptiMIM

We have seen several medical manufacturers fall into the trap of using a "shortcut" manufacturing process, such as machining from bar stock, to validate their prototype and get to market as quickly as possible. While these processes may create a functional prototype, they are not scalable over the life of the programme. When these medical manufacturers move to a new process to scale for mass production, they must restart process validation from scratch, setting them back several months. In addition, using different processes for the prototype and final component may require 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 product lifecycle. Rather than having to switch from another process and undergo revalidation and potential redesigns, OptiMIM engineers can help guide your programme from conception to mass production so that you can benefit from the full range of advantages offered by the MIM process. The earlier we are involved, the more value we can engineer into your component.

Streamline FDA approval at scale

If you are looking for a supplier with medical-industry experience and expertise in FDA process and design validation, look no further than OptiMIM. Contact our engineering team today to learn more about how OptiMIM can add value to your medical component programme.