Streamlining FDA approval with OptiMIM

Staying ahead of production roadblocks such as FDA validation is essential to reaching the market before your competitors. Since FDA validation can take anywhere from six months to two years to have the product fully assessed, approved, and brought to market, it is important to choose a superior process that reduces risk, variation, and part failure to facilitate FDA approval.

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 activities. You can also do this 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 ensure 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," applicable 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 guaranteed 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 each time. Our proprietary furnace recipes also provide higher strength and elongation properties in our components—especially stainless steel components. With OptiMIM, our superior process reduces 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. Given these high stakes, 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 achieve your net-shape component with minimal up-front investment compared with other processes. With years of experience in the medical industry, OptiMIM has a detailed understanding of design validation requirements for medical components. With early supplier involvement, you can leverage our extensive engineering expertise to move your component quickly from concept to production with all your desired part features—without supply chain disruptions.

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

Eliminate scalability setbacks with OptiMIM

We have seen several medical manufacturers inadvertently use an expedient manufacturing process, such as machining from bar stock, to validate their prototype and reach the market as quickly as possible. While these processes may create a functional prototype, they are not scalable throughout 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 life of the product. Rather than having to switch from another process and undergo re-validation and potential redesigns, OptiMIM engineers can help guide your programme from concept to mass production, enabling you to 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 experience in the medical industry and in FDA process and design validation, OptiMIM is the right choice. Contact our engineering team today to learn more about how OptiMIM can add value to your medical component programme.