Streamlining FDA approval with OptiMIM

Staying ahead of production roadblocks such as FDA validation is essential to reaching the market before your competitors. As FDA validation can take anywhere from six months to two years for the product to be fully reviewed, approved and brought to market, it is important to select 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, source your components from a single supplier, and streamline your supply chain to shorten your design and process validation timelines. This can all be achieved 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 assure 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," applying to both process and design validation.

During the approval process, your selected manufacturing process will be scrutinised during 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 produce our feedstock in-house, we can guarantee its exact composition every 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 selected 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, enabling you to achieve a net-shape component with minimal up-front investment compared with other processes. With years of medical-industry experience, OptiMIM understands the design validation requirements for medical components. Through early supplier involvement, you can leverage our extensive engineering expertise to move your component quickly from concept to production with all the 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, source your components from a single supplier, 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 use a "shortcut" manufacturing process, such as machining from bar stock, to validate their prototype and reach the market as quickly as possible. While these processes may produce a functional prototype, they are not scalable throughout the life of the programme. When these medical manufacturers move to a new process for mass-production scale, they must restart process validation from scratch, delaying them by several months. In addition, using different processes for the prototype and final component may require different design considerations, depending on each process's capabilities.

With OptiMIM, we can produce fully functional prototypes to validate your design in a manner that is scalable throughout the product life cycle. Rather than switching from another process and undergoing re-validation and potential redesigns, OptiMIM engineers can help guide your programme from conception through to mass production so that you can benefit from the full range of MIM process advantages. 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 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.