<p>Advancing global industries with metal injection molding technology that transforms complex concepts into reality</p>

OptiMIM company overview and metal injection molding process

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<p>Staying ahead of production roadblocks such as FDA validation is essential to reaching the market before your competitors. <strong>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.</strong></p><p>With <a href="/additional-capabilities/part-improvement" target="_self">OptiMIM’s value-added process</a>, 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.</p><h2>Working with FDA approval requirements in mind</h2><p>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.</p><p>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.</p><p>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.</p><h2>OptiMIM process guarantee</h2><p>With our proprietary <a href="/metal-injection-molding/process" target="_self">metal injection moulding process</a>, 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.</p><p>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.</p><h2>Early supplier involvement to streamline design validation</h2><p>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 <a href="/additional-capabilities/engineering" target="_self">engineering expertise&nbsp;</a>to move your component quickly from concept to production with all the desired part features—without supply chain disruptions.</p><p>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.</p><h2>Eliminate scalability setbacks with OptiMIM</h2><p>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.</p><p>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.</p><h2>Streamline FDA approval at scale</h2><p>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.</p>

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Discover how OptiMIM’s expertise supports medical device developers by producing MIM components that meet stringent FDA material and quality standards.

Streamlining FDA approval with OptiMIM | OptiMIM article

Selecting the right manufacturing process, such as OptiMIM's metal injection moulding process, with its complex capabilities, early supplier involvement and scalability, can significantly streamline FDA approval for medical devices. 

Streamlining FDA approval with OptiMIM

<p>Metal injection moulding offers a unique combination of metal strength and durability with the design flexibility of injection moulding. At OptiMIM, two different types of <a href="/metal-injection-molding" target="_self">metal injection moulding</a> are available – standard and Multi-Slide. Both offer similar advantages, such as producing complex geometries, combining multiple parts, enhancing features, dramatically reducing cycle times, and achieving greater precision and consistency. Further details about each type will be shared in a future blog post. For now, let’s discuss the steps in the MIM process.</p><h2>Metal injection moulding process</h2><p>The <a href="/metal-injection-molding/process" target="_self">metal injection moulding process</a> involves four steps: compounding, moulding, debinding, and sintering. These four steps, together with feedstock, will be the focus of the next five parts of this blog series. Here is a brief overview of each process.</p><h3>Feedstock/compounding</h3><p>MIM uses metal powders combined with a plastic and wax binder, known as feedstock, as the basis for producing parts. By mixing feedstock in-house, a wide range of metals can be offered, including NiFe, 316SS, 420SS, 17-4SS, titanium, and copper. Pre-alloyed metal powders are also available. Once mixed, the feedstock is processed through a twin-screw extruder and pelletised.</p><h3>Moulding</h3><p>The pellets are loaded into either a standard MIM machine or a proprietary Multi-Slide MIM machine. At this stage, the component is called a “green part”. The final part will have the same geometry as the green part but will be about 20% smaller. </p><h3>Debinding</h3><p>In this step, some of the binder is removed from the feedstock. Heat, chemicals, or a combination of both are used to remove the binders and prepare the part for sintering. Once the binder is removed, the part is referred to as a “brown part”.</p><h3>Sintering</h3><p>The brown part is placed in a continuous or batch vacuum furnace and subjected to temperatures near the material’s melting point. This removes the remaining binder and densifies the part, resulting in the 20% shrinkage mentioned earlier. Sintering takes approximately 15-20 hours.</p><p>Part two of this series will focus exclusively on the feedstock aspect of the&nbsp;MIM process. To answer any questions or for further discussion,&nbsp;contact our engineering team today!</p><p><strong>Other articles in the series:</strong></p><ul><li><a href="/resources/article/mim-series-part-1"></a><a href="/resources/article/mim-series-part-2-feedstock">MIM series part 2 – Feedstock</a></li><li><a href="/resources/article/mim-series-part-3-compounding">MIM series part 3 – Compounding</a></li><li><a href="/resources/article/mim-series-part-4-molding">MIM series part 4 – Moulding</a></li><li><a href="/resources/article/mim-series-part-5-debinding">MIM series part 5 - Debinding</a></li><li><a href="/resources/article/mim-process-series-part-6-sintering" target="_self">MIM series part 6 - Sintering</a></li></ul>

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Begin your MIM programme with an overview of powder metallurgy fundamentals, material selection, and the critical stages of the MIM process flow for production.

Metal injection moulding overview series | OptiMIM article

Metal injection moulding (MIM) combines the strength of metal with the flexibility of injection moulding to produce complex parts through a four-step process: compounding, moulding, debinding, and sintering. 

MIM series part 1

<p>At OptiMIM, a key differentiator is its customisable feedstock, produced in-house. This feedstock is made by combining very fine metal powders with thermoplastic and wax binders in a precise formulation to achieve between 95 and 100% of theoretical density and close tolerances across high-production runs.</p><p>Making <a href="/materials" target="_self">metal injection moulding materials</a> to achieve higher strength and density may sound promising, but that only begins to address the problems that can be solved with proprietary feedstock capabilities.</p><p>In this webinar, MetalSolutions series veteran John O’Donnell and OptiMIM Engineering and Tooling Manager Steve LeBlanc will cover the many ways MIM materials can solve common manufacturing problems, including:</p><ul><li>Modifying materials to suit project requirements</li><li>Creating custom materials to suit project requirements</li><li>Achieving higher strength, density and durability than powder metallurgy</li><li>Shortening your supply chain</li><li>Enabling greater design freedom, and more!</li></ul><p><strong>Please complete the form to download our free on-demand webinar.</strong></p>

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Learn how to resolve common issues in MIM projects, from material flow concerns to final part properties, with guidance from OptiMIM engineering specialists.

Solving MIM material problems | OptiMIM webinar

This webinar explores how customisable metal injection moulding (MIM) materials can solve manufacturing challenges by enabling higher strength, tailored properties, shorter supply chains and greater design freedom. 

Molded withprecision

Next-generation
metal injection molding

Leverage MIM in
any industry

Maximise performance with custom alloys

Low alloy steels

Special & custom materials

Stainless steels

Global reach,custom solutions

Beyond the basics

Metal injection molding resources

Article

Article

Webinar

Interested in starting your MIM project?

Molded withprecision

Next-generationmetal injection molding

Leverage MIM inany industry

Maximise performance with custom alloys

Low alloy steels

Special & custom materials

Stainless steels

Global reach,custom solutions

Beyond the basics

Metal injection molding resources

Article

Article

Webinar

Interested in starting your MIM project?

Next-generation
metal injection molding

Leverage MIM in
any industry