Medical Device Engineering Consulting

With many years of industry experience in engineering consulting, our in-house team of engineers can provide the personal service you need to achieve your project goals.

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Bring your concept to market

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Front End Design Guidance

Defining the clinical need, clarifying the proposed solution and refining the requirements aid in our approach to creating a working prototype.

We work with our partners to create potential solutions through a variety of design approaches and strategies.

Product Development

Our team of engineers possesses extensive knowledge of the engineering design process, allowing us to keep our projects on track with both our short-term and long-term goals.

To achieve our short-term objectives, we rapidly iterate R&D prototypes while maintaining quality traceability. Long-term, we provide the crucial information required to manage any potential risks associated with sourcing raw materials and components for design verification/validation testing and production-scale builds over the product development timeline.

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Regulatory

We provide customers with a full business plan, including a clearly outlined regulatory and clinical pathway.

Whether it’s with our team alone or with additional experts, we help determine if you need a 510(k) or Pre-Market Approval (PMA) pathway. The agreed upon track will dictate the high-level milestone chart you will be operating under.

Material Options

Our team has extensive experience in working with metals and polymers. The material that we recommend will depend on the clinical need and function that the engineering team determines.

Whatever the best fit for your project, our expertise in many different materials can help make your project a success.

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Rapid Prototyping

If you can prototype and iterate rapidly, you can move from the concept to a benchtop model in weeks instead of months.

Rapid prototyping allows you to refine your understanding of how the design solution can meet the clinical need. Because of our short lead times and expertise, we can typically iterate much faster than other development houses helping you get to market quickly.

Contact Us

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