Medical Device Engineering and Product Development, from the most specific non-invasive product to high tech or invasive surgical instruments, can take many years and thousands of dollars. Products in the medical field typically need more than the usual rounds of engineering and prototyping due to the precision and accuracy required and the use on or near the human body. In addition, the FDA approval and certification process can be daunting.

IDP works with many doctors and medical professionals who come up with unique and helpful product ideas from their experience and working in real-life scenarios. Some individuals and start-ups do not have the capital required to complete full medical device engineering, product development, and FDA approval.

IDP utilizes a proof of concept prototype development process that effectively assists doctors and medical professionals validate and feasibility so the innovative concept can be monetized down the road.

A proof of concept prototype is a great way to demonstrate a products’ functional effectiveness and design features. A skilled engineer and developer with a robust medical product engineering background can develop a high-grade functional medical device prototype. This concept prototype still usually requires several rounds of engineering and prototyping. Still, the time and cost are a fraction of what it would take to bring the device to manufacturing and FDA approval.

An engineer can make proof of concept medical device prototypes with custom components, existing products, and usually a combination of the two. They are never intended to be used or tested on human subjects. Often, engineers can use a human model/dummy for demo purposes. While the IDP development team understands medical products and FDA approvals, we can skip the formal FDA process since there is no plan to manufacture- resulting in lower development time and fees.

Once a high-grade prototype has been produced, the concept can be effectively explained and demonstrated. Funds can be raised, or the product can be sold/licensed to a medical device company in the appropriate field with development, production, and FDA approval resources.

Depending on the industry and uniqueness of the product, it may also be advisable to seek some patent protection/Non-Disclosure Agreement before sharing an idea with a large medical company.

IDP’s medical device engineering services can help take your idea from infancy to a professional prototype. Inquire today!

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