The Steps In Medical Device Product Development

by | Oct 30, 2017 | Molding

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Many new medical devices are first conceptualized by individuals or companies with limited experience in the medical device field. Understanding how to take an idea and go through the various stages and steps of the process can be a challenge, which is why it will be essential to find a trusted company to provide medical device product development.

There is a difference between medical device design and development companies. Design companies work with the inventor or originating company and create the design that will be used to create the prototype. With a company specializing in medical device product development, the scope of work is much more complete and can assist in everything from material selection to the most effective manufacturing processes.

Getting Started

After the initial research to determine there is a market for the idea and that the idea solves a problem or offers a solution not already on the market, the next step will be to become familiar with the various regulations around the specific intended use of the device.

This is another area of expertise where the company providing the medical device product development can provide assistance and support in ensuring the device will meet all FDA regulations for approval.

Throughout the development process, the medical device will be improved, changed and modified to become more efficient, effective and viable to produce to keep the price within the market. The company completing these changes will need to understand the recording and documentation requirements as this data will be critical for final product approval.

With the support from a top medical device manufacturing service, the prototype, once refined and finished, is then ready to be moved into production. Look for development and manufacturing companies with the capacity to scale up quickly to take advantage of emerging markets.

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