Medical device design and development is an extremely challenging task. Even the best concepts and technologies can be deterred by regulatory, design, market and/or financial hurdles.

While each project is unique, the following checklist breaks the process down into typical stages and components and indicates who will contribute to the completion of each step. Note that certain components will stretch over two or more stages - notably regulatory affairs and marketing, which demand attention throughout the entire process.

Whether your idea is a brand new concept or is a major improvement on an existing medical device or process, this initial stage of development is a critical step. If executed properly, it will provide a solid foundation, both technically and financially, for all of the subsequent stages. The two key products of this stage are the fabrication of a working prototype that will prove that the new or improved technology actually works in the real world, and a business model that shows how it will be introduced and accepted in the market place. With these firmly established, the potential for investor interest is increased exponentially.

This stage is where the engineers create the actual product design in a way that will meet the many demand s of not only market requirements, but also those of government regulatory laws and guidelines. It is here that a limited number of working models will be fabricated and tested in laboratories to ensure that the desired outcomes are safe, reliable and consistent. These results will often provide designs and data that will be useful in applications for patents and especially useful in seeking ongoing funding.

Here the designs of the working models and the results of the initial testing will be thoroughly reviewed and analyzed by scientists and engineers as well as sales, marketing and regulatory personnel . The results of these analyses will be incorporated in more sophisticated and complete devices. More of these devices will then be constructed for more advanced testing, typically in selected clinics with human subjects.

In this stage the designs will be fine tuned for large scale manufacturing, including designing the production lines for maximum throughput and minimum costs. The final regulatory documents and submissions will be prepared and these will ensure that the devices are validated against the claims that will be made in the marketing information. In depth clinical testing with humans takes place as part of this validation.

The device is now ready for release to the market place. It is here that all marketing information, distribution plans, and sales and service operations must be defined, developed and fully implemented for the product launch.

The final goal of improving patient care is realized by the development and implementation of your idea, and your dream is made reality!