DesignWise Medical’s development process is in full compliance with the FDA QSR as well as ISO 13485 for those portions of the regulations we are involved in such as Design Controls. We are not a finished medical device manufacturer and therefore the portions of the regulations that address those aspects are not part of our Management system.
DesignWise Medical works in close collaboration with its local network of pediatric hospitals and other clinical partners to determine clinical area that requires the most urgent attention and then within that area multiple approaches will be deployed to determine the unmet needs.
By working with an appropriate clinical sponsor for an unmet need, DesignWise Medical determines the scope of the development program and the resources necessary for success [human and financial]. If the project fits within the resources available or planned to be available and the project represents the highest social return project on the project queue list then it will become an active project.
The project is then scoped against the skills and availability of DesignWise Medical’s network of engineering schools [student design projects, medical device curricula, faculty research], medical device professionals, retirees and other volunteers. The project team is assembled and the project development work commences. DesignWise Medical staff and volunteers continue the development work on the device until the product is sold or licensed to another entity or it has reached commercialization.
When intellectual property is developed in the course of the project it will be owned and managed by DesignWise Medical, either alone or in conjunction with any sponsors based on previously executed development agreements.
Once a project is proved to be viable, DesignWise Medical will look for a current medical device company to either license the product, to purchase the full rights to the product or enter into a distribution-only arrangement. As part of any of these relationships, the partner may wish to become the manufacturer of the device.
If no interested medical device company is found, DesignWise Medical will explore alternate options to manufacture and distribute the product. DesignWise Medical itself will not become a primary manufacturer of medical devices.
Join the effort and contribute at any level desired, from simple idea suggestions to participation on a solution development team.