Do you have a good idea or functional prototype and are wondering what is next? Do you need to determine the regulatory path, how much testing is required and expected, or what the medical device development process really looks like and costs? Our engineers have developed and are actively developing medical devices in various stages of development. We understand what the process looks like and can share insight into costs and timelines for device development. Having this knowledge is helpful when seeking funding or making decisions on whether to pursue an idea.
One aspect of our Engineering services that has seen increased interest over the years has been design and development planning. Planning is specifically called out in the 21 CFR regulations:
“Design and development planning. Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.”
Putting time and effort into planning is critical to moving a device through development. Planning involves development of a coherent plan for what activities are performed to develop a medical device and the costs and timelines associated with device development. Part of this planning, from a business perspective, is determination of budgets and timelines to develop a medical device. We have seen success with using these documents for SBIR grants, investment groups, and licensing opportunities.
Design and Development Planning, Product Development Planning, Budgets, Timelines, Costs