Developing new medical device from concept through to production is not a simple process. This is a multi-year endeavor even when everything goes as planned and no mistakes are made along the way.
Simple errors such as not submitting the necessary documentation can add months to that timeline. More serious errors such as failing to understand what is currently available to doctors and patients by other companies can completely derail medical device product development after months of work has already been completed.
Pay Professionals With Specialized Expertise
The biggest challenge with many new products is the time between the start of the process and the time to marketing the device and making a profit. As this can be years, many new companies try to cut corners on costs by doing a lot of the initial work in-house.
The biggest issue with this is the domino effect of this decision. All medical device product development is predicated on the design and design validation phase. If this is done incorrectly, incompletely or with errors, there is a good chance the device will never be marketed.
By hiring experienced companies with engineers and design teams to assist in medical device product development from the early stages, costs can be cut later on with better efficiency in production, lower material costs and even simpler designs that will have longer life cycles.
Know the Process and the Product
While hiring professionals as early as possible in the process will be one of the biggest factors for streamlining the approval process, it is also necessary to keep on top of what is happening in the market during the design, development and approval phase.
Additionally, take the time to review the process in detail. While you don’t need to be an expert, it is essential to have a good understanding of why timelines are set and what steps are occurring next at each point.
