In the United States, the FDA (Federal Drug Administration) has to approve all medical device submissions. In studies looking at the 510 (k) submissions for new medical devices between 2006 and 2013, it was determined by the Emergo Group that the typical approval process for the submission was about 5 months, but this varies greatly based on the specifics of the device.
In another study by Harvard Business School it was found that new companies into the market looking for approval for an innovative device might face significantly longer approval periods, often just over seven months longer than what the next follow-on company will have to go through. Then after that approval, the average time from idea to begin marketing of the device is about 5.6 years.
By working with a top rated medical device design company, these issues can be proactively addressed prior to the submission. Avoiding the need to send additional documentation to the FDA is a critical factor in seeing the shortest approval time, which is all part of what an experienced medical device design service will provide.
Streamlined Designs
One factor that is at the core of being able to get medical devices to market faster is to make the design and the production of the product as streamlined as possible. Often additional features over those necessary for the device to complete the desired medical treatment simply complicate the approval and manufacturing process.
Work With a Company With Scalability
Even after the initial support in the design stage of the project, companies offering medical device design, prototyping and production are a benefit when all tSree are possible through the same company.
Look for companies that offer scalability and have the capability to not just complete the prototype and the smaller initial production run, but that have the capability to continue to grow with your production requirements.
