Taking a medical device to market can bring many unexpected challenges, so it’s important to establish expectations of the timeline, cost, resources and FDA requirements and timeframe, as this will help ensure a roadmap to success. Always consult with your project manager (PM) at the design & development firm you have chosen about your goals and expectations before beginning your journey, as well as any changes that arise along the way; to help give your PM an idea of what you want to achieve by bringing this device to market, explain to them what your objective is: get the device to the market as quick as possible or take the path that will lead to the greatest success. Often, people want to get their device to the market as fast as possible, but also with a small amount of money, which is incompatible.
While it’s difficult to predict a project’s timeline as each has different requirements and constraints, the minimum time to get a basic device, such as a simple balloon, from concept to FDA submission is about 7 months and to market, if your device is cleared on the first try, is about 10 months. To help keep the project timeline moving efficiently and on budget, have weekly meetings with your PM to prioritize and set reasonable expectations for the project – know what you need the device to accomplish, meaning the device will not function without these features, versus what you want it to accomplish.
Again, while it’s challenging to estimate an average range of a project’s cost, a simple balloon catheter can cost around $300,000 to $400,000 while more complex devices can easily cost $700,000 on up. Sterilization, and biocompatibility testing plus packaging alone can cost around $75,000. Obviously, the more complex the device is, the more engineering labor and materials and tooling are required, therefore increasing the cost.
The largest resource during your project’s life will be your selected design & development company and their PM, who you should be able to turn to for advice, guidance and depend on to take your device to market. It’s vital that you trust your PM as you are giving them the reins to your project and entrusting them with your money that you have worked hard to fundraise. If you feel more comfortable with bringing on your own regulatory person, make sure you trust their judgment and that they have years of experience in the medical device field, but keep in mind this will be an additional cost, although how much extra will vary depending on the individual’s fee.
While the FDA has a requirement that they have to reply within 90 days of the initial submission, they generally come back and ask for more documentation. As a result, when estimating your timeline, keep in mind that the average time to get clearance from the FDA is about 6 months. Unfortunately, it is out of the PM’s or your hands at this stage and you have to wait for the FDA to reply before moving on. If your objective is to get the product to market as fast as possible, consider marketing your product in Europe as the CE Mark is much quicker, with an average of 3-4 months to get authorization.