Every step of the medical device development process comes with its own set of challenges, as well as its own expenses. Before you get too far into your project, it’s important to know how much it’s going to cost. By knowing the type of product you’re creating and understanding the associated costs, you’ll be able to get a good idea of just how much you can expect your project to be.
Medical Device Development Cost
Your product must go through all the stages of the medical device development process before it can make it to market. These stages include engineering, prototyping, testing, and documenting, and these are in addition to steps required for FDA approval and marketing efforts.
The cost of these steps depends on what type of product you’re making. If you’re planning to manufacture a me-too device (something that’s been done before), the costs will be set already. Me-too products are generally low-cost because most of the research will be done already. This means it’s also easier to get regulatory clearance and move through the processes of clinical trials.
However, if you’re coming up with a new and innovative product, then the pricing might be different because most of the research will be started from scratch. The upside is that if you can create something new and incredibly useful, you’ll be more likely to make a big profit from it once it hits the market.
How Much Does It Cost?
Now you probably have an idea of how much it will likely cost to develop your medical device, and as you can imagine, it’s definitely not cheap. The total cost of bringing your medical device to life and ready for the market ranges anywhere from $31 million to $94 million. If you’re developing a high-risk device, you can expect the cost to be on the higher end of that range.
Most of the costs go to the steps required by the FDA to approve your device. Additionally, you will also have some costs associated with the FDA submission. However, there are many other factors that might influence the price of your device. For instance, you might have to engineer new technology to complete your device. This extra engineering will be more costly than if you were building a device with pre-existing components.
Apart from that, your device could also require a lot of clinical research. So some of the costs will go to scientists and laboratory space. The time it takes to bring your device to market also contributes to the cost. If the device takes a long time, that might drive up the prices as well. Lastly, if there are delays in the regulatory processes, that also means more costs.
Are You Ready to Start Your Medical Device Project?
If you’re going to get your product to market, then you’re going to need some money to do it. But don’t worry — you don’t need to have millions of dollars lying around before you can get started. Investors can help you turn your idea into reality. By partnering with a medical device engineering company, you can not only ensure a smooth development process guided by experts, but also a successful launch helped along by the pros.
To learn more about our services, contact us today!