Medical device startup companies play an integral role in the medical device industry. They have the ability to be nimble and take more risks on a unique product that larger, more established companies don’t often have.
The Clinician eXchange has been developing medical devices for so long, and we have seen medical device startup companies make some common mistakes.
Common Mistakes Medical Device Startup Companies Make
#1 – They want the first thing they roll out to be perfect.
Medical device startup companies often want to come out strong with their first product, with every advanced feature they can dream up. But adding all the bells and whistles to your device will likely increase your budget, lengthen your timeline, and subject it to added scrutiny by the Food and Drug Administration (FDA).
Our advice: We counsel startup medical device companies to focus on perfecting the core functions of the device and save the extra features for later, especially those that are not critical to how the device meets the intended use.
Once the core elements are solid, then turn your attention to the added features. This will keep your investors happy, get your product to market faster, and prevent the FDA requirement creep for your device.
#2 – They don’t plan for problems.
If yours is one of the medical device startup companies aiming to bring a device that has never been produced before to the market, the odds are greater than challenges that will arise that are difficult to plan for completely. The more cutting-edge and unprecedented the device is, the more time it takes to develop the technology, the extra nuance the FDA will require to review potential concerns, which lead to increased cost.