What we do
Bringing a new medical device to market can be exciting, but it will also inevitably involve facing down a great many challenges. The medical industry in general is the most heavily regulated of all, and this is not about to change anytime soon. While regulators might sometimes seem heavy-handed or unpredictable, there tend to be good underlying reasons for their requirements and pronouncements. Even so, many medical technology companies encounter problems that can easily come to seem almost unfair.
In many such cases, these can be avoided with help from a specialist at medical device consulting like Empirical. As can be seen online at empiricaltech.com, companies of this kind offer a full range of services designed to make it easier, faster, and more affordable to bring a medical device to market. Empirical Consulting services cover everything from the regulatory minutiae that ensnare so many companies to advice concerning timing, marketing, production, and other important factors.
What that will mean will vary from one case to another, but a few general trajectories crop up again and again. In some cases, for example, a company will propose to bring to market a device that is not itself novel, but which reflects an improved or more cost-effective take on an existing one. When this source of inspiration has already passed the scrutiny of regulators, repeating that expensive work will not always be necessary, and a consulting firm will often be help.
In the United States, for instance, the Food and Drug Administration has an established process for those who wish to preemptively seek approval under such conditions. Unfortunately, that 510(k) system is complicated enough that many companies find it difficult to navigate on their own. As a result, some struggle with this supposedly streamlined option nearly as long and painfully as they might have with the full approval process.
A consulting company that understands the intricacies of the process, on the other hand, will typically be able to guide clients through it with a minimum of delay and expense. Recognizing from the start that regulators can be difficult to work with, companies that seek out assistance tend to fare the best of all. In the end, that can mean saving a great deal of money and positioning a company for much greater success, particularly in especially challenging markets. Bringing a new medical device to market sooner will also typically mean deriving sought-after revenues from it that much earlier and for longer overall, helping to repay investments made into even more.
This project was last updated 22 days ago