Startups often ask me, "do we really need someone like you?” My usual answer surprises them: “Not necessarily. At least, not until it’s time to bring your device to market.” And to do that, you need regulatory approval. Without it, even the best innovations can’t be sold. For this, you need someone who understands different regulatory frameworks worldwide.
A proper, early plan helps find the quickest way to market. Depending on device characteristics and intended use, one path may be wiser than another. US and EU requirements are similar, but can vary in specific situations. These key differences can affect time to market by up to 2 years and impact costs.
Another advantage of defining the regulatory plan early on is that the regulatory requirements can be identified, still in the design stage, before the design freeze. Let's look at the following example:
A start-up wants to market a new vascular stent, which is a high-risk product. During the regulatory plan, all applicable product- (e.g., ISO 25539-2) and horizontal (e.g., ISO 14971) standards will be identified. The product standards will dictate certain requirements that must be complied with, and the development team still has time to implement these requirements. The other aspect would be risk management. During risk management activities, there will be unacceptable risks that need to be mitigated in either production or the product itself. If these risk management activities happen too late because the start-up did not know that risk management in that form is mandatory, it is possible that mitigation changes have to happen after the design freeze. This will lead to a huge step back in the process. Depending on the impact of these changes, some of the already performed tests will have to be repeated.
In conclusion, one can say that having a proper early regulatory plan will smooth the road to market and can help with performing the necessary activities in the right order. If you want to have regulatory plan for your medical device or IVD product, give us a call and we create a plan with you based on your device and target markets.