Today, we’re talking about FDA approval.
In my opinion, most healthcare startups should avoid seeking FDA approval early in their product development and avoid it altogether if possible. It’s high cost, unpredictable and causes startup killing delays.
Instead, if you want to get your product live sooner, there are some common tactics to help:
1. Change your classification, for example, rather than being a device that cures some serious leg ailment, instead label yourself as a consumer fitness tracker, focused on people with leg issues.
2. Change your use case, for example, it may take years to get approval for your product to be used on humans but you may find it can help animals much sooner due to less regulation.
3. Change your location, for example, trying to launch in the US may require various agency approvals but you may be allowed to launch immediately in a different country.
