Amazon has floated the drone idea, launching public discussion and regulatory contemplation. By contrast, 23andMe blazed ahead with its personal genomic tests. The FDA’s approach is almost always to prioritize the prevention of harm and will want to be part of crafting the solution if it’s potentially accountable for the potential harm.
There are important lessons to learned by comparing these two situations:
1. Both are new technologies, which will require regulatory understanding and adaptation.
2. Both are best served by proactive vs. reactive regulatory engagement
3. Amazon has approached the regulatory environment more cleverly by "floating" its idea early.
4. It's possible to re-engage after facing regulatory problems, but more difficult.
5. Inadequate or missing systems for regulatory content management is another area where many firms fail.
Full insights are available here: http://www.body1.net/
About Body1, Inc.
Body1, Inc. (http://Body1.net) is a cloud software technology leader that powers web platforms for medical marketing. These platforms include content-rich health sites, medical condition communities, mobile solutions, and social media engagement campaigns. Body1’s historic clients range from Fortune 100 medical firms like Abbott to venture-backed start-ups like Zila.