23andMe's Anne Wojcicki: Embrace the gatekeepers

Regulatory Pathways

Anne Wojcicki's journey with 23andMe highlights the importance of regulatory collaboration, particularly with the FDA. Initially, Anne and her team navigated state-level regulations with clever workarounds, but a cease and desist letter from the FDA in 2013 marked a turning point 1. Instead of fighting the FDA, Anne saw it as an opportunity to build trust and credibility, realizing that working with regulators could lead to sustainable growth 2.

The FDA sees a lot, and there's a lot of bad actors out there. And so I have a lot of respect for them, having gotten to know them now better, like, they have a tough job.

--- Anne Wojcicki

This approach allowed 23andMe to establish a direct-to-consumer pathway, setting a precedent for future companies in the industry.

   

Healthcare Hurdles

23andMe faced significant challenges from the traditional healthcare system and medical professionals. Anne Wojcicki noted that the company's approach often generated non-billable questions, which were not well-received by doctors accustomed to treating diseases rather than focusing on prevention 3. Despite these hurdles, Anne was committed to changing healthcare by working with the FDA and other gatekeepers, understanding that this long-term effort could lead to substantial societal impact 4.

If you can change regulators and you can help them understand and you can prove out, then you're gonna have a much bigger impact on society.

--- Anne Wojcicki

This strategy mirrored the experiences of other innovators, like Spotify's Daniel Ek, who also navigated complex gatekeeper relationships to achieve success.