Getting to 'Yes' with FDA

Embarking on a life science startup journey means facing a complex set of rules and regulations that could make or break your venture. In this playbook, trailblazing experts in the field lay out a roadmap for navigating the regulatory landscape.

Key Lessons From This Playbook

• Overengineering can wait: Gather insights from all stakeholders and build only what’s essential. Keep it simple, and consider FDA from the start—overengineering can weigh you down more than lift you up.

• Involve the right regulatory experts early: Ensure compliance by seeking domain expertise from the start. But remember, while subject matter experts are valuable, rigid, one-size-fits-all strategies may not suit every project.

• Balance risk with tradition: In regulatory work, experience and expertise are invaluable, but so is the ability to think outside the box. You get the best of both worlds by hiring a team that balances seasoned pros with creative thinkers who can push boundaries and find creative solutions.

• Keep an open dialogue: Think of the FDA as a partner in bringing your technology to patients—initiate contact early, keep communication lines open, and be prepared to adapt your strategy as the regulatory landscape shifts.

• Educate when necessary: Work closely with regulators early on and be ready to educate them about the nuanced aspects of your technology—especially when you’re breaking new ground.