In 2011, instead of viewing the FDA as a blocker, G-Tech's founder believed the widespread adoption of technologies like Bluetooth in smartphones would make medical wearables inevitable, forcing regulatory bodies to create pathways for their approval.

Dealing with regulatory bodies can be terrifying, especially for a startup facing a recall. The key is to present objective facts, demonstrate a rigorous process, and make decisions that protect the product and patient. This builds trust and ensures long-term viability.

Drug developers often operate under a hyper-conservative perception of FDA requirements, avoiding novel approaches even when regulators might encourage them. This anticipatory compliance, driven by risk aversion, becomes a greater constraint than the regulations themselves, slowing down innovation and increasing costs.

Bio is creating a formal system for biotech companies to report challenges with the FDA. Bio will synthesize this feedback monthly and present it directly to FDA leadership, creating a novel channel to elevate systemic issues and improve accountability.

To avoid an adversarial relationship, actively reposition gatekeeper functions like legal and compliance as essential partners. Their role is to ensure the company's long-term success by keeping it safe. This partnership mentality leads to more creative and collaborative problem-solving.

In regulated spaces like healthcare, product managers must move beyond surface-level collaboration. They need to develop deep domain knowledge and partner with clinicians who are embedded in the product process, co-writing requirements and ideating on solutions, not just acting as consultants.

Industry sentiment on the FDA is not monolithic. A recent survey reveals that while biotechs largely maintain confidence in the agency's hardworking staff and their day-to-day interactions, there is deep concern and a lack of trust in the agency's top leadership. This nuanced view highlights that the perceived problems are rooted in politicization and leadership competence, not frontline operations.

For smaller biotechs, the key to a successful CRO relationship is treating them as a genuine partner. This requires moving beyond a transactional, fear-based dynamic to one of open communication and mutual respect. Biotechs should actively solicit CRO feedback, as they possess valuable cross-industry insights and can identify sponsor-side behaviors that need to change.

While competitors publicly blamed the FAA for delays, Zipline engaged the agency as a partner. They co-developed regulatory frameworks and flew officials to their Rwanda operation to demonstrate high safety standards. This partnership approach was key to securing critical flight approvals in the U.S.