As companies grow, communication becomes fragmented across more people, increasing the risk of "translation errors." Regular, firsthand customer experience for all roles—not just founders—is essential to prevent internal models from diverging from customer reality.

Before automating a manual process, leaders should deeply engage with the people on the line. These operators possess invaluable, often un-documented, knowledge about process nuances and potential failure modes that are critical for a successful automation project.

Extend premortems beyond failure scenarios to consider overwhelming success. This reframes success as a potential failure if you're unprepared, helping teams proactively identify and plan for scaling risks and organizational readiness before they become critical issues.

When preparing to scale a manufacturing team, the highest priority is the well-being of the core, foundational members. They hold the critical tribal knowledge and culture. Losing them to burnout right before a major expansion can cripple the entire operation.

Don't assume a contract manufacturer understands the unwritten context behind your designs. Often, teams provide only partial information but expect perfect results. Success hinges on treating them as a partner, sharing the 'why' and performance nuances beyond the drawing to prevent misinterpretations and build a strong relationship.

Instead of immediately scaling up the manufacturing process between clinical Phase 1 and 2, it is strategically better to produce more batches using the established Phase 1 process. This approach builds critical knowledge about process parameters and CQAs through repetition and increased clinical exposure.

Choosing a modular, reworkable product architecture can save money during early development. However, this approach often creates operational complexity that is difficult to scale. This strategy is only viable if there's a clear plan and trigger point to transition to a more fixed, scalable design.

To ensure a smooth transition from development to production, an operations or manufacturing SME must be part of the design process from the start. Otherwise, products are developed without manufacturability in mind, leading to expensive, reactive fixes and subjective quality control during scale-up.

Relying on a single "gifted" individual for a skill like copywriting creates a bottleneck. To scale that expertise, the expert must deconstruct their intuitive process into a concrete, teachable system for their team.