Hardware development is often stalled by supplier lead times. To combat this, proactively map out multiple, redundant manufacturing options for every component. By maintaining a constantly updated "lookup table" of suppliers, processes, and their current lead times, teams can parallelize workflows and minimize downtime.

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.

Unlike software, hardware iteration is slow and costly. A better approach is to resist building immediately and instead spend the majority of time on deep problem discovery. This allows you to "one-shot" a much better first version, minimizing wasted cycles on flawed prototypes.

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.

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.

Founders instinctively obsess over the product as if it's the primary constraint. In the "case study factory" model, the product is not a stage itself, but a tool that enables sales and delivery. The true bottleneck is almost always in pipeline, sales, or delivery—not the product.

Companies, especially in early stages, should resist outsourcing production too quickly. Keeping a new process in-house is essential for understanding its pain points, which is a prerequisite for being able to specify clear, effective requirements to an external vendor later on.

Instead of arguing for more time, product leaders should get stakeholder buy-in on a standardized decision-making process. The depth and rigor of each step can then be adjusted based on available time, from a two-day workshop to an eight-month study, without skipping agreed-upon stages.

Founders in CPG should personally master the hands-on production of their product before outsourcing. This deep knowledge of the process is invaluable, equipping you to ask specific technical questions and properly evaluate a co-manufacturer's capabilities, ensuring quality is maintained at scale.