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.
Emil Michael warns defense tech founders that a prototype is not enough. The Department of War requires a credible plan for mass production. Startups must prove they have mastered the "skilled manufacturing piece" to win large contracts.
At Rainbird, engineers build the first 'production intent' units for field trials themselves, on the actual assembly line. This serves two critical functions: it produces the necessary test units and simultaneously allows the engineering team to validate and debug the manufacturing process before scaling up.
The common product development process is a sequential handoff model. A better approach is a "jazz band" model where cross-functional teams collaborate harmoniously from the start. This fosters creativity and reduces rework by including engineers in early ideation, rather than treating them as a final step.
Designers should consider the human operators and machines that will assemble their product. By making choices that simplify manufacturing—providing clear instructions and avoiding known difficulties—the process becomes smoother and more efficient, akin to 'riding a bike downhill.'
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.
Unlike most biotechs that start with researchers, CRISPR prioritized hiring manufacturing and process development experts early. This 'backwards' approach was crucial for solving the challenge of scaling cell editing from lab to GMP, which they identified as a primary risk.
A 'healthy tension' exists between research teams, who want to continually iterate on a therapy's design, and manufacturing teams, who need a finalized process to scale production for trials. Knowing precisely when to 'lock down' the design is a critical, yet difficult, decision point for successful commercialization.
Boom Supersonic accelerates development by manufacturing its own parts. This shrinks the iteration cycle for a component like a turbine blade from 6-9 months (via an external supplier) to just 24 hours. This rapid feedback loop liberates engineers from "analysis paralysis" and allows them to move faster.
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.
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.