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.

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.

A great molecule isn't enough to attract investment. Scientists must demonstrate they've considered manufacturing from day one. Designing a robust process that fits a consistent GMP facility shows investors that the project is not just a scientific curiosity but a viable path to a scalable product.

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.

Frontline Medical chose to develop the Cobra OS not because it was their most revolutionary concept, but because it was manufacturable with limited resources. They prioritized the idea that 'checked all the boxes' for feasibility, market success, and patient impact, ensuring they could bring a product to market.

Scaling manufacturing isn't a fast ramp-up. For a complex catheter, increasing output from 800 to 5,000 units per month took a year and a half. This required a multi-phased approach that balanced market demands with quality, careful capacity planning for machinery and headcount, and correcting initial assumptions along the way.

The primary challenge for many MedTech innovations is not the initial science but translating a lab process into a robust, scalable, and GMP-compliant manufacturing system. This requires a shift from proving a concept to ensuring consistent quality and patient safety.

Manufacturing excellence is predetermined by how easily a product can be assembled. The product and its manufacturing line must be designed in parallel. If you wait to consider manufacturing until after the design is complete, you will have engineered in inefficiencies that are costly or impossible to fix.

A process that seems simple in a development lab is often not viable in a strict GMP manufacturing environment. To create truly manufacturable therapies, process development scientists need direct, hands-on exposure to GMP constraints and workflows to avoid significant rework and delays.