Manufacturing scale-up for single-use endoscopy
Opyflow developed a staged manufacturing roadmap and first-line design for a single-use endoscopy company. The company built a 15,000-unit pilot line from the design and routed volume production to a contract manufacturer.
The company had to decide its manufacturing footprint before it knew how far demand would grow.
Opyflow linked demand scenarios, footprint choices, first-line design and contract-manufacturing criteria into one staged roadmap.
Pilot line built to the design, 15,000 units a year · Volume production routed to a contract manufacturer · Scenarios to 1.5 million units kept as expansion options
The challenge
The company was preparing for demand that could grow far beyond launch volumes, or not. Build too much in-house capacity too early, and the business carries it. Design only for launch, and manufacturing becomes the constraint the moment adoption accelerates. And the know-how that sets quality and unit cost had to stay in-house while external partners carried volume.
Opyflow's work
We linked capacity scenarios from 30,000 to 1.5 million units a year to footprint, labour and investment choices, in stages: a launch site, lower-cost production, then automation, each with its own trigger. We mapped the first line at process level and sized its workstations, staffing and space against a 100,000-unit annual target. We assessed contract manufacturers on regulatory and technical capability, technology-transfer practicality, moulding and sterilisation access, cost structure and proximity to markets. The make-or-buy criteria covered core know-how, scalability, redundancy and supply resilience, and set what stays in-house and what a qualified contract manufacturer must bring.
What changed
The company built a pilot line for 15,000 units a year from the design and placed volume production with a contract manufacturer, the route the make-or-buy criteria pointed to. The 100,000-unit first line and the larger scenarios stay on the roadmap as expansion options.
How did the roadmap address uncertain demand?
In stages, each with its own trigger. The roadmap set out the capacity steps and the logic for moving from one to the next, so leadership could expand, outsource or automate as demand became real instead of committing against one forecast.
See the capability: Manufacturing strategy and footprint →