When planning a catheter development or production program, real production output is often underestimated. Many teams focus on advertised cycle time or early feasibility results, only to discover later that their actual daily throughput falls short of program needs.
In practice, production output is not defined by how fast a machine can cycle. It is defined by how many validated, in-spec catheter tips the entire process can consistently produce under real manufacturing conditions—accounting for tooling performance, cooling time, operator handling, yield, changeovers, and equipment downtime.
Understanding true output early helps prevent delays, re-validation, missed builds, and unexpected capital expenses.
The most common mistake is sizing equipment based on best-case cycle time instead of validated throughput under production conditions.
This typically includes:
These assumptions may appear valid during early trials. However, once validation standards tighten and production begins, the gap between theoretical speed and actual output becomes clear.
Production shortfalls are often discovered too late—after validation protocols, regulatory submissions, and launch timelines are already defined.
Common contributors include:
Even small output gaps compound quickly over weeks of builds, leading to missed milestones and delayed submissions.
Cycle time includes heating, forming, stabilization, and cooling. Cooling is frequently underestimated, especially for thicker walls and longer tips.
Manual loading, inspection, and adjustments affect throughput. At volume, even a few extra seconds per part add up quickly.
Switching sizes reduces available production time. Programs with multiple SKUs require tooling strategies that minimize changeover time and protect uptime.
Real-world production includes:
Ignoring downtime during planning leads to unrealistic daily output assumptions.
Material choice impacts heating and cooling behavior:
PVC allows shorter cycles
PEBAX benefits from controlled motion
PU, PTFE, PEEK require tighter control
Tip geometry also plays a major role:
Simple tips → Faster, more stable cycles
Long or complex tapers → Longer heating and cooling phases
As complexity increases, validated output naturally decreases unless equipment and tooling are sized accordingly.
Engineers should evaluate production output during early design and feasibility—not after validation begins.
Early planning prevents:
At ONEX RF, we help customers evaluate true production throughput by:
This allows customers to move from feasibility to validation and production with fewer surprises.
Machine speed does not equal production output.
Real throughput is defined by how many validated, sellable catheter tips can be produced per shift—under real operating conditions.
By planning for yield, tooling, materials, geometry, operator interaction, and downtime from the beginning, teams can protect their timelines and reduce program risk.
If you are sizing a new tipping process or scaling production, ONEX RF can help you evaluate true production output before it impacts your launch schedule.