Moving from proof of concept to proof of principle and early product launch involves verification of performance over a large number of devices as well as field or beta testing to harden the design without committing to a high-volume manufacturing process with long lead times and high NRE.
ALine Rapid Manufacture
High Quality Components
Rapid Manufacture Challenge:
Rapid Manufacture Solution:
Manufacture for pilot scale, which is 10,000 to 50,000 units per month, often requires not just rapid scale up with high quality, but also the ability to make design and material changes as results come in. Our expertise in materials and processes supports troubleshooting failure modes and recommending successful modifications to keep the program on track without producing a ton of parts that are no longer usable.
Rapid Manufacture Results:
We structure our processes to allow revisions under document control and produce new product within a week. We track material lot numbers, designs, and process modifications in highly detailed Work Instructions; all part of our ISO 13485 quality system.
ALine has demonstrated over the last 20 years, through numerous client programs, including companies such as DxNow, Epicore and Interlink, our ability to scale rapidly, converting batch processes into flow processes to produce high quality components and complete assembled product to meet critical customer timelines.
Our customers appreciate our experience in rapid manufacture, our expertise in identifying the source of failure modes and our consistent delivery of quality parts.
