the microfluidics experts

ISO13485:2016 certified

the microfluidics experts
ISO13485:2016 certified
ISO9001 certified


What is Design for Manufacture?
Design for Manufacture (DFM) starts with designing a product that:
- most readily conforms with existing manufacturing technologies
- produces the least amount of in-process scrap
- requires the least amount of in-process quality checks
- lends itself readily to finished goods statistical sampling for quality assurance
ALine DFM expertise is exhibited in their proprietary “Phased Development Program”.
Right-Sizing Design for Manufacture
Complexity = High Cost of Quality = High Cost of Goods
While every design must fulfill functional requirements, getting there at the price-point needed to go to market requires an intimate knowledge of the manufacturing processes you will use.
ALine’s proprietary “Phased Development Program” creates the best device design suited to the manufacturing process, minimizes the requirement for exotic, high cost processes and complex assemblies.
Phase 1: Proof of Concept
This phase’s goal is to achieve a functioning alpha prototype. The biggest drivers of the program are speed and quality. The result of this phase is a “product-like” device that produces good quality data.
Phase 2: Proof of Principle
Proof of Principle is a system integration effort. Results from the Phase 1 serve as the design inputs for the Proof of Principle product; ultimately achieving a soft design lock with manufacture in volumes of 10k to 100k units as the system achieves robust performance.
Phase 3: Clinical Trial and Scale
DFM for the scaled product occurs as results from clinicals verify product performance.

Frequently Asked Questions
I’m still working through my idea and don’t have a design or development team yet. Would reading about Systems Engineers benefit me?
Absolutely! The best time to bring in a Systems Engineer is early in the process, so you might be closer to needing one than you realize.
I’m part way through the design or development process and things aren’t working out. Is it too late for me to bother with this?
Not at all! Although Systems Engineers love to start early on, they can definitely bring clarity and work their magic part way through a project as well.
What will you do with my email address?
Well, we’ll send you this ebook. After that, if you choose to stay on our list, we’ll send you periodic industry updates. If that doesn’t appeal to you, you can opt-out at any time. And, of course, we’ll never sell your information.
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ALine shares industry lessons and tips on the journey to creating products that incorporate DFM from the earliest stages.
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