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Design For Manufacture

Design for manufacture (DFM) starts with designing a product that most readily conforms to existing manufacturing technologies.

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.

When the channels in the device do not confer functionality, but serve as fluid conduits from one part of the device to another, stick to dimensions that are easy to process with standard, high volume processes.

An objective of DFM is to make the best device design suited to the manufacturing process, minimizing the requirement for exotic, high cost processes and complex assemblies.

DFM through a Phased Development Program

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.

It’s meant to work in limited volumes of hundreds to understand the analytical limit of detection and sensitivity. The data produced using the Proof of Concept design provides the benchmark for performance to which future design iterations must meet and exceed.

DFM through a Phased Development Program

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.

DFM for this phase includes a manufacture and assembly process that scales to 1MM units per year. COGs is still more than the ultimate high volume costs with complete automation, but allows market entry and profitability. Results from clinicals may require further minor changes to the design or materials.

DFM through a Phased Development Program

Phase 3: Clinical Trial and Scale

Results from clinical trials verify product performance, and may lead to minor modifications to improve performance. After these final modifications are validated, the product is ready for product transfer to high volume production.

Manufacturing processes and assembly will change with increasing automation, but information in the product transfer package will include critical QA and performance validation parameters to benchmark performance and assure product compliance.

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