Many new companies have a business model based on transitioning their product to high-volume manufacturing and distribution. Unfortunately, this is more complex than breaking out the parts from a working prototype and selecting a manufacturer. Mistakenly thinking the development is wrapped up at this point will cause schedule projections to be significantly off, and seed doubt in knowledgeable investors.

It is important to understand that these steps alone won’t fix the output from a broken development process; a house needs a solid foundation to remain standing. The entire evolution, from thoughtful design through prototypes and iteration, inherently becomes the footing for an efficient transition to manufacture. The five steps discussed within this article identify what to expect, and how to respond as a team to move a well-designed device to volume production.

1. Prepare A Request For Quote Package

When it’s time to start shopping around for vendors, it is important to gather the necessary information into a concise Request for Quote (RFQ) package. Remember that everything is on the table at this point, so if a potential customer appears disorganized, unprepared, or generally unknowledgeable, it sends up a red flag that a project may involve significant hand-holding; prices will be adjusted accordingly. Having a complete, up-to-date database is in your best interest and will pay repeated dividends over the life of a product.

The RFQ package should start with an engineering Bill of Materials (BOM). This is the full parts list, including part descriptions, materials, proposed manufacturing processes for custom components, any secondary processes, quantities, file names, and revision tracking. For a contract manufacturer (CM), a complete BOM is a quick reference for the submitted parts that implies experience and attention to detail. If quoting at individual vendors for specific manufacturing capabilities, segment the data so they aren’t overwhelmed with extraneous information.

Vendors also will need part files to know what they are quoting. Stay away from sending any native file formats; in addition to document reference headaches, outside parties are less likely to attempt to modify CAD data without design tree information. Instead, identify which file formats fit a vendor’s process. For instance, two-dimensional process manufacturers (stamping, die cutting, water jetting, etc.) can usually work with 3D part files, but many prefer flat pattern DXFs, as these can feed directly into their machine software. Three-dimensional process manufacturers (molding, casting, multi-axis machining, etc.) need 3D part files, like IGS or STP.

Image pulled from original article.

This article first appeared on Med Device Online and was written by Jon Wenderoth. You can read the full article here.