Aug 2, 2007

You mean we have to actually make this stuff?

Creo Quality asks When Should Design for Manufacturability be considered? and gives his current situation:

This time, the product development project is for a new start-up medical device company with no products on the market and none with FDA clearance. We are developing the first product for this company. As with many start-ups, funding presents issues and often influences decisions. For this project, there has been little to no effort with DFM. The product design is entering design verification and validation. A 510(k) submission is a few weeks away. Yet, manufacturing processes are ill-defined and the product design and components has hampered production of prototype and pilot units. The company has hired suppliers and contract manufacturers to assist with current, limited production units. It’s been a bit of a struggle. Product piece prices are ridiculously expensive–due in part to components selected during design, low volume, and lack of DFM.

We have the same issues, we have great financial backing for a start up company, so our investors are more far sighted than I think is typical, but the focus is still very much on product approval, then we'll think about how we make it profitably. The mood is without an approval you don't really have anything anyway, so get that as quickly as possible and grow from there. Although the engineers have already started to make some plans and changes, I'm positive there will be about 30 seconds between approval and management demands to get the product costs down, all part of the fun!

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