I had the opportunity to appear as a guest Author on the Product Realization Group's regular blog on Product Design and Development a few week's ago.
"There is a world of difference between making one unit versus 100,000 units of a product, especially if what you are developing and manufacturing is a medical device. Moving into manufacturing is not just about design readiness, it serves as the defining point in an organization’s maturity. In medical devices, it is the terrifying leap from producing a few carefully-crafted clinical units, to the thousands of units that will go into the hands of strangers. Because of this, your “manufacturing readiness” needs to be assessed across multiple key areas."