Posts categorized as“Manufacturing”

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When developing a medical device, it’s easier both in time and effort not to reinvent the wheel. Sometimes, off-the-shelf (OTS, or COTS – commercial off the shelf) components don’t meet the device needs, and usually these deficiencies are obvious. The problem arises when we unconsciously ask for more than the original widget design requires.

“What’s the difference between production vs prototype tooling?” and “What quality can I expect?” are often questions that I get asked from development or clients. The best answer begins with other questions: “What quality do you really need?”, and “How many are you making?”

In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?