In Reply to Parent Post by WisdomseekerSC
A customer is filing a submission to the FDA, they have asked us for information that we feel is proprietary for our component that we provide for their device. What type document (drug master file like) document should we be looking at to protect our 'trade secrets'?
In Reply to Parent Post by Koivisto123
I assume you make this component to their blueprint in which case there is nothing proprietary about it.
There can be trade secrets to machines used, setups, intermediate steps, etc.
Don't disclose any of this stuff in a public forum. You probably could ask your company attorney to recommend a consult with another attorney versed in such matters regarding what you can safely disclose to the customer and what you probably should withhold, as well as what type of confidentiality agreement you may require from the customer.
There are many unscrupulous customers [or unscrupulous employees working for decent customers] who might "borrow" some of the information to give to a more favored supplier or use itself inhouse, to the detriment of the original supplier who created such trade secret processes.
When I was in the high tech machining business, we had a number of trade secrets in making parts for some customers which gave us a competitive advantage. The customer does not have an inalienable right to the processes of a supplier, only to the finished product, regardless whether it is a proprietary product of the supplier or made to order using the customer's engineering drawings. Any disclosures are a matter of trust, regardless of a printed agreement.