7 Tips for Outsourcing Medical Devices and Protecting
A major concern for many companies when they consider outsourcing the manufacturing of a medical device they have developed or may be already manufacturing internally is the protection of the Intellectual Property (IP) they have invested in the development of that device. Here are some tips for you to consider for protecting your investment.
1. The first step is standard due diligence on the outsource provider you're considering. Things like how long have they been in business, how experienced are they in medical device manufacturing, do they have a certified quality system, what is their delivery track record and how stable are they financially should be evaluated.
2. Are they receptive to Non-Disclosure agreements? In fact, are they really pro-active about these agreements?
3. Do they have an internal process for ensuring protection of information that is designated proprietary?
4. Are they involved in other market areas where equal caution is involved, such as government work covered by ITAR, and, if so, are they ITAR registered?
5. Are there any 'company connections', parent companies, subsidiaries, etc. where there could be a danger of your product being produced under a new name and then competing with you?
6. If you are going outside the USA to outsource your product, do you have an agreement that permits recourse in the United States legal system? Or, will you have to rely solely on the legal system where your product is produced?
7. Counterfeit parts and materials are a major concern today. Does the outsource provider take serious steps to prevent the use of counterfeits that could affect the performance of your product?