American companies that are developing prototype medical and surgical instruments and devices or those transitioning to production have a wide range of different manufacturers to choose from.
There are several different factors to consider with surgical instrument manufacturers. While many companies will initially go to the price per unit or the quote for the prototype development, the price is only one factor that fits into the selection process.
Location and Proximity
There is an advantage to working with a local, American company for all medical equipment production. Unlike in some countries, there are very strict requirements for traceability and quality control for validation throughout the process. American surgical instrument manufacturers that have experience with these regulations can be essential in getting the approval of the prototype and then transitioning to production without violating any of the regulations.
Proximity to your company and team also has benefits. It allows for lower shipping costs, fewer problems with logistics and it can eliminate the challenges involved in working with overseas companies.
Past Projects Completed
Always take the time to look at past projects completed by the companies you are considering. Look specifically at the work they have done in the surgical instrument prototype and production areas.
Top companies will have no difficulty in providing references and many companies provide images of their projects on their website for your review.
Ability to Work to Deadlines
With the price, experience, and location, also consider the ability and capability of surgical instrument manufacturers to work to your required deadlines for delivery. If you are using the same company to go into volume production, ask about their delivery record for orders. It will also be important to ensure they have the current capacity to complete your order should your production needs increase in the future.