Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market.
Especially if you don’t know much about the technical part but you are aware of what your product’s requirements are, getting in touch with a manufacturer can be challenging and scary.
Of course, the best option is to choose a manufacturer that has the ability to turn your idea into something substantial, on a high-quality level, which is nice to imagine, but hard to find in the real world.
There are a few important things to consider before making your choice.
It doesn’t matter on which part of the planet you are located; you might consider manufacturing domestic or overseas. Benefits when you choosing to work with a domestic manufacturer are speaking the same language which is really important for good cooperation. Then there is a possibility to see first-hand how the manufacturer creates a product. There are also things like more flexible payment options and the cost of shipping and handling are less. Benefits if you choose overseas manufacturers definitely lower costs and it’s easier to find a manufacturer on several well-known platforms.
Another thing that should be considered is to preferably, (if possible) the outsourced manufacturer is working by ISO 13485, it also includes credentials of FDA compliance. That will fill the requirements for a quality management system. Considering they have a quality focus, it’s most likely that they have high-quality standards for their own staff and procedures, so there is no need for additional guidance for creating a quality system.
Asking for a list of references will probably help you to come closer to your final decision. If customer service was satisfactory, and if they would use their service again in the future, then it puts your doubts on a minimum level.
Keep in mind that usually, as more employees the outsourced manufacturer has, and the bigger their facility is, it means they are longer in manufacturing business which leads to the fact that they are more likely to have a lot of experience in their respective fields.
Depending on your medical device, you have to pay attention also on their production capacity. You might start as a small business, but with patience and effort, soon you might have a need to be able to produce it on a big scale.
Outsourced manufacturing is often a time-consuming and expensive aspect of the business, it’s worthy to put some extra energy to make sure the company you finally choose will be able to meet your requirements and produce a quality, cost-effective product.
The more you prepare, is more likely you will make the right choice.