3 Misunderstandings About Medical Device Contract Manufacturing

With the increasing costs and time involved in getting a medical device from concept through approval, prototype development, clinical trials and onto the market, companies were looking for medical device contract manufacturing services more than ever in the past.

This is actually a benefit to the company as it allows specialized processes to be completed by experts in the field. However, there are also mistakes, pitfalls, and errors that even experienced medical equipment OEMs can make in determining the medical device manufacturers to choose.

Not All Medical Device Manufacturers are the Same

It is important to consider the reputation of the medical device contract manufacturing service under consideration. Look for companies that are established in the industry and that have ISO 13485 certified. In addition, check to verify that the contract manufacturing service is FDA registered.

Don’t Assume Confidentiality and Intellectual Property Protection

Always ensure that the medical device contract manufacturing service has a written policy with regards to confidentiality and intellectual property protection of the parts and components they are designing and producing.

Not only is this essential to prevent information about the new device from leaking to the competition, but it also prevents the use of technology developed for one device to be used in another product. Never assume this is the case, particularly in working with overseas companies where laws may be very different in this regard.

Comparing Services, Experience and Cost

Not all medical contract manufacturing providers offer the same services for the same cost. It is important to verify that the services and the processes quoted between different companies are the same or understand what is included in the bid for the contract.

It is also important to choose a company that offers medical device contracting that has the professionals and the technology to complete the project on time and within the budget.

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    Author: Greene Connor

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