There are many different companies and services involved in medical device manufacturing processes today. Many of the OEM or original equipment manufacturers are using medical device contract manufacturing as a cost effective way to produce components and to even be involved in the initial design and development stage.
Finding the right company to work as a medical device contract manufacturing service is important. These companies have to perform to all required standards and to also have a top understanding of the implications for use of the device. This is becoming more relevant as medical devices become increasingly “smart” devices, actually performing in the patient based on complex factors for higher effectiveness and increased safety.
Lacking Early Involvement
The contract manufacturing companies are often not brought in by the OEMs early enough in the process. This can result in costly delays and changes to the design that could have been easily prevented.
This may be a case of the OEM not being aware of the latest in technology and research or simply lacking the experienced professionals in microelectronic design and components on the in-house team.
Regardless of the reasons, working with the contract manufacturing company early in the design and development process is increasingly important.
Not Shopping Options for Companies
When the OEM has a solid partnership with a contract company and is satisfied with the past experiences from design through production, shopping around for qualified contracts manufacturers may not be important on each project.
However, if there were challenges in working with the contract manufacturer in the past, including late delivery or other issues, shopping around for a new contract manufacturer is always a good option.
Ideally, look for medical device contract manufacturing that can provide a wider scope of tasks based on the specific component or device. It is more effective to have one quality contract manufacturer doing multiple aspects of the project rather than using several different contract companies.
The fewer the contractors working on the device, the lower the costs will be and the higher the quality. Multiple contract manufacturers can lead to a greater risk of a failure between different systems or aspects of the device, which may lead to an increased risk of overall device failure.
At the very least this will result in delays in getting the device approved and to market. With the fast pace of today’s medical device development, these delays can be incredibly costly and a very real challenge to the reputation of the OEM.
