Original Equipment Manufacturers in the medical device industry face a long and very complex approval process to see their concept finally reach the market. At each step along the way the correct documentation, analysis, and verification must be developed and provided for use in the approval process.
One of the key stages in any type of medical device design is the early research and planning stages. Moving through this component of the development is easy to do, but it can have a significant and costly impact later on in lost time and wasted efforts.
When working with a contract manufacturing service for production of some or all of the parts and components for the device, it is a wise decision to bring these companies in as early as possible in the concept development phase. These companies can provide insight into medical device design and production concerns which can be beneficial in meeting rigorous standards while also helping to manage the cost of production.
Keep It Simple
A very real factor found in many medical device design stages is the desire to add too much to the equipment or device. Instead of focusing in on the reason for the device, the benefit to patients and physicians, the emphasis is often on trying to include too many features and functions.
Not only will this complicate the design of each element or component in the device, but it will also significantly increase cost and the challenge of testing and verification. By being very specific about the intended use of the device and avoiding adding on, OEMs can avoid many common issues.
Focus on the Subsystems
With any type of device, system or component, each subsystem has to fully integrate with the other subsystems to work as a whole. By hiring experts in the of medical design for complex and simple devices, each of these subsystems, including electronics, will be designed from the beginning of the process, to fully integrate into the device as a whole.