The Process of Medical Device Development

MedTech Outlook | Sunday, April 26, 2020

There are several stages that a company must go through when developing a medical device.

Fremont, CA: Medical device design and development is a multi-step process that requires a lot of resources, a lot of money, and a lot of time. To survive in the competitive landscape for a long period, a Medical Device Design must be adaptive. In the current environment, where the majority of Medical Device OEMs outsource their projects, the Medical Device Contract Manufacturing partner they select for mass manufacturing their Medical Device Design has a significant impact.

Medical device development process:

Research and conceptualization

Clients usually come to the contract manufacturer with an idea or a specific change request. The main responsibility of the Medical Device contract maker is to do a 3600 evaluation of the requirements and come up with a relevant solution concept. Also, there doesn't always have to be a problem to address; sometimes, the client isn't sure where to start. In this case, the contract manufacturer's design and engineering team play a critical role in conceptualizing the design for scaled manufacturing.

Medical device prototyping

After the medical device design phase is completed, it is sent to prototyping. Prototyping entails transforming the design into a three-dimensional form. Multiple iterations are carried out to ensure that the design is user-friendly. Once the design has been finalized, and the prototype stage has been completed, the design can be moved forward for mass production.

Manufacturing of medical devices

Medical device manufacturing refers to the stage when the device enters the scaling phase. The manufacturing process in an Electronic Medical Device Manufacturing facility is closely monitored to ensure compliance and efficiency. The QA staff monitors the products and procedures for improvements and adjustments on a regular basis.

Validation, testing, and packaging

To completely minimize the possibility of an error during use in the end-user environment, the testing method after PCBA includes Burn Test, Leakage Test, and so on. After passing the testing stage, the product is packaged in accordance with FDA rules.