The process involved in bringing a new medical device to market is long and complex and required documentation at every step in the process. For a medical device manufacturer, working with an experienced medical device contract manufacturer is critical to ensure all documentation, verification, and requirements of the process are completed.
There are different steps in medical device product development. By working with an experienced contract manufacturer, the in-house engineering and design team has the expertise and support of the experienced product development service. In addition, the product development service can also move quickly from prototyping into production, helping to reduce the critical time period from approval to market.
The Steps Involved
In most cases, the initial stage of medical device product development is done in consultation with the contract manufacturing team based on the specifics of the device. This is the pre-development stage where the device is considered based on the opportunities in the market as well as preliminary risk assessment.
In the second and third stage, the formulation of the concept, feasibility study, and the design and development aspects are more focused on the outsourced company. This is where the early design is solidified, the prototype is developed and analyzed, and the product design development is completed. This includes multiple verification and validation steps, which are all critical to medical device product development.
Of course, there are also requirements to meet specific regulatory approvals and to conduct clinical trials and studies. This only moves forward once the testing of the design is completed both in virtual form as well as through prototyping and testing.
The last two stages include the final validation and the product launch. The contract manufacturer is essential in these stages, providing necessary documentation as well as ramping up from prototyping to full production requirements.