In the early stages of developing medical devices, particularly implanted devices, it is essential to put time and consideration into all aspects of the device. This is more relevant today than in the early to mid-1950s when the first devices were being designed and tested.
Today, with the regulations and requirements in place for implantable medical devices, companies have more of a structured framework to work from. However, this doesn’t mean there aren’t areas of challenge or where the ability to choose the correct design, material, and technology may still be in a pioneering type of application.
The market for implantable medical devices continues to grow, with companies often outsourcing the design and development of these devices to a variety of companies overseas. However, with the rigid standards required for FDA approval, choosing the right company for everything from design to production will be the single biggest consideration.
One Provider
While it is possible to utilize multiple medical device contract services from designers through to manufacturers, using one company to complete concept to production of implantable medical devices has its benefits.
By utilizing one recognized, reputable and experienced medical device manufacturing contractor there is an assurance of full quality control, traceability and validation and verification throughout the entire process.
When using multiple services throughout the production, there is a greater risk of error and possible failure to adhere to regulations and standards. Additionally, with multiple companies and services involved, there is also a more complicated supply chain and logistics consideration where any delay in the process can have very significant consequences for approval and moving into full production.
Always choose to work with the best possible provider of medical implant manufacturing services. This is not a place to cut corners or to choose a provider based on price alone.
