Are you thinking of an innovative electronic device for the medical industry? Perhaps this new product is currently just an idea or plan. So what happens next, to bring this new product to doctors and patients and earn your company new business? Let’s explore the process of bringing medical device designs to life.
Food and Drug Administration
Devices manufactured for the healthcare industry must meet specific FDA qualifications, standards and rules. One of the most important qualifications concerns quality.
Quality
Your company must have a quality assurance system in place (like ISO). In other words, you must prove to the FDA you have a quality system which addresses all their regulations. If you do not meet these standards you cannot proceed with your medical device designs in the United States. Here are the basic components of a quality system:
* Controls – you must prove that your product is safe for people to use. This may require a great deal of research and development, including testing and trials.
* Risk assessment and management
* Records management
* Material suppliers management
It’s important to remember, these issues are not optional, they are mandatory.
The Importance of Prototypes
Medical device designs may need to change from the time your product is tested until it starts production. This is where prototyping can be invaluable and here is why:
* Prototypes give you working models for testing.
* They do not have to be perfect. In fact, this is the place to uncover errors and design flaws, which can be corrected with the next prototype.
* You don’t need to use expensive materials for prototypes.
There is a great deal of work before you can bring a new medical device to market. This is why many companies hire design services that can assist in the process and do most of the hard work.
