The medical product design process usually begins after the conceptualization of a new medical device or product. It is the most important phase in the medical product development process and a single mistake or flaw in the design graphs or charts could lead to the end product being unsafe or ineffective, thus being refused or cleared by the regulatory agency. In this article, you will learn about the A B C of medical product design and all the complicated factors involved:
The Design Control Process
As part of the quality system requirement in the designing stage, a design control process has to be initiated, which includes simple and logical steps to ensure what you end up developing is actually what you ‘meant’ to develop.
The process begins with a set of interrelated procedures and practices which are documented and incorporated during the design phase. Through the design control activities, companies can:
Establish and maintain a plan that properly describes the development and design activities involved and allocates the individual responsibility for each specific activity. Of course, you won’t be presented with one plan, so make sure review and update all plans until the device design is started, completed, verified, and validated.
The next step in the product design process is to use regulatory requirements and business economics, safety and outputs of risk management as a basis to design the product. This way, you can make sure the purpose of the product and the intent is absolutely clear. Design input can also be taken from surveying your customers, including patients, clinicians, and nurses. Once this information is gathered, review and address it while developing the product specifications.