Everything You Need to Know About Medical Product Design
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:
• Identify the consumers’ needs.
• Understand the competitors’ products.
• Establish a consistent designing process.
• Detect early discrepancies and inconsistencies.
• Ensure that the end product meets consumer needs.
• Achieve high-quality products from inception through production.
Medical Product Design
To begin the medical product design, businesses must follow the steps below:
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.
Design output specifications are required to refer to the design input document produced by the development team. This way, you can immediately detect and identify critical measures or outputs that will affect the proper functioning of the product. These may include procedures or tests that have already been developed and adapted. A few examples of design outputs include:
• The product or device itself
• A risk analysis of the product.
• Product or device specifications.
• Technical files regarding the product.
• The user manual produced by the development team.
In this phase of medical product design, the product design is once again reviewed to detect any discrepancies and inconsistencies. Some of the common types of medical product design reviews include failure mode and effect analysis. This way, you can identify any issues prior to the designing process, thus making it easier to correct them immediately without facing extra expense.
As the name implies, in this phase, the design has to be verified. For verification, you will need to confirm the product design through objective evidence and examination. Verify that all the design outputs meet the design inputs. Make sure to carry out activities and routinely examines in a planned manner and also document all results. This design verification documentation then comes in handy to assess third-party certifications, transit tests, biocompatibility tests, software verification, and carry out risk analysis.
So, now that you are familiar with the design control process and the steps mentioned above, creating a successful medical product won’t be a problem. However, make sure all the processes are done under the supervision of a professional medical product designer or company.
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