Knowledge Hub

FDA Medical Device Classifications Explained

by Ger O'Carroll
To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device. Not only will the classification determine much of the design and development process, it will also determine what is required to get approval. This is because the process for getting FDA approval differs depending on the classification of your medical device. This is very similar to the system in the EU. We covered the EU medical device classification system in a previous blog. In this one,...

EU Medical Device Classifications Explained

by Ger O'Carroll
Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system. In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval. EU vs US Regulations...

Quality Systems and Design Controls in the New Medical Device Development Process

by Ger O'Carroll
Design controls are essential to ensuring your medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. What are design controls? Design controls are part of the Quality System that you must have in place before regulators will allow your product to enter the market. So, let’s start there. An Introduction to Quality Systems All new medical device products need a Quality System to comply with regulations. In the US, this...

What is DFM – Design for Manufacture?

by Mark Pugh
Design for Manufacture, or DFM, involves designing medical device products so they can be easily manufactured within a target manufacturing cost. It takes into account other aspects of designing a medical device product too, such as ensuring regulatory compliance and performance, however it doesn’t ignore the manufacturing element. DFM typically involves simplifying and refining the product at all stages in the design process with the aim of optimising it for manufacturability. An example is the number of parts used to manufacture a medical device product. By going through a DFM process, design engineers will seek to eliminate or combine parts...

The Importance of Prototyping When Developing a New Medical Device Product

by Mark Pugh
It is not enough when designing a new medical device product to just create a design based on an initial ideal before moving straight to testing and real-world evaluation. In fact, most medical device products go through several iterations during the design and development process to get to the final design. Often, this final design can be significantly different from the original sketched-out idea. The prototyping process is crucial to achieving this final design. What is Prototyping? Prototyping usually starts after the concept development stage, i.e. once detailed drawings are produced. It’s about turning the digital design of the product...

An Overview of the Medical Device Design and Product Development Process

by Mark Pugh
While each new medical device product design and development project is different, the process followed is typically well-structured. There are many reasons for this, not least the importance of ensuring the product is safe to use as well as ensuring both the product itself and the design process adheres to medical device regulations. At Arrotek, we have a well-established medical device design and product development process. It is outlined below. Before going through it, however, it may also be helpful to read our blog on the Considerations that Inform and Guide the Medical Device Product Design Process. Both blogs together...

Considerations that Inform and Guide the Medical Device Product Design Process

by Mark Pugh
Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before. This overview of the medical device design and development process will outline the things you and your design/development team will consider. In the next blog, we’ll look at the steps and stages you will go through. Considerations During the Design and Development Process for New Medical Devices There are many concepts, principles, and requirements that will determine the course of the design process. This includes: Regulations DFM – Design...