In a previous blog, we gave an overview of human factors engineering and how it relates to medical device product design. It is primarily about anticipating potential user errors and making adjustments to the product’s design to reduce the risk of those errors from occurring. The primary objective is to improve safety, but human factors engineering also offers commercial and user experience benefits. The company you appoint to design and develop your new medical device product will look after the specifics of human factors engineering. That said, it is a process that impacts everything from the packaging and instructions to...
In product design, designing a product that works on the engineer’s bench or desk is not enough. You also have to consider real-world factors, such as who will be using the product, their level of expertise or knowledge, and the situation or environment where the product will be used. In medical device product design, it is also essential to consider safety. The collective term for these considerations is human factors engineering. Human factors engineering is part of the design and development process for new medical devices, and it is an important regulatory requirement. It is also known as usability engineering...
You have an idea for a new medical device. What do you do now? What are the next steps you should take? Each medical device development project is different, but there are common steps regarded as best practices in the industry. You might have already gone through some of the points below, but this will give an overview of the first stages of the medical device design and development process. Ideation As you already have an idea for a new medical device, you are likely to be part of the way through this stage. It’s helpful to review what ideation...
As we in Arrotek endeavour to support the measures to tackle the COVID-19 situation, one aspect that has been identified is a possible lack of cleanroom space. As I`m sure you all know, Arrotek Medical recently moved into a new facility in Sligo. The previous facility is currently empty and available. This is a facility with over 2,000 ft² of cleanroom space in a detached building of over 10,000 ft² split between warehouse and office space. Less than a year ago this facility was running as a fully validated class 7 cleanroom, and could be returned to this status quickly....
In medical device design projects, there are both product risks and project risks. Product risks are talked about a lot as they are about the safety and effectiveness of the product. Managing product risks is also an essential part of the regulatory approval process. From a commercial perspective, project risks are critical too. Therefore, it’s also important to manage project risks when designing a new medical device. Product Risk Management vs Project Risk Management Product risk management is about product safety and ensuring the product does what it is expected to do. There are well-document guidelines, standards, and requirements you...
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...
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...
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...
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...
