Sligo is the base of our operations here at Arrotek. We moved into a new purpose-built facility in 2019 following a significant investment, and we are part of a strong and growing medical device industry in Ireland’s northwest. Why Sligo, though? What is Sligo like, and what does it have to offer? These are questions we are regularly asked by clients from Europe and elsewhere in the world. Ideally, we’d like to bring you here so you can see first-hand what is on offer not just in Arrotek’s state-of-the-art facility, but in the region more generally. As a taster, however,...
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...
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices need to go through this regulatory pathway? How do you prepare your submission? What happens after you make your 510k submission? Below is an introduction to FDA 510(k) submissions. What is a 510(k) Submission? A 510(k) submission is a pre-market notification that you must submit...
You will probably work with a design partner to develop your idea for a new medical device. They will handle the design process, bringing the concept through to the initial prototype and then final prototype stage, ready for you to move to the next stage of your business plan. There are things that you can do to facilitate the design process as well as to ensure the developed product meets your goals and objectives. The following tips are a good place to start. Focus on Designing a Product One of the mistakes that is sometimes made when designing new medical...
Design verification is an important part of the medical device design and development process. It is an element that will be largely looked after by your medical device design partner. However, given it’s important to the overall process, it helps considerably if you have an overview of medical device design verification, why it’s important, and the key steps involved. Medical device design verification ensures design outputs meet the design input requirements. In other words, it is a process that ensures the new medical device is designed correctly. Design verification is required by regulators when they evaluate new medical device products....
A product requirement specification outlines what needs to be achieved during the medical device design process. It is an important step in the process as it ensures design engineers fully understand what is required so they can deliver the best possible product. A good product requirement specification also makes the design process more efficient, and it ensures the development of a better-quality product. Furthermore, your product requirement specification will make it easier to ensure compliance, and it helps with progressing your product through the regulatory approval process. Your medical device design and development partner will guide the process of creating...
A crucial part of the medical device design and development process is to create a product requirement specification. The creation of this document takes place in the very earliest stages of the process. In fact, in our Six-Step Medical Device Design Process at Arrotek, creating the product requirement specification is one of the primary objectives of Step 1. A product requirement specification clearly defines the purpose, functionality, features, and behaviour of your new medical device idea. Importantly, it focuses on what you want to achieve with the new product, but it doesn't look at how. Looking at how you deliver...
Our new video explains how to use the free Arrotek calculator tool to estimate the design and development costs that will be involved to turn your idea for a medical device into a new product. It only takes a few minutes to complete, and you don't need to provide any commercially sensitive information. Watch the video to find out more. https://youtu.be/ioNb61FfTec
Medical device design projects require a broad range of expertise as well as established processes and procedures. The project management function and the project manager are central to ensuring medical device design projects run smoothly. Of course, effective project management plays a crucial role in the product design process in other industries too. However, because of regulatory considerations, safety issues, and the complexity of many modern medical device products, project management is even more important in the medical device industry. The Path to Successful Medical Device Product Launches The overall objective of a medical device design project is to bring...
