Knowledge Hub

Six-Step Medical Device Design Process Whitepaper

by Richard McLoughlin
This whitepaper outlines in detail the design process required to successfully design a new medical device product, developing it to a point where it can obtain regulatory approval and move into the manufacturing and commercialisation phases. Go to the whitepaper download page. The whitepaper is based on Arrotek's well-established Six-Step Design Process. This process has a proven track record of success in advanced catheter design projects and other projects involving the design of minimally invasive medical devices and advanced catheter technologies. In addition to covering in detail the six essential steps in designing a new medical device product, the whitepaper...

Arrotek’s Complete Service Offering

by Richard McLoughlin
There is a detailed and complex process involved in bringing an idea for a new medical device product from the early concept point through to a stage where it is being used by physicians in real-world clinical settings. The process includes all the typical elements you would find in any product design project. However, there are also regulatory considerations that need to be taken into account. Those considerations focus on minimising patient risk while ensuring the medical device is effective. At Arrotek, we can offer a complete service offering. This means we can work with you to bring your idea...

Medical Device Design and Development Trends for 2022

by Richard McLoughlin
Innovation and the medical device industry go hand in hand. At the same time, the industry is impacted by broader challenges, as well as being influenced by the demands and expectations of healthcare professionals and patients. Taking all this into account, what are the trends we should look out for in 2022 and beyond? More Complex Minimally Invasive Medical Devices Minimally invasive medical devices have transformed healthcare, but innovation in this field continues at pace. Existing medical devices, including ultra-thin-walled catheters, multi-lumen devices, and other advanced catheter technologies, will be improved. New, novel medical devices will also be developed. One...

What is DFA – Design for Assembly – in Medical Device Design?

by Ronan Scott
Design for assembly, or DFA, means designing a new medical device product so it can be assembled as easily as possible. It is a crucial part of the design process, particularly as the product moves to the pilot manufacturing, full manufacturing, and commercialisation stages. DFA is a process that applies to medical device products with multiple components and is particularly important for complex devices. With the right DFA approach, assembly costs and timescales can be reduced to a minimum. Essential DFA Considerations Minimise the Components One of the main objectives of DFA is to design the device with as few...

Top Catheter and Medical Device Design and Development Blogs of 2021

by Arrotek Medical Ltd
We regularly publish blogs, case studies, and other articles on our Knowledge Hub covering various catheter and medical device design topics. Here is a collection of the top blogs of 2021. Catheter Design and Development – Key Considerations to Get Your Product to Market In this blog, Arrotek's Richard McLoughlin explains the key considerations when designing and developing a new catheter device. This includes everything from the intended use of the catheter to performance considerations to the makeup of the various layers in a reinforced catheter. Read Now An Overview of Steerable and Deflectable Catheter Design Steerable and deflectable catheters...

What is a Design History File (DHF)?

by Laura Kelly
Documentation is an essential part of designing a new medical device, getting regulatory approval, and then maintaining compliance while the product is on the market. A crucial part of that documentation is the Design History File (DHF). There is a lot involved in creating and maintaining a DHF file. This blog provides an overview of the essential elements you need to know if you are about to begin, or are in the early stages of, designing a new medical device. What is a DHF? A DHF is a file of documents that outlines the design and development history of your...

An Overview of Multi-Lumen Catheter Design

by Adrian Moran
Multi-lumen catheters are used for several different applications, including highly complicated procedures. They can also be designed with a wide range of performance characteristics. Furthermore, advances in the design of catheter devices are opening up new opportunities and making it possible to create new multi-lumen catheter products that will improve the treatment and diagnosis of patients with various complex conditions. In simple terms, a multi-lumen catheter is a single catheter with multiple internal channels or lumens. As it is a single catheter, there is only one entry point. However, the multi-lumen design allows more than one activity to take place...

What is an EU Authorised Representative, When Do You Need One, and What Do they Do?

by Deirdre Caheny
According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person must be a "natural or legal person" in the EU. The main role of an Authorised Representative is to represent the manufacturer in dealings with EU regulators. If you are a European-based medical device manufacturer, you will deal directly with regulators. There is no need...

An Overview of Steerable and Deflectable Catheter Design

by Arrotek
The steerable and deflectable catheter design process helps produce some of the most advanced minimally invasive medical devices currently in use. This includes both diagnostic and therapeutic catheter devices. Furthermore, technology advances mean it is now possible to design advanced catheter technologies that are more complex than ever before. Steerable and deflectable catheters are designed to navigate through complex and tortuous vasculatures. This could be, for example, for use in cardiovascular, neurovascular, or peripheral vasculature procedures. The process of designing steerable and deflectable catheters involves using various technologies and materials, as well as taking into account the performance characteristics required...

Catheter Design Capabilities

by Richard McLoughlin
At Arrotek, we have significant experience in catheter design, particularly in the development of advanced catheter technologies. This includes atraumatic catheters with ultra-thin walls as low as 0.1mm (0.004"). The projects we regularly work on involve the development of catheters with intended usage applications that require the ability to navigate small and complex vasculatures to access difficult to reach parts of the body, such as in high-risk neuro and coronary interventions. We also have experience in the design of large-bore catheters, including multi-functional devices, that deliver high levels of performance. Examples include catheters designed for the delivery of innovative therapies...