Knowledge Hub

An Introduction to Stent Delivery System Design Considerations

by John Egan
Stent delivery systems, particularly those that involve balloon catheters, have been used in a range of different medical procedures for many years. This doesn’t mean innovation in this area of medical device design has stopped. Quite the opposite, in fact, as new and highly innovative solutions continue to be developed. This includes stent delivery systems capable of delivering stents to the body’s most difficult-to-reach locations, including the brain. New innovations are also improving the performance of stent delivery systems in existing applications, while new technologies like robotics continue to push boundaries. When going through a stent delivery system design process,...

Occlusion Balloon Catheter Design and Development Overview

by Adrian Moran
Occlusion balloon catheters are widely used for a range of medical procedures and treatments, from emergency haemorrhage control or the treatment of neurovascular aneurysms, to temporarily stopping the flow of blood during heart surgery. Despite the varied applications that currently exist, there continues to be new innovations in occlusion balloon catheter design. Those innovations are improving the treatment of patients, including in highly complex surgeries where the catheter must reach parts of the body through tortuous vasculatures. When going through an occlusion balloon catheter design and development process, there are several important factors to consider. Balloon Inflation and Deflation The...

Device Master Record – What Is It, and Why Is It Important?

by Laura Kelly
The world of medical device design and regulations has a lot of abbreviations. We are going to focus on another of them in this blog – DMR. It stands for Device Master Record, but what is a DMR, why do you need one, what is included, and why is it important? What is a Device Master Record? A DMR is a file that contains everything that is needed to manufacture your medical device. It is a centralised record, so you don’t need a binder with all the documents included. Instead, the relevant documents can be referenced. You don’t need a...

Balloon Catheter Design – Process Overview and Key Considerations

by Richard McLoughlin
Balloon catheters are used for a range of medical procedures and applications, from delivering stents to opening blockages to dilating vessels to delivering therapeutics directly to a target location in the body. As a result, balloon catheters have transformed patient outcomes, particularly in complex procedures. Balloon catheters have been used in healthcare for many years now, but the level of innovation in this area of minimally invasive medical devices continues at pace. Well-established balloon catheter applications are being enhanced, and new innovations are being developed. From embedding electronics such as sensors and thermistors to developing balloon catheters that can access...

An Overview of Braid Reinforced Tubing for Catheters and Other Minimally Invasive Medical Devices

by Richard McLoughlin
There are two main types of tubing reinforcement for catheters and other minimally invasive medical devices – braid reinforcement and coil reinforcement. While there is often a crossover between the two, we are going to focus on braid reinforcement in this article. Advanced catheter technologies and other minimally invasive medical devices continue to transform healthcare, including in the most complex of procedures. Braid reinforcement is a crucial component of many of these innovative medical devices, as the braid reinforced layer of the tube enhances its performance. For example, braid reinforcement enables the use of ultra-thin wall tubing. It is also...

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...