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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
