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...
Arrotek are delighted and honoured to be shortlisted as one of three finalists in the Irish Medtech Associations Medtech Rising awards 2021 in the category of "Medtech Company of the Year". We are delighted to be part of this prestigious awards ceremony. The awards annoucement will take place on December 2nd. The entire team at Arrotek are looking forward to the event.
Arrotek strives towards a greener future, and we fully support the move towards environmental sustainability. Work is currently underway to install electric car charging facilities outside of our premises in Finisklin Business Park in Sligo. More of our staff are investing in electric vehicles and this charging point will give them a convenient and hassle-free way to fuel up whilst also being kind to the environment. We are delighted to be able to offer this electric car charging point to our staff and customers.
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...
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...
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...
