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The services we provide bridge the gap between the initial product idea/concept and the production of a market-ready medical device.
SECTOR: Company Insight
The services we provide bridge the gap between the initial product idea/concept and the production of a market-ready medical device.
We work with a broad range of clients developing new products and helping get those products to the commercialization stage. As a result, the products we help create are now being used around the world to improve patient outcomes.
Our expertise includes braid and coil reinforced catheters, catheters with wall thicknesses as low as 0.1mm (0.004″), embedded technologies, smart catheter devices, wireless technologies, fiber optics, and more.
We have also developed catheters for a broad range of applications, including cardiovascular, peripheral vasculature, and neurovascular applications, in addition to gastrointestinal and ENT applications. The projects we have been involved in have included everything from delivery systems to balloon occlusion catheters to steerable shafts, and much more.
All prototyping work is completed in-house. In fact, prototyping is an essential part of our Six-Step Design Process to develop new catheters and other medical device products and components. We have a range of manufacturing and production capabilities that we use to produce prototypes, including Stage 1 prototyping for internal testing and evaluation with the design team and client, as well as Stage 2 prototyping. Stage 2 prototypes are typically produced in small-batch manufacturing runs and are used for further trials and tests as part of the regulatory approval process.
Research and development are also a core part of what we do at Arrotek. We have always operated at the cutting edge of medical device technologies, designing and developing novel minimally invasive medical devices on behalf of our clients. We stay at the cutting edge of our industry through continuous R&D and investment in new technologies and equipment.
In addition to design expertise and experience, we also have extensive regulatory knowledge. We have an accredited Quality Management System for the design, development, and manufacture of catheters, introducers, delivery systems, handles, and more. We are also FDA registered, plus we have extensive experience of the FDA regulatory process, as well as the process required for CE marking. That experience includes detailed knowledge of the new EU MDR.
We have manufacturing capabilities, too, and we provide contract manufacturing services. Our state-of-the-art facility is in Sligo in the stunning northwest of Ireland, where we have three cleanrooms and capability levels that range from pilot production of newly launched medical devices up to full-scale production of established products.
We work with a range of clients, including entrepreneurs, multi-national companies, start-ups, and medical professionals. Our services are fully customizable, and we operate on the basis that all intellectual property remains completely with our clients.
Arrotek Medical Device Design, Manufacturing, and Regulatory Services – for Medical Device Developments
Arrotek provides medical device design consultancy and contract manufacturing services for minimally invasive medical devices. We specialize in the development of ultra-thin-walled catheters and other advanced catheter technologies.
Medical Device Design Services
Our experienced design engineers and project managers can bridge the gap between the concept you have for a new medical device and the production of a product that is ready for commercialization.
We use various design best practices and techniques to optimize the design process. This includes Design for Manufacture, Design for Assembly, and Human Factors Engineering.
We also have our own fully established and extensively tried and tested Six-Step Medical Device Design Process. This process includes:
Our medical device design services are provided on a contract basis, with all intellectual property remaining firmly with our clients.
Contract Manufacturing of Medical Devices
Arrotek provides contract manufacturing services to medical devices companies in Europe and around the world. Our state-of-the-art facility in the northwest of Ireland has extensive capabilities, enabling us to provide fully tailored services.
Those capabilities include three cleanrooms, in addition to multiple manufacturing and assembly capabilities. For example, we have braid and coil reinforcement equipment in-house to produce reinforced thin-walled tubing. Other manufacturing capabilities include balloon blowing, injection molding, tipping, bonding, laser welding, printing, film welding, and finished product assembly.
Regulatory Services
We have extensive knowledge of the medical device regulatory requirements in various jurisdictions, with particular experience assisting clients obtaining FDA and EU certifications for new medical device products. This includes knowledge of the 510 (k) submission process and Europe’s new MDR (Medical Device Regulations).
We have an accredited Quality Management System for medical devices, and we provide a full range of regulatory consultancy services.
Medical Device online quote calculator: https://www.arrotek.com/medical-device-design-development-calculator/
Medical Device Regulatory calculator: https://www.arrotek.com/your-medical-device-regulatory-estimate/
Join our knowledge Hub: https://arrotek-8550172.hs-sites.com/knowledge-hub-sign-up
Specialising in the design & manufacture of minimally invasive catheter-based medical devices
Download White Paper“Arrotek is a medical device design and development company. We specialise in catheter design and development, advanced catheter technologies, minimally invasive medical devices, braid reinforced catheters, coil reinforced catheters, smart catheter technologies, ultra-thin-walled catheters, and embedded technologies. We help companies, entrepreneurs, and medical professionals bridge the gap between product concept and market commercialisation. We do this through our in-house design, regulatory, quality, and prototyping expertise and capabilities. We also provide medical device contract manufacturing services at our state-of-the-art facility in Sligo in the North West of Ireland. We have three cleanrooms and we offer pilot manufacturing and full-scale production capabilities.”
Download White PaperAccording 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.
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.
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).
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.
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?
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.
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.
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.
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.
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.
Neurovascular microcatheters have transformed the treatment of patients around the world. They enable minimally invasive treatments in a challenging part of the body, so have significantly advanced healthcare in this field.
Catheter shafts are a core component of medical devices designed for minimally invasive procedures. The main objective when designing a catheter shaft is to get the right balance of performance between the various functional requirements of the device.
Usability engineering is a common concept in many areas of product design, but its importance is elevated in medical device product design because of issues of safety and effectiveness.
Since their introduction in the early 1980s, interventional guidewires have transformed medical procedures beyond recognition. This, in turn, has transformed patient outcomes, highlighting the importance of innovative interventional guidewire design.
The treatment of coronary heart disease has advanced rapidly over recent decades. For example, in patients deemed unsuitable for cardiac surgery, the introduction of percutaneous procedures significantly reduced mortality rates. Further advances in minimally invasive approaches have improved patient outcomes even further. This includes high-risk percutaneous coronary interventions (PCI), where interventional cardiologists treat extreme cases.
