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.
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.