News from Arrotek

Medical Device Design Validation Explained

by Arrotek Medical Ltd
Medical device design validation is an essential part of the product development process. Effective and efficient design validation can help ensure the smooth running of your project. It is also essential for patient and user safety, and it is a key requirement to get regulatory approval for your new medical device product. There is sometimes confusion about what is involved in the design validation process and its objectives. Design validation can also be mixed up with design verification which is a related but different process. The following explanation will give an overview. What is Design Validation? Design validation is a...

Arrotek Co-Founder Mark Pugh Named CEO of Theragenics Corporation

by Arrotek Medical Ltd
Arrotek's Co-Founder, Mark Pugh, has been appointed as CEO of Theragenics Corporation, the US-based parent company of Arrotek. The Theragenics Corporation includes the brands Theragenics, Arrotek, Galt, and NeedleTech. It specialises in the supply, design, and manufacture of minimally invasive medical devices. Mr Pugh succeeds Frank Tarallo who retired at the end of 2023 following a decade leading the Theragenics Corporation. Mr Pugh said: “I am deeply passionate about Theragenics' mission of delivering life-changing minimally invasive medical solutions. This company possesses a robust foundation, innovative products, and a diversified portfolio of capabilities across multiple growing therapeutic areas.” Strong Medical Device...

Designing Medical Device Braiding – Achieving Optimum Levels of Performance

by Arrotek Medical Ltd
Braiding is an essential component in many minimally invasive medical devices, including some of the most advanced interventional and diagnostic catheters. Medical device braiding is also used in positioning devices, occlusion devices, expandable delivery sheaths, and more. As it’s an essential component, designing medical device braiding is an important part of the new product development process. Braiding is essential because it creates a more robust, reinforced structure that enhances key performance characteristics, including kink resistance, torque control, and flexibility. The design and specification of braiding for medical devices can vary depending on specific requirements. The main elements to consider include:...

Arrotek will be exhibiting at MD&M West

by Arrotek
The Arrotek Medical team are looking forward to exhibiting at the upcoming MD&M west show in Anaheim Convention Center, Anaheim, CA, USA from 6 - 8 February 2024. Drop by booth #2711 to meet with one of our technical sales team to discuss your next medical device design and manufacturing project.  

Arrotek Opens New Cleanrooms in US Facility

by Arrotek Medical Ltd
We have opened new cleanrooms in our medical device design and manufacturing facility in the US. Our base in North Attleboro, Massachusetts now has two new cleanroom facilities, extending and enhancing the service we offer to customers. The new cleanrooms in our US facility include: ISO Class 7 cleanroom – this 2,500 sq. ft. cleanroom is used for assembly, gluing, final packaging, and labeling. ISO Class 6 cleanroom – this 350 sq. ft. cleanroom is specially designed for completing critical coating processes for guidewires. Bill Fralick, Director of Quality Assurance and Regulatory Affairs at Arrotek, said: “The additional cleanroom facilities...

Designing Transcatheter Aortic Valve Implantation (TAVI) Systems

by Arrotek Medical Ltd
Transcatheter aortic valve implantation (TAVI) systems are commonly used in procedures to treat aortic stenosis by improving the flow of blood in the heart. This can have a transformative impact on patients, especially as TAVI procedures are minimally invasive and significantly reduce the need for open heart surgery. TAVI procedures are also referred to as transcatheter aortic valve replacement (TAVR) procedures. We'll use TAVI throughout this blog, but both TAVI and TAVR are interchangeable as they both refer to the same type of procedure. While TAVI treatments are common, they aren't recommended for all patients, they are not always successful,...

Medical Device Design for Manufacturing (DFM) Best Practices

by Arrotek Medical Ltd
Design for manufacturing (DFM) or design for manufacturability involves designing a medical device component or product so it can be efficiently manufactured. Adopting DFM principles during the product design stages of your project ensures a smoother design transfer process and, ultimately, improves the quality of your product once manufacturing begins. Examples of the questions that engineers will work through as part of the DFM process include: Can the product and all its components be manufactured as it has been designed? Will the component or product meet the defined functionality requirements? Is the manufacturing process cost-efficient? What level of variability does...

Design Considerations When Integrating Sensors into Catheters

by Arrotek Medical Ltd
Sensors are becoming increasingly critical components of new and innovative catheter products. As sensor technologies develop further, a number of design considerations must be taken into account when integrating sensors into catheters. A key objective in the design process is to ensure the catheter is safe and performs as intended. When that is achieved, sensors can significantly enhance a new catheter product, leading to transformed patient outcomes. For example, sensors can provide data that guides medical procedures, enhances decision-making, and helps detect complications and risks. They are also a useful tool to help monitor the progress of treatments. To achieve...

Arrotek and Sister Company NeedleTech Will Now Both Trade Under the Arrotek Brand Name

by Arrotek Medical Ltd
Arrotek and its sister company, US-based NeedleTech, will now both trade under the Arrotek brand name. The new brand offering will have enhanced operating bases in the US and EU, as well as an extended service offering covering the design, development, and manufacture of minimally invasive medical devices. Arrotek specialises in medical device design with a particular emphasis on interventional/diagnostic catheters and related technologies. Arrotek also has manufacturing capabilities at its facility in Sligo, Ireland, as well as regulatory expertise. From its base in Massachusetts, USA, NeedleTech specialises in needles, cannulas, stylets, and similar medical device components. Both companies have...

The Benefits of Integrating Sensors into Catheters

by Arrotek Medical Ltd
Interventional and diagnostic catheters have transformed healthcare. They enable increasingly advanced minimally invasive medical procedures that are precise, targeted, and effective while minimising patient trauma and recovery times. While the benefits of advanced catheter technologies are substantial, integrating sensors into these devices is taking their capabilities to another level. Sensors integrated into interventional and diagnostic catheters provide medical professionals with real-time procedural and patient data. This enables more precise and customised treatments and diagnoses. Medical professionals use the information from sensors for a range of purposes, including: Making decisions and guiding medical procedures based on the response of the patient....