Whether you have a concept idea for a new medical device, a product in a more advanced developmental stage, or a product ready for manufacturing either on a pilot or scale-up basis, we have the capabilities, capacity, and expertise at Arrotek to help. We partner with medical device companies at all stages of the product life-cycle journey. That said, we can add the most value to your business, project, and product with our finished device capabilities.
The international reach of our operations and our highly specialized expertise makes us the ideal partner of choice for start-up medical device companies, SMEs, and international corporations alike.
Here are the highlights of what sets us apart from the competition:
- Finished medical device expertise and capabilities, from concept development and product design to regulatory support to manufacturing and commercialization.
- Capacity to scale our services as your needs expand.
- Local support in all major medical device markets, including the US and EU.
- Production facilities in the US, Europe, and Latin America.
- Extensive RD capabilities.
- Cutting-edge technologies and extensive technical capabilities.
- FDA registered and audited with an outstanding quality performance record.
- Preferred partner status for many well-established medical device companies.
- Extensive experience with over 300 customers in more than 25 countries.
Medical Specialties
We have extensive medical device design, regulatory, and manufacturing expertise across a range of different medical specialties including:
- Neurovascular medical devices
- Cardiovascular medical devices
- Peripheral vascular medical devices
- ENT/endoscopic medical devices
- Gastrointestinal medical devices
- Wound closure medical devices
- Hemorrhagic stroke devices
- Ischemic stroke devices
- Clot retrieval systems
- Structural heart devices
- Stent devices
- Mitral valve repair devices
- Heart repair devices
- Delivery systems
- Minimal access repair devices
- Leg ischemic devices
- Robotic devices
- Micro needling devices
Manufacturing Capabilities
We have extensive manufacturing capabilities across three main sites:
USA
Our Center of Excellence for Metal Manufacturing is located in Boston, Massachusetts where we specialize in manufacturing high-precision, intricate, and complex metal components used in medical devices. This includes everything from needles and cannulas to guide wires and marker bands to electrodes, shields, and capacitor components.
Ireland, Europe
Our purpose-built medical device development and manufacturing facility in Sligo in the northwest of Ireland specializes in catheters and other minimally invasive medical device products. We have extensive clean-room facilities and extensive materials expertise to manufacture polymer-based and composite components.
Costa Rica
Our high-speed, high-volume Latin American manufacturing facility in Costa Rica serves our clients as they move into a scale-up phase of their product’s life-cycle. We have advanced manufacturing equipment, robust processes, and a skilled workforce able to deliver on our customers’ volume manufacturing requirements.
Design Services
With our extensive medical device product design capabilities and expertise, we can adapt to your specific requirements. Our goal is to support your project to help bring your idea for a new medical device product to the commercialization stage.
Our medical device design expertise includes:
- Development of functional requirement specifications
- Concept development
- Defining user needs
- Quality management system
- Rapid prototyping
- Project risk management
- Product compliance
- Process validation
- Product testing
- Human factors design
- Design for Manufacturing (DFM) and Design for Assembly (DFA)
- Label design
- Risk management file
- Design verification and validation
Regulatory Consultancy Capabilities
We have a global regulatory team to help you obtain approval for your new product in your target markets. This includes expertise in the FDA’s various regulatory approval processes, including 510(k) submissions. It also includes extensive knowledge of the EU’s new Medical Device Regulations (MDR) and the process to obtain CE certification.
The range of regulatory support services that we can provide includes:
- Process validation
- Sterilization validation
- Shelf-life age testing
- Transportation testing
- Bench testing
- Testing to ISO standards
- Usability testing
- Label design
We can also help with file compilation and preparing regulatory submissions.
Benefits of Working with Arrotek
The capabilities, services, and expertise outlined in the above sections lead to multiple benefits of working with us. The benefits of our manufacturing, design, prototyping, and regulatory services include:
- Increasing speed to market for your new medical device product
- Accelerating product development pipelines
- Delivering innovation in the product development process
- Streamlining your supply chain
- Bringing predictability and reliability to the manufacturing process
- Achieving market advantage
- Driving sales
- Increasing profitability
To discuss how Arrotek can support your medical device company or project, please get in touch.
