News from Arrotek

GALT ACQUIRES ARROTEK MEDICAL

by Arrotek Medical Ltd

GALT ACQUIRES ARROTEK MEDICAL

Combination of Arrotek’s Product Development with Galt’s Manufacturing Capabilities will Benefit Customers and Provide Access to New Segments of the Interventional Market

GARLAND, TX – May 20, 2019 – Galt Medical, a subsidiary of Theragenics Corporation® and a global supplier of access and procedure products for a range of interventional and endovascular procedures, today announced it has acquired Arrotek Medical Limited. Arrotek, located in Sligo, Ireland, develops and designs minimally invasive medical devices supporting a range of catheter-based, interventional applications. Arrotek’s capabilities include concept, design, product development, regulatory approval, and certain manufacturing services. Mark Pugh and Ger O’Carroll, co-founders of Arrotek, will remain with Arrotek in Sligo as co-Managing Directors.

Frank Attardo, President of Galt Medical commented, “The capabilities of Arrotek and Galt are highly complementary to each other. Arrotek’s product development capabilities, combined with Galt’s manufacturing and processing capabilities, will allow the combined company to better serve existing customers and address and serve a wider segment of the interventional market.”

Mark Pugh and Ger O’Carroll commented, “Galt provides Arrotek with access to markets, capabilities and expertise previously unavailable to us. The combination with Galt will benefit existing customers of both companies, as well as provide Arrotek with opportunities to serve new segments of the market in Europe, North America and other global markets. Becoming part of the larger Theragenics organization also provides the resources to accelerate our growth and continue to expand.”

Considerations that Inform and Guide the Medical Device Product Design Process

by Mark Pugh

Turning an idea for a new medical device into a product that is ready for testing and evaluation is a complex process, particularly if you have never been through it before.

This overview of the medical device design and development process will outline the things you and your design/development team will consider.

In the next blog, we’ll look at the steps and stages you will go through.

Considerations During the Design and Development Process for New Medical Devices

There are many concepts, principles, and requirements that will determine the course of the design process. This includes:

  • Regulations
  • DFM – Design for Manufacture
  • Quality systems
  • Testing, verification, and validation

Let’s look at each in more detail.

Regulations

It’s essential in the design and development process to ensure your device meets the regulatory requirements and product standards for all markets it is intended to be sold in.

It’s also important that the design and development process itself adheres to Good Manufacturing Practice (GMP) as this is a regulatory requirement for medical device products.

One thing that is important to note when considering regulations is that while there are many similarities between regulations in different jurisdictions, there are important differences too. Understanding these differences and working through them at the design and product development stage avoids delays in getting the product approved.

Remember, even though there are ongoing efforts to harmonise medical device regulations and standards through organisations like the International Medical Device Regulators Forum, regulations are still enforced, determined, and governed on a national basis.

DFM

Designing a product is very different from designing a product that can be effectively manufactured. Therefore, DFM is the design philosophy that should be used in the development of your product.

In practice, this means giving consideration at the design stage to the practicalities of manufacturing the product. The benefits of doing this include:

  • Ensures the product meets your target manufacturing cost
  • Creates a higher quality product
  • Ensures the manufacturing process is reliable
  • Ensures the assembly process is as simple as possible
  • Makes sure the device meets all regulatory requirements

Quality Systems

Regulators require new medical device products to follow a quality system through the design and development process. The FDA, for example, requires a quality system to be in place before a product can enter the US market.

For most medical device products, a quality system should have the following components:

  • Design controls, i.e. controls in the design stage to ensure the product is safe, is suitable for the use it is intended, and to make sure it meets the needs of the end user as well as your requirements
  • Risk management
  • Document control
  • Supplier management

Testing, Verification, and Validation

Testing, verification, and validation of your new medical device product is a requirement from a regulatory perspective, but it’s also essential from a user/patient safety perspective too.

Other benefits include controlling the cost of development, controlling the cost of manufacturing the product, reducing delays in getting the device to market, anticipating the impact of future changes, and analysing issues when exporting the device.

Therefore, testing, verification, and validation should be considerations throughout the process.

The Process for Designing and Developing Medical Devices

The above outlines the factors a professional and experienced medical device product design and development team will consider when making your idea for a new product a reality. What about the design and development process, though?

We cover this in our next blog: An Overview of the Medical Device Design and Product Development Process. Check it out today.

Finisklin premises update

by Sinead Duffy

We are delighted to announce that construction is well underway at our new Arrotek premises in the IDA Business Park, Finisklin, Co. Sligo. This new purpose built facility is the result of up scaling our production to meet rising demand and to allow for the continuous expansion of our company. The new facility is 52,000 square feet and will provide Arrotek with extra lab space for engineering, development, and testing. This move is due to be completed by the end of summer 2019. For more information on the move, contact sinead@arrotek.com or call us on +353 71 91 15111.

 

IMR Manufacturing and Supply Chain Awards

by Arrotek Medical Ltd

We are delighted to announce that Arrotek have won the Best Small/Medium Manufacturing Company of the Year award at the Manufacturing and Supply Chain Awards!

The award ceremony took place last night at Citywest Hotel and we’re so proud of our team’s immense efforts and happy that this has been recognised by Irish Manufacturing Research.

IMR Supply Chain and Manufacturing Awards

by Arrotek Medical Ltd

Thank you to Irish Manufacturing Research for shortlisting us for Manufacturing Team of the Year and Small/Medium/Large Manufacturing Company! We’re absolutely delighted to be part of Ireland’s inaugural Manufacturing and Supply Chain Awards.

We owe these nominations to the hard work of our expert team and the continuous quality service we have provided over the past 12 months. Congratulations to all nominees and fingers crossed for January!

https://www.awards.manufacturingevent.com/finalists/