Today is International Women's Day and the theme for 2023 is Embrace Equity. Equity involves recognising that providing people with equal levels of support and opportunity is not sufficient to achieve equality, as everyone starts from a different position and has different circumstances. To achieve equality, you need equity, where support and opportunity are provided based on personal requirements. This is a concept we embrace at Arrotek, but we wanted to get the first-hand experiences of some of our female employees. We talked to three to get their views on this year’s International Women's Day theme, Embrace Equity. Deirdre Caheny,...
Getting a new medical device product approved by regulators is complex and often challenging. What do the statistics tell us about the approval process for a new medical device? What can we learn, and how can you ensure your path to regulatory approval is as smooth as possible? The following five statistics about the medical device regulatory approval process are not only informative, but also highlight the importance of getting expert support as early as possible. 1. The Average Time it Takes to Get an FDA 510(k) Decision is 5 Months The most common regulatory pathway in the US is...
Medical device regulations are complex. They are also regularly updated and refined. So, rather than being a fixed set of rules, they constantly evolve. Therefore, it’s essential to have access to medical device regulatory experience and expertise during the application process. Third-party regulatory support can be beneficial for companies of any size, but it is particularly helpful in organisations that have a limited level of in-house regulatory expertise. What Support Can a Medical Device Regulatory Consultant Provide? An experienced regulatory consultant can support all aspects of bringing a new medical device product to market. This includes regulatory compliance consultancy as...
Medical device company SmartWise Sweden AB selected Arrotek as its design partner for the development of a novel endovascular injection catheter. It is an ongoing project, but this case study outlines the work we have done with the SmartWise team to date, developing the product, optimising the design, and providing support as it achieved FDA regulatory approval. You can download and read the SmartWise case study here. Arrotek specialises in the development of catheters and other minimally invasive medical devices. We work with start-up companies, medical professionals, SMEs, and international corporations, providing medical device design, regulatory, and manufacturing support. If...
Arrotek has been named as one of two finalists for the MedTech Company of the Year Award at the Irish MedTech Awards 2022. The Irish MedTech Awards are run by the Irish MedTech Association, Enterprise Ireland, and IDA Ireland. The MedTech Company of the Year Award is one of nine awards that will be announced at the MedTech Awards Ceremony in Galway at the start of December. The other finalist in the MedTech Company of the Year category is Cerenovus Galway. Richard McLoughlin, Sales and Marketing Manager at Arrotek said: “Being announced as a MedTech company of the year finalist...
Arrotek Medical has opened a new office in Massachusetts, USA. The office is part of our strategic growth plans and will enhance the service we offer to our growing client base in the US and Canada. Richard McLoughlin, Sales and Marketing Manager at Arrotek, said: “The United States has been an important market for us for many years now. It is a region where there are exciting new innovations being developed, including in the areas of minimally invasive medical devices, advanced catheter technologies, guidewires, and specialty needle devices. We are proud of the ground-breaking work we do with large companies,...
We regularly publish blogs, case studies, and other articles on our Knowledge Hub covering various catheter and medical device design topics. Here is a collection of the top blogs of 2021. Catheter Design and Development – Key Considerations to Get Your Product to Market In this blog, Arrotek's Richard McLoughlin explains the key considerations when designing and developing a new catheter device. This includes everything from the intended use of the catheter to performance considerations to the makeup of the various layers in a reinforced catheter. Read Now An Overview of Steerable and Deflectable Catheter Design Steerable and deflectable catheters...
Arrotek strives towards a greener future, and we fully support the move towards environmental sustainability. Work is currently underway to install electric car charging facilities outside of our premises in Finisklin Business Park in Sligo. More of our staff are investing in electric vehicles and this charging point will give them a convenient and hassle-free way to fuel up whilst also being kind to the environment. We are delighted to be able to offer this electric car charging point to our staff and customers.
Arrotek has made a donation to UNICEF’s Get a Vaccine, Give a Vaccine campaign to help the organisation in its efforts to deliver Covid-19 vaccines to the world's most vulnerable people. UNICEF's goal is to help vaccinate two billion people across the globe, with a focus on health workers, vulnerable families, and other high-risk groups. It is doing this because scientists and health professionals believe nobody is safe from Covid-19 until everyone is safe. The money donated to UNICEF will help to buy, transport, and administer Covid-19 vaccinations. Richard Loughlin from Arrotek said: “We are proud to support this...
All medical device design and development projects require effective project management from the start. Watch our video to find out more about our approach to project management here at Arrotek. https://youtu.be/s-ZPad8cAOY
