The design of the packaging for your medical device product is often as important as the design of the medical device. Packaging is critical for compliance, quality, and patient safety, and it can be a key factor in the commercial success of the product. In a previous blog, we gave an overview of sterile barrier medical device packaging, including what it is, the key characteristics, and when packaging should be considered in the product development process. The answer to that last question is as early as possible, i.e., packaging should be part of design direction and decision-making processes from the...
At Arrotek, we continuously work to improve how we operate to enhance the quality of the services that we offer. This includes using Lean Manufacturing methodologies to optimise production processes for our manufacturing customers, but we take a similar approach to other parts of our business, including medical device product design. Specifically, we use Lean Six Sigma to optimise and continuously improve our design and development processes. Lean Six Sigma uses the principles, methods, and tools of Lean Manufacturing and Six Sigma to: Improve business operations Streamline product development processes Optimise product quality Lean Six Sigma combines the Lean concept...
Packaging is often one of the last things that is thought about in a medical device product development project. The reality is it takes time to properly design and test packaging for medical device products, especially sterile barrier medical device packaging. Furthermore, the importance of packaging to the success of your product, not to mention product quality and safety, should not be underestimated. In this blog, we’ll provide an overview of sterile barrier medical device packaging design, including why it is so important and the main characteristics of this highly specialised type of product packaging. What is Sterile Barrier Medical...
1. Describe your job in one sentence? Meeting with customers, understanding their requirements from a technical point of view and translating that into a body of engineering work for the engineering team to assist with. 2. What is the best thing about being on the Arrotek Team? The work environment and team are always friendly and there is potential to progress professionally. 3. What is a fun fact about you? I’ve been to the cinema 33 times in 2023 so far!!
Arrotek won two awards at 2023's Life Science Industry Awards, including Life Sciences Company of the Year. We also took home the top prize of the night – the Overall Excellence in Life Sciences award! The awards ceremony for Ireland's Life Science Industry Awards took place in Dublin on Thursday 6 July. The event aims to recognise and celebrate the life science industry in Ireland and is open to medical device companies as well as pharmaceutical and biotechnology companies. Both indigenous Irish and global multinational companies are considered for the awards. Arrotek was up against five other shortlisted life sciences...
Arrotek's medical device manufacturing facility in Sligo, Ireland has been successfully inspected by the USA's Food and Drug Administration (FDA). The inspection was officially completed with no actions required. Catrina Hunter, interim Quality Manager at Arrotek, said: “We are delighted to receive an Establishment Inspection Report from the FDA’s Division of Establishment Support following our recent inspection. The successful inspection is another milestone for Arrotek as we continue with our growth strategy and optimising the services we deliver for our clients.” An FDA inspector attended Arrotek's facility in Sligo at the beginning of March 2023. The inspection was a routine...
Steerable catheters are used in a range of different applications, including cardiovascular, respiratory, gastrointestinal, and neurological procedures. One thing these types of procedures often have in common is the need to navigate complex vasculatures to reach the required treatment or diagnostic site. As a result, steerable catheters have transformed healthcare by improving minimally invasive procedures. Steerable catheters have also made more minimally invasive procedures possible. Furthermore, innovations in the field of steerable catheter devices continue. If you have an idea or development project for a new steerable catheter device, what are the main performance characteristics you need to be aware...
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...
