News from Arrotek

An Introduction to Human Factors Engineering in Medical Device Design

by Mark Pugh
In product design, designing a product that works on the engineer’s bench or desk is not enough. You also have to consider real-world factors, such as who will be using the product, their level of expertise or knowledge, and the situation or environment where the product will be used. In medical device product design, it is also essential to consider safety. The collective term for these considerations is human factors engineering. Human factors engineering is part of the design and development process for new medical devices, and it is an important regulatory requirement. It is also known as usability engineering...

Workplace Wellbeing at Arrotek: The Right to Disconnect

by Arrotek Medical Ltd
Last month, the Government published its Code of Practice on the Right to Disconnect.  At Arrotek, this code of practice is something we fully support. Throughout our 16 years in business, we have recognised the importance of relaxation and rest during personal time for all members of the Arrotek team. Today, all employees are encouraged to finish work on time and to switch off and disconnect from work at weekends and when on annual leave. Tracey Kelly, HR Manager at Arrotek, said: “We follow the ethos here at Arrotek that when you are off, you are off! This approach is...

Sligo MedTech Companies Sponsor Irish Olympic Hopeful John Travers

by Arrotek Medical Ltd
Sligo medical device companies Arrotek Medical, Ward Automation, and Verus Metrology have come together to provide sponsorship for Irish middle-distance runner, John Travers. John aims to make it onto the Irish Olympic team to compete in the 5,000 metres long-distance track event in Japan in July/August. John said: "It is absolutely brilliant getting this support. I work full-time so it was hard to put my full focus on running. I've now given up work to concentrate on getting to the Olympics and this financial support has completely taken away the stress. I can now get into the qualifying races that...

What is an FDA 510(k) Submission

by Fidelma Conway
If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices need to go through this regulatory pathway? How do you prepare your submission? What happens after you make your 510k submission? Below is an introduction to FDA 510(k) submissions. What is a 510(k) Submission? A 510(k) submission is a pre-market notification that you must submit...

Arrotek Team Covers Over 3,360km in March Fitness Initiative

by Arrotek Medical Ltd
At Arrotek, we ran another virtual Sports and Social Club event during March to promote Spring fitness. We split up into four teams to compete in a challenge to see who could walk, run, and cycle the furthest. Team Carrowmore came out on top covering 931km during the month. Congratulations to them and everyone who took part. Results: Team Carrowmore - 931km Team Knocknarea - 857km Team Benbulben - 802km Team Lissadell House - 771km  

Top Tips to Ensure a Successful Medical Device Design Process

by Ronan Scott
You will probably work with a design partner to develop your idea for a new medical device. They will handle the design process, bringing the concept through to the initial prototype and then final prototype stage, ready for you to move to the next stage of your business plan. There are things that you can do to facilitate the design process as well as to ensure the developed product meets your goals and objectives. The following tips are a good place to start. Focus on Designing a Product One of the mistakes that is sometimes made when designing new medical...

Virtual Eat Well, Feel Well Workshop at Arrotek

by Arrotek
Employees in Arrotek have taken part in an Eat Well, Feel Well workshop. It was presented by nutritionist Aoife Clancy. Aoife is the performance nutritionist with Sligo GAA's Senior football and hurling teams. She also runs a nutrition clinic. The aim of the virtual workshop was to discuss a balanced approach to a healthy lifestyle, nutrition, and the immune system. Aoife also talked about the link between food and mood, gut health, and snacking at work. Tracey Kelly, HR Manager at Arrotek said: "We have a sports and social club which is normally very active. It has been more difficult...

Medical Device Design Verification – What You Need to Know

by Arrotek Medical Ltd
Design verification is an important part of the medical device design and development process. It is an element that will be largely looked after by your medical device design partner. However, given it’s important to the overall process, it helps considerably if you have an overview of medical device design verification, why it’s important, and the key steps involved. Medical device design verification ensures design outputs meet the design input requirements. In other words, it is a process that ensures the new medical device is designed correctly. Design verification is required by regulators when they evaluate new medical device products....

3 Essential Tips for Creating a Product Requirement Specification for a New Medical Device Idea

by Ronan Scott
A product requirement specification outlines what needs to be achieved during the medical device design process. It is an important step in the process as it ensures design engineers fully understand what is required so they can deliver the best possible product. A good product requirement specification also makes the design process more efficient, and it ensures the development of a better-quality product. Furthermore, your product requirement specification will make it easier to ensure compliance, and it helps with progressing your product through the regulatory approval process. Your medical device design and development partner will guide the process of creating...