The process for bringing your idea for a new medical device from the concept stage through to commercialisation is known as a New Product Introduction, or NPI. The exact steps required will depend on the device you plan to develop. As each marketplace has varying regulatory requirements, where you plan to launch will also influence the NPI process. That said, a good place to start to get an overview of a typical NPI process is guidance provided by the Food and Drug Administration (FDA) in the US on how to bring a novel medical device to market. This guidance describes...
Intellectual property (IP) is a high priority consideration when designing a new medical device. If you are outsourcing all or part of the development to a third-party contractor, it's even more important to take steps to ensure your IP is protected. There are many reasons for this, but one of the most important is that third-party contractors are treated differently to employees of your organisation. In most jurisdictions, your organisation owns the IP of any work that an employee does. This doesn't apply to work done by a third-party contractor, however. Therefore, it is absolutely critical that IP issues are...
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...
Effective catheter design and development are essential to successfully bring your idea for a new device to market. From the earliest stages of concept development through to scaled-up manufacturing, it is a complex process with a range of considerations and potential challenges that can impact success. However, with the right approach and expertise, there are also opportunities in a range of areas, from getting the design right early in the process to minimising manufacturing costs to getting your product to market in the shortest possible timeframe. Headline Considerations The intended use of your new catheter device – it is important...
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
The treatment of coronary heart disease has advanced rapidly over recent decades. For example, in patients deemed unsuitable for cardiac surgery, the introduction of percutaneous procedures significantly reduced mortality rates. Further advances in minimally invasive approaches have improved patient outcomes even further. This includes high-risk percutaneous coronary interventions (PCI), where interventional cardiologists treat extreme cases. Mechanical circulatory support is a crucial component of many high-risk PCI procedures to maintain blood flow. This is an evolving area of cardiac treatments. The success of these treatments is often dependent on vascular access and closure. However, in many situations, vascular access and closure...
Arrotek has won an award at the 2021 Healthcare & Pharmaceutical Awards: Best Medical Device Design & Development Specialists - ROI. The Healthcare & Pharmaceutical Awards are run by Global Health & Pharma. The annual awards highlight innovation and outstanding levels of performance. Richard McLoughlin from Arrotek, said: “We are thrilled to have won this award, it is testament to the amazing team we have inhouse in our facility in Ireland. At Arrotek, we continuously strive to deliver on client expectations while also pushing the boundaries of minimally invasive medical device design. “Every member of the Arrotek team is committed...
Sligo is the base of our operations here at Arrotek. We moved into a new purpose-built facility in 2019 following a significant investment, and we are part of a strong and growing medical device industry in Ireland’s northwest. Why Sligo, though? What is Sligo like, and what does it have to offer? These are questions we are regularly asked by clients from Europe and elsewhere in the world. Ideally, we’d like to bring you here so you can see first-hand what is on offer not just in Arrotek’s state-of-the-art facility, but in the region more generally. As a taster, however,...
In a previous blog, we gave an overview of human factors engineering and how it relates to medical device product design. It is primarily about anticipating potential user errors and making adjustments to the product’s design to reduce the risk of those errors from occurring. The primary objective is to improve safety, but human factors engineering also offers commercial and user experience benefits. The company you appoint to design and develop your new medical device product will look after the specifics of human factors engineering. That said, it is a process that impacts everything from the packaging and instructions to...
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...
