News from Arrotek

Guidewires are an essential component of many minimally invasive medical devices, including many advanced catheter products. There are multiple types of guidewires available, with different technologies, materials, designs, and performance characteristics. In this blog, we’ll look at the essential design features that should be considered when looking at guidewires for your product. Guidewires are designed to navigate often tortuous vasculatures to reach target treatment or diagnostic sites within the body. They are also used in the placement of interventional devices, and they enable the placement of catheter devices while also helping to stabilise and precisely position catheters at the target...

The medical device industry is predicted to achieve an annual growth rate of 5.6 percent over the coming years, bringing total revenues from USD $443 billion in 2022 to almost USD $585 billion in 2027. Innovations in product design will be a key factor in achieving this predicted growth, as will corporate M&A and investment strategies. However, there are pressing challenges faced by companies across the industry. Those challenges have the potential to limit innovation and increase time to market for new products, two issues that are continuous focus areas for large medical device companies. There is also the risk...

Overmoulding is a production technique used in the manufacture of medical devices. While it is a well-established technique, it has never been more important both in terms of manufacturing and the design of new medical device products. With advanced overmoulding manufacturing methods, medical device product designers can push the boundaries of innovation to enhance existing products and create novel medical devices. This includes minimally invasive medical devices and, specifically, advanced catheter technologies. What is Overmoulding Overmoulding is an advanced form of injection moulding for specialist applications, making it an ideal solution in the medical device industry. It involves the full...

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...

With the development of new products, innovations, and technologies, analysts are predicting healthy growth in the medical device industry over the coming years. What are the main trends in MedTech as we go into 2023? More specifically, what are the trends in minimally invasive medical device design? Prioritising Ease of Use, Clinical Outcomes, and Patient Satisfaction We all live in a world of rapid innovation, where technology influences multiple aspects of our lives. It isn't just any technology, either, as we are all now very accustomed to technologies that are easy to use, highly functional, and that deliver beyond expectations....

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...

Running a start-up medical device company is an exciting but often very busy time with so many things to do and decisions to make. It’s not surprising that much of your focus is on the here and now, i.e., what you need to do to move your company, project, and product to the next stage. Despite this, it remains important to also have a long-term view to ensure you maximise the future value of your company. For example, you might have a particular exit strategy in mind for your company. The decisions you make today and the actions you take...