Knowledge Hub

How Arrotek Adds Value to Your Medical Device Start-Up Company

by Ronan Scott
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...

Three-Phase Design Transfer Process to Prepare a Design for Manufacturing

by Gearoid Kerins
Design transfer is a phrase that describes the activities and processes that introduce a medical device design to production. Effective design transfer is required by regulators but it also keeps manufacturing costs under control and ensures production milestones and deadlines are met. Furthermore, effective design transfer can reduce time to market and improve product quality. What is involved in the design transfer process and what are the requirements? At Arrotek, we have a Three-Phase Design Transfer process to prepare a design for commercial manufacturing. The final phase involves a comprehensive checklist that is important for the process itself as well as...

Tailored Support for Your Medical Device Start-Up Company

by Richard McLoughlin
There is a problem in the medical device industry and as a start-up company, it will be a problem that you may already be familiar with. You need support for your project, whether you are at the concept and prototyping stage or are further along on the research and development journey. However, all too often, the support that is available comes with a big price tag. You also have to make big commitments while putting up with the fact the support you get is not tailored to your specific needs. There must be a better way. There is a better...

Arrotek’s Modular Approach to Medical Device Design and Development Services

by Deirdre Caheny
Our modular approach to the delivery of medical device design and development services means we can help with whatever level of support you need, whatever expertise you need, and wherever you are in the development process. While there are similarities across all medical device design and development projects, our experience at Arrotek is that every project is different. As a result, we have experience in everything from providing consultancy services to handling a single element of a larger project to providing full end-to-end services from ideation to commercialisation. With our modular approach, we can slot in wherever you need us,...

Bottlenecks, Timelines, and Complexity: Overcoming EU MDR Challenges

by Gearoid Kerins
It is now over a year since the new EU Medical Device Regulation (MDR) came into effect. Whether you are an early-stage start-up, a company further advanced in your start-up journey, or an established medical device company, what are the current realities of EU MDR compliance? The fact is, there are challenges that will impact just about every medical device company operating or planning to operate in the EU. Before we get into those challenges, though, a quick recap of where we are. Fast-Approaching Deadlines All new medical devices seeking approval for the European market must now go through the...

Interventional Guidewires – Important Design Considerations

by Ronan Scott
Without interventional guidewires, many minimally invasive medical procedures that are common today simply wouldn’t be possible. They are an essential component of many interventional, therapeutic, and diagnostic devices, including catheters, and they have become increasingly sophisticated and innovative. Excitingly, however, we haven’t yet reached the innovation peak of interventional guidewires. Cutting-edge technologies, new ways of using materials, and intelligent design concepts are continually being developed, pushing the boundaries of what is possible. If you have an idea for a new medical device, what are the design considerations that you need to be aware of for the interventional guidewire component? Here’s...

Interventional Guidewires Design – An Overview

by Ronan Scott
Since their introduction in the early 1980s, interventional guidewires have transformed medical procedures beyond recognition. This, in turn, has transformed patient outcomes, highlighting the importance of innovative interventional guidewire design. Those first devices were basic compared to today's sophisticated interventional guidewires, but they were pioneering. That said, technologies and innovations in the field of interventional guidewires continue to advance at an exciting and rapid pace. As a result, outcomes for patients continue to improve, more advanced procedures are becoming possible, procedure times are being reduced, and the risks associated with complex medical interventions are continually being mitigated. The Importance of...

Introduction to Usability Engineering in Medical Device Design and What it Means for Your Product

by Ronan Scott
Usability engineering is a common concept in many areas of product design, but its importance is elevated in medical device product design because of issues of safety and effectiveness. In fact, the importance of usability engineering is increasing as medical devices become more complex and smarter. Medical devices are also being used in a growing number of situations and to treat an ever-widening range of conditions. Microcatheter technologies are a good example, given the advances that are being made in neurovascular microcatheters. What is usability engineering in medical device design, and what does it mean for your design project or...

Catheter Shaft Design Considerations to Optimise Device Performance

by Patrick McGowan
Catheter shafts are a core component of medical devices designed for minimally invasive procedures. The main objective when designing a catheter shaft is to get the right balance of performance between the various functional requirements of the device. For example, getting the right balance of torque control, pushability, kink resistance, flexibility, compression resistance, etc. During the development process, engineers work through various design considerations to achieve the right performance balance and ensure the device is suitable for the application it is being designed for. Braid and Coil Reinforcement of Catheter Shafts Polymers are a crucial part of a catheter’s shaft,...

Neurovascular Microcatheter Design Overview

by Richard McLoughlin
Neurovascular microcatheters have transformed the treatment of patients around the world. They enable minimally invasive treatments in a challenging part of the body, so have significantly advanced healthcare in this field. The range of neurovascular conditions that microcatheters are used to treat includes cerebral aneurysms, ischemic stroke, and other conditions that affect the vessels that supply blood to the brain and spine. While there have been significant advances in the design and development of neurovascular microcatheters, there is a constant strive to push the boundaries of innovation, particularly in relation to the miniaturisation of catheter devices and components. Further advances...