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,...
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...
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...
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...
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 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 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...
Stent delivery systems, particularly those that involve balloon catheters, have been used in a range of different medical procedures for many years. This doesn’t mean innovation in this area of medical device design has stopped. Quite the opposite, in fact, as new and highly innovative solutions continue to be developed. This includes stent delivery systems capable of delivering stents to the body’s most difficult-to-reach locations, including the brain. New innovations are also improving the performance of stent delivery systems in existing applications, while new technologies like robotics continue to push boundaries. When going through a stent delivery system design process,...
Occlusion balloon catheters are widely used for a range of medical procedures and treatments, from emergency haemorrhage control or the treatment of neurovascular aneurysms, to temporarily stopping the flow of blood during heart surgery. Despite the varied applications that currently exist, there continues to be new innovations in occlusion balloon catheter design. Those innovations are improving the treatment of patients, including in highly complex surgeries where the catheter must reach parts of the body through tortuous vasculatures. When going through an occlusion balloon catheter design and development process, there are several important factors to consider. Balloon Inflation and Deflation The...
The world of medical device design and regulations has a lot of abbreviations. We are going to focus on another of them in this blog – DMR. It stands for Device Master Record, but what is a DMR, why do you need one, what is included, and why is it important? What is a Device Master Record? A DMR is a file that contains everything that is needed to manufacture your medical device. It is a centralised record, so you don’t need a binder with all the documents included. Instead, the relevant documents can be referenced. You don’t need a...
