Documentation is an essential part of designing a new medical device, getting regulatory approval, and then maintaining compliance while the product is on the market. A crucial part of that documentation is the Design History File (DHF). There is a lot involved in creating and maintaining a DHF file. This blog provides an overview of the essential elements you need to know if you are about to begin, or are in the early stages of, designing a new medical device. What is a DHF? A DHF is a file of documents that outlines the design and development history of your...
Multi-lumen catheters are used for several different applications, including highly complicated procedures. They can also be designed with a wide range of performance characteristics. Furthermore, advances in the design of catheter devices are opening up new opportunities and making it possible to create new multi-lumen catheter products that will improve the treatment and diagnosis of patients with various complex conditions. In simple terms, a multi-lumen catheter is a single catheter with multiple internal channels or lumens. As it is a single catheter, there is only one entry point. However, the multi-lumen design allows more than one activity to take place...
According to the EU MDR (European Union Medical Device Regulations), medical device manufacturers must, in some circumstances, appoint a European Authorised Representative in order to obtain CE certification for their products so they can be sold in Europe. What is a European Authorised Representative, though? According to the definition in EU regulations, an Authorised Person must be a "natural or legal person" in the EU. The main role of an Authorised Representative is to represent the manufacturer in dealings with EU regulators. If you are a European-based medical device manufacturer, you will deal directly with regulators. There is no need...
The steerable and deflectable catheter design process helps produce some of the most advanced minimally invasive medical devices currently in use. This includes both diagnostic and therapeutic catheter devices. Furthermore, technology advances mean it is now possible to design advanced catheter technologies that are more complex than ever before. Steerable and deflectable catheters are designed to navigate through complex and tortuous vasculatures. This could be, for example, for use in cardiovascular, neurovascular, or peripheral vasculature procedures. The process of designing steerable and deflectable catheters involves using various technologies and materials, as well as taking into account the performance characteristics required...
At Arrotek, we have significant experience in catheter design, particularly in the development of advanced catheter technologies. This includes atraumatic catheters with ultra-thin walls as low as 0.1mm (0.004"). The projects we regularly work on involve the development of catheters with intended usage applications that require the ability to navigate small and complex vasculatures to access difficult to reach parts of the body, such as in high-risk neuro and coronary interventions. We also have experience in the design of large-bore catheters, including multi-functional devices, that deliver high levels of performance. Examples include catheters designed for the delivery of innovative therapies...
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...
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...
