Knowledge Hub

The Importance of Effective Project Management for Medical Device Design Projects

by Ronan Scott
Medical device design projects require a broad range of expertise as well as established processes and procedures. The project management function and the project manager are central to ensuring medical device design projects run smoothly. Of course, effective project management plays a crucial role in the product design process in other industries too. However, because of regulatory considerations, safety issues, and the complexity of many modern medical device products, project management is even more important in the medical device industry. The Path to Successful Medical Device Product Launches The overall objective of a medical device design project is to bring...

Step-By-Step Guide for Estimating the Cost of Developing Your New Medical Device Idea

by Ronan Scott
There are costs involved in designing and developing the idea you have for a medical device. Those costs can vary, however, depending on a range of factors. This includes the complexity of the device and the intended use. Understanding the costs of designing and developing your idea for a medical device is an important part of the business planning process. For example, it will help you understand the level of funding that you require, it can influence the timeline for the project, and it will start to build a picture of the commercial viability of the product. The Stages Involved...

Video: Learn More About Our Six-Step Medical Device Design & Development Process

by Arrotek Medical Ltd
We use a well-established six-step process here at Arrotek to design and develop new medical device products. The process takes new product ideas from the concept stage through to final prototype production, ready for testing and evaluation. The six steps are: Requirements Concept generation Concept development Stage-1 prototype Concept refinement Stage-2 prototype Watch our video to find out more.

You Have an Idea for a Medical Device – Find Out How Much It Will Cost to Design and Develop

by Arrotek Medical Ltd
One of the most important questions to find the answer to if you have an idea for a new medical device is how much it will cost to design and develop, i.e., how much it will cost to turn the idea into a working, manufacturable product that is ready to go to the next stage. One of the challenges of getting this information is that there are a lot of variables. However, at Arrotek, we have used our extensive experience in the industry to develop a calculator that will give you an estimate of the costs involved to design your...

The UDI Requirements of the New EU MDR – What You Need to Know

by Fidelma Conway
The new EU MDR (Medical Device Regulation) changes several aspects of obtaining and then maintaining regulatory approval for medical devices. One of the major changes is the introduction of an identification system, or UDI, for medical devices approved for use in the EU. While the implementation of the new EU MDR has been delayed because of COVID-19, everyone in the industry is impacted by this change in UDI requirements. This includes those with products that have been on the market for years, to companies and start-ups developing new medical devices that have yet to go through the approval process. Introduction...

Using Coil Reinforced Polymer Tubes with Ultra-Thin Walls to Develop Advanced Catheter Technologies

by Ger O'Carroll
Coil reinforced polymer tubes have enabled the development of a wide range of minimally invasive medical devices, including catheter solutions. The coil reinforcement increases the flexibility of the device inside the body, preventing the tube from kinking or collapsing. These kink-resistant capabilities make it possible for catheters to access difficult to reach parts of the body. As a result, many coil reinforced catheter solutions have been developed and are currently being used for both diagnostic and therapeutic purposes. Just because there are effective coil reinforced catheter solutions in use doesn't mean the medical device industry can declare mission accomplished, with...

Getting Started with Your Idea for a Medical Device

by Mark Pugh
You have an idea for a new medical device. What do you do now? What are the next steps you should take? Each medical device development project is different, but there are common steps regarded as best practices in the industry. You might have already gone through some of the points below, but this will give an overview of the first stages of the medical device design and development process. Ideation As you already have an idea for a new medical device, you are likely to be part of the way through this stage. It’s helpful to review what ideation...

How Much Will It Cost to Commercialise Your Idea for a New Medical Device?

by Arrotek Medical Ltd
Do you have an idea for a new medical device and want to know how much it will cost to get it from where you are now to the point that it is regulatory approved and ready for commercialisation? Do you also want to know the steps involved and the timescale that is likely to apply? At Arrotek, we have extensive experience designing and developing new, innovative, and cutting-edge medical devices, particularly minimally invasive medical devices. Therefore, we are asked the above questions a lot. So, we decided to make getting the answers as easy as possible. Introducing Our Medical...