Knowledge Hub

Top Tips to Ensure a Successful Medical Device Design Process

by Ronan Scott
You will probably work with a design partner to develop your idea for a new medical device. They will handle the design process, bringing the concept through to the initial prototype and then final prototype stage, ready for you to move to the next stage of your business plan. There are things that you can do to facilitate the design process as well as to ensure the developed product meets your goals and objectives. The following tips are a good place to start. Focus on Designing a Product One of the mistakes that is sometimes made when designing new medical...

Medical Device Design Verification – What You Need to Know

by Arrotek Medical Ltd
Design verification is an important part of the medical device design and development process. It is an element that will be largely looked after by your medical device design partner. However, given it’s important to the overall process, it helps considerably if you have an overview of medical device design verification, why it’s important, and the key steps involved. Medical device design verification ensures design outputs meet the design input requirements. In other words, it is a process that ensures the new medical device is designed correctly. Design verification is required by regulators when they evaluate new medical device products....

3 Essential Tips for Creating a Product Requirement Specification for a New Medical Device Idea

by Ronan Scott
A product requirement specification outlines what needs to be achieved during the medical device design process. It is an important step in the process as it ensures design engineers fully understand what is required so they can deliver the best possible product. A good product requirement specification also makes the design process more efficient, and it ensures the development of a better-quality product. Furthermore, your product requirement specification will make it easier to ensure compliance, and it helps with progressing your product through the regulatory approval process. Your medical device design and development partner will guide the process of creating...

Establishing the Product Requirement Specification for Your New Medical Device Idea

by Ronan Scott
A crucial part of the medical device design and development process is to create a product requirement specification. The creation of this document takes place in the very earliest stages of the process. In fact, in our Six-Step Medical Device Design Process at Arrotek, creating the product requirement specification is one of the primary objectives of Step 1. A product requirement specification clearly defines the purpose, functionality, features, and behaviour of your new medical device idea. Importantly, it focuses on what you want to achieve with the new product, but it doesn't look at how. Looking at how you deliver...

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...