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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...

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....

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...

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...

Our new video explains how to use the free Arrotek calculator tool to estimate the design and development costs that will be involved to turn your idea for a medical device into a new product. It only takes a few minutes to complete, and you don't need to provide any commercially sensitive information. Watch the video to find out more. https://youtu.be/ioNb61FfTec

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...

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...