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...
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...
