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Design for assembly, or DFA, means designing a new medical device product so it can be assembled as easily as possible. It is a crucial part of the design process, particularly as the product moves to the pilot manufacturing, full manufacturing, and commercialization stages. DFA is a process that applies to medical device products with … What is DFA – Design for Assembly – in Medical Device Design?

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 … An Overview of Multi-Lumen Catheter Design

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 … An Overview of Steerable and Deflectable Catheter Design

If you have an idea for a new medical device and want to sell that product in the US, you will need approval from the Food and Drug Administration (FDA). Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. What is a 510(k) submission? What types of devices … What is an FDA 510(k) Submission

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 … Top Tips to Ensure a Successful Medical Device Design Process

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

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

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 … Getting Started with Your Idea for a Medical Device

You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors. Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and … How Design Changes Impact Medical Device Product Development Costs and Time to Market