White Papers

Regardless of what type of medical device you develop, the FDA requires you to follow a regulated process. Each step of the medical device design process lays the foundation for ... Read More

Table of Contents After settling on a winning concept, prototype development is the next step in product development. In this phase, you will transform your drawings and CAD models into ... Read More

Concept development is the part of the product development process where you will generate, evaluate, and refine your abstract ideas, turning them into a well-defined, practical, and actionable product design ... Read More

DFM stands for Design for Manufacturing or Design for Manufacturability and is also sometimes referred to as DFMA, where the A represents Assembly. This manufacturing process occurs during the product ... Read More

Human factors engineering is a complex and multi-disciplinary area of risk management. It involves knowledge integration from various scientific fields, including psychology and engineering. The FDA plays a key role ... Read More

Verification and validation are design controls required by the FDA to ensure the medical devices you manufacture are safe, effective, and fit the intended use. Often, they happen in combination, ... Read More

The challenge The medical device market is historically fueled by innovation. The robotic surgical space is an area with a lot of device development and has many players competing at ... Read More

3D printing is a prototyping method that "prints" a three-dimensional physical object in layers from a digital file. Compared to traditional prototyping methods, 3D printing is fast and low-cost. While ... Read More