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6 Things to Know About Human Factors Engineering of Medical Devices
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 in regulating human factors engineering in medical devices in order to reduce the risk of injury to the user and the patient. The goal is to identify any errors that can result in serious harm before they happen and reduce or eliminate them. What is human factors engineering? The FDA defines human factors engineering as:"The application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users ... Read More
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FDA Medical Device Regulatory Controls Explained
Part of the Medical Device Regulation Act involved establishing specific regulatory controls for each of the three classes of medical devices. The higher the class of device, the more risk ... Read More
How the FDA Classifies Medical Devices
In 1971 a new IUD called the Dalken Shield entered the market and was implanted in almost 3 million women in the United States. Over the next few years, the ... Read More
3 Things to Know About Design for Manufacturing (DFM)
DFM stands for design for manufacturing and is a part of the product development process initiated when your design shifts from prototype development to new product introduction. When done correctly, it can lower ... Read More
How to Make a Prototype in 4 Easy Steps
Once you have identified your product specification and brainstormed concepts for how your idea aligns with those product specifications, it is time to make a prototype. Prototypes are a great way to showcase your ... Read More
4 Tips to Improve Your Pilot Production Build
The Pilot Production Phase is the beginning of the end of product development. Pilot Production is just a step away from contract manufacturing and is used at the end of ... Read More
9 Prototype Testing Methods to Prove Your Invention Works
Prototype testing provides a cost-effective method for ensuring products meet user requirements and regulations. Simple proof of concept tests can predict future design problems and determine if further development is ... Read More
4 Brainstorming Techniques That Generate Successful Ideas
Brainstorming can be a fun exercise to solve a particular problem or expand on an idea. As an inventor, you probably already have an idea of where you would like ... Read More
Webinar: Are You Ready For Manufacturing?
No matter what your product is, the end goal is to make it to production. Make sure your product is ready by watching this free webinar. Synectic President Adam Lehman ... Read More
