Manufacturers can rely upon internal human factors engineers and/or external consultants to apply HFE effectively during device development.
Why you can’t afford to overlook this important part of product development.
The unpredictability of the process can make it difficult to stay on track throughout every phase.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
Don’t ignore the changing medtech landscape; it will continue to affect product design and manufacturing. A discussion with Kenneth Fine about design challenges.
Developing next-generation technology for medical devices is only half the battle when it comes to being first to market in today’s fast-paced global environment.
From contacts and sealing, to cable assembly requirements and miniaturization, here’s a step-by-step guide for engineers to help them ask the right questions as they determine connectors they will be need for their devices.
Micro molding is has been debated over last number of years, and while size certainly plays a part in defining what it is, other aspects like precision, complexity and details involved are more the drivers for micromolding techniques.
When developing highly complex medical devices, the mountain of “interesting” ideas that result from traditional brainstorming all too often buckles under technical scrutiny. A more efficient and effective way to generate and refine ideas that are technically viable is needed.