AAMI Uses Brain Science to Help Manufacturers Understand Standards

Even after the U.S. FDA's adoption of ISO 13485 into its Quality Management System Regulation (QMSR), misconceptions about it and other standards documents remain.

The Association for the Advancement of Medical Instrumentation (AAMI) seeks to remedy misconceptions about documents like ISO 13485 and ISO 14971 with new AAMI trainings on each standard.  

AAMI has joined with the Amplifire Healthcare Alliance to develop custom medical device and health technology courses for medical device manufacturers, independent service organizations, and healthcare delivery organizations.

The Amplifire platform was developed by neuroscientists and cognitive experts from Harvard and four other academic institutions. It uses memory “triggers” to promote rapid learning and long-term retention.

According to AAMI’s Chief Learning and Development Officer Robert Burroughs, “I’ve been focused on organizational effectiveness for decades and this is the first time I’ve felt we have the power to really do something radically different and better than we could before the advent of online learning. This isn’t just about using online learning to drive down the cost curve or facilitate distribution, it’s about leveraging science to do something we couldn’t even imagine doing 20 years ago—in the classroom or online.”

“AAMI is the de facto world leader driving the safe and effective use of healthcare devices,” Amplifire CEO Bob Burgin added. “Their standards are used worldwide in manufacturing, servicing, and healthcare delivery; their education programs set the bar for quality; and AAMI members, like members of our own Science Board, are thought leaders in their field.”

The Amplifire platform incorporates seven research-based “triggers”:

1. Adaptivity provides each employee with exactly what they need when they need it.
2. Evaluating confidence keeps employees focused and improves their memory.
3. Delayed feedback to correct an error makes the correction more powerful.
4. Gamification keeps dopamine levels optimal so employees keep learning.
5. Priming by asking questions prepares the brain to learn—even if the material is brand new.
6. Retrieval of information from memory is the best way to strengthen knowledge.
7. Spacing between learning sessions makes the learning far more durable.

Amplifire can also identify and correct confidently held misinformation among users. The self-paced e-learning courses on ISO 14971 and ISO 13485 are designed to prevent misunderstandings of these standards.

The Amplifire platform is fully online and constantly updated. This means each training will align with the new regulatory and device updates. Its dashboard allows for monitoring of individual learning progress and identification of strengths and weaknesses.

Interested in purchasing the training and finding out what it can do for your organization? You can find out more and sign up here.