podcast_research-collective_2 guests

The relationship between human factors and design controls often creates confusion in the medical device industry.

Today’s guests are Russ Branaghan and Bryant Foster from Research Collective, a human factors and user experience consultancy. In this episode they discuss how to integrate human factors into design controls to reduce risk and improve patient outcomes.

 

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Some of the highlights of the show include:

  • Research Collective helps design medical devices that are easy to learn and efficient to use to reduce risk and improve patient outcomes.
  • Product development involves experts and scientific knowledge about how people work, make decisions, and learn to reduce risk.
  • Human factors is defined as area that applies all human sciences to design of products and processes.
  • Usability consists of four components: easy to learn, efficient to use, memorability, and subjective satisfaction.
  • Human factors (above the neck) and ergonomics (below the neck) are one and the same, but have slightly different connotations.
  • Best practices for human factors include understanding, testing, and evaluating user needs, capabilities, and limitations.
  • Class II and III (some Class I) products require usability testing that includes observation. Design input should be objective and measurable.
  • Victory Lap: Validation usability study should represent culmination of work completed to make sure people can use the product.

 

Links:

Research Collective

Research Collective's Blog

Bryant Foster’s Email

Regulatory Affairs Professionals Society (RAPS)

Jakob Nielsen

Ultimate Guide to Design Controls for Medical Device Companies

Human Factors and Medical Devices (FDA Guidance)

IEC 62366

1-10-100-Rule

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow 2019

Greenlight Guru

 

Quotes:

“We’re particularly interested in designing medical devices that are easy to learn and efficient to use to reduce use error...leads to better patient outcomes.” Russ Branaghan

“To be serious about reducing risk, then we need to know some of the scientific knowledge...about how people work, how they make decisions, how they learn.” Russ Branaghan 

“If we can integrate that into our design, then we’re doing a good job. Good intentions aren’t enough.” Russ Branaghan

“If you’re designing a product just because you’re trying to satisfy a regulation, you’ve kind of missed the point. Factor those humans into this equation.” Jon Speer


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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.