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Lightning Workshop: Reducing Risk — How to Successfully Develop a Product with Effective User-Centered Design Techniques

Virginia Lang  (Chief Scientist, HirLan Inc.)

James Jackson  (Principal Industrial Designer & Technical Lead , Starfish Medical)

David Nalan  (Research Associate and Lab Operations Medical Device Human Factors, HirLan Inc.)

Aimee Pulley  (Director of Quality/ Regulatory and Legal Counsel Medical Device, Hirlan, Inc.)

Location: 210B

Date: Thursday, February 13

Time: 10:45 am - 12:15 pm

Vault Recording: TBD

Medical Devices that are designed from the beginning using user-centered design techniques can ensure that use risk is reduced as far as possible. This interactive workshop will illustrate and demonstrate various user-centered design and evaluation techniques that can be incorporated into the design of a medical device. This session will start from collection of user needs, design through and even discuss post launch activities. In addition, discussion will also touch on all FDA and MDR requirements for human factors testing. Topics covered include:

  • Solutions to reducing use risk design
  • Exploring user-centered design vs. human-centered design
  • Tackling regulatory requirements for human factors testing

*Participants are encouraged to bring their medical device design challenges and benefit from firsthand solutions.