FDA Approval: Why You Need to Include Human Factors

What Hackers/Hustlers need to know:

SYNOPSIS: The US FDA expects medical device companies to incorporate human factors (usability) engineering in their development process. You should understand the FDA’s expectations early to avoid costly re-work late in development when it could delay your market launch. The last step in the process is to conduct human factors validation testing, and that is not the time to discover that users make errors with your device that could lead to patient harm. Beth will provide an overview of the medical device human factors process so you will know what is expected.

The Mission of this group is to facilitate a connection between the two core personas needed to create a successful technology startup: the Hacker and the Hustler. We recognize this probably won't happen the first night, so we are here to encourage those early stage conversations in a friendly social environment.

Agenda

6:30 - Food, drinks and socializing.

7:00 - 7:30: Guest Speaker - Beth Loring, Principal, Loring Human Factors, LLC

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Beth is a Certified Human Factors Professional with over 25 years of experience in product design and usability, having expertise in user requirements gathering, ethnography, ergonomics, user interface design, usability testing, and training.

Beth is experienced in the design and evaluation of a wide array of consumer products, software applications, web sites, mobile applications, and medical devices. For healthcare clients, Beth leads ethnographic studies in clinical settings, conducts formative and summative usability tests, and advises device manufacturers on the human factors engineering components of their FDA 510(k), PMA, and CE Mark submissions.

Before founding Loring Human Factors (https://www.loring-hf.com/), Beth led usability teams at Radius, Farm Design, Bentley University, and AIR. She is author of 31 papers and articles and contributor to four books. She is co-author with Joseph Dumas of Moderating Usability Tests: Principles and Practice for Interacting (Elsevier, 2008).

7:30 - 8:00: Cathy Yee presenting Happy World Movie Project ( http://happyworldmovieproject.com ), a social justice project.

8:00 - 8:30: Presenter 3 - Open

8:30 - 9:00 - Lightning Talks, Networking, and Cleanup

Call for Presenters

Do you have a startup idea, but don't know if it has legs? Are you an early stage startup looking to reach an interested audience? Don't worry if you don't have a fully formed idea. If you are passionate about an area, but don't quite know how to approach it, this is the perfect place to present, get feedback, and meet other people interested in the same idea! Please email jeff@g-teklabs.com with a brief summary of your topic.