Shannon Clark

UserWise

Based in Palo Alto, California, Shannon is the Founder & CEO of UserWise, a firm consulting medical device start-ups and established companies on the user-centered development of home-use medical devices and IVDs, professional-use medical devices and IVDs, and combination products.

Shannon writes:
I am passionate about designing safe, usable, and effective medical devices.

General Skills and Experience:
–Human Factors project implementation
–Ensuring conformance to IEC 62366 and the new FDA guidance for HF
–Risk Management and Use Error Identification
–Contextual inquiry in hospital settings
–Task analysis for next-generation on-market products
–Design of formative and summative usability studies
–Planning and Documentation of human factors activities
–Creation of human factors procedures and guidelines

I launched UserWise, Inc. in March 2015 to broaden my reach of impact in spreading knowledge about human factors engineering. At UserWise, Inc., I help both start ups and established companies to learn about human factors and implement human factors projects.

At Intuitive Surgical, Inc., I implemented human factors engineering projects to ensure the safety and effectiveness of medical devices related to robotic surgery.

In 2012, I completed Abbott Laboratories’ Professional Development Program, in which I rotated to different divisions and positions within the company every 6 months. In this program, I fulfilled supervisory, R&D, Quality and Regulatory functions.

Prior to Abbott I held several internships in both Engineering and Marketing. I have also worked abroad in Madrid. In 2006, I researched, wrote, designed and published a 150-page history book about a district in San Jose, California. My second book, “Roses on Parade–A Santa Clara Valley Tradition,” was released on July 4, 2010 at the third annual Rose, White and Blue Parade in San Jose.

I graduated in March 2010 from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. I completed a Spanish minor, and I am proficient in Spanish and Latin.