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FEATURED SERVICE
Usability Testing
Human factors/usability testing of medical devices not only makes the product better by designing with the user as the focal point it is also an FDA requirement as part of the 510(k) or PMA submission.
If you are responsible for getting a medical device ready for market we have extensive experience in this area and have prepared a presentation to educate on how we can help your company and product. For further information or questions on our Usability Testing processes please contact Intersection-Inc.or direct contact Milt Halsted at 949-533-9352.
To create a premium service to help you meet your Usability and Usability Testing / cmc / IFU requirements, Intersection has put together the most experienced team of experts in California to address your needs. Our group is led by Dr. Joely Gardner, widely known in Human Factors & Usability Testing services (See link to her recent presentation on IFU Testing: http://www.thedesignacademy.com/#!joely-gardner-article/ip8). Dr. Gardner has a Certificate in Project Management and is a licensed psychologist and a Fellow and Diplomate in the American Board of Medical Psychotherapists & Psychodiagnosticians. She has performed extensive usability testing and voice of customer research projects for companies such as Mitchell Medical, ThermoFisher (Life Technologies), Quest Diagnostics Clinical Trials Division, and Cardinal Health. She is a part-time professor at California State University at Fullerton in the graduate-level certificate program in Customer Experience and User-Centered Design.
Joan Gregor, Founder / CEO, Intersection-Inc and The Design Academy
Business is Better When Connected Through Design is Joan’s passion for fueling innovation by translating business strategy into meaningful human-centered design experiences, products, and services with her design innovation consultancy, Intersection-Inc. and its education collaboratory, The Design Academy. She has helped organizations leverage the value of design by integrating it into their processes, solving business challenges, building internal capability and transforming culture through cross-functional collaboration and leadership coaching.
Her work includes the development of The Design Academy’s Human-Centered Design Essential Pathways Training, HCDiTM, Human-Centered design innovation framework, design assessments and brand language experience for organizations such as GE Healthcare, Jewish Family Services, the Port of San Diego, GE Oil and Gas, Bose, and CVS. Joan is the founder of the global Power of Collective ThoughtTM a global network which is key to solving today's complex, multi-dimensional issues. As an entrepreneur, she has practical experience in design resulting in several patents for a retail product line, including elements of business start-up from market to commercialization.
Joan’s expertise spans consumer/empathic research, user-centric ethnography, trend studies, design assessment, creative management & integration, and business design planning. As an entrepreneur, she has developed her own line of retail products which resulted in 5 patents and afforded her the opportunity to experience taking that business from a start-up through to the market launch of those products and subsequent product licensing. Having a diverse background in design and sales in corporate, non-profit and entrepreneurial environments has provided Joan with a strong passion and expertise for mentoring clients in optimizing the value of design for their business or project.
Joan Gregor is founding Board member and co-creator of the inaugural Design Forward Summit. Her goal at DFA is to position San Diego as a global design innovation hub though mentoring of individuals, teams, and leaders as to Why human-centered design matters and the actual translation of design thinking into meaningful, tangible and measurable results. She is also on the advisory board for Blue Ribbon worldwide.
Through her multinational clients & sense of adventure, she has traveled extensively and sailed in the South Pacific, gaining cultural insights, knowledge, and empathy.