Innovation / Design Strategy / Brand Experience
Innovation | Brand Design Language | Design Assessments | Process Improvement | Cultural Shifting |
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.
Michael Liedtke joins TDA/Intersection, bringing his knowledge about innovation at a global scale and complex program management to the group. Michael's expertise stems from experiences with dynamic, multi-national global brands, including BMW Group, Singapore Airlines, Airbus, Boeing, Mercedes and Embraer (perhaps add some Id companies to broaden the scope? Heildberg etc..). He is an engineer by training, having received an MS from the University of Karlsruhe in Germany and has worked for BMW Group, heading up the transportation design group at BMW Group DesignworksUSA in California for Chuck Pelly. While there he introduced them to the airline, airframe and business aviation world, working with many leading companies in their respective fields. His guiding philosophy is to keep "the user at heart and the client in mind", making sure to always look at the end user experience while delivering to the objectives of the actual client.
During his time with Boeing, Michael headed up the design efforts for new interiors, for a conceptual long range, high capacity aircraft program which holistically explored new service concepts, seating layouts and cabin architectures. As a Program Manager for the MD-2015 narrow body future flight deck, he oversaw integration of new avionics technologies into a cohesively integrated, pilot driven project, which was considered to be at least a decade ahead of its time. While with Mercedes Benz, Michael was part of the Management trainee program which rotated him between project teams focused on the car, bus and truck divisions of Daimler. As Assistant Manager for the CL line (Mercedes high end coupe), Michael focused on the entire vehicle program and worked across multiple disciplines to manage this complex program. And most recently, he added business development to his repertoire of skills, working with Maxwell to market and sell their green technology enablers for the mobility and renewable energy sectors.
Undoubtedly, Michael's experiences and knowledge will add diversity and depth to the work we provide to our clients, allowing us to help them by applying a expanding wealth of knowledge to new opportunities and challenges.