BlackHägen Design, a user-centered medical device development consultancy, is pleased to announce that Jeff Morang has been promoted to Director of Human Factors Engineering. Jeff, an executive-level engineer, joined BlackHӓgen Design in 2022, bringing 20 years of experience in applying usability engineering to medical device design practices.
“Jeff, a true industry visionary, will lead our team of human-factors engineers and certified ergonomists with wide-ranging expertise in human factors engineering/usability engineering (HFE/UE) processes for medical research and development,” said Philip Remedios, BlackHägen’s CEO, and Director of Design and Development. “Talented in research, design, and innovation methodologies like robotics, surgical instrumentation, drug-delivery/combination products, as well as packaging, Jeff’s expertise and leadership is a valuable complement to BlackHӓgen’s mission to bring exceptional R&D services to our customers across the world.”
Prior to joining BlackHӓgen, Jeff led all pre-clinical and commercial human factors activities for two flagship drug-device combination product (DDCP) projects at Sanofi. A device platform project included regulatory strategies and budget planning, user/use-related design device inputs for development, multi-cultural usability evaluations for verifying and/or validating use-related design features, requirements and risk control measures, and identifying design improvement opportunities. His co-leadership of concept creation and selection of the commercial labeling and packaging differentiation schemes as well as designs for controlling risks resulted in a Notified Body (TÜV) and regulatory (EMA) approval for one of Sanofi’s DDCP programs.
At Ximedica, Jeff led initiatives involving Class II and Class III medical device designs for a wide variety of users and use environments from hospitals to in-home. He supervised the human factors engineering team for an innovative surgeon-controlled robotic program for minimally invasive surgical procedures as well as other efforts involved with drug-device combination products, surgical and diagnostic medical devices and systems, and clinical instrumentation.
At Siemens Healthcare Diagnostics, Jeff managed human factors engineering activities on two significant programs for their Point of Care (PoC) business unit involving the RAPIDPoint® 500 Blood Gas Analyzer and the breakthrough Xprecia Stride™ coagulation measurement analyzer.
“BlackHägen’s mission, company culture, and dedication to its customers align with my values and vision for taking human factors engineering to the next level,” Morang emphasized. “These are exciting times for the healthcare industry and for medical device manufacturers. As design innovations emerge at an even faster pace, human factors engineering plays a critical role in ensuring users, and their worlds, guide med-device designs to maximize market acceptance and establish clear market advantages over the competition.”
In addition to being an active member of the Human Factors and Ergonomics Society (HFES), Jeff has also been a member of the Association for the Advancement of Medical Instrumentation (AAMI) and contributing author to ANSI/AAMI HE75 and the book “Applied Human Factors in Medical Device Design.” He received his MS in Human Factors & Ergonomics from San Jose State University and applied his training to NextGen Air Traffic Control systems at the NASA Ames Research Center, followed by leading human factors activities for the United States Army’s principal modernization program, Future Combat Systems (FCS) and the Armed Robotic Vehicle variants.
About BlackHägen Design
Headquartered in Dunedin, Florida, BlackHägen Design is a multidisciplinary, user-research and product design firm supporting start-ups through Fortune 50 companies. Its pragmatic approach to product design is well-suited to safety-critical and environmentally challenging industries and has a long-standing history of serving those clients. At BlackHägen Design’s core, user-centered processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to more than 100 patents and trade secrets over the last two decades.
BlackHägen Design continuously optimizes the quality of its methodologies and services through rigorous deployment of its Quality Management System, which is structured to be compatible with both 21CFR 820 (FDA) and ISO 13485, while easily adaptable to clients’ in-house QMS for seamless documentation transfer. For more information visit: www.blackhagen.com