Presentation
MDD5 - An Integrated Framework for Comprehensively Defining, Designing, and Evaluating Medical Devices
DescriptionHistorically, Medical Device (MedTech) companies have been technology-driven rather than user-centric, operating in commonly structured tech silos such as mechanical and electrical engineering and software development. These silos are optimized to their parts rather than addressing the entire stakeholder journey (nurses, physicians, and family members) and the patient experience. Merely complying with user testing regulations and guidelines do not make an organization user-centric, and ambiguous and rigid development structures discourage the collaborative work needed to deliver the entire patient experience and improve clinical outcomes.
How do we evolve the device design and development process to launch a competitive product that successfully meets user needs, brings a highly satisfying user experience, and achieves FDA approval, all within the current constraints of tight product development timelines and budgets?
With increasing importance placed on the user and patient experience while maintaining appropriate rigor in evaluating the safety, effectiveness, and usability, we will propose a new integrated device definition, design, and validation framework. This multidisciplinary approach integrates the disciplines of Design Research, Human Factors Engineering, and User Experience Design into a cross-functional design team capable of delivering solutions that reduce device definition, design, and regulatory timelines. This framework will enable device manufacturers to craft a stronger, more compelling case that they have considered all aspects of the use of a medical device—from understanding the needs and pain points to identifying opportunities for effectively addressing those to developing design requirements centered on the use, user, use environment, and context of use (including a renewed focus on the emotional aspects of use), to designing for an optimal and enjoyable user experience, to evaluating against the more appropriate heuristics and user needs, as well as safety and usability and submitting a robust case of good design and evaluation to the FDA for approval.
ABOUT THRIVE
THRIVE is a strategic design and research firm innovating at the frontiers of health and well-being.
We work with ambitious leaders to build brands and experiences that people love through Informed Design™. Our work gives leaders, teams, and organizations the courage and conviction to move confidently forward and design what's next.
Our in-house human factors professionals have decades of experience in human factors psychology and applying human factors methods in various work environments and industries. Our human factors specialists are up to date on the latest regulations set forth by the FDA in the United States and other regulators worldwide and guide organizations from a strategy and execution perspective.
We have extensive experience applying human factors to products ranging from medical devices used by specialized healthcare professionals in clinical environments to combination products used by laypeople in the home to in-vitro diagnostic systems or reprocessing workflows used by technicians in the lab.
How do we evolve the device design and development process to launch a competitive product that successfully meets user needs, brings a highly satisfying user experience, and achieves FDA approval, all within the current constraints of tight product development timelines and budgets?
With increasing importance placed on the user and patient experience while maintaining appropriate rigor in evaluating the safety, effectiveness, and usability, we will propose a new integrated device definition, design, and validation framework. This multidisciplinary approach integrates the disciplines of Design Research, Human Factors Engineering, and User Experience Design into a cross-functional design team capable of delivering solutions that reduce device definition, design, and regulatory timelines. This framework will enable device manufacturers to craft a stronger, more compelling case that they have considered all aspects of the use of a medical device—from understanding the needs and pain points to identifying opportunities for effectively addressing those to developing design requirements centered on the use, user, use environment, and context of use (including a renewed focus on the emotional aspects of use), to designing for an optimal and enjoyable user experience, to evaluating against the more appropriate heuristics and user needs, as well as safety and usability and submitting a robust case of good design and evaluation to the FDA for approval.
ABOUT THRIVE
THRIVE is a strategic design and research firm innovating at the frontiers of health and well-being.
We work with ambitious leaders to build brands and experiences that people love through Informed Design™. Our work gives leaders, teams, and organizations the courage and conviction to move confidently forward and design what's next.
Our in-house human factors professionals have decades of experience in human factors psychology and applying human factors methods in various work environments and industries. Our human factors specialists are up to date on the latest regulations set forth by the FDA in the United States and other regulators worldwide and guide organizations from a strategy and execution perspective.
We have extensive experience applying human factors to products ranging from medical devices used by specialized healthcare professionals in clinical environments to combination products used by laypeople in the home to in-vitro diagnostic systems or reprocessing workflows used by technicians in the lab.
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives