Presentation
Tailoring HF Development/Validation Processes to Software and its Changes
SessionValidation/Testing (MDD8)
DescriptionIntegrating mobile and digital technologies into medical devices is the next frontier of healthcare. Digital healthcare tools can empower lay users to take a more active role in their own care than ever before. The easily accessible, rapidly deployable nature of these devices also allow medical device companies to be more responsive to evolving user needs, post-market surveillance data, and competitive technologies. In order to leverage the potential benefits of accelerated development cycles, regulatory processes and paradigms need to evolve to keep pace. This joint presentation from the Tidepool Project, a 501(c)(3) nonprofit organization dedicated to developing innovative technologies in the diabetes space, and Core Human Factors, human factors experts specializing in medical devices, will explore potential avenues for bringing human factors practice into the age of rapid technological advancements.
The presentation will cover:
- Leveraging the full wheelhouse of human factors methodologies to support development of medical software and interoperable devices. Employing flexible task lists, variable study formats (i.e., in-person vs. remote), a tunable study scope and responsive, iterative stimuli can all support making human factors research expeditious, efficient, and cost-effective.
- The importance of establishing documentation systems up front. In an age of ever-evolving device interoperability, having forward-looking risk analyses and protocols sets companies up for more agile development and supplemental validation as needed.
- Bringing FDA into the development process as a partner, rather than an adversary. FDA need not (and should not) be seeing devices for the first time during submission. Involving FDA reviewers throughout device development, through the pre-submission process and other pathways, can smooth submission and communication between FDA and industry.
- “Safe” Plug and Play Interoperability: How the human factors process can be leveraged to validate software revisions and new device integrations.
The presentation will cover:
- Leveraging the full wheelhouse of human factors methodologies to support development of medical software and interoperable devices. Employing flexible task lists, variable study formats (i.e., in-person vs. remote), a tunable study scope and responsive, iterative stimuli can all support making human factors research expeditious, efficient, and cost-effective.
- The importance of establishing documentation systems up front. In an age of ever-evolving device interoperability, having forward-looking risk analyses and protocols sets companies up for more agile development and supplemental validation as needed.
- Bringing FDA into the development process as a partner, rather than an adversary. FDA need not (and should not) be seeing devices for the first time during submission. Involving FDA reviewers throughout device development, through the pre-submission process and other pathways, can smooth submission and communication between FDA and industry.
- “Safe” Plug and Play Interoperability: How the human factors process can be leveraged to validate software revisions and new device integrations.
Event Type
Oral Presentations
TimeWednesday, March 279:15am - 9:37am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices