By Gee Burke MD PhD, recently former FDA (CDER)
There has been a shift in the MedTech space. Digital health and wearable technologies recently have flooded the market with innovative devices for consumer use. The explosion of these products isn’t just evolving consumer choices, it’s fundamentally reshaping what regulators expect to see in a combination product submission.
For today’s smart injectors, connected inhalers, and diagnostic wearables, Human Factors Engineering (HFE) is the backbone of the new submission strategy. The FDA’s 2023 guidance on combination products makes it clear: Evaluation of a combo submission consisting of device and drug/biologic does not occur individually. It’s about the seamless system they create.
The Regulatory Alarm: It’s the System Priority
The core evaluation mandate is simple in theory. A sponsor must apply HFE principles to each component and to how they work together as a unified system.
What does this mean for the sponsor? They must proactively identify and analyze unique use-related risks that only exist because of the combination. For example:
- Conflicting Cues: A user gets one instruction from the phone mobile app and a different one from the device’s physical wearable interface.
- Interface Complexity: An overly complicated phone mobile app menu leads to a dosing error with a Bluetooth connected auto-injector.
- Connectivity Gaps: A wearable sensor fails to sync data to the phone mobile app correctly, causing a user to miss a critical health alert.
Regulatory bodies now expect documented evidence that a sponsor has done their due diligence to completely discover incidence points for these specific system-level failures. This often results in the need for human factors validation studies to be more comprehensive than ever.
The Digital Leap: Usability Testing Moving Forward
Usability testing has digital interfaces and wearables, where testing protocols must expand to cover:
- The Hardware-Software Cooperation Boat: Does the user transition from physical device operation to the digital companion app feel instinctive and seamless?
- Diverse User Profiles: Is there testing accessibility for users of different ages, tech-literacy, and physical abilities?
- New Patterns of Risk: How will mobile app updates be revised if it causes user confusion? What about misinterpreted data visualizations or Bluetooth pairing failures?
The new standard requires simulated-use and actual-use validation in realistic environments. This means testing not just the device, but the entire user journey across all physical and digital touchpoints.
The User-Centric Pivot: Designing for Real-World Engagement
The best combo devices today are designed with user-centered compatibility under general-use technology in mind. The goal is to minimize errors while maximizing user adherence.
Best practices we’re seeing lead to success:
- Radical Simplicity: Streamlining both physical and digital interfaces to reduce cognitive load by the user.
- Personalization: Configuring device for custom alerts, font sizes, and comfort settings.
- Actionable Feedback: Using clear data visualization and positive reinforcement to keep users engaged and informed.
Products like continuous glucose monitors demonstrate this pivot. They combine medical-grade accuracy with the intuitive, daily usability of a consumer device.
Key Takeaway
As digital and wearable technologies become standard products submitted for regulatory approval, demonstrating safety and efficacy means proving the entire user experience. Integrated HFE is the most critical tool for securing regulatory approval, confirming meaningful user adoption, and achieving better health outcomes. The question isn’t if you need a robust HFE strategy, but how quickly you can adapt the medical device product to this new reality.
What’s the biggest HFE challenge you’ve faced with a digital or wearable combo device? Head over to our LinkedIn post and let us know in the comments!
