Observation and Problem Identification
in Medical Device Design
26. Human Factors Engineering (HFE) in Observation
Human Factors Engineering is essential in identifying how people interact with medical
devices and systems. Observation focuses on:
- Cognitive load: How much mental effort users exert.
- Physical ergonomics: Is the device intuitive? Does it cause strain or fatigue?
- User variability: Accommodating age, training levels, disabilities, and handedness.
- Stress impact: In emergencies, even simple devices can become hard to use.
Example:
In emergency departments, staff often misread infusion pump settings due to small
displays. This observation leads to HFE-based redesigns with larger screens and color-
coded alerts.
27. Triangulation of Data Sources
Observation should be validated through multiple sources:
- Direct observation (clinics, ICUs)
- Interviews (with nurses, physicians)
- Literature review (case studies, device recalls)
- Incident reports (error logs, audit data)
This multi-source verification is known as triangulation, and it ensures the problem
identified is both genuine and significant.
28. Importance of Documenting Workarounds
Often, users find ways to compensate for device limitations. These workarounds are gold
mines for innovation.
Examples include:
- Using rubber bands to hold tubing in place on IV poles
- Manually counting beeps when a device lacks memory recall
Documenting such hacks shows what real users need—even when they don’t explicitly state
it.
29. Global Health Innovation: Comparative Insights
Observations vary across countries based on infrastructure:
- India: Frugal innovation dominates (e.g., battery-powered ECGs)
- USA: Focus on interoperability and data compliance (HIPAA, HL7)
- Africa: Emphasis on off-grid functionality (e.g., solar nebulizers)
Designers must contextualize their observations and needs.
30. Behavioral Observation Ethics
You must be aware of how your presence may alter user behavior:
- Known as the Hawthorne Effect, clinicians may behave differently under observation.
How to minimize it:
- Be unobtrusive
- Build rapport before critical observations
- Conduct repeat visits for natural behavior capture
31. Transitioning Observations to Requirements
After needs are identified, they must be translated into Engineering Design Requirements
(EDRs):
| Need Statement | Engineering Requirement |
|----------------|--------------------------|
| A nurse needs an easy way to carry oxygen meters | Device must weigh < 500g and include
a strap |
| Patients need minimal pain during injections | Needle force must be < 2N |
This traceability is essential for ISO 13485 audits.
32. Red-Flag Observations
Some observations must be escalated immediately:
- Infection control breaches
- Safety hazards (exposed wires, uncalibrated equipment)
- Near misses with high patient risk
Such issues must be reported, even if not part of your design focus.
33. Role of Mobile Apps in Field Observation
Mobile-based data collection apps streamline observation:
- Examples: Epicollect, KoboToolbox, REDCap
Features include time-stamping, photo logging, and real-time syncing.
They support structured data collection even in remote locations.
34. Observation During Device Lifecycle
Observation is not just for early-stage design. It plays a role in:
- Post-market surveillance: After device launch, to catch unexpected use-cases
- Version upgrades: Identifying what users want in V2 or V3
- Training evaluation: Observing how users adopt and learn to use a new device
35. Observation as Storytelling
Each observation is a user story. Use storyboards, journey maps, and role-playing to present
problems effectively.
Example storyboard:
1. Patient arrives at rural clinic
2. Staff tries to find a working BP monitor
3. Battery is dead; delay in care
4. Manual method used; potential error
5. Patient frustrated, leaves
→ Problem: No backup or charging method