Custom Sound Pro global usability strategy
Building a scalable, international usability testing framework for regulatory compliance and market expansion.
Overview
The challenge
Cochlear's flagship professional software hadn't seen a major update in 20 years. As we redesigned this critical tool used by audiologists worldwide, we faced a complex usability testing challenge.
The constraints
- Multi-year development timeline requiring continuous validation
- Regulatory requirements mandating that every usability error be documented and resolved
- Global rollout across regions with varying network security restrictions
- Need to enable use by junior audiologists and clinicians in countries without formal audiology education paths
- Testing required across multiple regions
- Secure clinical networks preventing online prototype access
The opportunity
Create a testing strategy that would not only meet regulatory compliance, but also scale our research capabilities globally whilst building local expertise across a specialised, distributed network of professionals. Equally important was the opportunity to strengthen relationships between HQ and regional teams by making them active partners in the product development process rather than passive recipients of centrally-designed solutions.
5
Continents
10
Testing countries
100%
Regulatory compliance
1 million
Patients benefit
My role
I was the senior UX designer responsible for the professional suite of products, but I was the hands-on, end-to-end designer for CS Pro. I was responsible for everything from research to wireframes, prototyping and visual design. In this case study I'm just talking about he usability.
Usability strategy
- Designing stakeholder alignment and capability-building activities
- Creating a global usability testing framework
- Developing training materials and protocols for regional facilitators
- Managing cross-timezone coordination
- Building data capture and analysis systems for regulatory compliance
- Presenting findings and managing systematic remediation processes
Strategy
1
Stakeholder alignment and regional validation
Before implementing any testing protocols, we needed to build trust and demonstrate local relevance across diverse regional markets.
Persona validation workshop
- Brought together clinical and marketing heads from multiple countries
- Validated user personas created from our earlier research against local market realities
- "Cochlear Money" budget activity: Each region allocated the same budget across personas based on their regional representation, creating shared understanding of regional priorities.
- Regions personalised personas with locally relevant names and photos for their primary user groups.
Testing framework introduction
- Explained how each region would participate in usability testing
- Outlined the comprehensive support structure of training, guides, scripts, dry runs, and ongoing assistance
- Addressed concerns about language barriers and local clinical practices
- Secured commitment by showing local value rather than just global benefit
Key outcome
By involving regional stakeholders early and explaining how this means they can better serve the clinical accounts in their region, we built strong buy-in and enthusiasm for the project, before asking for participation.
2
Building global testing capabilities
Aside from regional buy-in, the biggest operational challenge was transforming non-UX professionals into confident, quality facilitators whilst managing technical constraints of secure clinical environments.
Training programme development
- Created comprehensive facilitator and observer training guides
- Developed dry-run protocols with practice sessions to build confidence
- Established quality standards for consistent data collection across regions
- Built ongoing support structure with regular check-ins and guidance
Technical solution for secure environments
Many clinics operated on isolated networks for security, preventing online prototypes or real-time data collection from usability sessions.
- Deployed offline prototype versions to regional facilitators
- Created structured survey templates for systematic post-session data capture
- Developed systematic process for recording, note-taking, and secure data transfer back to Australia
- Ensured consistent data quality despite technical limitations
Key outcome
Transformed non-UX professionals into confident, quality facilitators capable of collecting regulatory-standard data.
3
Dual testing framework
Formative testing (fortnightly cycles)
- Sprint-based testing of new features every two weeks.
- Rapid iteration cycle with immediate stakeholder feedback at fortnightly showcases.
- Early testing globally.
- Ongoing Australian testing for speed and continuous improvement.
Summative testing (regional validation)
- Comprehensive user flow testing in real clinical settings.
- Multi-region deployment for cultural and regulatory validation.
- Focus on end-to-end workflows and edge cases.
- Full regulatory documentation for compliance requirements.
Key outcome
Balanced rapid iteration with thorough regulatory validation across diverse markets.
4
Regulatory compliance integration
Systematic documentation
- Every usability error documented in Jira tickets for development team action.
- Captured evidence for feature inclusions based on user research findings.
- Created remediation workflows linking research findings directly to design iterations.
- Established clear criteria for issue resolution and retesting requirements.
- Built traceable audit trail from finding to solution for regulatory compliance.
Key outcome
Created comprehensive evidence base meeting medical device regulatory standards whilst seamlessly integrating compliance into development workflows.
Delivery
Locations
Usability sessions were facilitated in:
- Australia
- Belgium
- Brazil
- France
- Germany
- Indonesia
- Singapore
- Switzerland
- Vietnam
- United States
Training and coordination
- Coordinated training sessions for our regional usability champions
- Managed intensive coordination days during initial setup phase
- Transitioned to efficient asynchronous workflows once protocols were established
- Maintained quality through regular check-ins and data reviews
Cross-regional operations
- Coordinated testing across countries with varying healthcare infrastructures
- Facilitated usability sessions within Australia
- Managed cultural and procedural differences in clinical environments
- Coordinated data transfer from isolated clinical networks
- Maintained consistent quality standards across diverse regional contexts
Data management and analysis
- Implemented survey-based data capture system for efficient analysis and synthesis
- Created streamlined reporting formats tailored to different stakeholder groups
- Developed action-orientated recommendations from cross-regional insights
- Built systematic feedback loops from regional findings to global design decisions
Results
Clinical research validation
- I was acknowledged for my research methodology contributions in two published clinical studies that validated the software's effectiveness.
- Parallel research collaboration demonstrated that "Optimisation of the CSPro user interface, software automation and enhanced AutoNRT, further improve clinical efficiency and patient management capability"
- Contributed research methodology expertise to validation of Cochlear Remote Assist, the remote version of Custom Sound Pro
- This work enabled research-quality data collection that supported evidence-based improvements to clinical workflows
Regulatory success
- 100% regulatory compliance achieved through systematic error documentation and resolution
- Created reusable framework for future product development cycles
- Established audit trail that met international medical device standards
Market expansion validation
- Key success metric: Testing validated that junior audiologists and clinicians without formal audiology training could successfully complete core workflows
- Simplified complex clinical processes enough to expand market accessibility
- Provided evidence base for market expansion into regions with limited audiology education pathways
- Enabled Cochlear to broaden markets previously considered less accessible
Organisational capability building
- Trained regional teams capable of becoming ongoing usability champions in their markets
- Created scalable testing infrastructure reducing dependency on central research team
- Established sustainable processes for continuous international validation
- Built knowledge transfer systems ensuring continuity beyond project completion
Product impact
- Multi-year continuous feedback loop directly influenced global design decisions
- Fortnightly iteration cycle significantly accelerated development timeline
- Regional insights prevented costly product acceptance issues post-launch
- Enabled product customisation for diverse clinical workflows
Operational excellence
- Reduced time-to-market through parallel regional validation
- Minimised post-launch support issues through thorough pre-launch testing
- Created template for future international product rollouts
This global usability strategy supported the successful launch of Custom Sound Pro, now used by audiologists across 12,000+ clinics worldwide to improve hearing outcomes for the 1 million+ Cochlear implant recipients.
Reflection
Creative problem-solving
When building global research capabilities, constraints resulted in a more secure solution. Our offline prototype and our facilitator and observer questionnaires were more secure than our original online-first plan.
Stakeholder strategy
Regional buy-in required demonstrating local value, not just global benefits. The "Cochlear money" activity and persona validation created ownership rather than compliance.
Regulatory UX
In regulated industries, usability testing isn't just user advocacy, it's a systematic quality process where every finding must be actionable, traceable, and documented for compliance.
Cultural adaptation
Global research requires balancing standardised processes with local flexibility. Success came from rigid data standards combined with local facilitation.
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