Phenomenon Studio combines medical expertise with award-winning design to create safer, more effective healthcare experiences
ISO 13485 Certified Medical Device Development
Contents
Why Healthcare Organizations Choose Our Product Design Expertise
In the high-stakes world of medical technology, product design decisions can literally mean the difference between life and death. As a specialized digital product design agency with healthcare focus, we bring:
14
Years designing FDA-regulated products
100%
First-pass FDA submission success rate
63%
Average reduction in user errors
Case Example: Emergency Room Physician Dashboard
For a major hospital system, we redesigned their trauma bay monitoring interface:
- Reduced critical medication errors by 58%
- Improved nurse efficiency by 41% during codes
- Achieved Class II medical device certification in record time
This project exemplifies our healthcare app development approach that blends clinical workflows with exceptional UX.
Our Healthcare Product Design Methodology
Clinical Workflow Analysis
We begin by shadowing healthcare professionals to understand real-world use cases, pain points, and environmental constraints (noise, lighting, stress levels).
Risk-Managed Prototyping
Our medical product design process emphasizes failure mode analysis from the first sketches, identifying potential use errors before they occur.
Evidence-Based Validation
We conduct simulated clinical trials with actual practitioners, measuring performance against ISO 62366 usability standards for medical devices.
“Phenomenon Studio’s redesign of our infusion pump interface not only passed FDA review on first submission but reduced nurse training time from 8 hours to just 90 minutes. Their understanding of clinical contexts is unparalleled.”
— Dr. Michael Torres, Chief Medical Officer, Vitalis Medical Systems
Comprehensive Healthcare Design Services
Regulatory-Compliant Healthcare App Development
- HIPAA/GDPR-compliant data architecture
- FDA 21 CFR Part 11 electronic records compliance
- HL7/FHIR interoperability integration
Medical Device UX/UI Design
- IEC 62366 usability engineering process
- Alarm hierarchy design per AAMI HE75
- Single-use device interface optimization
Clinical Decision Support Systems
- AI-assisted diagnostic interfaces
- Risk communication visualization
- Prognostic tool dashboards
Beyond Healthcare: Our Digital Product Design Excellence
While we specialize in medical applications, our product design and development expertise extends to:
Enterprise SaaS Platforms
We’ve designed complex workflow systems for:
- Financial risk analysis dashboards
- Supply chain management tools
- AI-powered business intelligence platforms
Consumer Health Technologies
Our human-centered approach shines in:
- Chronic condition management apps
- Wearable health monitor interfaces
- Telemedicine patient portals
Why Partner With Phenomenon Studio?
Unique Cross-Disciplinary Team
Our designers work alongside:
- Board-certified physicians (our clinical advisory board)
- Former FDA reviewers
- Human factors PhDs
- Medical device engineers
This rare combination ensures your product design meets both user needs and regulatory requirements.
Proven Track Record
- 3 “Best in Show” awards at HIMSS
- Recognized by Fast Company for health innovation
- Featured in FDA case studies on usability best practices
Start Your Project With Confidence
Whether you’re developing a new medical device or transforming clinical workflows, our product design agency brings the expertise to ensure success.
Schedule Your Free Design Consultation
Discover why leading healthcare organizations trust Phenomenon Studio for their most critical product design and development challenges.
