Embedding user centred design at global scale
How we transformed Johnson & Johnson MedTech's development process by embedding UCD into the SDLC, building DesignOps capability, and shifting to agile ways of working.
The Challenge
Johnson & Johnson MedTech develops sophisticated software for medical devices used in operating rooms and clinical settings worldwide. Their products directly impact patient outcomes, making usability and safety critical.
Despite the high stakes, user centred design (UCD) was not embedded into their software development lifecycle (SDLC). The organisation operated primarily in waterfall methodology with minimal user research, no consistent design process, and UX happening as an afterthought rather than integrated into development.
💡 The problem: UX happened too late in the process - after requirements were locked, code was written, and changes became expensive and difficult.
Specific Pain Points
- No UCD in the SDLC: User research and usability testing weren't integrated into the development process. Design decisions were made by engineers and product managers without user validation.
- Waterfall mindset: Long development cycles with big-bang releases. No iterative design, no continuous user feedback, minimal flexibility to adapt based on learning.
- Global coordination challenges: Teams spread across US, Europe, and Asia with no shared UX methodology or design system. Everyone working differently.
- Late-stage usability issues: Problems discovered during validation testing when changes were prohibitively expensive. Products shipped with known usability issues.
- No DesignOps foundation: No tools, templates, or processes to scale UX practice. Every project started from scratch.
The Approach
We took a systematic approach to embed UCD into J&J MedTech's culture and processes, focusing on three pillars: process transformation, capability building, and DesignOps infrastructure.
1. Embedding UCD into the SDLC
We redesigned the software development lifecycle to bake UCD in from the start rather than bolt it on at the end:
- Discovery phase UX: User research and contextual inquiry became mandatory before requirements definition. Understand users and workflows before deciding what to build.
- Design sprints in development: Rapid prototyping and testing cycles integrated into sprint planning. Design ahead of development by 1-2 sprints.
- Continuous usability testing: Regular testing with clinicians and medical professionals throughout development, not just at the end.
- Design QA gates: Usability sign-off became required before code handoff. No development starts until design is validated.
2. Agile Transformation
We led the shift from waterfall to agile ways of working, with UX leading the change:
- Dual-track agile: Design track running ahead of development track, creating validated designs ready for implementation.
- Sprint ceremonies with UX: Design participated in planning, stand-ups, and retrospectives. UX became part of the team, not external consultants.
- Incremental delivery: Breaking big releases into smaller, testable increments. Ship, learn, improve.
- Cross-functional collaboration: Designers, engineers, product managers, and regulatory working together from day one.
3. Building DesignOps Infrastructure
We established the operational foundation to scale UX practice globally:
- Shared design system: Component library, interaction patterns, and visual language used across all products. Consistency and efficiency at scale.
- Research repository: Centralised library of user research findings, personas, and insights accessible to all teams.
- Templates and toolkits: Standardised research plans, usability test protocols, design documentation templates. Stop reinventing the wheel.
- UX governance: Design review process, quality standards, and approval workflows that worked within regulated medical device environment.
- Metrics and reporting: Dashboard tracking design maturity, usability metrics, and UX impact across products.
4. Change Management & Training
Technical process changes only work if people adopt them. We focused heavily on change management:
- Stakeholder workshops: Leadership alignment sessions showing the value of UCD and addressing concerns about timeline and cost impacts.
- Hands-on training: Engineers and product managers learning UX basics - when to involve design, how to write good user stories, understanding usability principles.
- Pilot programmes: Started with one product team, demonstrated success, then scaled to others. Proof beats theory.
- Champions network: Identified UX advocates across teams who championed the new approach and helped others adopt it.
The Results
Business Impact
Earlier issue detection: Usability problems caught in design phase cost 10-100x less to fix than during validation testing or post-launch. The shift to continuous testing dramatically reduced rework costs.
Faster time to market: Agile delivery with validated designs meant features shipped incrementally rather than waiting for big-bang releases. Products reached market faster with higher quality.
Improved clinician satisfaction: Products designed with real user input resulted in software that clinicians actually wanted to use. Training time reduced, errors decreased, satisfaction increased.
Regulatory confidence: Well-documented UCD process satisfied regulatory requirements (FDA, MDR) for human factors engineering. Smoother approvals, less back-and-forth.
Cultural Shift
The most significant change was cultural. UX went from "nice to have" to "how we work":
"We used to debate whether to do user research. Now we debate what type of research to do and when. UX became table stakes, not optional." - Engineering Lead, J&J MedTech
Engineers started requesting UX support earlier. Product managers involved designers in roadmap planning. Leadership championed UCD in strategy discussions. The shift was organisation-wide.
Key Learnings
- Process change requires cultural change: You can mandate UCD in the SDLC, but people won't embrace it unless they understand why it matters and see the value themselves.
- Start with proof, then scale: Pilot with one team, demonstrate clear results, then expand. Success stories convince skeptics better than presentations.
- DesignOps is infrastructure: Without shared tools, templates, and systems, UX practice doesn't scale. You need operational maturity to support the work.
- Agile and UX belong together: Dual-track agile (design ahead of development) creates the rhythm for validated, iterative delivery. They reinforce each other.
- Training is critical: Engineers and product managers need to understand UX enough to know when to involve designers and how to collaborate effectively.
- Medical device UX is high stakes: In healthcare, poor usability isn't just frustrating - it can harm patients. This reality helped drive urgency and commitment to the transformation.
What We Delivered
- Redesigned SDLC with UCD embedded at every stage
- Agile transformation roadmap and training materials
- DesignOps framework including design system, research repository, and templates
- UX governance process compatible with medical device regulations
- Stakeholder training and change management programme
- Metrics dashboard for tracking UX maturity and impact
- Global rollout plan across US and European teams
Similar Transformations We Lead
Embedding UCD, agile adoption, and building design capability at scale.