Manufacturing Digital Workflow
Overview
In response to an FDA mandate for real-time tracking of manufacturing non-conformances, Cook Medical faced significant disruptions due to an unsuccessful attempt to digitize this workflow. The initial digital system caused a 40% drop in production, leading to extensive backlogs for life-saving medical devices and increased employee dissatisfaction. To address these issues, we developed a streamlined, intuitive system that balanced regulatory compliance with usability. The redesigned platform featured simplified workflows, upgraded hardware, and interactive training stations to empower employees and restore operational stability. Through ongoing employee feedback and a user-centered approach, the project restored productivity to within 5% of pre-implementation rates and boosted morale, setting a strong foundation for a future integrated system. This initiative underscored the importance of engaging end-users in design processes to create solutions that meet both regulatory standards and user needs.
Project Detail
Team
Project Manager • Product Owner • Global UX/UI Manager (my role) • Business Analyst • Data Architect • Solution Architect • Development Lead • Developer x4 • Security Lead • UX/UI Designer x3 (my role) • Production Employee
Duration
Six weeks from kickoff to implementation.
Tools
Figma • FigJam • Confluence • Jira
Case Study
Business Problem
In response to an FDA warning letter mandating real-time tracking of product issues in manufacturing (non-conformance), Cook Medical encountered substantial challenges in its manufacturing and quality control processes. An initial attempt to digitize the non-conformance workflow—intended to ensure compliance and streamline operations—resulted in a 40% drop in production and a significant backlog of life-saving medical devices. This system failure led to widespread employee dissatisfaction, with HR data indicating increased complaints and disciplinary actions directly linked to the system’s use. Additionally, over 30 support tickets pointed to usability issues, technical limitations, and inadequate hardware, all of which disrupted workflows and frustrated employees.
The failed digitization effort revealed deeper issues. While leadership required real-time tracking for regulatory compliance, the system’s complexity confused production staff who were accustomed to manual processes and unfamiliar with technology. A technical audit uncovered multiple software bugs and hardware limitations, including outdated workstations and barcode scanners. Compounding these issues was a toxic work environment where frontline supervisors resorted to threats and bullying. An urgent need emerged for a stable, user-friendly solution to restore productivity, improve morale, and meet regulatory demands.
Solution
Given the critical nature of Cook Medical’s products, we worked within a six-week timeframe from design to implementation. To address the challenges, we developed an intuitive, efficient system that balanced compliance needs with ease of use. Key improvements included moving from a green screen to a touchscreen interface modeled on user-friendly applications familiar to employees, implementing robust hardware upgrades with fifteen additional machines, and focusing on employee training and engagement.
User-Friendly Interface and Streamlined Workflows: We redesigned the platform with a clean, intuitive interface, incorporating large tap targets for ease of use by staff wearing gloves and masks in clean rooms. Collaborating with internal teams, we also revised workflows to match employees’ tasks better. By reducing unnecessary steps and clarifying key actions, the new system simplified daily tasks. Enhanced error messages allowed employees to troubleshoot independently, minimizing reliance on IT support. To foster engagement, we included a cafeteria menu—a direct user recommendation—making the system more enjoyable and signaling that user feedback was valued.
Real-Time BI Dashboards for Compliance and Oversight: For leadership, we implemented real-time BI dashboards displaying essential production insights and compliance metrics, enabling proactive monitoring and quicker decision-making to address compliance concerns.
Hardware Upgrades: Based on technical audit findings, we recommended upgrades to workstations and barcode scanners, along with increasing device availability to reduce wait times. These hardware improvements ensured greater system stability, faster processing, and enhanced data accuracy.
Comprehensive Training and Feedback Mechanisms: Training was critical for achieving high adoption rates and minimizing disruption. We developed interactive tutorials, set up practice stations simulating the manufacturing environment, and offered refresher courses presented in a fun, approachable tone to make learning engaging. Additionally, we introduced a direct feedback mechanism, allowing users to report issues or offer suggestions directly to the project team and CEO from their workstations, empowering employees and fostering a culture of engagement and continuous improvement.
Iterative Testing and Refinement: We conducted iterative testing with production staff to identify usability issues and refine the design. Prototypes and A/B testing enabled us to detect and address potential problems early, ensuring design improvements before full implementation.
While intended as a temporary solution until a fully integrated system could be developed, this initiative significantly improved operational stability and workplace morale. Production levels returned to within 5% of pre-implementation rates, employee satisfaction increased, and the practice stations became valuable tools for future projects, supporting real-world testing and feedback for ongoing system enhancements.
Business Strategy
The strategic goals for this solution focus on restoring operational productivity, enhancing compliance tracking, and improving employee morale. We aimed to establish a platform that met FDA requirements, empowered users, and positioned Cook Medical for a smoother transition to a future integrated manufacturing system.
Objective Alignment and Value Proposition: The redesign balanced compliance and usability, addressing leadership’s need for real-time tracking while simplifying workflows for production staff. This approach reduced production bottlenecks and provided a more efficient tool, strengthening workforce productivity and morale.
Scalability and Long-Term Vision: The modular design and upgraded hardware allowed the platform to evolve alongside Cook Medical’s needs, ensuring a stable, adaptable solution until the fully integrated system could be developed.
Employee Engagement and Feedback Integration: Direct feedback channels empowered employees to contribute to the system’s continuous improvement, supporting a more engaged and satisfied workforce. This focus on engagement underscored Cook Medical’s commitment to a user-centered approach, which would be valuable for future digital transformation efforts.
Experience Drivers
Simplified Interface and Workflow: A cleaner, more intuitive interface with clearly defined workflows made the system easier to use, reducing user frustration and increasing productivity.
Real-Time Compliance and Production Tracking: BI dashboards provided leadership with essential compliance and production metrics, supporting proactive decision-making and improved oversight.
Enhanced Hardware Stability: Upgraded workstations and barcode scanners improved system stability, reduced lag times, and provided reliable data accuracy, addressing previous technical limitations.
Effective Training and Support: Comprehensive training resources, including interactive tutorials and practice stations, ensured employees were comfortable with the system, reducing disruptions and building confidence in their workflow.
Continuous Improvement Through Feedback: The in-system feedback mechanism allowed employees to report issues or suggest improvements directly, fostering a culture of engagement and continuous system optimization.
Metric
To evaluate the success of the redesigned system, we defined KPIs aligned with Cook Medical’s goals of improved productivity, compliance, and employee satisfaction:
1. Production Recovery:
KPI: Restore production levels to within 15% of pre-implementation rates within two months of launch.
2. Reduction in Support Tickets:
KPI: Decrease support tickets related to system usability by 50% within the first three months.
3. Employee Satisfaction:
KPI: Achieve a 20% increase in employee satisfaction scores related to the system, as measured by HR surveys and feedback.
4. Compliance and Tracking Efficiency:
KPI: Improve compliance tracking by achieving 90% real-time data accuracy, as monitored through the BI dashboards.
5. Training Completion and Proficiency:
KPI: Ensure 100% completion of interactive training sessions for all production employees, with a 90% pass rate on post-training assessments.
Design Process
Discovery Phase
The Discovery phase was crucial in identifying the underlying factors contributing to the initial system failure and understanding user needs within the non-conformance workflow. To ensure a comprehensive perspective, we expanded the project team to include a frontline production employee along with the core members: project manager, product manager, business systems analyst, developer, data architect, and UX/UI designer. The team conducted multiple research initiatives:
Ethnographic Study: We observed production staff within their work environment to gain insights into their daily routines, workflows, and interactions with the non-conformance system. This hands-on observation highlighted practical challenges such as the physical distance between the work table and computer station and connectivity issues between the computer and barcode scanner. These findings provided specific areas to target for efficiency improvements.
User Behavior and Feedback Analysis: Analyzing HR data and over 30 support tickets revealed key pain points, including training gaps, technology apprehension, and a negative work environment. These insights indicated the need for a more intuitive interface and improved training support to boost morale and productivity.
Stakeholder Interviews: Discussions with corporate leadership, production staff, and support teams underscored the need for real-time tracking, simplified workflows, and reliable hardware. Feedback also highlighted a desire to move away from outdated processes, allowing the system to meet compliance while simplifying daily tasks.
Technical Audit: A comprehensive audit of the existing system exposed limitations such as outdated barcode scanners and software bugs, which disrupted workflows. These findings emphasized the need for hardware upgrades and connectivity improvements.
Summary of Discovery Insights:
The Discovery phase revealed the primary factors causing system failure, pointing to a need for:
1. An intuitive, familiar interface
2. A reimagined workflow
3. Hardware upgrades
4. Real-time tracking
5. A supportive, user-friendly work environment
Ideate Phase
With insights from the Discovery phase, we transitioned into the Ideate phase, where a combination of workshops and ideation techniques were used to generate solutions that balanced compliance requirements with enhanced usability.
Heuristic Evaluation: We conducted a heuristic evaluation of the existing system, identifying usability issues such as unclear navigation, redundant steps, and inefficient workflows. These findings highlighted areas for improvement, such as moving from a green-screen application to an interactive touchscreen interface.
Task Analysis: Led by Product Owners, UX designers, process engineers, and production leads, we performed a task analysis, conducting a step-by-step review of the non-conformance workflow. This allowed us to simplify processes, eliminate unnecessary legacy steps, and retain only essential compliance tasks, achieving a balance between regulatory needs and ease of use.
Hardware and Technical Needs Assessment: Collaborating with IT, developers, and technical support teams, we audited hardware and technical requirements. The assessment recommended increasing the number of workstations, upgrading computers, and implementing compatible barcode scanners to enhance system reliability and efficiency.
User Journey Mapping: A user journey mapping workshop visualized the non-conformance workflow from the perspective of production staff, identifying friction points and areas for improvement in navigation, support options, and feedback.
Create Phase
In the Create phase, designers, developers, and a production representative worked closely to build and test the new system iteratively, incorporating user feedback through newly constructed practice stations.
Agile Design and Development Collaboration: Using Figma for prototyping, the design and development teams collaborated closely, holding frequent feedback sessions—often hourly—to address design feasibility and resolve technical challenges in real time. This agile approach ensured the project stayed on track and aligned with user needs.
Prototyping and Usability Testing: Prototypes were tested with production staff in controlled environments to identify usability issues early on. Feedback from these sessions was used to refine the user interface and optimize workflows before full-scale implementation, ensuring a smooth transition for employees.
Hardware Installation and Integration: New workstations and barcode scanners were installed and integrated into the redesigned system, providing stable performance, faster processing, and improved data accuracy for production workflows. Practice stations included a game created by a second development team, allowing employees to familiarize themselves with the new workstation and scanner in a low-stress environment, further boosting engagement and comfort with the setup.
Evaluate Phase
Throughout the design process, continuous evaluation and feedback loops were employed to ensure the system met user needs and operational expectations.
Usability Testing and Employee Feedback Loops: Testing with selected production staff provided ongoing feedback, allowing us to verify new workflows, evaluate hardware performance, and address any remaining usability issues
Post-Launch Analytics and Monitoring: After launch, we monitored system performance metrics, user behavior, and support ticket volume to assess adoption rates and measure ongoing user satisfaction. Insights from this data led to immediate adjustments, such as expanding tap targets to accommodate glove and eye protection use in cleanroom environments.
HR and Satisfaction Surveys: To evaluate the system's impact on morale and usability, HR conducted post-launch surveys, gathering qualitative feedback from employees. Results showed a marked improvement in morale and a more positive attitude toward technology in the workplace.
Challenges
One of the initial challenges was building trust and rapport with the production staff. Many team members had long-standing concerns, feeling both resistant toward "office workers" they believed “didn’t care about the average person” and fearful that their jobs might be at risk if they couldn’t keep up with the new system. Overcoming this required consistent effort. We began joining them for lunch and breaks, which helped bridge the gap and allowed for more informal conversations. Eventually, we facilitated a meeting with the CEO, providing a safe space for production staff to express their concerns openly. While they never fully embraced us, they began to understand that our goal was to improve their daily work experience, not impose changes that would make it harder.
Another significant challenge stemmed from the workforce's demographic and long-standing routines. Many production staff had been with the company for over 20 years and were deeply accustomed to manual processes. For some, the idea of technology integration felt overwhelming, sparking anxiety. Although many were familiar with basic tools like email or their favorite apps, they were hesitant to expand their usage or engage with newer systems, fearing that any misstep could affect their performance.
The most substantial hurdle, however, was the toxic work environment that had built up over time. We found that before we could proceed with basic system improvements, we needed to address this underlying issue. Corporate leadership and human resources were brought in to help create a healthier work culture, ensuring production staff felt supported and respected. This intervention was essential for creating an environment where employees could approach the new system with openness, fostering collaboration and more effective progress toward our project goals.
