Task 1: Understanding the Problem & Exploring Opportunities - With this project being sponsored by senior executive stakeholders after a previously unsuccessful version, there was a lot of pressure to get things right. This made forming a concrete understanding of the complex, highly regulated problem space essential in the face of competing approaches and priorities across the team.
To establish alignment and smooth collaboration quickly, I conducted an aggressive research effort, sharing and integrating my findings into developing team goals along the way. This motivated everyone to take a step back, to balance the need for progress with the discipline of understanding the problem space and its scope.
Creating a Shared Understanding of the Problem Space
A detailed round of primary & secondary research formed a clear picture of user needs and existing system processes, for a shared understanding of how they interacted within applicable FDA frameworks (GAMP 5, 2nd edition / 21 CFR Part 211).
What This Achieved:
- Provided Detailed Problem Definition at User & Process Levels - In addition to highlighting essential user needs and pain points, a broader perspective was provided for these discoveries to be harmonized within a broader business process context.
- Introduced Confident, Collaborative Practices Early - By including subject matter experts, stakeholders, and users as soon as possible, fruitful collaboration was set as the norm early on in the project.
Team Alignment Through Ideation, Milestone Planning, & Refined Concept
I conducted an ideation session to get all ideas on the table, think through potential solutions, and develop a shared vision and regulatory approach (i.e. “does our use of AI make this a medical device subject to ISO 13485 / IEC 62304?”). The refined concept then highlighted relevant regulatory considerations (i.e. 21 CFR Part 11) for upcoming requirements/project planning.
What This Achieved:
- Further Deepened Collaboration - With key representatives from all contributing disciplines at the same table, the initial ideation and refinement process made everyone an essential contributor rather than a siloed asset.
- A Better-Informed Idea - Rather than starting from a preconceived notion to solve the problem at hand, all relevant expertise was brought to bear to produce a concept that was both feasible to build, and viable according to discovered user & process needs.
- Set Clear Milestones & Stakeholder Confidence - With a clear, feasible, and well informed idea in hand, communicating team goals became much easier. Stakeholders were provided with clear product capabilities and milestones for ongoing project approval.
Task 2: Driving Project Clarity & Initial Design - With an exciting solution concept, it was time to break it down into concrete requirements that could be shared with stakeholders for approval. Our goal was to keep the effort nimble through realistic milestones and tight-knit collaboration. I was delighted by how quickly the team developed a mutual trust, which allowed us to design a successful MVP.
Prioritized Requirements & Detailed Project Releases
I broke user workflows down into prioritized requirements targeting identified milestones, tightening a previously ambiguous timetable to reflect clear project goals using the FDA Computer Software Assurance (CSA) framework.
What This Achieved:
- Set Clear Scope for Design/Development - Again utilizing key representatives from each contributing discipline, broad project milestones were broken down into specific requirements. Potential complications and design/technical/reguatory debt were identified up-front, significantly reducing the risk of future complications.
- Stakeholder Communication & Project Resources - With specific requirements, I was able to lay out the most appropriate design strategy, scope out the work it would entail, and project the timelines & resources needed for success.
Detailed Workflows & Initial Interface Designs
Before designing on a screen-by-screen basis, I drafted detailed user-flows (using ALCOA+ principles) that provided a clear structure, and enabled us to think out complex functionality in the user’s context that was then translated into finished individual screens for ongoing Verification & Validation (V&V) efforts.
What This Achieved:
- Provided Stress-Tested User-Flows - With minimal investment, entire workflows were validated before a single screen was produced, ensuring that design work was targeted and comprehensive.
- Design Patterns Quickly Established - Using rapidly produced "throw away" sketches, interface concepts could be fully explored before a more expensive investment in finished mockups/prototypes was made.
- Vitually Eliminated Unnecessary Rework - By eliciting cross-disciplinary feedback, these sketches surfaced potential user pain points and technical friction before they were integrated into a delivered design that would have to be reworked.
Task 1: Iterating towards a Full-Solution Design - With a successful MVP demonstrating value, it was time to ramp up the effort to fully flesh out our solution. This involved me moving into a more strategic design role, providing guidance and high-level governance for the growing team to produce:
Expanded Milestones & Design Team Oversight
With the core product and regulatory strategy established (i.e. keeping to the non-medical device pathway), I carefully scoped extensions to what the system could do for the next design/development iteration while working with management to scale the design team by onboarding new members, tracking requirements (i.e. for category 5 GAMP software), and providing design oversight for the Software Development Life Cycle (SDLC).
What This Achieved:
- Informed, Cross-Discipline Product Decisions - With a habit of effective collaboration deeply established, the team was able to come together during critical inflection points to inform ongoing product decisions with critical regulatory implications.
- Scaled Design Capability with Critical Regulatory Oversight - Additional designers, with the needed experience in complex environments, were folded into the team as my role shifted towards design oversight, mentorship, and regulatory diligence.
A Validated “Human in the Loop” Solution, Smoothly Implemented
With each tested iteration, AI agents worked to inform - not replace - the human user. This scoping decision kept the system on a non-medical-device pathway, preserving regulatory simplicity and the project timeline. As the solution neared completion, we scoped and developed a detailed system of procedures, best-practices, and educational resources (21 CFR Part 11 / 211) to make deployment as simple and accurate as possible.
What This Achieved:
- Maximized User Confidence & Productivity - By eliciting and integrating user feedback regularly, trust and excitement for the developing product grew with each passing milestone. This progress was regularly shared with stakeholders to keep them updated on our progess.
- "Human-in-the-Loop" Focus & System Comprehension - User feedback also served as a critical bulwark against design decisions that could result in confusion, costly mistakes, and "cognitive surrender" in essential production processes.
- Precise, Confident Implementation - Armed with clear guidelines and best-practices, the new system could be integrated into existing production lines quickly, accurately, and with minimial downtime.