AstraZeneca: Incorporating Design Strategy within MedTech Product Governance

Stage 1: Understanding Standardization (4 Weeks)

Task 1: Understanding Current Governance - In many areas, standardization of practices can be essential to organizational efficiency. But, when market realities demand innovation across wildly different regulatory contexts, an overly restrictive approach becomes risky and wasteful. To begin reversing this trend, I lead a deep research initiative that:

Highlighted the Risks of an Over-Standardized Approach

I overlaid the benefits and limitations of established Agile practices against different projects and regulatory contexts, producing a clear mapping of benefits and shortcomings.

What This Achieved:
  • Tied Common Frustrations to Key Causal Factors - The "Scrum" Lean/Agile methodology was examined in detail to understand how it's supposed to work (i.e. time boxing, velocity, & siloed teams), and what situations it's best suited for (i.e. maximizing individaul contributor efficiency).
  • Clearly Demonstrated with Real-World Examples - Several real-world projects were used as case studies to demonstrate situations where the standardized approach worked well (i.e. well-defined product optimization), and where it didn't (i.e. generative "net new" product work).
  • Established Shared Fluencies - This collaborative effort between disciplines allowed all of us to be exposed to new concepts, regulatory requirements, and project considerations that needed to be understood to establish a flexible framework for complex projects.
Identified Limitations of “Siloed” Org Structure in Regulatory Contexts

I mapped the range of contributors necessary to meet regulatory requirements across project types, and after rigorous consultation, clarified the implications for human-factors engineering, development, and QA/RA contributors.

What This Achieved:
  • An Accurate, Shared Understanding - Vague frustrations and siloed perspectives were replaced with a common challenge that every contributing party could recognize and contribute to solving.
  • Identified Key Regulatory Risks - With many projects in the Digital Health & MedTech spaces, I identified the specific regulatory shortcomings and costs that a restrictively standardized process could create, and how significant opportunites for quality were being lost.
  • Cemented Relationships with Common Goals - Shared conversations and perspectives created a shared understanding and desire to address this issue to create opportunities for more meaningful contributions across disciplines.

Stage 2: Introducing Design Flexibility (3 Weeks)

Task 1: Setting & Managing Product Expectations - Especially within industries that are highly-regulated and/or in highly populated/competitive markets, product initiatives can have wildly different contexts and challenges. To simplify this potentially overwhelming complexity and reduce it down into actionable insights, I carefully crafted:

Regulation-Informed Design Strategies

Across various contexts (i.e. regulated & unregulated), I demonstrated appropriate design strategies in the delivery of safe and trustworthy solutions, along with any needed documentation (i.e. Design History File [DHF]/UEF/Risk Management [ISO 14971]).

What This Achieved:
  • Demonstrated Market & Regulatory-Aware Design Strategy - I was able to introduce the specific design approaches to enable flexible teams to ship successful products, and highlighted how this created cross-disciplinary trust & fluency that vastly improved product outcomes in a regulated environment.
  • Incorporated Context-Based Design Flexibility - With every project facing its own business constraints, I was able to show how design strategies could be modified to meet those particular challenges. This further moved design strategy away from being a "nice to have" abstraction, and made it much more of a pragmatic practice.
Comprehensive Design Guide

To break down a selected design strategy into actionable steps, I produced a comprehensive listing of needed design competencies and techniques to highlight costs & benefits across different types of projects.

What This Achieved:
  • Demonstrated Breadth of Design Competencies & Activities - This directly countered the notion of design being a late-stage "interface-only" activity, and clearly demonstrated how design-based competencies contributed across the entire product development cycle.
  • Activities' Explicitly Highlighted Purpose, Value, & Risks - Each individual design activity (and its associated deliverable) was boiled down its essential purpose, potential value, and risk-associated costs. This positioned each of these items as flexible tools, rather than proscribed activities with unknown or doubtful benefits.
Meaningful Frameworks for Measuring Project Success

I presented clear methodologies for measuring project success across both new and established products, with an emphasis on establishing meaningful measurements across audience segments with differing priorities and levels of trust.

What This Achieved:
  • Provided "Connective Tissue" across Business & User Priorities - To address the frequent tension between measuring business metrics and user outcomes, I developed and shared clear frameworks that reconciled these related concerns without resorting to "cherry-picked" metrics.
  • Included Frameworks for New & Existing Products - A user-centric, qualitative framework was developed to start with user outcomes and break them down into worthwhile metrics, and a business-centric, quantitative framework was introduced to highlight business metrics and work back to key user needs. This allowed product teams to glean key insights for product success across product contexts.

Stage 3: Showing by Doing (2 Weeks)

Task 1: Unlocking Expertise for Better Solutions - While it was no surprise that AstraZeneca had a lot of smart people working for them, what did surprise me was how little of a contributive voice most of them were allowed. This environment was ripe for UX facilitation activities that gave these voices a chance to lend their skills, experience, and ideas to otherwise troubled project efforts through:

Collaborative Ideation & Planning Workshops for Project Kick-Offs

Rather than requirements being dictated in isolation, contributors took part in ideation workshops that leveraged existing research, regulatory frameworks, and feasibility considerations to build shared alignment from the start.

With clear project roadmaps in hand (i.e. user-story mapping), teams and stakeholders gained project clarity that directly informed critical planning activities - milestones, budgets, and essential regulatory requirements including UEF/URRA and QMSR considerations.

What This Achieved:
  • Created Team Alignment through Early Collaboration - Although leery at first, project teams quickly came to see the value of collaborative activities that allowed for much more meaningful contribution, and naturally limited misunderstandings, putting everyone on the same page.
  • Increased Stakeholder Confidence - Establishing product expectations and integrated teams at the same time, meant that stakeholders developed a much deeper sense of confidence in both their teammates and the product being developed.
  • Demonstrated Deeper Design Capabilities - Instead of viewing design as an interface-level implementation activity, our strategic contributions were now visible for all to see and leverage.

Stage 4: Advocacy through Education (8 Weeks)

Task 1: Design Strategy Awareness & Education - To effectively advocate for this expanded approach to project governance, I pitched to IT leadership that we should share the work we had done up to this point as a series of expert-led learning opportunities. Working with the broader governance team, I built a curriculum for that included:

Immersive, Guided Video Training

To reach 2,000+ contributors, a series of online "lunch and learn" sessions were designed to promote a detailed 4 week training program that delivered guided learning, real-world examples, and recorded reference material for over 500 participants in the first six months.

What This Achieved:
  • Earlier Regulatory Engagement in the Design Pipeline - To fully leverage our capabilities, project teams began engaging the Global Design Team earlier in their process. This drove initial research and intended-use, including IEC 62366-1 considerations, CDS guidance, and pre-classification scoping.
  • Deeper Design Awareness & Trust - Rather than treating design as an implementation layer, contributors began to see it as a strategic driver of value that directly informed regulatory work and strengthened collaboration across RUO, CDS, and SaMD product contexts.

© 2016 David Service

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