(Overview) AstraZeneca: Incorporating Design Strategy within MedTech Product Governance

The Business Problem & What I Learned:

With an IT department of more than 2,000 people struggling to balance a highly-standardized development approach across wildly different regulatory environments, a more comprehensive set of flexible approaches was needed for product success.

User Pain Points & Business Impacts:


  • Restrictive Project Approach
    Aiming to maximize efficiency across product development, the organization had created a structure so rigid it created an atmosphere of frustration and disengagement.

  • No Flexibility for Project Context
    Little-to-no attention was paid to specific project needs, objectives, and regulatory context, often leading to significant amounts of wasted effort and product delays.

  • Lack of Strategic Design Awareness
    While project teams were aware of a range of different approaches to project strategy, there was no trusted source of expertise to show them how this could be leveraged.

Project Context & Design Strategy:

Approached by IT leadership to spearhead this cross-disciplinary best practices initiative, I began comprehensive research and relationship-building to surface:

Identified Issues:


  1. Rapid Team Scaling took priority over Project Insights
    Rushing to be efficient, many key project insights were missed (i.e. user research, regulatory planning), leaving software catalogue 95% untouched.

  2. Difficult Stakeholder Management & Expectations
    Blind adherence to established practices over project needs had normalized the expectation of increased delays, costs, and frustration.

  3. Limited Cooperation created Confusion & Waste
    Team members had little facilitation between disciplines, creating considerable ambiguity with project goals, regulatory requirements, and processes.

  4. Lack of Strategic Regulatory & Design Resources
    Teams wanted to find better ways to work, but tightly siloed disciplines made this cross-functional collaboration difficult to put into practice.

I compiled a comprehensive framework of strategies, critical design capabilities, and specific approaches into accessible guides, workshops, and curated courses for MedTech product teams across the organization.


What We Delivered & The Impact:

Initially conceptualized as a “side project” to encourage best-practices in the wider Digital Health organization, this initiative quickly gained momentum to enable:

Outcome #1: Regulatory-Informed Best-Practices for Across Digital Health Contexts


By emphasizing the need to recognize individual project goals and regulatory contexts, we were able to:

  • Identify governance shortcomings that created needless friction and limited project outcomes.
  • Introduce individualized project strategies to account for differing user needs, regulatory requirements, and business constraints.

Outcome #2: Awareness of Design Strategy as a Critical Digital Health Capability


Leading workshops, seminars, and project kickoff sessions to facilitate the creation of a more cooperative environment, we:

  • Conducted “kick off” ideation sessions to create project alignment quickly, reducing guesswork, expensive rework, and project “crunch”.
  • Reduced ineffective planning activities by 50% through guided requirements mapping seminars informed by regulatory needs (i.e. Usability Engineering File [UEF]/Use-Related Risk Analysis [URRA], and Quality Management System Regulation [QMSR]).

Outcome #3: Enabled Organization-Wide Collaboration & Team Development


Created educational resources for direct distribution to the wider, international product development organization (2,000+ contributors):

  • Engaged with over 500 participants (first 6 months) via new UX Strategy training courses, “lunch & learn” sessions, and product workshops.
  • Established early-stage "problem definition & ideation" engagements, which coincided with a 30% increase in RFPs to the Global UX Design Team over the same six-month period.