Operations & Supply Chain · Project Management

Hybrid Agile-Waterfall in a Regulated Industry — Designing the Governance Bridge

MBA-tier Modern Project Management simulation. Participants run the joint Engineering / Product / Quality / Regulatory task force at CoEditor Health after a leaked FDA pre-submission memo flags the firm's continuous-deployment release cadence as inconsistent with IEC 62304 and 21 CFR 820.30.

3 rounds Executive English, Español

Preview

About this simulation

MBA-tier Modern Project Management simulation. Participants run the joint Engineering / Product / Quality / Regulatory task force at CoEditor Health after a leaked FDA pre-submission memo flags the firm's continuous-deployment release cadence as inconsistent with IEC 62304 and 21 CFR 820.30.

Across three rounds — Diagnose, Design, Defend — the team builds a hybrid-delivery architecture across five levers: cadence by quadrant, validated-platform / iterative-app pattern, tooling-mediated artefact bridge, definition-of-done by quadrant, and team-of-teams topology.

The simulation tracks FDA inspection-finding probability, artefact freshness, board confidence, engineering velocity, culture friction and roadmap NPV penalty, and exposes the team to a second leaked FDA memo in Round 3 that flags the validated-platform pattern unless explicit architectural fitness functions enforce platform invariants.

Who it is for

An advanced simulation for participants used to working with the main frameworks and trade-offs of the subject, designed for executive education and experienced professionals.

How a session runs

  1. The instructor creates a session from the Eureka dashboard and invites the participants.
  2. Participants play 3 rounds. In each one they submit their decisions and the simulation calculates the results.
  3. The simulation can be run in English, Español.
  4. The instructor follows each participant's progress and results from the dashboard, and uses the class results for the debrief.

Decisions participants make

The decisions participants make during the simulation:

  • Cadence Architecture
  • Artefact-Bridge Tooling Investment ($M)
  • Architectural Fitness Functions
  • Migration Approach

What participants track

What participants follow on screen as the rounds go by:

  • The FDA pre-sub memo just landed
  • Your Architectural Levers
  • Regulatory posture trajectory
  • Velocity vs audit-trail strength

Subjects covered

Designed for courses in Project Management.

Ready to use Hybrid Agile-Waterfall in a Regulated Industry — Designing the Governance Bridge with your students?

Contact us and we'll set you up with a free trial session.

Contact us