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Simulation: Deliver the Medical Device

Kaylee Finnegan

Created on February 19, 2026

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Transcript

Simulation: Deliver the Medical Device

Begin

SCENARIO

A new life-saving medical device is ready for launch. Hospitals are waiting. Patients need it. You are the Project Engineering team responsible for getting it into production - safely, on time, and within budget. But problems are about to hit....

Start the Project

What's your role?

  • Project Engineer: facilitates discussion
  • Budget Lead: protects money
  • Schedule Lead: protects timeline
  • Quality Lead: protects patient safety
  • Manufacturing Rep: protects feasibility

Proceed to Launch Phase

If any category drops too low, the launch fails...

Supplier Crisis!

Your primary material supplier calls. They are 2 weeks late on delivery.

What will you do?

Pay for emergency shipping.

Your team decides to pay for emergency air shipment of the material from the supplier - the project budget takes a hit. The shipment still arrives a couple days late, but we are no longer 2 weeks behind schedule.

Proceed with Development

Wait for supplier to deliver.

Hospitals are frustrated. Launch is delayed by two weeks.

Proceed with Development

Switch to new supplier.

Material from a new supplier requires extra validation activities. The new supplier charges more for equivalent material and there is still a minor delay in the shipment of this material.

Proceed with Development

Testing Failure!

While testing the material for this device, your team encounters a drop test failure - 4% of the devices crack during testing.

How does the team want to proceed?

Add Inspection Step

Added inspection mitigates the risk associated with the testing failure, but takes away from the project budget and schedule due to resourcing time & money to complete the inspection prior to launch.

Proceed with Development

Redesign & Delay

Significant delays in the schedule, but patient safety is improved for the device. Budget loss due to resourcing for redesign.

Proceed with Development

Launch Anyway

Significant decrease in device safety for use with patients.

Proceed with Development

Leadership Pressure!

The CEO of your company sits in on your project meeting. He says the hospital launch date CANNOT slip. You must protect two areas...but one must take a hit.

Which will you sacrifice?

Protect Safety & Schedule -> Sacrifice Budget

Emergency testing is done, production works overtime, and supplier rush fees to ensure project is delivered safely and on time. Leadership questions the overspend.

Protect Safety & Budget -> Sacrifice Schedule

The launch is delayed. Hospitals are frustrated. But the product is safer.

Protect Schedule & Budget -> Sacrifice Safety

The device launches on time and under budget! But field complaints begin to rise. A patient is injured. Investigation begins.

SUCCESSFUL LAUNCH

The device launches safely. The patients receive treatment. You balanced risk, cost, and time. Congrats! This is why project engineering matters! Project engineers live in this space every day. There's rarely a perfect answer - only the most responsible one.

restart

FAILED LAUNCH

The project collapsed. Either safety, budget, or schedule fell too far. Ignoring safety risks is how recalls happen, and how companies lose trust. This is why project engineering matters! Project engineers live in this space every day. There's rarely a perfect answer - only the most responsible one.

restart