1. Multidisciplinary Senior Design I
Problem Definition Review Preparation

2. Agenda Questions to be Answered by the Problem Review
Goals of the Problem Definition Review
Mechanics of the Review
An Example

3. Questions to be Answered
What is the current state and why is it unacceptable?
What does the desired state look like?
Who are the stakeholders that benefit from the desired state?
What are those benefits (can be qualitative or quantitative)?
What stakeholders can be negatively impacted by the desired state?
What are the limits of those negative impacts (can be qualitative or quantitative)?
How will your system be used by stakeholders?
What are quantifiable responses (engineering requirements) that your system must produce?
Do you have a project plan (objectives, key milestones, responsibilities) that your team, Guide, and Customer agree to?
What are some systems that already do (or are similar to) what you want to do?
How do these (similar) systems compare to the desired state? What can you learn/borrow from them? Where should they be improved?

4. Goals of the Problem Definition Review
Demonstrate that your team can answer the questions posed by:
Clearly defined and agreed upon problem statement & project deliverables
Prioritized list of Customer requirements
Engineering requirements
Use scenarios
Draft of project plan
Identify any gaps that exist between your ability to meet the above goal and your actual state
Be honest (Don’t try to BS)
Show your action plan to close gap by next review

5. Mechanics of the Review

6. P13026: Portable Ventilator
Derek Zielinski
Chris Freeman
Melissa Harrison
Ryan Muckel
Roberto Castilla Zavala
Daniel Fenton
Kennedy Kong
Marie Revekant
David Engell
Eric Welch

7. Agenda Introduce Team Project Background
Problem statement & project deliverables
Use scenarios
Prioritized list of needs (customer rqmts)
Engineering requirements
Draft of project plan

8. Team Introduction & Roles

9. Current Product- Mediresp III
Provide positive pressure ventilation
3 modes:
CMV (constant mandatory ventilation)
Assist
CPR
Manual
Large and heavy
2-4 hour battery life
FDA approval
Patented
Contains BVM backup

10. What is a PEV?
A Portable Emergency Ventilator (PEV) is a device that can provide mechanical ventilation to a person who is incapable of breathing on their own
Volume controlled
Pressure controlled
Spontaneously controlled
Negative pressure controlled

11. PEV Theory of Operation
Pressure controlled cycling is based on an applied positive pressure that is set by the clinician. In pressure controlled modes the total volume is variable as the ventilator is using only the pressure as a measurement for cycling.

12. P13026 Problem Statement Current State Desired State Project Goals
A prototype was developed in 1990 that is too heavy, consumes to much energy and is not easy to use.
Desired State
The device should not interfere with first responders’ abilities to administer life-saving measures.
A functional prototype which can be marketed to companies and ultimately be manufactured
Project Goals
Analyze the current design and the patent database
Identify opportunities
lighter
more energy efficient
easier to use
more feedback and control to the user
Constraints
Consistent with the intellectual property and FDA approvals

13. Additional Project Deliverables
Functional prototype which can be marketed to companies and can be the basis for a product that will ultimately be manufactured
Appropriate design, test, manufacturing and supply chain documentation to support transition to a manufactured product
Test data verifying correct operation
Designs alternatives
Other possible configurations
Other possible use environments
User’s guide for operation

14. P13026 Stakeholders
I need to put this is pretty graphic

15. Use Scenarios Considered
Scenario 1: Unresponsive patient, heart beating but not breathing – PEV assist and transport to hospital
Scenario 2: Unresponsive patient, heart beating but not breathing – PEV assist and administer life-saving measure X
Scenario 3: Unresponsive patient, heart not beating and not breathing – PEV assist and CPR

16. Unresponsive patient, heart beating but not breathing

17. P13026 Needs List Need Priority Have a modern look and feel 3 3
Is Light weight
Is Small
Is Easy to Use  9
Has Long-Lasting Portable Power
Low Cost Functional Prototype
Low UMC for Final Design
Alert user of the following data: XXX
Measure Oxygen Levels
Measure CO2 Levels
Transfer Data Wirelessly
Assist Human to Breathe
Integrates into CPR Process
Does not interfere with the following life-saving measures: XXX
Improves air quality delivered to patient
Is safe
Is reliable
Needs to use principles in patents #5,211,170 and # 5,398,676
Needs to be consistent with FDA 510K Approval
Ed, there is no way to sugar coat this, the needs list was terrible. This is a start, we need to rework the list

18. Key Performance Metrics
Talk about value (coverage and avoid redundancy)

19. P13026 Engineering Requirements
Talk about value (coverage and avoid redundancy)

20. P13026 Preliminary Schedule

21. P13026 Preliminary Schedule

22. Issue & Corrective Actions
Please highlight any gaps
Identify action plans to close them