1. P18325: Automated Breast Pump Cleaning System (Team ABC’s)
Angelo Vitelli, Kyla Driver, Christopher Swider, Yohance Basdeo, Jake Kremer, Meg Froehlich, Rachel Wu
Angelo

2. Agenda Who we are Background info Problem statement and deliverables
Use-Scenarios
Customer Requirements
Engineering Requirements
Risk Management
Project Plan
Angelo <3
These are the deliverables that we worked on through Phase I

3. Team - ABC’s Team Member Role Major Angelo Vitelli
Project Manager & Communication
ISE
Kyla Driver
Purchasing & Budgeting
BME
Christopher Swider
Integration Engineer & EDGE Facilitator EE
Yohance Basdeo
Lead Electrical Engineer
Jake Kremer
Lead Mechanical Engineer
MECE
Meg Froehlich
Facilitator & Notetaker
Rachel Wu
Research & Development Engineer
Angelo

4. Project Background Infants are becoming sick from contaminated milk.
NICU babies are more at risk from necrotizing enterocolitis, a disease that affects the intestines and is often fatal.
Parents are not adequately cleaning and sterilizing their breast pumps.
There is no unified system that does everything.
Mothers have a lot do worry about when their baby is born
Chris
Germs and bacteria can grow in uncleaned pump parts.
Proper cleaning involves rinsing, washing with hot soapy water, let the parts air dry. Can be accomplished by putting parts in a dishwasher.
Proper sterilization involves boiling water – takes long and is difficult
There doesn’t exist a dedicated system to clean and sterilize breast pump parts.

5. PROJECT STATEMENT Current State Project Goals Constraints
Desired State
Rachel

6. Current & Desired State
Current State
Systems Availability
Various Procedures
Cleaning
Sterilizing
Standard
FDA & CDC
Pump types
Manual
Automated
Hospital grade
Usage
Hospital
Home
Work .
Fully functional system that cleans and sterilizes different types of pumps
Possibly with other baby items such as pacifiers and bottles.
Desired State
Rachel
Cleaning - Hand-washed/Dishwasher
Sterilizing - Not done - Procedure is to put in boiling water, or use microwave bags
Standard - FDA/CDC but few parents follow them

7. Existing Technologies
No formal procedure and specific product
Currently Used Methods
Electric Sterilizer
Microwave bags
Dishwasher
Hand wipes
Rachel
Bottle brushes

8. Project Goals & Constraints
Create an automated cleaning & sterilization system for breast pumps.
Safe
Cost Effective
Easy to Use
Reliable
Constraints
Follow CDC, FDA and ISO guidelines
Testing
Budget
Timing
Safety Requirements
Kyla
Cleaning - Hand-washed/Dishwasher
Sterilizing - Not done - Procedure is to put in boiling water, or use microwave bags
Standard - FDA/CDC but few parents follow them

9. Project Deliverables
Working prototype that can be used in the NICU with the possibility of future use for mothers at home or work
Test to verify that system cleans pump effectively
Optional use with more than one type of pump
Follows guidelines set by ISO to be approved for hospital use
User guide for operation
Kyla
Client vs group management?

10. Stakeholders Dr. Casey Rosen-Carole (Customer) Parents
Insurance companies
Hospital (University of Rochester)
RIT MSD Team Guides
Manufacturing companies
Yohance

11. Use-Scenario
Use in NICU
Issues with System
Yohance

12. Risk Management Likelihood Rank Average: Technical: 7/9
Resource: 4.5/9
Safety: 5.33/9
Environmental & Social: 2.33/9
Severity Rank Average:
Technical: 2.33/9
Resource: 2.5/9
Safety: 2.33/9
Environmental & Social: 4.33/9
Importance Rank Average:
Technical: 4.33/9
Resource: 5/9
Safety: 5.6/9
Environmental & Social: 3.33/9
Meg

13. Customer Requirements
Meg

14. Engineering Requirements
Jake

15. Requirements Matrix
Jake

16. Priority Safe: Device must not harm the user. Ever.
Easy to Use: Using this device is supposed to relieve stress, not give it.
Reliable: If it doesn’t do its job, what use it is?
Cost Effective: Cost is important but the other requirements outshine it (just a little).
Jake

17. Draft Plan, Results, and Next Steps

19. Angelo

20. Next Steps Systems Design (Starts 2/6) Functional analysis
Concept Generation
Engineering Analysis
Experimentation, teardown, analysis
First order modeling, analysis, and simulation
February 27th SDR (System Design Review)
Detailed Design & Component Selection (Starts 3/6)
Detailed Design
End state deliverables → Requirements flow-down to subsystems
POC (Proof-of-concept)
Analysis, simulation, prototyping
April 24th Final DDR (Detailed Design Review)
Angelo
Systems design:
Drawings, teardown, analysis of the current parts and what we will need
Detailed Design
More in depth breakdown, subsystems of the product, proof of concept → ensuring the prototype has being tested
Talk about our plan on how to achieve them as well

21. Questions?