1. Marcos Esterman, Associate Professor Industrial and Systems Engineering Department Rochester Institute of Technology marcos.esterman@rit.edu Multidisciplinary Senior Design I Problem Definition

2. Agenda Some Introductory Comments Expected Outcomes by the End of Week 3  Clearly defined and agreed upon problem statement & project deliverables  Prioritized list of needs  Use scenarios  Engineering Requirements  Draft of project plan Tools & processes to develop expected outcomes EDGE/SVN Tutorial

3. WHAT IS THE DESIGN PROCESS?

4. What you should walk away with… Detailed Design is about solving the correct problem  Elegant solutions to problems people don’t care about are meaningless  1 st 3-weeks are about asking the right questions Solution exploration is both divergent & convergent  Think ‘inside’ and ‘outside’ the box  Iterate, iterate, iterate  Float between needs, specification & solutions Most importantly, trust & work the process

5. Design Process: Take 1 Possible Solutions Less than Satisfied “Undesired” Performance “Desired” Performance Needs Problems Qualitative System Response Variables Quantitative Specifications System Functions Concept Selection Detail Design Target Specs Final Specs Achieved & Validated Specs Original Hardware Artifact Improved Hardware Artifact

6. Design Process: Take 1 Possible Solutions Less than Satisfied “Undesired” Performance “Desired” Performance Needs Problems Qualitative System Response Variables Quantitative Specifications System Functions Concept Selection Detail Design Target Specs Final Specs Achieved & Validated Specs Original Hardware Artifact Improved Hardware Artifact Qualitative Problem Space Quantitative Problem Space Physical Solution Space

7. Qualitative Problem Space Quantitative Problem Space Physical Solution Space Design Process: Take 1 (cont.) Key Take-Away: MSD Needs to be Event Driven We are Establishing a 3-week cadence for events So that you can finish in 32 Weeks!

8. The Design Process: Take 2 Finished Prototype! Concept Design Subsystem Design Subsystem Design Needs & Problems Modeling & Analysis Modeling & Analysis Modeling & Analysis Troubleshooting = PDCA

9. Let’s Begin the Journey!

10. PROBLEM STATEMENT & PROJECT DELIVERABLES

11. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes to much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market.

12. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy(?) efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Current State

13. P13026 Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Desired State

14. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Project Goals & Key Deliverables

15. P13026 Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy(?) efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market. Key Constraints

16. HOW DID WE GET THERE?

17. Project Overview (Directly from PRP) The PEV (Portable Emergency Ventilator) is a life supporting device which quickly and efficiently provides positive pressure ventilation for a non-breathing patient. It is a contaminant free resuscitator that eliminates mouth-to-mouth procedures while permitting life saving treatment for shock, cardiac arrest, heart attack, drug overdose, drowning, smoke inhalation, and other respiratory trauma. Emergency personnel equipped with the PEV have the opportunity to vastly improve a person’s chance of survival and avoid brain damage. Additionally PEV can be used as patient’s transport ventilator for aviation and ground transportation. Currently the existing PEV utilizes analog circuitry, and the most advanced developments in airflow sensing techniques to produce an innovative, life-saving device. By replacing imprecise mouth-to-mouth resuscitation, it provides clean, filtered air and automatically regulates flow and pressure to suit a victim's critical needs. Additionally, the PEV’s unique “CPR mode” eliminates direct patient-rescuer contact, thereby reducing the chances of transmitting communicable diseases. Working prototypes were built and tested successfully thus enabling to receive FDA “Permission to Market” status. In addition to military applications, the PEV can be effectively used in hospitals, clinics, emergency and security vehicles as well as private homes. The Project is based on US patents entitled Portable Emergency Respirator #5,211,170 and # 5,398,676 authored by Roman Press and Jeff Gutterman and their FDA 510K approval to manufacture and market the device. A full working prototype of the ventilator based on now outdated technology serves as a useful example and inspiration for a revised and updated model. The product has a number of unique features including a CPR mode which allows the machine to work in synch with a person administering CPR and an integral sterilizer to provide clean air without any biological contaminations. The goal of the proposed project is the creation of light weight state-of-the-art digital electronic PEV version. This multidisciplinary project can create a positive RIT image as a new technology developer, and may potentially prove to be financially advantageous to RIT as well.

18. Portable Emergency Ventilator (PEV): Current State Current PEV Problems/ Undesired State Desired Attributes Assist Unresponsive Patient to Breathe Integrate into the CPR Process It must not interfere with the administration of life-saving measures It must be portable Out Dated Technology As a team, take 10 minutes to identify the Desired Attributes and the Undesired States

19. Team Problem Statement (from EDGE) A Portable Emergency Ventilator (PEV) is a device that can provide positive pressure ventilation to a person who is incapable of breathing on their own. This device can eliminate the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device can also be used when transporting patients or in home use when a large ventilator is too expensive and impractical. This project focuses on improving a PEV developed in the early 1990s by Jeff Gutterman and Roman Press (shown on right below). The goal of this project is to update the model using technology available today by making it lighter, more efficient, easier to use, and provide more feedback. The expected end result is a functional prototype (shown on left below) which can be marketed to companies and be manufactured.

20. Modified Problem Statement A Portable Emergency Ventilator (PEV) is a completely untethered device that assists a person to breathe who is incapable of breathing on their own. This device also eliminates the need for mouth-to-mouth resuscitation used by first responders during CPR, thus drastically eliminating the spread of diseases. The device should not interfere with first responders’ abilities to administer life-saving measures. A prototype was developed in 1990 that is too heavy, consumes too much energy and is not easy to use. The goals of this project are to analyze the current design and the patent database to identify opportunities to make the device lighter, more energy efficient, easier to use, and to provide more feedback and control to the user. The expected end result is a functional prototype which can be marketed to companies and ultimately be manufactured. The resulting design and prototype need to be consistent with the intellectual property and FDA approvals that have been granted to the stakeholders in order for them to have a competitive advantage in the market.

21. 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

22. Recap A good problem statement contains  A description of the current state  A vision of the desired state  Key goals and deliverables  Key constraints

23. NEEDS ELICITATION

24. Desired Needs List NeedPriority Have a modern look and feel 3 Is Light weight 3 Is Small 3 Is Easy to Use 9 Has Long-Lasting Portable Power 9 Low Cost Functional Prototype 3 Low UMC for Final Design 9 Alert user of the following data: XXX 9 Measure Oxygen Levels 3 Measure CO 2 Levels 3 Transfer Data Wirelessly 9 Assist Human to Breathe 9 Integrates into CPR Process 9 Does not interfere with the following life-saving measures: XXX 9 Improves air quality delivered to patient 9 Is safe 9 Is reliable 9 Needs to use principles in patents #5,211,170 and # 5,398,676 9 Needs to be consistent with FDA 510K Approval 9

25. Goals of Needs Identification Provide basis for PD decisions Elicit needs that may not be so obvious Provide basis for specifications Ensure critical needs are elicited Develop a common understanding of the needs Archiving of needs Ulrich,K.T. and S. Eppinger, Product Design and Development, Third Edition, 2004 25

26. Steps in Identifying Customer Needs Gather the raw data Interpret the raw data Organize the needs Establish relative importance of needs Sanity Check! Ulrich,K.T. and S. Eppinger, Product Design and Development, Third Edition, 2004 26

27. Identify the Stakeholders 27

28. Identify the Stakeholders Unresponsive person By-standers First Responders FDA Hospitals Home Users Insurance Companies Ambulance Service Doctors/Ultimate Care- takers Inventors RIT MSD MSD Team Investors? 28

29. Methods for Gathering Raw Data Brainstorming  Method best suited for your projects Interviews  1-on-1  Dialog Directly w/Company personnel Focus Groups  8-12 People (Typically Paid)  Moderator  Company personnel observe group Observing the Product in Use  Direct Observation (Contextual Inquiry)  Virtual Observation Benchmarking Use Cases  Task Oriented  Simulate and document the steps to accomplish the task Ulrich,K.T. and S. Eppinger, Product Design and Development, Third Edition, 2004 29

30. Raw Data Used for P13026 PRP Interviews of  Inventors  EMTs RIT Student External Benchmarking  Other PEVs  PTO

31. Eliciting Customer Needs Prepare an interview guide Elicit dialog on a particular task or problem  Have them walk through a specific instance Don’t ask them to generalize! Better yet, have them show you Go with the flow Use visual stimuli and props Avoid leading questions  Avoid yes/no questions  Be prepared for latent needs Focus on the customer pain  What’s the underlying problem that needs to be solved Document, Document, Document 31

32. What a team should know after the customer interview What is (are)…  project about? the problem? the opportunity? deliverables? constraints? Why…  are we doing this? motivation? Higher level goals (profit, productivity, etc.)? commercialization? When…  key milestones? time constraints? is client available and not available? (& how) interact with the client? Who is (are)…  Is client? Stakeholders? Approves? Funds? Uses? How…  Be careful here, how’s are not needs, but you should understand client’s preconceived notions about the solution

33. Developing Needs Statements: Guidelines for Interpreting the Data Understand the value proposition  Your product is solving some problems What are they? What value do you allow your customer to deliver? Stay close to the customer language What, not how Specificity equal to the raw data Positive, not negative Product Attribute Avoid “must” & “should” Ulrich,K.T. and S. Eppinger, Product Design and Development, Third Edition, 2004 33

34. Team’s Cut at Needs NeedPriority Design Similarity3 Maintain Portability3 Include Audio Feedback3 Optimize Battery Life3 Replaceable Batteries3 Minimize Expense3 Display Relevant Data3 Measure Oxygen Levels2 Measure CO 2 Levels2 Transfer Data Wirelessly1 3 – Must Have; 2 – Nice to Have ; 1 – Preference Only

35. Establish Relative Importance of Needs: Development Team Consensus RatingWeight Very Important9 Important3 Somewhat Important1 35

36. Sanity Check Did you miss any key stakeholders? Are there any areas that you need to follow- up on or get more information? What do we know now that we didn’t before? Surprises? 36

37. USE SCENARIOS

38. Unresponsive patient, heart beating but not breathing

39. Step 1: Identify Scenarios 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

40. Step 2: Think Through Process Steps

41. Step 3: Create Workflow Map

42. WRAP-UP

43. Homework Revisit/refine problem statement Prepare for customer interview  understand objectives, constraints, assumptions; needs and relative importance EDGE/SVN tutorial with embedded questions to answer Update project website on EDGE  by Thurs 8/29 at 8am  problem statement, questions posted for customer. Read PRP for P13026

44. At least show draft project schedule Show draft project schedule  Note that there will be a session in week 2 on this Direct to website with all of the examples Homework expectations Hand over to Beth