1. P18044 – Tremor Mitigation Device 2
Phase 2- Systems Design Review
We will happily take questions throughout
Marie

2. Agenda Team (re)introductions
Narrowed scope of project – problem statement
Team Vision for Phase 2
Updates to phase 1 documents
Customer requirements, Engineering requirements, House of quality, Risk assessment
Functional decomposition
Alternatives considered (concept development)
Bench marking
Predicate device testing - outcome
Patent research, market research and outcomes
Feasibility analysis and outcomes
Morphological chart – concept generation
Pugh chart – concept selection
System level design proposal
Systems architecture
Design flow charts
Goals and vision for phase 3
Proposed engineering test plan
Draft of project plan for phase 3
Marie

3. Team introductions – some old and some new
Everyone- Share your Name, Major, Team Role

4. Phase 1 Problem Statement
A tremor mitigation device is a wearable assistive medical device that helps to control the patient's involuntary rhythmic muscle movement.
Specifically, the device should diminish the intensity of the tremors and augment the patient's ability to perform daily tasks.
Currently, prototypes include a proof of concept device with a testing platform for the integrated system.
The prototype in place lacks some features and functionality that limit the device's readiness for implementation.
The efficacy of the device should be improved, specifically determining and refining the sensitivity of the system and addressing a wider range of movements.
Drew

5. Agreed Upon Project Scope Modification
 Being aware the we were operating in parallel with DAQ and test arm team
Ruled out active EMG signal analysis to perform electrical or vibrational stimulation to limit tremor (out of scope w.r.t. time)
Address a less severe case of essential tremor
Manifesting mostly from the elbow down, not the shoulder down
Ashley

6. Phase 2 Highlights
Defined a narrowed project scope and agreed upon scope changes with customer and guide. Updated engineering requirements, customer requirements, house of quality, and risk documents.
Went to Strong Deep Brain Stimulation Clinic, got more insight into clinical aspects of essential tremor.
Brainstormed concepts for device functions as defined by functional decomposition generated in this phase.
Performed feasibility analysis, benchmarking, and patent research to select final concept(s).
Generated system architecture document, control system and electrical flow charts, and drafted and engineering test plan for the next phase.
Generated a project plan, team, and personal goals for the next phase.
Spoke with Dr. DeBartolo – IRB from applies to our team
Marie

7. Updates to Customer Requirements
Ashley

8. Updates to Engineering Requirements
Dan

9. Updates to House of Quality
Dan

10. Updates to Risk Assessment – Technical Risks
Nick

11. Updates to Risk Assessment – Resource Risks
Thomas

12. Updates to Risk Assessment – Safety and Environmental Risks
Ashley

13. Functional Decomposition ( Flow of Energy and Information)
Dan

14. Functional Decomposition (Break down of sub-functions)
Marie -- Each of our sub functions ties back to an engineering requirement

15. Effectiveness vs. Comfort Concept
Drew

16. Alternatives Considered (Concept Development)
Ashley

17. Benchmarking
Nick

18. Preliminary Predicate Device Testing
Testing with 9-DOF sensor
Thomas

19. Patent Research Concepts removed based on patent and market research:
Gyroscopes
Raised mass dampers
Power springs and dashpots
Mechanical governor
Nerve stimulation
Nick

20. Feasibility Research– Linear actuator
Ruled out based on:
High weight of components
High cost of components
High power draw
Low speed actuators
Drew

21. Power Block Feasibility Analysis
Thomas
iPhone 7+ battery capacity is 2900 mAh
 Time to recharge battery from dead to full with 2 A current draw will take roughly 2 hours

22. Batman Material
A soft material that becomes rigid when a voltage is applied to the material.
Hydrogel based material that would act like an actuator or claw when electrically stimulated (not a wearable fabric).
Precious metal based substance with tunable material properties by application and manipulation of an electric potential (not feasible based on cost, availability)
Proprietary material by SRI international (not feasible base don availability)
Marie

23. Feasibility Analysis – MR Fluid
Research
Ashley

24. MR Fluid Testing
Dan

25. Morphological Chart – Concept Generation
Nick

26. Generated Concepts
Nick

27. Pugh Chart – Concept Selection
Nick

28. System Design Proposal
“Concept 5”
Fabric with inner lines of rubber / silicone
Brace construct
May go to upper arm with exposed elbow
Power on with switch
Sensor components are accelerometer with or without a flex sensor
Active damping by magnetic braking
Passing damping by selective banding (depending on outcomes of testing)
Powered with a rechargeable battery
Power block for energy transfer stored on belt
Active control logic with microcontroller
Nick

29. Concept Sketch and Simulation Tool
Dan

30. Systems Architecture
Drew - IDENTIFYING MAJOR SUBSYSTEMS

31. Design Flow Chart – Electric System
Thomas

32. Design Flow Chart - Microcontroller
Drew

33. Goals and Vision for Phase 3 Review
Prototyping, Engineering Analysis, Simulation, and Feasibility Analysis
Sensitivity analysis, updated concept selection, PQT spread sheet*
Engineering test plan report
Design file hierarchy and design flow charts
Software design plan
Parts list, Bill of Materials, Budget Plan
All deliverables up on edge!
*PQT = Spread sheet containing design parameters, quantified targets, and acceptable tolerance limits
Marie

34. Proposed Engineering Test Plan for Phase 3
Marie

35. Quantitative testing with John Thomas
Type 1 – displacement video analysis
Quickly obtain baseline frequency and amplitude data
Concept obtained from searching through national physiological signal samples database for signal analysis feasibility testing
Dan

36. Quantitative testing with John Thomas
Type 2 – selective banding Assumption: Asymmetrical tremor magnitude
Dan

37. Draft of Phase 3 Project Plan
Marie

38. Draft of Phase 3 Project Plan
Marie

39. Lessons Learned from Phase 2
Get detailed quickly
Generate documentation early in phase to leave time for edits and EDGE
Order materials early on
Test concepts early to determine if theory is feasible
Take more pictures
Ashley

40. Any more questions?
Dan