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

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

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

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

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

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 17044 applies to our team Marie

Updates to Customer Requirements Ashley

Updates to Engineering Requirements Dan

Updates to House of Quality Dan

Updates to Risk Assessment – Technical Risks Nick

Updates to Risk Assessment – Resource Risks Thomas

Updates to Risk Assessment – Safety and Environmental Risks Ashley

Functional Decomposition ( Flow of Energy and Information) Dan

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

Effectiveness vs. Comfort Concept Drew

Alternatives Considered (Concept Development) Ashley

Benchmarking Nick

Preliminary Predicate Device Testing Testing with 9-DOF sensor Thomas

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

Feasibility Research– Linear actuator Ruled out based on: High weight of components High cost of components High power draw Low speed actuators Drew https://www.ultramotion.com/wp-content/uploads/2014/12/inline-linear-actuator-d1.jpg

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

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

Feasibility Analysis – MR Fluid Research Ashley

MR Fluid Testing Dan

Morphological Chart – Concept Generation Nick

Generated Concepts Nick

Pugh Chart – Concept Selection Nick

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

Concept Sketch and Simulation Tool Dan

Systems Architecture Drew - IDENTIFYING MAJOR SUBSYSTEMS

Design Flow Chart – Electric System Thomas

Design Flow Chart - Microcontroller Drew

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

Proposed Engineering Test Plan for Phase 3 Marie

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

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

Draft of Phase 3 Project Plan Marie

Draft of Phase 3 Project Plan Marie

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

Any more questions? Dan