Advancing Medical Devices by Capturing the Sense of Touch. MD&M West 2017 February 7, 2017 Jae Son, Ph.D. - Founder & CEO

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2 Advancing Medical Devices by Capturing the Sense of Touch MD&M West 2017 February 7, 2017 Jae Son, Ph.D. - Founder & CEO

3 Importance of Touch in Medicine 400 B.C. Hippocrates physical exams to detect hardening or pain Over 2000 years ago The Yellow Emperor s Classic of Internal Medicine physical exam and pulse measurement

4 What is Touch? Touch has been redefined by electronics Sense of Touch includes Tactile, Shear, Temperature, Vibration & Moisture Touching is the ultimate expression of closeness between two people.

5 Outline Capacitive Tactile Sensing Basics Tactile Sensor Evolution Improving Products with Tactile Sensors Products Using Tactile Sensors Blood Pressure Application

6 Capacitive Tactile Sensing Basics

7 Pressure, Force &Tactile Pressure Omnidirectional Scalar Force One direction Vector Tactile Multi-DOF Surface

8 Understanding Tactile Fundamentals Contact Area Air Pressure Piston Force Plate Object Piston Contact Pressures

9 Capacitive Tactile Sensing What is a Capacitor?

10 Capacitive Tactile Sensor Arrays Two electrodes form capacitor that measures pressure Capacitors arranged as individual elements or matrix arrays Flexible. Sensitive. Stable.

11 PPS Capacitive Tactile Sensor Evolution

12 1996 University to DARAP R&D Grasping with tactile sensors Capturing what a surgeon does for surgical simulators

13 Tactile Glove Evolution C500 ConTacts FingerTPS Tactile Glove Analog voltage out Single Element Sensors Molded to finger tip shape Finger cot over the sensor Bluetooth wireless Single Element Sensors 6 sensors per hand Not integrated into a glove BTLE Array Sensors 53 elements per hand Integrated into a glove

14 Tactile Glove Data

15 Tactile Glove

16 Sensor Materials CONFORMABLE Conductive Cloth Moldable and Sensitive STRETCHABLE Stretches 10% without artifacts Thicker, simpler geometries INDUSTRIAL High temperatures and pressures Very thin Copper-clad Polyimide HYBRID Conductive cloth + FPCB base Can integrate electronics

17 Full Scale Range (FSR) Fine Mist Pattern & Spray Pressure Sensing Human Body Motion Industrial Manufacturing < 1 PSI 5 PSI 80 PSI 700 PSI Wearable Technology Fit and Form Automotive

18 Geometry and Connectivity Distributed tactile pressure measurements USB mm x 1.5 mm finest spatial resolution 1,024 elements per electronics, 8,192 max All sensor materials Embeddable OEM-based sensors SPI or I2C for integration, Bluetooth wireless or USB out for simple PC/tablet interface 1 mm x 1 mm finest spatial resolution Up to 240 elements(16 x 15 array) Industrial and hybrid sensor materials Recently achieved SNR > 2,000

19 SingleTact Miniature Force Sensors

20 Tactile Sensing Comparison Capacitive (PPS) Resistive Construction Conductive material separated by compressible dielectric Resistive ink printed on membrane Sensitivity Excellent Fair Repeatability Excellent Poor Number of Elements Good Excellent Design Flexibility Excellent Fair Speed Fair Excellent Temperature Stability Excellent Fair

21 R&D and Improving Products with Tactile Sensors From Head to Toe

22 Head Comfort Pressure Mapping Need: Pressure mapping of hearing protector on headform Challenge: Low pressure, high spatial resolution sensor mounted on curved surface Product Benefits: Validated hearing protector designs provided adequate seal when adjusted for comfort

23 Bra Pressure Measurement Need: New standard for bra comfort and fit testing Challenge: Low pressures, 1,764 pressure-sensing elements, high accuracy, minimally intrusive integration Product Benefits: Quantitative approach to test comfort and fit while developing next-generation products

24 Diaper Seal Measurement Need: Develop leak proof diapers that are comfortable Challenge: Low pressures, flexible to mount on articulating mannequins, minimally intrusive integration Product Benefits: Product development tool in accessing fit

25 Mannequin Projects Protective Gear product development Pat-Down Mannequin for Security Training Tactile Sensors for Ultrasound Training

26 Waterproof Insole Tactile Sensors

27 Medical Products Using Tactile Sensors

28 Tools for Medical Device R&D Tracheostomy Tubes Knee Joint Study Fit and ergonomics of prosthetics Eyelid Pressure Hand-Assisted Laparoscopic Surgery Copyright 2016 by PPS 28

29 Manometric Assessment Need: Faster, simpler exams to replace long, uncomfortable procedure & analysis Challenge: 36 sensors in a ¼ catheter, Accuracy, Thermal Stability Product Benefits: Improved state-ofthe-art by factor of 10, dominated market, acquired by Medtronic

30 SureTouch Breast Exam Need: Breast cancer screening that women love Challenge: New product class, medical regulations, sensor geometry, reliability, system robustness, Time Product Benefits: Radiation and pain free. FDA cleared and Clinically validated effective screening tool Awards:

31 Need: esoles 3D TruCapture Kiosk Automate the custom insole orthotic fabrication process Challenge: 3D scanner, Large Tactile Sensor, Advanced algorithms, System engineering, Reliability Product Benefits: Dramatically reduced return/refit rate

32 SmartTouch Artery Finder Need: Needle-stick injuries & multiple punctures specifically for arterial puncture Challenge: High-resolution (0.7mm) sensor, Algorithms to reliably finding the artery Product Benefits: Personal protection equipment that maximizes first-attempt success rate

33 BP

34 Blood Pressure and Health Cardiovascular disease (CVD) is the leading cause of death worldwide (1) Human Life Cost of CVD 17.5 million, or 31% of all global deaths (1) Economic Cost of CVD $1,044 BILLION $863 BILLION (4) (1)

35 Blood Pressure vs. Pulse Pressure Pulse Pressure (mmhg) Potential Pulse Pressure Ranges High (>60-70 mmhg) Atherosclerosis, hypertension, diabetes, CVD, CAD, hypertrophy Normal (30-50 mmhg) Can vary for certain individual (i.e. athlete, short) Low (<20-30 mmhg) Blood loss, Heart Failure, Shock, Stenosis, Tamponade Pulse Pressure (mmhg) Ex. Men over age 50 with PP>70mmHg had 3X more coronary heart disease risk than men with PP<50mmHg. (Assman 2009)

36 % increased risk for cardiovascular DEATH Pulse Pressure and Death (Figure adapted from Bangalore ,576 CAD patients with essential hypertension > 50 years (avg 66+/- 10 years), mean follow-up 2.7 years)

37 Current BP Measurement Methods

38 Tactile Sensor vs. Cuff Pressure at the device is only ~3mmHg 3 feet Sensor close and over artery Provides Tactile BP waveform of 30mmHg to obtain PP

39 Tactile Blood Pressure Need: Hypertension is the number one risk factor for premature death worldwide Challenge: Integration into a wristband, Algorithm with mechanical artifact rejection Product Benefits: Simple way to check arterial health with a wearable device

40 What if...

41 plug & play sensor evaluation kits Thank You. Questions? Customized and OEM solutions Jae Son, Ph.D