Medical devices vs 6 Cardinal Health 12.4 6 Broadcom 15.5 6 - PDF document

2019/2/26 Context Challenges in the Design of Integrated Circuits for Wireless Power Delivery • Medical devices vs Semiconductors industries and Information Transfer in • How to develop a medical instrument, equipment, or device Implantable Medical Applications • Design considerations of a transceiver used for implemented medical device • The possible application and research directions of the Wireless Zhihua Wang, IEEE Fellow Transceiver Institute of Microelectronics, Tsinghua University • Wireless Power Transfer for Miniaturized Medical Devices Mobile/WeChat: +86 13501703 Mail: Zhihua@Tsinghua.edu.cn The total market size of the medical device industry is similar to that of Top Medical Devices and Semiconductor Companies in 2017 Rank Medical Device US$ B Rank Semiconductor US$ B 1 Medtronic plc 28.8 1 Samsung Electronics 61.2 the information industry 2 Johnson & Johnson 25.1 2 Intel 57.7 3 GE Healthcare 18.3 3 SK Hynix 26.3 4 Siemens Healthineers 15.2 4 Micron Technology 23.1 5 Becton Dickinson 12.5 5 Qualcomm 17.1 Medical devices vs 6 Cardinal Health 12.4 6 Broadcom 15.5 6 Philips HealthTech 12.4 7 Texas Instruments 13.8 Semiconductors industries 8 Stryker 11.3 8 Toshiba 12.8 9 Baxter 10.2 9 Western Digital 9.2 10 Abbott Laboratories 10.1 10 NXP 8.7 Similar annual sales of top 20 companies , but different in … Sub total 156.3 Sub Total 245.3 Others 232.8 Others 174.4 Total Market 389.1 Total Market 419.7 Sales in US exceed 60% China’s imports more than 60% A single enterprise in the medical device The market et or medic ical al devic ices es is still l large e enoug ugh industry is smaller than the information industry CRO ： Contract Research in millions US$ Pharmaceutical factory Medical equipment factory Dealer Hospital, clinic Dealer 250,000 233,715 Organization 229,234 药厂 医疗器械药厂 经销商 医院、诊所 病人 Apple Revenue 委托、合同（临床）研究机构 215,639 Intel Revenue 市场空间 15000 亿 RMB 市场空间 530 亿 RMB 市场空间 29000 亿 RMB Medtronic Revenue 200,000 182,795 CMO ： Contract Chemical and biological CSO ： Contract Sales Physical Examination Center Dealer Medical equipment/Devices Sonova Holding AG 170,910 基本 Manufacturing Organization medicine Organization Medical center 医疗设备、装置、器械 156,508 化学药、生物药 体检中心、医学中心 委托、合同（临床）生产机构 委托、合同销售机构 医疗保险 150,000 支出 10000 亿 RMB 市场空间 110 亿 RMB 市场空间 6450 亿 RMB 市场空间 2070 亿 RMB 市场空间 150 亿 RMB 市场空间 150 亿 RMB API ： Active Pharmaceutical Dealer Traditional Chinese Medical information 108,249 Mobile medical equipment Retail pharmacies Ingredient medicine system 商业 移动医疗设备、装置、器械 零售药店 100,000 原料药 中药 医疗信息系统 医疗保险 市场空间 4200 亿 RMB 62,761 市场空间 5800 亿 RMB 市场空间 8 亿 RMB 市场空间 240 亿 RMB 市场空间 2750 亿 RMB 65,225 支出 1400 亿 RMB 55,870 59,387 55,355 53,999 53,341 52,708 37,491 43,623 Vaccine, blood 42,905 50,000 37,586 Chinese herbal medicine Consumes material Third party diagnosis Online pharmacies products 28,833 29,710 中药材 耗材 第三方诊断 网上药店 20,261 疫苗、血液制品 17,005 14,256 15,392 15,508 16,184 16,590 13,186 1,071 351.27 1,475 1,617 1,620 1,795 1,951 2,035 2,072 2,396 2,646 市场空间 1460 亿 RMB 市场空间 2800 亿 RMB 市场空间 1500 亿 RMB 市场空间 45 亿 RMB 市场空间 70 亿 RMB 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 • Make medical device smarter and smaller Sourec ： CITI ， WIND 6 1

2019/2/26 What is a medical device • An instrument, apparatus, implement, machine, How to develop a medical contrivance, implanted in vitro reagent, or other similar or related article, including a component instrument, equipment, or device part, or accessory which is: • Recognized in the official National Formulary • Intended for use in the diagnosis of disease or other conditions With the Integrated Circuit is Enabling Technology • Intended to affect the structure or any function of the body of man or other animals 7 8 Research and Development of an medical system Classification of medical Devices • Class I: General controls Idea / Large Research Validation Concept Production • Class II: General controls with special controls • infusion pumps, and surgical drapes… • Class III: General controls and premarket approval Design Review • implantable pacemaker, pulse generators, automated external defibrillators … Prototype/ Small Technology Specification Design Verification Product Production Transfer 9 10 A Medical System with Portable and/or Implantable Medical Composition or Development Platform Devices Portable and/or Deep Brain Display / control unit • Communication protocols and modules Implantable Medical Neurostimulator Devices - IMDs • information security • Sensing modules Cochlear implant • Pacing modules • Wireless battery recharge module Controller / Programmer • Lead impedance measurement modules Endoscopic Capsule External Host Devices - • Accelerometer modules EHDs • FW download module • RTC module Gastric stimulator (Terms and Definitions) Others IMDs 11 12 2

2019/2/26 Examples of Portable and/or Implantable Medical A Portable and/or Implantable Device Devices • Electronic implantable medical devices (IMD) are designed to be fully or partially implanted in the human bodies through surgeries[1], and remain in bodies for several hours to several years or even permanently after Total hip replacement capsule endoscopy Robot hand the surgical intervention. What is a Portable and/or Implantable Medical Device? [1] R. Ritter, J. Handwerker, T. Liu, and M. Ortmanns , “Telemetry for Implantable Medical Devices,” IEEE SOLID-STATE CIRCUITS MAGAZINE, vol. 6, Issue. 2, pp. 47-51, Spring 2014. Cochlear implants Total Knee replacement Nerve Stimulator 13 14 About the information security - Mostly at the Enabling Technology is Integrated Circuit system level and implemented in software • Information Sciences: Acquisition μ C processing, Analog Storage Sensor Front ADC Radio Transmission End DSP CIAA policy of (medical and life ) signals Confidentiality Integrity Power management, battery, harvester Accountability Availability 15 16 Well known implemented medical devices in clinical application • cardiac pacemakers, Design considerations of a transceiver • implantable defibrillators, • Cochlear implants, used for implemented medical device • nerve stimulators (Functional Electrical Stimulation-FES), • limb function stimulation, • bladder stimulators, • Sphincter stimulators, • diaphragm stimulators, • implantable infusion pumps, • bio-monitoring devices such as the capsule endoscope. 17 18 3