I am an expert of biomedical engineering.

I am an expert of biomedical engineering. I have exceeded decade years’ experience of medical device research and development.

I have medical physiology expertise and electronic information engineering expertise, and have more than 10 years of practical experience in the industry, familiar with system integration and design planning, and long-term investment in biomedical related equipment and software systems. After many years of experience in production, research and research, I specialize in research and development of practical technical details, specializing in product planning, research and development integration, product practice, R&D management practice, reviewing detailed technology, familiar with international standards and regulatory requirements related to medical equipment, and possessing project leadership management and Technological innovation ability, from EVT, DVT, PR, MP to sales, rapid development of medical equipment that can be certified by medical, can lead the team to develop commercial medical equipment and system equipment.

我的人工智慧(專家系統)研究經歷

我的人工智慧(專家系統)研究經歷如下：

(1). 修習台大資工研究所「專家系統」課程，獲學習成績 92 分。
(2). 使用 CLIPS 程式語言建構「休克(Shock)輔助診斷專家系統」，輔助急診醫學應用。
(3). 發表期刊論文：
Cheng, Y.P.*, & Chou, A. N. G. 2011 April, Bi-level weights sum method for shock diagnosis, Expert Systems with Applications Vol.38 Issue 4, pp. 4497-4504. （SCI, 2017 IF=3.768, Rank=20/132 15.15% in subject categories COMPUTER SCIENCE, ARTIFICIAL INTELLIGENCE）

臨床評估報告 Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.

我在 2018 年公司的 CE 稽核時完成了 Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.的撰寫。因為是最新的修正，連稽核老師也不知道詳細內容，只能要求我方完全按照文件內所要求的內容全部都要寫上去，這真的是艱難的任務，但我還是完成了。

MDR 法規將取代醫療器材指令（Medical Device Directive, MDD, 93/42/EEC）和主動植入式醫療器材指令（Active Implantable Medical Device Directive, AIMD, 90/385/EEC），將原先醫療器材指令整合、升級成法規（Regulation），藉此提高對歐盟成員國的約束力。新法規大幅提升有關醫材認證的規範與限制，例如關於醫材分級便增加至超過 20 條規範，增加醫材追溯性、臨床試驗規範嚴謹度、臨床證據的掌握度與增加上市後的產品安全性與效能監督。

其中，增強臨床評估與臨床證據監管。MDR 要求醫材製造商必須進行臨床性能（performance）研究，依器材風險等級提供其安全性及性能相稱的臨床證據，並收集、保留上市後的臨床資料，以持續評估產品的潛在安全風險。

屬 Class Ⅲ 醫材與植入物，若需進行實質相等性（substantially equivalent）比對也有更嚴格的規定，(1) 僅能與製造者自己生產的設備進行比對；(2) 欲與其他製造商的設備進行相等性比對，雙方必須先簽訂合約方可進行。

Clinical Performance Evaluation Report, MEDDEV 2.71 Rev. 4, 2016.這份報告，並不是一般人就可以寫得，是有規範撰寫人的資格的：

ANSWatch 心律大師 中醫應用

除了量測血壓,HRV,心跳,及心律不整外,最新型的心律大師已兼具脈象分析(卽脈診儀)功能。

雖然心電圖機(ECG或EKG)也可以透過心電訊號量測HRV,但對於心臟打血及血液循環狀況都無法得知。

心律大師利用腕帶內獨家特製的生物感應器(美國,台灣,中國大陸專利),直接測得手橈動脈(卽中醫師把脈處)之血壓波完整的動脈血壓波型,蘊含有多重生理資料,包括心肌收縮打血,大動脈閥(Aortic Valve)開合,二尖瓣膜心閥閉鎖,及周邊血管阻力等。

詳細資訊可參見：心律大師脈象分析

ANSWatch 心律大師介紹

我曾參與心律大師早期在工研院開發時期的研究，後來計畫主持人離開工研院創立台灣科學地公司進行心律大師的開發與販售。

我之前曾協助推廣心律大師，特別建立一個專業的部落格 HRV and ANS 心跳變異性 與 自律神經檢測，並設計 DM 進行推廣。

My Current Work -- Proton Therapy System 質子治療系統 (質子刀)

我現在的工作是開發目前最先進的癌症精準放射治療系統-質子刀(proton  therapy  system)，負責最核心的控制系統規劃與設計開發，這是結合同步輻射與放射治療的領域，我從理論基礎開始學習到加速器控制系統的規劃與設計，並同時要符合FDA  510(k)  的要求。

工作內容大致如下：

Medical engineer/R&D Department,
    • Research and development of proton therapy system for Precision Radiotherapy.
    • Planning and establishing Accelerator Control System (ACS) of “iProton”.
    • ACS subsystem integration and controlling:
        ◦ Ion Source system
        ◦ LINAC system
        ◦ Magnet power supplier system
        ◦ RF synchrotron ring system
        ◦ Beam diagnostics
        ◦ Master timing system
        ◦ B-Train system
        ◦ Vacuum system
        ◦ Cooling system
        ◦ Interlock system
    • SCADA network monitoring system and Database development.
    • Integration of ACS, TCS (Treatment Control System), OIS (Oncology Information System), Dose Delivery System, Robotic Couch System, etc. for proton therapy.
    • LabView programming and establishing software system for ACS.
    • Software V&V (Verification and Validation).

Blood Pressure Waveform Analysis, 血壓波分析

I involved the project “Portable wrist physiological monitoring system for new drug side effect” of Dr. Sun at 2002-2003. I used Labview to design GUI and analysis blood waveform. This project was selected for the ITRI and MOEA best forward-looking plan. Dr. Sun now is CEO of Taiwan Scientific Corp.

此計畫為FY91 前瞻計畫「連續式，非侵入性新藥副作用監視系統」及FY92 前瞻計畫「連續式，非侵入性藥物副作用之預警監視系統」，已於美國進行臨床動物實驗及台灣三總/慈濟進行臨床測試。

食道壓量測信號之心跳雜訊濾除方法, Research of adaptive filtering method for removal of cardiac beat artifact in measured esophageal pressure signal.

  Information on volume-pressure relationships of human lungs is usually based on indirect determination of intrapleural pressure (Pip) obtained from the esophagus. Esophageal pressure (Pes) measurements are important in medical research and useful in clinical diagnosis. Unfortunately, the measurement results contaminate heavily by cardiac artifact and complicate further analyses. In clinical measurement of Pes, the conventional strategy to minimize cardiac beat artifact is to adjust the position of esophageal balloon or the posture of the body. Adaptive finite impulse response (AFIR) filter and modified adaptive noise cancellation (MANC) method are adopted to filter cardiac beat interference in this research. Six experiments on two Brown-Norway rats are used to verify filters’ performance and these filtered results are later compared.

  In MANC methodology, an airflow signal is used as the reference signal with least mean square (LMS) method as the adaptive algorithm. The proposed MANC filter has successfully demonstrated the ability to significantly reduce the apparent cardiac pulsation without noticeably distorting the sharp deflections in the measured Pes signal. Furthermore, the MANC filter also shows evidence of suppressing peaks at integer multiples of heart rate in the Fast Fourier Transform (FFT) of the Pes signal while leaving the remaining spectrum largely unperturbed. A t-test method and the ratio of standard deviations to means (std/mean) statistics of airway resistance (Raw) values were used to evaluate the performance of MANC filter. In all six experiments, with the MANC filter, reductions of std/mean of Raw by 12.5% to 68% were obtained.
  

  In the frequency domain, frequency variations and spectral overlap between the Pes components and cardiac beat signal components impact on the performance of filter. In this paper, the spectrum and waveform of measured Pes signal obtained after carefully adjusting the esophageal balloon are the best situation in clinical medicine and is used as the standard reference. From our experimental results on power strength, the 4th or higher harmonics did not have any significant effect on the filter performance. However, the 2nd harmonics of these signals had a significant effect on the filtering result. Thus, in the design of AFIR filters, attention is needed to minimize these effects. In frequency analysis, these harmonics or overlapping frequencies do not affect MANC. MANC is the better method for eliminating cardiac beat artifact in Pes measurement. The dynamic compliance (Cdyn) was also used to evaluate the performance of MANC and AFIR. The standard deviation of Cdyn is less than 0.15 using MANC, compared with the standard deviations as high as 0.57 for AFIR.
  

  Experimental results indicating the effectiveness of MANC scheme as a filtering method to remove the cardiac beat artifacts in Pes measurement and we can conclude that MANC has better performance than AFIR. Furthermore, the LMS algorithm is simple to implement the online signal-processing device by DSP chips. (in 2001)

這是本人之博士論文題目，研究重點如下：

肋膜壓(Pip)在肺生理是相當重要的生理參數，通常它是利用間接量測的方法由食道量測食道壓(Pes)來取代肋膜壓的量測。
但是在食道壓量測信號中，有嚴重的心跳信號的干擾，這干擾會影響到之後許多的肺生理參數的計算與分析。在臨床上，通常是以調整食道球（esophageal balloon）的位置與受測者的姿勢來降低心跳信號的干擾。
在這個研究中，適應性有限脈衝反應（Adaptive finite impulse response； AFIR）濾波器與修正型適應性雜訊消除法（modified adaptive noise cancellation； MANC）方法被使用來濾除心跳干擾。
我們使用兩隻棕色挪威鼠（Brown-Norway rats）設計了六個實驗來驗證濾波器的效能並在之後比較兩種濾波方法的優劣。

此研究已發表論文如下：

鄭怡平,Research of adaptive filtering method for removal of cardiac beat artifact in measured esophageal pressure signal. (食道壓量測信號之心跳雜訊濾除方法之研究)，國立台灣大學電機工程學研究所博士論文，January, 2001.
Y.P. Cheng, H.D. Wu, G.J. Jan, and C.Y. Wang, “Adaptive method for removing cardiac beat artifact in esophageal pressure measurement”, Annals of Biomedical Enginerring, March , Vol. 29, p. 1-8, 2001. （SCI，2006 Impact Factor 2.276 ）
Yi-Ping Cheng, Huey-Dong Wu, Cheng-Yi Wang and Gwo-Jen Jan, “Removal cardiac beat artifact in esophageal pressure measurement”, Medical & Biomedical Engineering & Computing, Vol. 37, Nov. p.776-783, 1999. （SCI，2006 Impact Factor 1.018）
Y.P.Cheng, H.D.Wu, G.J.Jan, “Comparing two adaptive methods for removing cardiac beat artifact in esophageal pressure measurement: MANC and AFIR”, Proceeding of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBS'98) , Hong Kong, China, pp. 1640-1642, 1998.
Yi-Ping Cheng, Gwo-Jen Jan, Hwei-Dung Wu, Cheng-Yi Wang, "Digital Filter Method for Cancellation of Heart Beat Artifact in Esophageal Pressure Measurement ", 全球華人醫學工程會議暨1996醫學工程科技研討會, Taipei, Taiwan, 五月29～30日, 1996. 

電腦輔助急症集中式監視系統, Computer assisted emergency monitoring system, CAEMS.

This system CAMES, a prototype for real-time integration of multitudinous devices into a physiological intelligent monitoring system useful in intensive care unit (ICU). An IBM compatible PC is used as a console and connects to one bedside monitor via A/D converter. A Z-80 controller is used as the slave of the console and integrates information of one ventilator and three infusion venous pumps (IV-pumps) via RS-232. The communication protocol between console and slave is the RS-232. The SCO UNIX operation system, ANSI C language and X-windows utility are used in developing CAMES. From experimental results, this system successfully provides a friendly operational interface for clinicians and nurses, integrates information from bedside devices, report patient’s state and physiological parameters, displays and records the results. It is highly effective to be used as an integrated physiological monitor, a patient information system or a computer-based patient recorder (CPR). It can be networked to the whole hospital networks. (in 1993)

這雖然是本人82年的碩士論文，但是這個觀念不僅在當時是十分先進的究領域，到現在醫院內也對此類系統有迫且需求，以衛生署新竹醫院為例，本人正是以此概念與技術為基礎協助建立檢驗儀器連線監測資訊系統。採用系統：SCO UNIX, X-windows。

概述 :
將每一病床所使用之量測儀器如Bedside monitor、IV pump、ventilator等儀器之資訊網路化，每一病房可有一主控電腦，或是一護理站一主控電腦。儀器資訊網路化後可以產生電子報表與可由遠端監控各病床之儀器資訊。

優點

具RS232埠之醫療設備均可連線上網
遠端監視病患生理參數
遠端存取並監視控醫療設備之狀態 (如: 警示…等)
病患生理參數記錄自動化，取代人工抄錄(自動化電子病歷)
病患資料輸入自動化
醫療設備之設定之自動化

可應用範例

生理參數之量測及監視設備
加護病房病人生理參數集中監視資訊系統
療養院、老人安養院病人生理參數集中監視資訊系統

My research paper 我的研究論文

Research paper

Wen-Chin Chou, Yi-Ping Cheng. 2012. A hybrid fuzzy MCDM approach for evaluating website quality of professional accounting firms, Expert Systems with Applications, Volume 39, Issue 3, 15 February, Pages 2783-2793.（SCI, 2011 IF=2.203）

Wen-Chin Chou, Yi-Ping Cheng. 2012. Evaluation of teaching hospital websites: an integrated three-stage fuzzy MCDM approach, Knowledge Based System, Revised.（SCI, 2011 IF=2.422）

Cheng, Y.P.*, & Chou, A. N. G. 2011 April, Bi-level weights sum method for shock diagnosis, Expert Systems with Applications Vol.38 Issue 4, pp. 4497-4504. （SCI, 2011 IF=2.203）

Y.P. Cheng, H.D. Wu, G.J. Jan, and C.Y. Wang. 2001 March, Adaptive method for removing cardiac beat artifact in esophageal pressure measurement, Annals of Biomedical Engineering, Vol. 29, pp. 1-8. （SCI, 2010 IF=2.374, rank=19/69）

Yi-Ping Cheng*, 2000, Medical expert system assisted physician diagnosis, MD News, Vol. 19, pp. 27-29.

Yi-Ping Cheng*, Huey-Dong Wu, Cheng-Yi Wang and Gwo-Jen Jan. 1999 Nov, Removal cardiac beat artifact in esophageal pressure measurement, Medical & Biomedical Engineering & Computing, Vol. 37, pp. 776-783,. （SCI, 2010 IF=1.791, rank=24/97）

Y.P.Cheng*, T.C.Wu, C.C.Chen and G.J.Jan. 1998 July/August, Design and Implementation of a Microprocessor-Based Ventilator Monitoring and Recording System in ICU, Journal of Clinical Engineering, Vol.23, No.4.

Kao, Shih-Dean, Cheng, Yi-Ping, Tai, Yu-Yuan, Jan, Gwo-Jen. 1996, Development and implementation of a simple digitizer for morphometry, Measurement Science & Technology, 7/8, pp. 1182-1186.

Y.P.Cheng, G.J.Jan, I.K.Fong, Y.C.Huang, H.D.Wu, Y.Z.Tseng, C.Y.Wang. 1994 Computer aided physiological monitoring system with graphic user interface, Biomed. Eng. Appl. Basis Comm. 6, 932-935. （EI, SCIE）

我的生醫電子產品與雛型機開發經驗. My development experience of bio-electronic product.

生醫電子產品與雛型機開發：

      (1).  『插卡式電子聽診器(Recordable  Electronic  Stethoscope  Using  SD  Card)』產品(已開模)。
      (2).  『可攜式腕式生理監視系統(Portable  wrist  physiological  monitoring  system)』雛型機(Mockup)。
      (3).  『可攜式肺音監測系統(Portable  lung  sound  monitoring  system)』雛型機。
      (4).  『可攜式模組化心肺生理監測系統(Portable  modular  cardiopulmonary  physiological  function  monitoring  system)』雛型機(Mockup)。

我的軟體系統與醫療資訊系統開發經驗. My development experience of software system.

My development experience of software system. 我的軟體系統與醫療資訊系統開發經驗

      (1).  使用  LabVIEW  與  NI  TestStand  開發及建構量測/驗證系統  (software  test  framework)。
      (2).  開發嬰兒睡眠監測系統  (Infants  care  system)，包含  LabVIEW、  Access  資料庫、SQL  語言、雲端資料儲存。
      (3).  使用  Matlab、C/C++  開發非接觸生理監測演算法。
      (4).  使用  Matlab  開發適應性濾波演算法與  FIR  濾波演算法進行食道壓之心跳雜訊濾除研究。
      (5).  研究電燒機韌體開發  (C  語言)。
      (6).  TI  MSP430  韌體開發  (C  語言)。
      (7).  STM32  (ARM  核心)  韌體研究  (C  語言)。
      (8).  使用SCO  UNIX上發展  X  windows  人機介面，整合加護病房內生理監視器、呼吸器與輸液幫浦的資訊  (C  語言、Motif  X  window、SQL  資料庫)。
      (9).  使用CLIPS語言完成一套shock輔助診斷專家系統。
      (10).  參與衛生署新竹醫院『門診數位叫號系統』計畫。
      (11).  參與衛生署新竹醫院『血液透析行動照護系統』，使用Labview  開發自動體重量測系統。
      (12).  使用Labview  開發DVD光碟片自動測試系統(DVD-chip  auto-detection  system)。
      (13).  使用Labview  開發X光機電源可靠性自動控制系統(automatically  reliability  test  system  of  X-ray  generator)。
      (14).  使用Labview  開發可攜式腕式生理監測系統軟體(portable  wrist  physiological  monitoring  system.)。
      (15).  使用Labview  開發  ODT  (Optical  Doppler  Tomography)  量測平台。
      (16).  使用Labview  開發肺音監測系統軟體  (lung  sound  monitoring  system)。
      (17).  使用Labview  開發電子聽診器之心肺音監測系統軟體  (cardiac  and  lung  sound  analysis  software  for  electronic  stethoscope)。
      (18).  使用VB開發1K*1K  乳癌用數位X光系統。

National Instruments: Certified LabVIEW Associate Developer (CLAD)

National Instruments
Certified LabVIEW Associate Developer (CLAD)

Asthma Attack Detector DEMO Video 氣喘發作偵測測試影片

Asthma Attack Detector DEMO Video
The device will alarm when it detects the wheezing sound.

My recently research and results 我最近的研究和成果

 Department head (Acting head of department).
 Create innovative technology R&D team.
 Research and development of innovative medical device.
 Research new technology.
 Research and development of Blood Glucose Meter.
 V&V for blood glucose meter.
 Research for regulations of medical device.

 Software Design Verification.
 Team leader of LabVIEW programnming development.
 Plan for software design verification (software engineering V-model) of medical device software integration and system testing.
 Develop automatic test programs and system for verifying the software design of medical devices.
 Cooperate with R&D team for reviewing customer's requirement specification, system specification and provide the revision suggestion.
 Cooperate with R&D team for reviewing R&D team's software design and provide the revision suggestion.
 Define verification plan, design test case, and analyze test result for improving design quality.
 Contact with clients (Germen), Workshop and weekly meeting.

 Head of System Software Department in Holux Co. Ltd..
 Ultra-wideband (UWB) development of physiological monitoring instruments.
 Software design.
 Signal analysis and algorithm development.
 Integration of vehicle electronics and medical electronics.
 Drowsiness/fatigue detector for driver.
 To conduct clinical test with the hospital cooperation.

 R&D of Electrosurgery products.
 Software design.
 Firmware design.
 To assist the GMP certification and new product development project Standard Operating Procedures.

我的營運計劃書 My Business Plan

如果能有機會將自己的研究成果付諸產品化，是我最大的心願。所以我整理了一份營運計劃書，現將摘要發表於此，若有任何公司願意討論詳情，請與我聯絡。

SCI 論文 -- Bi-level weights sum method for shock diagnosis

Cheng, Y.P.*, & Chou, A. N. G. 2011 April, Bi-level weights sum method for shock diagnosis, Expert Systems with Applications Vol.38 Issue 4, pp. 4497-4504. （SCI, 2010 IF=1.924, rank=48/247, Rank in subject categories ENGINEERING, ELECTRICAL & ELECTRONIC）

Abstract

A new inference mechanism using bi-level weights sum method for clinical computer assisted shock diagnosis algorithm is proposed in this paper. Shock is a very emergency physiological sign in clinical medicine. It predisposes to multi-organ failure. This inference method provides completely shock trend for clinician’s judgments. We use seven paths to infer the type of shock, including hypovolemic shock, cardiogenic shock, septic shock, anaphylactic shock, neurogenic shock, endocrine shock, and pulmonary shock. A knowledge base is composed of many possibility weights that are built by experienced medical expert, each path has further detail items and every item has respective weights for each shock type. Some items are then spilt into server, moderate and mild. In this study, nine patients’ data are collected and analyzed. The results provide order of shock type by bi-level weights sum method. The inference results computed by this system are coinciding with diagnosis by clinician and imply other potential shock type. These results are important for clinician because the results are not unique and which corresponds with shock physiological condition. We also distribute patients’ data to another six doctors for diagnostics, and for evaluating system performance. Results reveal it can provide sufficient complete information for clinician to ensure good diagnostics and treatment for patients. This system could be used either as a clinical decision support system or as educational software.

插卡式電子聽診器 Recordable Electronic Stethoscope Using SD Card

English version DM

Patent List

論文--遠離氣喘死亡陰影--配戴式居家氣喘發作偵測警示系統

鄭怡平“遠離氣喘死亡陰影--配戴式居家氣喘發作偵測警示系統”, 「智慧生活科技區域整合中心計畫」暨「前瞻優質生活環境計畫」聯合成果發表會, Taipei, Taiwan, Jan.19-20, 2009.