BIOMEDE 458 Outline, a draft

  1. Week 1, An introduction to biomedical instrumentation: systems & signals
    1. Introductory Lab
  2. Week 2, Cardiac systems
    1. ECG Lab 1 and 2
      1. Reading 1: 4.i; 4.ii; 12.ii
      2. Reading 2: 8.i; 9.i; 12.i
  3. Week 3, Signals measurement
    1. ECG Lab 3 and 4
      1. Reading 3: 2.ii; 8.iii; 10.i
      2. Reading 4: 10.v; 10.vi; 11.i
    2. Big List of Medical Devices I
  4. Week 4, Cardiovascular systems
    1. ECG Lab 5 and 6
      1. Reading 5: 4.v; 12.iii; 12.iv
      2. Reading 6: 2.iv; 9.ii; 11.v
    2. ECG Notebook Review
    3. ECG Shareout
  5. Week 5, Signals processing
    1. Pulse Ox Lab 1 and 2
      1. Reading 7: 7.i; 7.ii; 8.v
      2. Reading 8: 11.ii; 11.iii; 12.viii
    2. Big List of Medical Devices II
    3. ECG Notebook Finalized
    4. ECG Reflection
  6. Week 6, Respiratory systems
    1. Pulse Ox Lab 3 and 4
      1. Reading 9: 4.iv; 9.iii; 12.v
      2. Reading 10: 2.iii; 11.iv; 12.vi
    2. ECG Lab Manual
    3. Roundtable article submission
  7. Week 7, Signals analysis
    1. Pulse Ox Lab 5 and 6
      1. Reading 11: 10.ii; 10.iii; 10.iv
      2. Reading 12: TBD
    2. Big List of Medical Devices III
    3. Pulse Ox Notebook Review
    4. Pulse Ox Shareout
    5. Homework
  8. Week 8, Systems integration
    1. Project proposals 1 and 2
      1. Reading 13: 4.v; 4.vi; TBD
      2. Reading 14: 2.i; 12.vii; 12.ix
    2. Pulse Ox Notebook Finalized
    3. Pulse Ox Reflection
  9. Week 9, A break
    1. Pulse Ox Lab Manual
  10. Week 10, Ethical roundtables
    1. Spirometry Lab 1 and 2
      1. Reading 15: 1.i; 1.ii; 3.ii
      2. Reading 16: 1.v; 6.i; 6.iv
    2. Big List of Medical Devices IV
    3. Roundtable discussion
  11. Week 11, Interviews: I. On law
    1. Spirometry Lab 3 and 4
      1. Reading 17: 3.i; 6.ii; 6.iii
      2. Reading 18: TBD
  12. Week 12, Interviews: II. On business
    1. Spirometry Lab 5 and 6
      1. Reading 19: 6.vi; 6.vii; 6.viii
      2. Reading 20: 3.iv; 3.v; 5.i
    2. Big List of Medical Devices V
    3. Spirometry Notebook Review
    4. Spirometry Shareout
  13. Week 13, Interviews: III. On regulation
    1. Project Lab 1 and 2
      1. Reading 21: 1.iii; 6.iii; TBD
      2. Reading 22: 3.i; 8.iii; 8.iv
    2. Spirometry Notebook Finalized
    3. Spirometry Reflection
  14. Week 14, Interviews: IV. On consequences
    1. Project Lab 3 and 4
      1. Reading 23: 5.ii; 5.iii; 5.iv
      2. Reading 24: 1.iv; 5.v; 13
    2. Big List of Medical Devices VI
    3. Spirometry Lab Manual
  15. Week 15, Philosophies of biomedical instrumentation
    1. Project Lab 5 and 6
    2. Project Notebook Review
  16. Week 16+, Ends 
    1. Project Lab 7
    2. Project Shareout
    3. Project Notebook Finalized
    4. Project Reflection
    5. Project Lab Manual

Readings

  1. Abdel-Aleem, Salah., “The Design and Management of Medical Device Clinical Trials Strategies and Challenges.” John Wiley, 2010. (https://search.lib.umich.edu/catalog/record/014327513)
    1. Chapter 1 – Challenges to the Design of Clinical Study
    2. Chapter 4 – Fraud and Misconduct in Clinical Trials
    3. Chapter 5 – Challenges to the Regulation of Medical Device
    4. Chapter 6 – Challenges of Global Clinical Studies and the CE Mark Process
    5. Chapter 8 – Bioethics in Clinical Research
  2. Baura, Gail D., “Medical Device Technologies a Systems Based Overview Using Engineering Standards.” Elsevier/Academic Press, 2012. (https://search.lib.umich.edu/catalog/record/011489120)
    1. Chapter 1 – Diagnosis and Therapy
    2. Chapter 2 – Electrocardiographs
    3. Chapter 9 – Hemodialysis Delivery Systems
    4. Chapter 11 – Pulse Oximeters
  3. Fries, Richard C., “Reliable Design of Medical Devices.” CRC Press, 2013. (https://search.lib.umich.edu/catalog/record/015118276)
    1. Chapter 7 – The FDA
    2. Chapter 12 – Liability
    3. Chapter 13 – Intellectual Property
    4. Chapter 32 – Transfer to Manufacturing
    5. Chapter 33 – Hardware Manufacturing
  4. Kaniusas, Eugenijus., “Biomedical Signals and Sensors I: Linking Physiological Phenomena and Biosignals.” Springer, 2012. (https://search.lib.umich.edu/catalog/record/016745783(
    1. Chapter 2.2 – Neurons and Receptors 
    2. Chapter 2.4 – Heart 
    3. Chapter 2.5 – Circulatory System 
    4. Chapter 2.6 – Respiratory System 
    5. Chapter 3.1 – Vital Phenomena and Their Parameters
    6. Chapter 3.2 – Parameter Behavior 
  5. Kendler, Jonathan. and Strochlic, Allison Y., “Usability Testing of Medical Devices.” CRC Press, Taylor & Francis Group, 2016. (https://search.lib.umich.edu/catalog/record/014995742)
    1. Chapter 3 – The Commercial Imperative
    2. Chapter 4 – Testing Costs
    3. Chapter 7 – Writing a Test Plan
    4. Chapter 12 – Conducting the Test
    5. Chapter 16 – Reporting Results
  6. Kucklick, Theodore R., “The Medical Device R&D Handbook.” CRC press, Taylor & Francis Group, 2013. (https://search.lib.umich.edu/catalog/record/015114086)
    1. Chapter 12 – Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory
    2. Chapter 14 – Intellectual Property Strategy for Med-Tech Start-Ups 
    3. Chapter 15 – Regulatory Affairs: Medical Device 
    4. Chapter 17 – Brief Introduction to Preclinical Research 
    5. Chapter 24 – Interview with J. Casey McGlynn 
    6. Chapter 25 – Keys to Creating Value for Early Stage Medical Device Companies 
    7. Chapter 27 – Medical Device Sales 101 
    8. Chapter 29 – How to Fail as an Entrepreneur 
  7. Liang, Hualou., Bronzino, Joseph D., and Peterson, Donald R., “Biosignal Processing Principles and Practices.” CRC Press/Taylor & Francis, 2013. (https://search.lib.umich.edu/catalog/record/012179290)
    1. Chapter 1 – Digital Biomedical Signal Acquisition and Processing
    2. Chapter 2 – Time–Frequency Signal Representations for Biomedical Signals 
  8. Norris, Michael., “Design and Development of Medical Electronic Instrumentation: A Practical Perspective of the Design, Construction, and Test of Medical Devices.” Wiley-Interscience, 2005. (https://search.lib.umich.edu/catalog/record/014327511)
    1. Chapter 1 – Biopotential amplifiers 
    2. Chapter 2 – Bandpass selection for biopotential amplifiers 
    3. Chapter 3 – Design of safe medical device prototypes
    4. Chapter 4 – Electromagnetic compatibility and medical devices
    5. Chapter 5 – Signal conditioning, data acquisition, and spectral analysis 
  9. Northrop, Robert B., “Noninvasive Instrumentation and Measurement in Medical Diagnosis.” CRC Press, Taylor & Francis Group, 2018.(https://search.lib.umich.edu/catalog/record/017413760)
    1. Chapter 4 – Measurement of Electrical Potentials and Magnetic Fields from the Body Surface 
    2. Chapter 9 – Plethysmography 
    3. Chapter 10 – Pulmonary Function Tests
  10. Semmlow, John L., “Circuits, Signals and Systems for Bioengineers : A MATLAB-basedIintroduction.” Academic Press, 2018. (https://search.lib.umich.edu/catalog/record/016172482)
    1. Chapter 1 – The Big Picture: Bioengineering Signals and Systems
    2. Chapter 2 – Signal Analysis in the Time Domain
    3. Chapter 3 – Signal Analysis in the Frequency Domain: The Fourier Series and the Fourier Transformation
    4. Chapter 4 – Signal Analysis in the Frequency Domain—Implications and Applications
    5. Chapter 13 – Analysis of Analog Circuits and Models
    6. Chapter 15 – Basic Analog Electronics: Operational Amplifiers
  11. Webster, John G., and Eren, Halit, “Measurement, Instrumentation, and Sensors Handbook: Electromagnetic, Optical, Radiation, Chemical, and Biomedical Measurement.” CRC Press, Taylor & Francis Group, 2014. (https://search.lib.umich.edu/catalog/record/015114037)
    1. Chapter 19 – Oscilloscope Voltage Measurement 
    2. Chapter 41 – Time Measurement 
    3. Chapter 42 – Frequency Measurement 
    4. Chapter 65 – Blood Pressure Measurement 
    5. Chapter 68 – Blood Chemistry Measurement 
  12. Wood, Andrew W., “Physiology, Biophysics, and Biomedical Engineering.” CRC Press, 2012. (https://search.lib.umich.edu/catalog/record/017414626)
    1. Chapter 2 – Fundamentals of Electrical Circuits for Biomedicine
    2. Chapter 8 – Cardiac Biophysics 
    3. Chapter 10 – The Vascular System: Blood Flow Patterns in Various Parts of the Circulation 
    4. Chapter 11 – Cardiovascular System Monitoring 
    5. Chapter 12 – Respiratory Biophysics 
    6. Chapter 13 – Renal Biophysics and Dialysis 
    7. Chapter 16 – The Biophysics of Sensation—General 
    8. Chapter 20 – Physiological Signal Processing 
    9. Chapter 25 – Physiological Modeling 
  13. World Health Organization (WHO), “Medical Devices: Managing the Mismatch : An Outcome of the Priority Medical Devices Project.” Geneva, 2010.(https://search.lib.umich.edu/catalog/record/008939040, https://apps.who.int/iris/bitstream/handle/10665/44407/9789241564045_eng.pdf)