BIOMEDE 458 Readings, a draft

  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)