- Week 1, An introduction to biomedical instrumentation: systems & signals
- Introductory Lab
- Week 2, Cardiac systems
- ECG Lab 1 and 2
- Reading 1: 4.i; 4.ii; 12.ii
- Reading 2: 8.i; 9.i; 12.i
- ECG Lab 1 and 2
- Week 3, Signals measurement
- ECG Lab 3 and 4
- Reading 3: 2.ii; 8.iii; 10.i
- Reading 4: 10.v; 10.vi; 11.i
- Big List of Medical Devices I
- ECG Lab 3 and 4
- Week 4, Cardiovascular systems
- ECG Lab 5 and 6
- Reading 5: 4.v; 12.iii; 12.iv
- Reading 6: 2.iv; 9.ii; 11.v
- ECG Notebook Review
- ECG Shareout
- ECG Lab 5 and 6
- Week 5, Signals processing
- Pulse Ox Lab 1 and 2
- Reading 7: 7.i; 7.ii; 8.v
- Reading 8: 11.ii; 11.iii; 12.viii
- Big List of Medical Devices II
- ECG Notebook Finalized
- ECG Reflection
- Pulse Ox Lab 1 and 2
- Week 6, Respiratory systems
- Pulse Ox Lab 3 and 4
- Reading 9: 4.iv; 9.iii; 12.v
- Reading 10: 2.iii; 11.iv; 12.vi
- ECG Lab Manual
- Roundtable article submission
- Pulse Ox Lab 3 and 4
- Week 7, Signals analysis
- Pulse Ox Lab 5 and 6
- Reading 11: 10.ii; 10.iii; 10.iv
- Reading 12: TBD
- Big List of Medical Devices III
- Pulse Ox Notebook Review
- Pulse Ox Shareout
- Homework
- Pulse Ox Lab 5 and 6
- Week 8, Systems integration
- Project proposals 1 and 2
- Reading 13: 4.v; 4.vi; TBD
- Reading 14: 2.i; 12.vii; 12.ix
- Pulse Ox Notebook Finalized
- Pulse Ox Reflection
- Project proposals 1 and 2
- Week 9, A break
- Pulse Ox Lab Manual
- Week 10, Ethical roundtables
- Spirometry Lab 1 and 2
- Reading 15: 1.i; 1.ii; 3.ii
- Reading 16: 1.v; 6.i; 6.iv
- Big List of Medical Devices IV
- Roundtable discussion
- Spirometry Lab 1 and 2
- Week 11, Interviews: I. On law
- Spirometry Lab 3 and 4
- Reading 17: 3.i; 6.ii; 6.iii
- Reading 18: TBD
- Spirometry Lab 3 and 4
- Week 12, Interviews: II. On business
- Spirometry Lab 5 and 6
- Reading 19: 6.vi; 6.vii; 6.viii
- Reading 20: 3.iv; 3.v; 5.i
- Big List of Medical Devices V
- Spirometry Notebook Review
- Spirometry Shareout
- Spirometry Lab 5 and 6
- Week 13, Interviews: III. On regulation
- Project Lab 1 and 2
- Reading 21: 1.iii; 6.iii; TBD
- Reading 22: 3.i; 8.iii; 8.iv
- Spirometry Notebook Finalized
- Spirometry Reflection
- Project Lab 1 and 2
- Week 14, Interviews: IV. On consequences
- Project Lab 3 and 4
- Reading 23: 5.ii; 5.iii; 5.iv
- Reading 24: 1.iv; 5.v; 13
- Big List of Medical Devices VI
- Spirometry Lab Manual
- Project Lab 3 and 4
- Week 15, Philosophies of biomedical instrumentation
- Project Lab 5 and 6
- Project Notebook Review
- Week 16+, Ends
- Project Lab 7
- Project Shareout
- Project Notebook Finalized
- Project Reflection
- Project Lab Manual
Readings
- 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)
- Chapter 1 – Challenges to the Design of Clinical Study
- Chapter 4 – Fraud and Misconduct in Clinical Trials
- Chapter 5 – Challenges to the Regulation of Medical Device
- Chapter 6 – Challenges of Global Clinical Studies and the CE Mark Process
- Chapter 8 – Bioethics in Clinical Research
- 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)
- Chapter 1 – Diagnosis and Therapy
- Chapter 2 – Electrocardiographs
- Chapter 9 – Hemodialysis Delivery Systems
- Chapter 11 – Pulse Oximeters
- Fries, Richard C., “Reliable Design of Medical Devices.” CRC Press, 2013. (https://search.lib.umich.edu/catalog/record/015118276)
- Chapter 7 – The FDA
- Chapter 12 – Liability
- Chapter 13 – Intellectual Property
- Chapter 32 – Transfer to Manufacturing
- Chapter 33 – Hardware Manufacturing
- Kaniusas, Eugenijus., “Biomedical Signals and Sensors I: Linking Physiological Phenomena and Biosignals.” Springer, 2012. (https://search.lib.umich.edu/catalog/record/016745783(
- Chapter 2.2 – Neurons and Receptors
- Chapter 2.4 – Heart
- Chapter 2.5 – Circulatory System
- Chapter 2.6 – Respiratory System
- Chapter 3.1 – Vital Phenomena and Their Parameters
- Chapter 3.2 – Parameter Behavior
- 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)
- Chapter 3 – The Commercial Imperative
- Chapter 4 – Testing Costs
- Chapter 7 – Writing a Test Plan
- Chapter 12 – Conducting the Test
- Chapter 16 – Reporting Results
- Kucklick, Theodore R., “The Medical Device R&D Handbook.” CRC press, Taylor & Francis Group, 2013. (https://search.lib.umich.edu/catalog/record/015114086)
- Chapter 12 – Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory
- Chapter 14 – Intellectual Property Strategy for Med-Tech Start-Ups
- Chapter 15 – Regulatory Affairs: Medical Device
- Chapter 17 – Brief Introduction to Preclinical Research
- Chapter 24 – Interview with J. Casey McGlynn
- Chapter 25 – Keys to Creating Value for Early Stage Medical Device Companies
- Chapter 27 – Medical Device Sales 101
- Chapter 29 – How to Fail as an Entrepreneur
- 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)
- Chapter 1 – Digital Biomedical Signal Acquisition and Processing
- Chapter 2 – Time–Frequency Signal Representations for Biomedical Signals
- 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)
- Chapter 1 – Biopotential amplifiers
- Chapter 2 – Bandpass selection for biopotential amplifiers
- Chapter 3 – Design of safe medical device prototypes
- Chapter 4 – Electromagnetic compatibility and medical devices
- Chapter 5 – Signal conditioning, data acquisition, and spectral analysis
- Northrop, Robert B., “Noninvasive Instrumentation and Measurement in Medical Diagnosis.” CRC Press, Taylor & Francis Group, 2018.(https://search.lib.umich.edu/catalog/record/017413760)
- Chapter 4 – Measurement of Electrical Potentials and Magnetic Fields from the Body Surface
- Chapter 9 – Plethysmography
- Chapter 10 – Pulmonary Function Tests
- Semmlow, John L., “Circuits, Signals and Systems for Bioengineers : A MATLAB-basedIintroduction.” Academic Press, 2018. (https://search.lib.umich.edu/catalog/record/016172482)
- Chapter 1 – The Big Picture: Bioengineering Signals and Systems
- Chapter 2 – Signal Analysis in the Time Domain
- Chapter 3 – Signal Analysis in the Frequency Domain: The Fourier Series and the Fourier Transformation
- Chapter 4 – Signal Analysis in the Frequency Domain—Implications and Applications
- Chapter 13 – Analysis of Analog Circuits and Models
- Chapter 15 – Basic Analog Electronics: Operational Amplifiers
- 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)
- Chapter 19 – Oscilloscope Voltage Measurement
- Chapter 41 – Time Measurement
- Chapter 42 – Frequency Measurement
- Chapter 65 – Blood Pressure Measurement
- Chapter 68 – Blood Chemistry Measurement
- Wood, Andrew W., “Physiology, Biophysics, and Biomedical Engineering.” CRC Press, 2012. (https://search.lib.umich.edu/catalog/record/017414626)
- Chapter 2 – Fundamentals of Electrical Circuits for Biomedicine
- Chapter 8 – Cardiac Biophysics
- Chapter 10 – The Vascular System: Blood Flow Patterns in Various Parts of the Circulation
- Chapter 11 – Cardiovascular System Monitoring
- Chapter 12 – Respiratory Biophysics
- Chapter 13 – Renal Biophysics and Dialysis
- Chapter 16 – The Biophysics of Sensation—General
- Chapter 20 – Physiological Signal Processing
- Chapter 25 – Physiological Modeling
- 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)