BIOMEDE 458 / EECS 458, Biomedical Instrumentation

Lectures: Wednesday, 3:00 p.m. – 5:00 p.m., 133 CHRYS
Labs: 002 – 9:00 a.m. – 12:00 p.m., 1220 LBME
004 – 12:30 – 3:30 p.m., 1220 LBME
006 – 4:00 – 7:00 p.m., 1220 LBME
 

Course description

From ABET course profile

Students design and construct functioning biomedical instruments. Hardware includes instrumentation amplifiers and active filters constructed using operational amplifiers. Signal acquisition, processing analysis and display are performed. Project modules include measurement of respiratory volume and flow rates, biopotentials (electrocardiogram), and optical analysis of arterial blood oxygen saturation (pulse-oximetry).

From your instructor’s heart

Human beings emit all sorts of signals. Those signals may be usefully harvested by those looking to do so. Such harvests may yield measurements of personally atypical heart problems, may sustain the lungs of those unable to do so for a time, may ensure oxygen flows through the veins of the living. The design of such instruments and their contemporary manifestation deserve our study. This primarily-laboratory-based course will teach good documentation skills, facilitate biomedical signal acquisition, and expand one’s notions of biomedical instrumentation.
 

Instructors 

Barry Belmont, Cyrus Najarian, Akshada Shinde, Alec Socha
 

Requirements

Previous/Concurrent Coursework

BIOMEDE 211 (“Circuits and Systems in Biomedical Engineering”) and BIOMEDE 241 (“Undergraduate Laboratory in Biomedical Engineering”) or EECS 215 (“Introduction to Electronic Circuits”) or EECS 314 (“Electrical Circuits, Systems, and Applications”) or graduate standing. 

Regular Access to the Internet

Administration of this course will be done primarily through Canvas, including but not limited to submissions of assignments, announcements for the class, etc. Documents necessary for laboratory work will also be available there. A group notebook using LabArchives will be kept by each team. This shared laboratory notebook requires each participant login through the internet to complete at least one section. 
Intended timeline of the class
 

Intended outline of the class

There are four laboratory modules (Electrocardiography, Pulse Oximetry, Spirometry, and a Project) that are each six lab periods long (with the Project having one additional lab period). Each laboratory module requires the team-based completion of:
  • A share-out, 16 days after starting the module;
  • A group-notebook, 21 days after starting the module;
  • A peer review and self-reflection, 22 days after starting the module; and
  • A formal laboratory report, 28 days after starting the module. 
The first half of the course (before the break) focuses primarily on the technical “nuts and bolts” of biomedical instrumentation, focusing primarily on those fields of electronics and physiology corresponding to electrocardiography, pulse oximetry, and spirometry.
 
The second half of the course (after the break) will broaden our scope to consider the contemporary landscape of medical devices including laws, businesses, regulations, and consequences of biomedical instrumentation in our world.
 
Creative exploration of biomedical instrumentation is afforded the patient student with an open-ended project involving one or more physiological monitoring systems. 
 

Assignments

 
To make things simple for everyone, every single assignment is worth 5%. They can be broken down into two main categories of effort: individual (accounting for 20% of one’s overall grade) and team-based (accounting for 80% of one’s overall grade). They are as follows
  1. The Big List of Medical Devices. Six concise descriptions (100-300 words) of medical devices submitted to Canvas on Jan 23, Feb 6, Feb 20, Mar 12, Mar 26, and Apr 9 by 9:00 a.m. EST. Each submission is worth 0.5% of one’s total grade (and is based on completeness). Once during the semester, one will participate in a small group discussion regarding a medical device of one’s choosing. Doing so is worth 2% of one’s total grade. Put differently, 0.5% x 6 + 2% = 5% overall. Individual assignments.
    • Must be a short summary (100–300 words) on a unique medical device (i.e., one that has not be previously written about
    • Always due Wednesdays by 9:00 a.m. EST
    • Due generally every other week
    • Once a semester discussion with others about a device
  2. Readings. The past and future histories of medical devices are written down in many areas. I have selected 72 readings, amounting to a whopping 2,400 pages of written material. Several of those pages include figures, tables, indices, practice problems, physiology, instrumentation, legislation, regulation, and ethical conceit. Once during the semester you will be required to give a short summary presentation of one of these in front of your peers (or an equivalent beforehand). Please prepare, approximately 15-20 minutes worth of audiovisual explanation of the reading. Presentation of such a summary is 5% of one’s grade and a copy of audiovisual aids must be submitted to Canvas by the time of one’s presentation. A list of the readings can be seen herein. 
  3. Interviews. Five entwined assignments, each worth 1% x 5 = 5% overall:
    1. Submit reading for consideration by Feb 26. Find some article somewhere about medical devices that made you think. These will be shared with the whole class, so make sure they’re interesting.
    2. Submit questions beforehand by Feb 26. Given that you have read at least one interesting thing about medical devices, submit at least five questions it made you ask about biomedical devices (especially instrumentation).
    3. Interview a biomedical professional by Mar 18. Given that the class has submitted many questions about medical devices based on background readings, go ask a medical professional some of the ones that most interest you. There are four main categories we are interested here: laws, businesses, regulations, and consequences. That said, make what you want of your interview.
    4. Moderate a discussion in class by Apr 8. Report out your interview to others in the class. Sharing your experiences in both small group and class-wide settings.
    5. Participate in a discussion in class by Apr 8. Listen to a peer report out their discussion with a medical professional on a topic.
  4. Homework. A single assignment designed to assess the individual instrumentation wherewithal will be due Mar 11. An exploration of topics covered in the class will be evaluated. The assignment is worth 5% of one’s grade.
  5. Laboratory Share-Outs. At the end of each laboratory module (Jan 30, Feb 20, Mar 26, Apr 21), teams will present their work and results to their peers for review, encouragement, and improvement. Tough questions will be posed and experiences shared. 5% each, 5% x 4 = 20% overall
  6. Notebooks. A group notebook demonstration good documentation practices will be collected via Canvas Feb 4, Feb 25, Mar 31, and Apr 24 by 9:00 a.m. EST. The notebook will be created via Lab Archives. 5% each module, 5% x 4 = 20% overall
  7. Review and Reflections. A little while after the end of each module (Feb 5, Feb 26, Apr 1, Apr 24), one will be given an opportunity to reflect on one’s learning and review one’s peer’s laboratory behavior. The review from one’s peers will be worth 3% each module, the self-reflection each worth 2%. That is, (3% + 2%) x 4 = 20% overall
  8. Laboratory Manuals. A brief formal write-up of the experiments conduct at one of two levels: K–12 (i.e., to less experience audiences) or university (i.e., to one’s peers). Each module 5% x 4 = 20% overall due Feb 18, Mar 10, Apr 7, Apr 24.
  9. Proposal(s). Ungraded periods in which one (1) brainstorms with one’s peers to propose medical instruments we are excited to create on Feb 25 and (2) selects a team and a project to work with and on for the remainder of the semester by Feb 27. Projects will be limited in budget and at the discretion of the instructor (mostly so they remain doable in the 7 periods).
In total there is 100% available. This class is the sort that the people in do not fail. Indeed, to get this far in one’s biomedical/electrical engineering education, you have learned a great deal about much and that has included (generally) how to earn a good grade. If you put forth good effort in this class (complete all assignments on time and with earnest) you will earn high marks and you will deserve it. If you fail to contribute positively to your team’s laboratory experience, your grade will slip, and it will break my heart to have to put it on your transcript.
 
A+ ≥ 97%; A ≥ 93%; A– ≥ 90%;
B+ ≥ 87%; B ≥ 83%; B– ≥ 80%;
C+ ≥ 77%; C ≥ 73%; C– ≥ 70%;
D+ ≥ 67%; D ≥ 63%; D– ≥ 60%;
59% ≥ Try Again
 

Policies

Late Policy

In a bid to keep the class rolling along, the instructors will endeavor to return graded assignments with about a week. That being the case, a deduction of one point per hour will be applied to every assignment submitted late (with lateness being measured as the rounded integer of hours displayed by Canvas as past the due date). If mitigating circumstances preclude you from submitting an assignment on time (e.g., taking care of your health; once in a lifetime family stuff, etc.) please let the instructors know in a reasonable amount of time so that accommodations may be made.
 

Sickness, Health Policy

I am going to assume that you will not lie to me about your health and so if you need to take care of yourself/your health for a period of time that precludes you from participating in the course, please let me know what I can do to best help you catch up, but also please do not feel compelled to tell me your health state or furnish me with doctor’s notes. If you need to take a couple of days for yourself, please do so. (But be mindful of those due dates! And of your responsibility to your team.)
 

Absence(s) in Class and in Lab

Try to attend lecture and lab regularly. This is where the bulk of your learning and work will be done, and every minute is best utilized to the maximum. That said, there will come times in life where you need to be somewhere that is not the lecture or the lab. If those times do not affect your ability to deliver what your team agrees you ought to, please inform your Instructional Aide prior to your planned absence, and best of luck for what you need to do.
 

Honor Code

All students in the class are presumed to be decent and honorable, and all students in the class are bound by the College of Engineering Honor Code. You may not seek to gain an unfair advantage over your fellow students; you may not consult, look at, or possess the unpublished work of another without their permission; and you must appropriately acknowledge your use of another’s work. Any violation of the honor policies appropriate to each piece of course work will be reported to the Honor Council, and if guilt is established penalties may be imposed by the Honor Council and Faculty Committee on Discipline. Such penalties can include, but are not limited to, letter grade deductions or expulsion from the University. If you have any questions about this course policy, please consult the course instructor.
 

Contact

Email is just the internet’s snail mail. If you need to get a hold of me as quickly as possible in a professorial capacity the following is the quickest route through the exhaustive ways:
  1. Talk to me in lab, 1220 LBME, I’ll be there a lot and am at your disposal;
  2. Stop by my office, 2130 LBME, if I’m in my office, I will almost always talk to you;
  3. Call my office phone, 734-647-8638, if I’m in my office, I will almost always answer it;
  4. Talk to me before or after class or in the hallway, but make sure I write it down;
  5. Send me an email to my email address, belmont@umich.edu (within 3-5 business days).

 

New and Experimental Features 

Readings

Previously readings were briefly presented by me as a sort of on-the-spot quiz by individuals in front of their peers. To improve upon the situation mightily, I am employing your help to summarize – in any way you would like but a short narrated slide deck will suffice – a reading on the topics of the class. While I do not expect every participant to read every single reading, the more that is read, the more that is known. At the very least, I suspect you’ll learn something listening to a peer you know did the reading!
 

Interviews

This assignment was born of these twin facts: (1) everyone could stand to learn a thing or two from someone actually in a profession and (2) most professions that pay don’t make one available at 3:00 – 5:00 p.m. on a Wednesday. That being the case, I still want you to learn from experts in the field. With your help and efforts we can canvas a wide swath of the biomedical landscape. I look forward to hearing what you learn.
 

Reviews and Reflections

Students have asked for a mechanism to evaluate one another and to reflect on their own learning. These assignments are meant to meet these requests. I hope that solidify solid foundational knowledge and strengthen the mortar of teamwork.
 

Readings by source

  1. Abdel-Aleem, Salah., “The design and management of medical device clinical trials strategies and challenges.” John Wiley, 2010
    • 1. Challenges to the Design of Clinical Study
    • 4. Fraud and Misconduct in Clinical Trials
    • 5. Challenges to the Regulation of Medical Device 
    • 6. Challenges of Global Clinical Studies and the CE Mark Process 
    • 8. Bioethics in Clinical Research
  2. Baura, Gail D., “Medical device technologies a systems based overview using engineering standards.” Elsevier/Academic Press, 2012.
    • Chapter 1. Diagnosis and Therapy
    • Chapter 2. Electrocardiographs
    • Chapter 9. Hemodialysis Delivery Systems
    • Chapter 11. Pulse Oximeters
  3. Fries, Richard C., “Reliable design of medical devices.” CRC Press, 2013.
    • Chapter 7. The FDA
    • Chapter 12. Liability
    • Chapter 13. Intellectual Property
    • Chapter 32. Transfer to Manufacturing
    • Chapter 33. Hardware Manufacturing
  4. V. Gavrishchaka, O. Senyukova and M. Koepke (2019) “Synergy of physics-based reasoning and machine learning in biomedical applications: towards unlimited deep learning with limited data”, Advances in Physics: X, 4:1
  5. Kaniusas, Eugenijus., “Biomedical Signals and Sensors I: Linking Physiological Phenomena and Biosignals.” Springer, 2012.
    • 2.2. Neurons and Receptors
    • 2.4. Heart 
    • 2.5. Circulatory System 
    • 2.6. Respiratory System 
    • 3.1. Vital Phenomena and Their Parameters 
    • 3.2. Parameter Behavior 
  6. Kendler, Jonathan. and Strochlic, Allison Y., “Usability testing of medical devices.” CRC Press, Taylor & Francis Group, 2016.
    • Chapter 3. The Commercial Imperative
    • Chapter 4. Testing Costs
    • Chapter 7. Writing a Test Plan
    • Chapter 12. Conducting the Test
    • Chapter 16. Reporting Results
  7. Kucklick, Theodore R., “The medical device R&D handbook.” CRC press, Taylor & Francis Group, 2013.
    • 12. Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory
    • 14. Intellectual Property Strategy for Med-Tech Start-Ups
    • 15. Regulatory Affairs: Medical Device 
    • 17. Brief Introduction to Preclinical Research 
    • 24. Interview with J. Casey McGlynn 
    • 25. Keys to Creating Value for Early Stage Medical Device Companies 
    • 27. Medical Device Sales 101
    • 29. How to Fail as an Entrepreneur 
  8. Liang, Hualou., Bronzino, Joseph D., and Peterson, Donald R., “Biosignal processing principles and practices.” CRC Press/Taylor & Francis, 2013.
    • 1. Digital Biomedical Signal Acquisition and Processing 
    • 2. Time–Frequency Signal Representations for Biomedical Signals 
  9. Medical Device Amendments of 1976. Public Law 94-295, 94th U.S. Congress.
  10. “Medicare-for-All”. H.R. 1384 and S. 1129, 116th U.S. Congress
  11. Northrop, Robert B., “Noninvasive instrumentation and measurement in medical diagnosis.” CRC Press, Taylor & Francis Group, 2018.
    • 4. Measurement of Electrical Potentials and Magnetic Fields from the Body Surface 
    • Plethysmography 
    • Pulmonary Function Tests
  12. Prutchi, David and Norris, Michael, “Design and development of medical electronic instrumentation a practical perspective of the design, construction, and test of medical devices.” Wiley-Interscience, 2005.
    • 1. Biopotential amplifiers 
    • 2. Bandpass selection for biopotential amplifiers 
    • 3. Design of safe medical device prototypes
    • 4. Electromagnetic compatibility and medical devices
    • 5. Signal conditioning, data acquisition, and spectral analysis 
  13. J. Rajeswari and M. Jagannath, “Advances in biomedical signal and image processing – A system review”, Informatics in Medicine Unlocked 8 (2017) 13–19
  14. Riegel v. Medtronic, Inc., 552 U. S. 312 (2008)
  15. Semmlow, John L., “Circuits, signals and systems for bioengineers : a MATLAB-based introduction.” Academic Press, 2018.
    • 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
  16. K. Shameer, K. W. Johnson, B.S. Glicksberg, et al. “Machine learning in cardiovascular medicine: are we there yet?”, Heart 2018;104:1156–1164.
  17. G. A. Van Norman, “Drugs and Devices: Comparison of European and U.S. Approval Processes”, JACC: Basic to Translational Science, Volume 1, Issue 5, 2016, 399-412
  18. Webster, John G., and Eren, Halit, “Measurement, instrumentation, and sensors handbook electromagnetic, optical, radiation, chemical, and biomedical measurement.” CRC Press, Taylor & Francis Group, 2014.
    • 19. Oscilloscope Voltage Measurement 
    • 41. Time Measurement 
    • 42. Frequency Measurement 
    • 65. Blood Pressure Measurement 
    • 68. Blood Chemistry Measurement 
  19. M. Wacker and H. Witte, “Time-frequency Techniques in Biomedical Signal Analysis: A Tutorial Review of Similarities and Differences”, Methods Inf Med 2013; 52: 279–296
  20. Wood, Andrew W., “Physiology, biophysics, and biomedical engineering.” CRC Press, 2012.
    1. 2. Fundamentals of Electrical Circuits for Biomedicine 
    2. 8. Cardiac Biophysics 
    3. 10. The Vascular System: Blood Flow Patterns in Various Parts of the Circulation 
    4. 11. Cardiovascular System Monitoring 
    5. 12. Respiratory Biophysics 
    6. 13. Renal Biophysics and Dialysis 
    7. 16. The Biophysics of Sensation—General 
    8. 20. Physiological Signal Processing 
    9. Physiological Modeling 
  21. World Health Organization (WHO), “Medical devices: managing the mismatch : an outcome of the Priority Medical Devices project.” Geneva, 2010.

Readings in order 

1. Kaniusas 2.2. Neurons and Receptors
2. Kaniusas 2.4. Heart
3. Wood 8. Cardiac Biophysics 
4. Northrop 4. Measurement of Electrical Potentials and Magnetic Fields from the Body Surface
5. Prutchi 1. Biopotential Amplifiers
6. Wood 2. Fundamentals of Electrical Circuits for Biomedicine 
7. Baura 2. Electrocardiographs
8. Prutchi 2. Bandpass Selection for Biopotential Amplifiers
9. Semmlow 1. The Big Picture: Bioengineering Signals and
10. Semmlow 13. Analysis of Analog Circuits and Models
11. Semmlow 15. Basic Analog Electronics: Operational Amplifiers
12. Webster 19. Oscilloscope Voltage Measurement 
13. Kaniusas 2.5. Circulatory System
14. Wood 10. The Vascular System: Blood Flow Patterns in Various Parts of the Circulation
15. Wood 11. Cardiovascular System Monitoring 
16. Baura 11. Pulse Oximeters
17. Northrop 9. Plethysmography
18. Webster 68. Blood Chemistry Measurement 
19. Liang 1. Digital Biomedical Signal Acquisition and Processing
20. Liang 2. Time–Frequency Signal Representations for Biomedical Signals
21. Prutchi 5. Signal Conditioning, Data Acquisition, and Spectral Analysis
22. Webster 41. Time Measurement
23. Webster 42. Frequency Measurement
24. Wood 20. Physiological Signal Processing
25. Kaniusas 2.6. Respiratory System
26. Northrop 10. Pulmonary Function Tests
27. Wood 12. Respiratory Biophysics
28. Baura 9. Hemodialysis Delivery Systems
29. Webster 65. Blood Pressure Measurement
30. Wood 13. Renal Biophysics and Dialysis
31. Semmlow 2. Signal Analysis in the Time Domain
32. Semmlow 3. Signal Analysis in the Frequency Domain: The Fourier Series and the Fourier Transformation
33. Semmlow 4. Signal Analysis in the Frequency Domain – Implications and Applications
34. Wacker and Witte. Time-frequency Techniques in Biomedical Signal Analysis
35. Rajeswari and Jagannath. Advances in biomedical signal and image processing
36. Sharmeer et al. Machine learning in cardiovascular medicine
37. Kaniusas 3.1. Physiological Phenomena and Biosignals 
38. Kaniusas 3.2. Parameter Behavior
39. Gavrishchaka et al. Synergy of physics-based reasoning and machine learning in biomedical applications
40. Baura 1. Diagnosis and Therapy
41. Wood 16. The Biophysics of Sensation
42. Wood 25. Physiological Modeling
43. Abdul-Aleem 1. Challenges to the Design of Clinical Study
44. Abdul-Aleem 4. Fraud and Misconduct in Clinical Trials
45. Fries 12. Liability
46. Abdul-Aleem 8. Bioethics in Clinical Research
47. Kucklick 12. Clinical Observation: How to Be Welcome (or at Least Tolerated) in the Operating Room and Laboratory
48. Kucklick 17. Brief Introduction to Preclinical Research
49. Fries 13. Intellectual Property
50. Kucklick 19. Intellectual Property Strategy for
Med-Tech Start-Ups
51. Kucklick 24. Interview with J. Casey McGlynn
52. Medical Device Amendments
53. “Medicare-for-All”, H.R. 1384 / S. 1129
54. Riegel v. Medtronic, Inc.
55. Kucklick 25. Keys to Creating Value for Early Stage Medical Device Companies
56. Kucklick 27. Medical Device Sales 101
57. Kucklick 29. How to Fail as an Entrepreneur
58. Fries 32. Transfer to Manufacturing
59. Fries 33. Hardware Manufacturing
60. Kendler 3. The Commercial Imperative
61. Abdel-Aleem 5. Challenges of Global Clinical Studies and the CE Mark Process
62. Kucklick 15. Regulatory Affairs Medical Devices
63. Van Norman. Drugs and Devices: Comparison of European and U.S. Approval Processes
64. Fries 7. The FDA
65. Prutchi 3. Design of Safe Medical Device Prototypes
66. Prutchi 4. Electromagnetic Compatibility and Medical Devices
67. Kendler 4. Testing Costs
68. Kendler 7. Writing a Test Plan
69. Kendler 12. Conducting the Test
70. Abdel-Aleem 6. Challenges to the Regulation of Medical Device
71. Kendler 16. Reporting Results
72. WHO Report. Medical Devices: Managing the Mismatch, An Outcome of The Priority Medical Devices Project