- Who are you and how will history remember you?
- Medical information is often treated differently than other sorts of information. An emphasis on privacy and integrity goes along with the sensitivity of the information. This can produce fragmentary systems where only certain parties only know certain things. To what extent does this alter the “objectivity” of one’s medical history?
- How should we take historical information into account for a present situation?
- Desperate times, we are told, often call for desperate measures. In today’s world there is talk of rescinding certain restrictions of established medical privacy law to facilitate the transmission of information during a quickly happening, slowly moving pandemic. How/Can we ensure information gets to where it’s needed and nowhere else?
- Is there a line (or set of lines) we can draw in which medical data is strictly the possession of the individual from which it comes and that data which is not? When data is “de-identified”/”anonymized” to what extent can the individual from whom it comes stake any claim?
- Nietzsche remarks “There is no set of maxims more important for an historian than … that everything that exists, no matter what its origins, is periodically reinterpreted… in terms of fresh intentions … in the course of which earlier meaning and purposes are necessarily either obscured or lost. … The whole history of custom, [thus] becomes a continuous chain of reinterpretations and rearrangements…” Why/Has medical practitioners’ “duties” (e.g., Hippocratic Oath) remained largely stable through successive reinterpretations? That is, we now allow “cutting for stone”, yet might still find wisdom in that contract to Apollo. Why?
- Baker (2002) contends that “If the unexamined life may not be worth living, then, in much the same way, advice by historically uninformed bioethicists may not be worth having.” How much history should be folded into bioethical discussions? Is there ahistorical bioethics? Must actions be justified by moral rules grounded in principles derived from ethical theories that will always be “of their time”?
- Is bioethics a recent historical creation? If so, why so? If not, why not?
- History, so far as I can tell, is the best evidence we have to the question, “Should we keep going?” Should we?
- How long should be our history?
Month: April 2020
A philosophy of circuits and systems in biomedical engineering, or, Love in the time of COVID-19
- In the first lecture,
- E. C. said we “walked […] through the syllabus and [got] important suggestions and notes on how to succeed this semester” and
- B. M. said “we will learn circuits and linear systems”, “will cover all fundamental circuit components and how to derive and characterize functions from them”, “a lot of this will be motivated by biomedical examples, “electrical circuits are everywhere”.
- In the second lecture,
- J. R. noted this “section of class focuses on describing the basic elements to be used in circuit analysis along with equivalent impedance”.
- In lecture 3
- I. D. relayed the fact that “impedance is the opposition of current, Z = R + jX. Equivalent impedance of circuit elements can be derived from Ohm’s law” and
- J. S. in his immaculately LaTeX set notes said: “We began our study of nodal analysis by learning the fundamental theorem of network topology and applying the definitions established there to the calculation of equivalent impedances. We then learned Kirchhoff’s current and voltage laws, analogs of the laws of conservation of mass and energy for circuits.”
- In lecture 4
- K. B. said “We discussed applications of Ohm’s Law and Kirchoff’s Voltage Law to evaluate circuit configurations and analyze nodes”.
- In lecture 5
- Y. L. gave procedures for nodal analysis, “1. Select a node as a ref, assign nodal voltages everywhere else, 2. Apply KCL at each node, and 3. Solve simultaneous equations” and mesh analysis “for each mesh, assign a mesh current, 2. Apply KVL to each mesh, 3. Solve the resulting equations”.
- C. D. showed us examples of everything from “nodal analysis w/ controlled sources”, to “mesh analysis w/ independent sources”, even supermeshes.
- In lecture 6
- We as a class came together to solve Homework I more correctly and more efficiently than any one of us could alone. Thus providing yet another example of one of the central tenets of this philosophy: many hands make for quick work.
- In lecture 7
- H. K. told us how “We applied the Thevenin and Norton theorems [to transform] circuits. The Thevenin theorem took a complex circuit between two terminals and represented it as a resistor in series with a voltage source. Norton theorem took a complex section of a circuits between two terminals and represented it as a current source in parallel with a current source.”
- J. O. outlined “a step-by-step procedure: 1. Perform two of these – determine the open circuit voltage, determine the short circuit voltage, zero the independent sources and find the resistance – 2. Use the equation Voc = isc*R to compute remaining value. 3. Thevein, 4. Norton”.
- Rory M. told us how “the voltage (or current) through an element (in a linear circuit) is the algebraic sum of the voltages across (or the current through) that element due to each independent source”.
- In lecture 8
- P. R. provided “the answers to Worksheet Lecture 8, Theorems and Transformations II, discussed in class on February 5th, 2020. The first three problems served as review, and the last three are more difficult problems that could appear on an exam. Questions were retyped to make the answers more clear.”
- In lecture 9
- B. R. said “We learned about the basic circuit within an operational amplifier as well as rules and conveniences associated with op-amps. We then learned about several different kinds of amplifiers” and
- S. S. said “we went over some basic examples of operational amplifiers (comparators, voltage followers, inverting amplifiers, summing inverting amplifiers, noninverting amplifiers, differential amplifiers, instrumentation amplifiers, differentiators, and integrators)”.
- In lecture 10
- K. W. said “Today was a worksheet day, where we just did the worksheet in class” – O, how we long for such days.
- In lecture 11
- A. B. presented “a long derivation of a simple model” starting from images of the system and seamlessly flowing into math describing it
- J. T. said “these notes are dedicated to exploring and examin[in]g bioimpedance”, “graphs were also made to convey our results graphically”
- In lecture 12 we worked in small groups to reexamine our exams and understood more thereby Of course, little did we know then, this was also one of the last times we would ever meet. One of the last times we’d get to help each other.
- In lecture 13
- E. F. said “We analyzed source free RC and RL circuits. Conditions can be analyzed in order to solve for responses of the system”
- Y. C. had a handwriting and organizational manner that made it clear how complete response is the sums of natural and forced responses and transient and steady state responses.
- In lecture 14
- D. M. said “Initially, we finished up last lecture’s topic concerning first-order ODE’s in an op-amp circuits. Then we got into second-order ODE’s”
- E. D. claimed “It started w/ an introduction to second order systems. Then, we talked about the extreme cases. Finally, we discussed source-free series RLC circuits and the 3 important cases (overdamped, critically damped, and underdamped).” – subtle use of red to highlight important results
- In lecture 15
- E. P. getting straight to the point said in this lecture there was an “Introduction to the Laplace transform and s domain here is a table of useful equations” getting a jump of this last homework of ours
- In lecture 16
- N. S. gave us the “General Form of the Transfer Function” and the time-dependent behavior of each of the four forms of BIBO stable systems
- In lecture 17
- M. D. stated that “Convolution shows how multiple inputs are [transformed] based on the transfer function to give the outputs”
- G. A. noted that this was “A mathematical operation of two functions that will produce a third function that expresses the shape of one is modified by the other or as shown in the notes below how they affect each other.”
- D. W. said “We learned about the pulse and impulse equations and how any signal can be represented as an infinite sum of shifted and scaled impulse. […] The main point […] is that of the effect of any linear time (or shift) invariant system on any arbitrary signal is the convolution of the input signal with the system’s impulse response function”
- In lecture 18
- We learned about the relationship between inputs and outputs of systems and how they be understood in both the s-domain and the frequency domain.
- In lecture 19
- W. C. documents it as being “all about filters. In the beginning we quickly went over passive filtering, focusing on a graphical understanding respective to frequency. We then moved onto a building block of active filtering, inverting amplifiers. We realized that we could write a lot of the other types of op. amps. that we learned initially by thinking about impendance (helpful in the s-domain).”
- M. O. notes that “High and Low pass filters can be combined”, that “Active Filters can be created by adding circuit elements that give way to a gain (amplification)”, that “Band Pass gain can be generalized for”, and “Transfer functions can be converted to bode plots)”
- In lecture 20
- A. R. shows how “we moved from considering open loops to considering closed loops” with “The Key difference is that closed loops attempt to achieve a desired output by comparing its current output to [a] desired value and adjusting based on the difference, which we will call error.”
- R. E. J. relays that “we ideally want the system transfer function to be equal to one (X = Y). However, at times this situation is not possible and we must consider certain trade-offs or change the system”
- In lecture 21
- M. L. said “we explored where electricity in the body comes from and how this electrical activity is measured in various parts of the body”
- E. B. said “These sources of electricity include the sodium/potassium pump, the capacitor-like properties of the membrane itself, the potassium channel, the sodium channel, and the leakage channel. […] The capacitance of the membrane governs this response. […] Ultimately, the membrane potential is described as [a combination of] conductance and […] Nernst potential […] of each of the ion channels”
- S. S. said “A generalized biopotential amplifier consists of [a] Pre-amplifier, Two voltage buffers connected to a differential amplifier, [and] Driver amplifier, High pass and low pass filters”
- E. P. shared “how an ECG measures signal from the heart. We split the wave up into different parts understanding […] each portion represents”
- In lecture 22
- P. S. reports of a “demonstrate[ion of[ the capabilities of function generators and oscilloscopes, as well as [a] display how a breadboard can be hooked up to produce a desired output. We started by looking at the Agilent 3320A function generator, learning how to change different aspects of the wave which it outputs. We visualized the output of the function generator using the Tektronix TDS 2012C oscilloscope. Following this, we saw how the SRS Model SR560 could filter input based on parameters like high pass, low pass, cutoffs, and gain. After demonstrations as to how these machines worked, we imitated an output of the function generator and preamplifier using the AD620 and LM 741 operational amplifiers, resistors, capacitors, and a power supply. Finally, we saw that it is possible to hook yourself up to an oscilloscope, and – given the proper equipment – you can visualize your heartbeat.” Something you, yourselves, were all meant to achieve during the lab portion of the class.
- In lecture 23
- A. K. remarked that “Today was a review day for the exam […] We did an example involving finding poles and zeros, interpreting dampedness, and sketching s-planes and bode plots. We then did a review on bode plots and dampedness, and sketching s-planes and bodes plots, […] Next we did a biopotential example of designing and bandpass filter given specific constraints.”
- L. W. tidily concluded “The behavior of a system can be characterized by looking at the equation in the Laplace domain. Setting the numerator equal to zero gives us the zeros, where the function equals zero, while setting the denominator equal to zero lets us solve for the poles, where the function approaches infinity. Negative poles decay away to zero as t \rightarrow \infty, giving us a stable system.”
- And here in the final lecture
- We learn it all again.
- G. A.
- A. B.
- K. B.
- E. B.
- Y. C.
- E. C.
- W. C.
- J. C.
- C. D.
- M. D.
- E. D.
- I. D.
- R. E. J.
- E. F.
- H. K.
- A. K.
- Y. L.
- M. L.
- D. M.
- R. M.
- B. M.
- M. O.
- J. O.
- R. P.
- E. P.
- P. R.
- J. R.
- A. R.
- B. R.
- P. S.
- N. S.
- S. S.
- J. S.
- S. S.
- J. T.
- L. W.
- D. W.
- K. W.
Philosophies of Biomedical Instrumentation, or, A Panopticon, a Pandemic
A final lecture delivered to the students of BIOMEDE 458 / EECS 458, April 15, 2020
- N. S. presented on Cardiac Biophysics;
- J. G. followed up on Biopotential Amplifiers;
- I. H. taught us Bandpass Selection for Biopotential Amplifiers;
- B. M. showed us Oscilloscope Voltage Measurement;
- P. V. drew the parallel to Cardiovascular System Monitoring;
- S. D. went through the foundations of Pulse Oximeters;
- J. B. demonstrated Signal Conditioning Data Acquisition, and Spectral Analysis;
- R. P.M. gave an overview of Physiological Signal Processing;
- J. C. explained Respiratory Biophysics;
- L. N. explained Renal Biophysics and Dialysis;
- R. P. conveyed some of the Implications and Applications of Signal Analysis in the Frequency Domain;
- K. A. explained Parameter Behavior;
- T. E. related it to Diagnosis and Therapy;
- L. R., – or, K. M., FBI – characterized Fraud and Misconduct in Clinical Trials;
- A. S. taught us How to be Welcome (or at Least Tolerated) in the Operating Room and Laboratory;
- L. M. relayed Intellectual Property Strategy for Med-Tech Start-Ups;
- M. B. concluded her presentation of Riegel v. Medtronic, Inc. saying “Go Ginsburg” while fist pumping in the air;
- R. R. gave us the Keys to Creating Value for Early Stage Medical Device Companies;
- L. W. told us when to Transfer to Manufacturing;
- C. Y. shared with us some of the Regulatory Affairs of Medical Devices;
- M. A. explained how to verify Electromagnetic Compatibility of Medical Devices
- M. S. told us about Writing a Test Plan, well; and
- N. P. distilled the findings of a World Health Organization report on the mismatch between medical device development and human health needs across the globe.
- B. A. summarized cochlear implants and H. H. expanded that to include bone conducting hearing aids;
- H. A. described image guided systems as a “Google Maps” of the body and K. W. described how those images were made via computed tomography;
- N. S. explained how smart insulin pumps and A. S. explained what smart inhalers do and we all wondered aloud what about them was “smart”;
- S. R. showed the cutting edge(s) of robotic surgery and A. S. sounded the benefits of the good vibrations coming from a bioresorable bone anchor;
- N. P. discussed laser-powered eye surgery and M. S. highlighted UV powered electronics;
- R. K. gazed to outer space for a medical device and T. E. probed our very neurons for one;
- J. W. advocated for the benefits of CPAP and S. D. of the necessity of ventilators; and
- H. L. shared the Cellex qSARS-CoV-2 IgG/IgM Rapid Test while M. A. shared the Xpert® Xpress SARS-CoV-2 automated molecular test for that disorder we hear about these days.
- R. K. to thank for interviewing someone who “helped establish the UM Export Controls Review Committee (ECRC), which helps UM researchers maintain compliance on export-controlled items”.
- A. S. spoke with the Associate Director of Licensing for Medical Devices at the University of Michigan Office of Tech Transfer, a patent attorney by training.
- M. T. told us it “was lovely learning more about patent law in the biotech and medical device industry from” Vice President of the Intellectual Property Counsel for a therapeutics company.
- M. G. recorded a Clinical Account Specialist as saying “About once a week, a failure or complication is seen. […] It’s not typical for a patient to be impacted by the failure of a device in the field […]: there are fail-safe switches in place so certain errors that could impact a patient do not occur.”
- C. S. showed how a manager of clinical informatics “implemented several changes in [the company] to force providers (or make it hard to not follow the correct workflow) into making sure they checked MAPS (state registry of all controlled substance prescriptions) when prescribing a controlled substance, […] ensuring that patients who received opioids were educated […].
- A. R. relayed from the field that, “In public health, many people go in thinking that there is something wrong for a particular community and try to build a solution only to realize that it’s not what the community actually wants or needs. The best way to bring about practical change is to form relationships to understand what they are actually experiencing.”
- M. B.’s interview subject expanded upon this point: “There is something to be said for consumer discovery early on. Current physicians don’t like to implement changes that bring unnecessary risk to patients (the possibility that they can’t do it right or confidently) During development it is important to ask clinicians what they want. There is not a ton of appetite for new things, they are very busy and have a lot to do, they don’t have time to learn how to use a new device. Some innovators will identify a problem and rush to commercialize it without consumer discovery. They need to talk to hundreds, even thousands of people to see what problems they encounter, their standard practices, etc. to understand the potential market and if the changes are viable to actual practitioners.”
- I. G.’s interview subject, a physician in the Pediatric Cardiology outpatient clinic, reminded us that “Under the Sunshine Act all gifts $10+ from manufacturers to physicians and hospitals are made public.”
- S. R. reflected from a pediatrician’s standpoint that “the most common medical devices used are pulse oximeters to read oxygen saturation, glucometers to test glucose levels, and cardiorespiratory monitors.”
- R. P. explained how a dental assistant in Canada “trains new employees to minimize potential problems [by] demonstrat[ing] how to use certain equipment […] and encourage[ing] them to ask any questions if they are unsure about anything.”
- H. L. interview an Anesthesia Resident who posited that “AI could be used predominately in administrative work, such as discharge paperwork, hospital bed management, emergency department management, scheduling assignments, ED triage, and even trends in certain hospitals like measures of health.”
- R. R. communicated that someone working for a company that provides IT for dozens to hundreds of hospitals across the Midwest and east coast thinks “To make this a viable approach, the patient needs to undergo some sort of standard evaluation method, which may be difficult to make universal.”
- N. A. said “A 510k [pathway] allows medical device companies to bypass the extensive clinical testing that comes with a pre-market approval from the FDA. They can avoid this testing by citing a similar predicate device that was already approved by the FDA.”
- S. D. had a first-year Medical Student “explain[] that there are four factors to consider for consent, those being: (1) the patient or the guardian should not be coerced, (2) the patient should be completely competent and able to make a clear decision, (3) the patient must be educated clearly on what they are being asked to give consent to, and (4) the patient’s best interest should be factored as a priority”.
- To S. H., a clinical fellow being from the Netherlands, expressed that his country had “universal health care for citizens in the form of community insurance, which is the same for everyone but care is provided based on the individual. […] Because of this, people in the Netherlands do not wait until a problem becomes a medical emergency to go to the doctor, unlike in the United States. All citizens are also guaranteed paid sick leave in the Netherlands, which he thinks will help stop the spread of the corona virus, because people do not go to work sick.”
- And A. L. recounted the differences in opinion between a medical professional practicing Internal Medicine at Christ Hospital and Jersey City Medical Center who “believes patients should not be able to control their own medical device. That should be done only by a medical professional and the professional should make their own medical judgement given the clinal scenario” and a nurse practitioner at C.S. Mott Children’s Hospital who “feels that patients should have a lot more control. The best way to go about doing something like this would be to have guidelines and recommendations from professionals. […] [S]he explained that giving patients some freedom to control their own devices would save them a lot of time from coming in and out of the hospital. She believes healthcare should be a partnership with the patients, and patients who are mentally stable and aware should be allowed more control in their care because it is their health.”
- A Senior Engineering Director interviewed by L. M. interviewed noted that “Because there are limited resources for funding, business leaders decide where funding should be directed. The decision is a combination of both research and business people, and also the legal teams.”
- A Division Chief of Physical Medicine who spoke with A. B. spoke with said, “decisions are made with considerations of recommendations given from providers, relationship with the company, as well as the service, reliability, and reputation of the device.”
- A chief medical officer at a hospital in Ghana told J. B. he “makes decisions regarding quantity of devices, budget for the department, and models of the devices.”
- Someone working at Michigan Medicine relayed to K. W. that “we often are able purchase equipment at a major discount through package deals (e.g., purchase x-ray, ultrasound, MRI equipment from the same company), so price isn’t as big a factor as it could be for others.”
- In pediatric emergency care, A. S. told us “providing individualized care is highly important […] in an emergency environment where each patient requires one-on-one attention.”
- An Operations Manager in a health system mentioned to S. J. “that hospitals are more adaptive than one would think to accept the change. Hospitals want to provide “the latest and greatest” device in the market so long [as] it is feasible and fits all the qualifications. For any n[e]w equipment, hardware or software, a business plan is created to weigh the pros and cons of implementation”
- A professor starting a company for applications of his research stated to P. Y. “His devices will be priced by the market but will depend on two factors: costs of the fixed parts of the device and costs of the disposable parts of the device. In fact, for most medical devices the cost for the disposable portions are significantly higher than the instrument themselves, leading to a free-rental strategy similar to printers and the high cost of cartridges.”
- A person who runs an acupuncture clinic mentioned to J. C. “that a long time ago, supplies were itemized to be reimbursed by insurance. Medicare has changed the method of billing items such that everything is lumped into a single item of “supply”. A lot of insurance companies do not even cover supplies.”
- Someone with 25 years of industry and consulting experience in the medical device sectors told S. K. “Ultimately, it is the payer customer that is paying for the medical technology and rendering reimbursement to your clinical customers for purchasing and using your medical technology. It is extremely important that companies include the payer customer in their R&D and commercial planning efforts.”
- A Senior Scientist in Translational Histopathology opined to M. A. “It is very crucial to know what you will be having to face before you start something. This is true in all aspects of life. You don’t want to dive into water before knowing how deep or shallow it is. It’s the same deal with research and biotech businesses.”
- An Associate Professor of Internal Medicine told S. N. that “US hospitals dispose of outdated equipment on a regular basis as newer models and technology become accessible. Some will require that vendors of new equipment take old equipment back to enable safe disposal, however few hospitals realize that it is actually possible to contractually organize for vendors to re-purpose or responsibly recondition take-backs.”
- A partner at a local venture capital firm explained to N. P. “healthcare venture capital is far more stable compared to other sectors due to the constant demand for healthcare, and that he sees a lot of growth in the non-invasive cost cutting sector of healthcare.”
- A. R. spent 10 “extremely insightful” minutes with a General Partner at a venture capital firm.
- A regulatory affairs specialist said to M. R. “how, often times, engineers like to focus on the design of products, but in a business setting the regulatory affairs is just as important.” He noted this is “Kind of a biased response given that [they] work[ in] this position.”
- An R&D manager told A. W. that “Engineers are responsible for the product risk analysis documentation, wherein they weigh how likely a risk is to occur vs. the severity of occurrence.”
- An R&D Engineer told J. L. of the “need to collaborate with the manufacturing teams to ensure there is the ability to bring a new product to full scale production.”
- R. P. M. warns us “In the event of a complete power outage including back up, the only tools that would be available to continue to provide sufficient care to critical patients are generators and hand-held ventilators.”
- A currently practicing physician said to S. D. in response to the current state of affairs, “Clinicians will be forced to look at what truly needs to be done for patients and change how they are approached. […] The backlog of cases that need to get done after the pandemic passes (guesses in a few months) will be huge and cause a large back up (physicians already were pressed for OR time).”
- And a currently practicing resident nurse explained to L. W. that “Hand washing frequently and thoroughly several times throughout the day is the best defense against any illness, including flu. If you are sick, you help protect your community by staying home when you have a fever and covering your mouth with your arm if you cough or sneeze.”
- A Regulatory and Clinical Affairs at a company that “operates in multiple countries” said to H. H. “the USA, EU and Canada typically have the gold standard when it comes to regulatory laws and standards meaning that many other countries typically follow the precedent those countries follow. However, even keeping up with the changing standards and laws in a few countries was a lot of work and could get very complicated. He said that compiling these standards and controls as well as ensuring that your development team is complying with these changes can be challenging.”
- A. B. interviewed a hardware engineer at Baxter Renal Care, who conveyed a few standards you have to meet for medical devices including the “International electrotechnical commission (IEC), International Organization for Standardization (ISO), and Association for the Advancement of Medical Instrumentation (AAMI).”
- A scientist at Eli Lilly and Co told C. Y. they think “most of the regulations enforced in drug development are there to ensure that safe, high quality medicines are released to help better the lives of the patients depending on them.”
- A Clinical Programs Coordinator told A. S. “the FDA regulatory process is the biggest hold up to new and improved medical devices being placed in hospitals. [… and] sometimes this process takes too long and doesn’t allow advancement in fields that need it.”
- A professor in the EECS department at UM told B. M. “his team’s goal was not to “create a new device”; rather, their goal was to cause the smallest possible change to a device which had already passed FDA regulations (in fact, they legally reverse-engineered these devices for their own research).”
- K. N. interviewed a research professor who “sees all this bureaucracy as a necessary part of the research process [and] would rather have to deal with paperwork than to accidentally come into contact with unknown pathogens and cancerous materials that could cost [them] their lives.”
- A nurse at a hospital in Detroit told J. D., “the system needs to be flexible in terms of emergency it still needs to do its job in trying to keep people as safe as possible”
- A family nurse practitioner for 24 years told M. L. “CLIA waived testing is also very helpful and easy to do because every test has a policy that serves as a step-by-step “recipe”. With the pandemic occurring, COVID needs to be a CLIA waived test so you can test for it on site in an office, reaching a wider population.”
- A nursing assistant told J. W. “that most of the devices that are used for patient care are pretty good and reliable, but that the computers they use to manage patient information desperately need to be upgraded.”
- A Clinical Programs Coordinator told N. H. “I believe one of the most difficult devices to work with are the electronic medical records. Although they have come a long way, they still provide too many places to document the same information which can become confusing – especially a patients recorded medication list. It seems like they could have integrated this feedback by now, […]and yet the issues remain.”
- A project manager told K. A. “HIPAA requires that hospitals develop and follow procedures that ensures the confidentiality and security of all their patients.”
- A person at a pharmaceutical company said to E. K. “how health care decisions are highly personal in […] and hopes that […] individuals would be fully informed in advance by health-care providers of the nature of the device in question and aware of the corresponding limitations.”
- N. H., research lab manager, “The discussion then led to how women typically are more harmed by medical devices than men, due to exclusion of women from clinical trials.”
- A senior clinical engineer told H. A. that the “department prepares an annual capital planning list for every department based on age, recalls, clinical needs, and OEM end-of-support notifications, and leave it up to each department to decide purchase priority based on their budgets.”
- An Assistant Professor of orthopedic surgery conveyed to J. G. that “the hospital’s policy is to replace the device after its service life is over. However, if a new device would provide improved functionality or higher quality of care, then hospital would be willing to upgrade the device before the service life date. He also mentioned that this typically happens when company representatives approach surgeons with the new products.”
- L. L. relays a post-doc focusing on marketing the application of nanoparticles to detect and diagnose the breast cancer saying “All the consumers will be vulnerable population, they deserve to be treated by the safe drugs and medical devices. He told me his belief is that only if you do regulation, you can assure the quality and safety of products. He doesn’t believe the commercial company can be trusted to regulate their products by themselves.”
- An associate professor of neurology told J. S. “When it comes to surgery, there is a tradeoff between the extent of [benefit] and the harm incurred to patients. If you remove the entire brain, there will definitely not be any seizure because there isn’t a brain, but this isn’t a good idea.”
- A consumer safety officer for the Food and Drug Administration and J. C. agreed, “the overall consequence reduction of commercialized products relies heavily on physicians and patients’ judgment. A physician should always be well informed about the regulatory and scientific process to ensure product safety. Consumers should also report any health-related issues as it is their report that initiates further FDA investigation to mitigate health related consequences.”
- A Product Engineer mentioned to J. S. that much of their day-to-day work includes Product Investigation, Root Cause Analysis, and Clinical Evaluations, wherein “they undergo a detailed failure analysis and attempt to list every failure/error they predict could happen with their device. They list probable risks and their percent chance of happening, even if this is incredibly small. Each failure is rated on a 1 (Patient Discomfort) to 4 (Death) scale”.
- An ICU nurse told D. J. “if she loses a patient, she helps transfer their body down to the morgue.”
- A nurse with experience various hospital systems told B. P. “When a patient is very ill, they are connected to a number of different monitors, all outputting continuous data that needs attention [and] it’s very easy to get preoccupied with the numbers, and lose track of the patient sitting in the bed.”
- A pediatrician in the making told D. K. “Sometimes the treatment that the patients undergo may only extend their life by a few years or even a few months, so at a certain point, it may not be worth the extra pain and money”.
- A pediatric endocrinologist explained to L. F. that “Insurance companies require a middleman to deliver devices from the company that manufactures it to the patient.”
- A nurse in the Henry Ford health system talked with P. V. “about the problems that arise when patients aren’t fully informed about the medical devices they use.”
- A Physiatrist stated to T. E. “that devices recommended are very significant for patients to use especially for rehabilitation. The main targets for treatment plans are to improve function, increase quality of life, and reduce pain. He stressed that it is essential that patients are thoroughly taught how to use device so that they actually use it, as patient compliance can sometimes prove an issue.”
- A Professor of Cardiovascular Physiology at the University of Michigan told N. S., “we need government sponsored basic science because pharmaceutical companies don’t really do basic science anymore, so our universities provide a pipeline to industry for future medical innovation [and] a large aspect of basic science funding, even indirectly, is education.”
- M. S. was told by a nurse with the Saint Joseph Mercy Health System in Michigan that “Humans are the weakest component of any security system”.
- An Anesthesiology specialist relayed to L. N. that “when it comes to medical devices, “I always trust them 100%”.”
- Various resident doctors and staff at the University of Michigan Emergency Department Critical Care Center said to I. H. “There are devices that are very good at either saving a patient’s life or prolonging the inevitable […] and sometimes it’s nearly impossible to tell which it will be at the onset of the treatment.”
- An ear, nose and throat surgeon explained to B. A. how “tools and devices are periodically checked and maintained. They are also checked right before being used in a procedure. If the device is found to be broken during this check, a backup can be used. However, on busy days with multiple operations, a backup might not be available. In this case a technician would try to fix it.”
- A Research Biomedical Engineer told B. N. “When there are deadlines involved and proof-of-concept/function is the current focus”, getting work done now can trounce usability and safety “at times.”
- A retired psychiatrist showed L. R. “the moral of the story is that it’s fun to think about ethics and positive choices, but that gets thrown out the window the moment money gets involved. Short-term economic benefit can have a lasting impact on peoples’ lives.”
- A postdoc said to H. T. that “Contextualizing things within the scientific processes, […] one can explicitly say that this is the point of the scientific process, to be challenged and peer reviewed”.
- I learned how to make a LabView program;
- learned a lot about what LabVIEW can do;
- I learned a lot about how labview handles large datasets i.e. how to use arrays in any level of detail;
- I learned how to input arrays and manipulate them to find the heart rate from an ECG signal in LabVIEW
- I also improved my knowledge of LabVIEW further by gaining experience with arrays and the different structures within LabVIEW (flat sequence, case, while loop, etc.);
- I also learned how to create sequences and while loops in LabView;
- I learned how collectors work, how to work with arrays in LabVIEW, and how to implement Equations. I also learned about different Algorithms to acquire the beats per minute such as a[n] amplitude based approach, a max value based approach, minimum distances between peaks, etc.;
- I learnt some useful VIs in labview that I can definitely revisit and reuse in the future when I am developing something else;
- I really learned a lot about how to process signals using LabVIEW;
- I learned how to use Labview software, like how to use DAQ assistant to acquire signals, how to use notch filter for reducing noisy signals;
- I learned how to build a notch filter;
- I learned that the hardware notch filter is superior to the software notch filter;
- How to build a notch-filter and remove DC noise from a signal to get the low amplitude signal;
- I learned how to create a notch filter in hardware as well as creating a T junction filter to increase gain;
- I also learned how to construct a Twin-T notch filter;
- I also learned how to use a T-Network in the feedback line of an op-amp to generate enormous gains
- I also learned how to construct and fine-tune a split t junction amplifier;
- I learned how powerful filters can be for amplifying a particular part of a signal;
- I learned the different types of noise;
- I learned a significant amount about filtering signals;
- how to build digital filters to alter a signal;
- I learned how to make hardware filters and amplifiers on the breadboard.
- I finally learned how to use a breadboard properly.
- How to PHYSICALLY build filters/amplifiers, troubleshoot with pesky wires/breadboards/etc;
- I relearned how to properly construct filters with the proper pinouts and best trouble shooting practices, especially the benefit of using the oscilloscope;
- I improved my oscilloscope technique significantly as well;
- I also became more comfortable using the oscilloscope and in my abilities to use pin-out/other schematics to build a physical circuit;
- I learned […] more than just surface level application and how to debug for many problems that came up;
- I learned many different ways of troubleshooting circuit designs
- I learned a lot about debugging circuits;
- I learned a ton about different types of circuits that I did not know previously;
- I learned that what works on paper does not usually work in practice;
- I learned that 100 microfarad capacitors are bad to use;
- I also learned how trial and error until finding the method that works can be inefficient and long, but also helpful;
- I learned how a potentiometer works;
- How to use potentiometers;
- I learned an important application of voltage followers when you want to reduce the impact of a load on a voltage measurement;
- I also learned that good wire management reduces a lot of noise;
- I learned that the presence of low frequency noise, such as the signal from the lungs, can mess up a peak detector that looks for global maximums;
- I also learned how difficult it is to stabilize such a signal under movement;
- I also learned how to construct a peak detector that looked for local maximums;
- I learned a lot about making electrical systems, especially regarding problems with things getting unplugged or ripped, dealing with unexpected outputs, and general troubleshooting practices;
- how to solder;
- I learned how to solder more;
- I also learned how to solder […];
- I also improved my soldering technique;
- I also gained a bit of drilling experience;
- I learned the importance of managing complex hardware so that the device can be used practically;
- how to combine both hardware and software into one large working system to be able to get a reading off of a human;
- I also learned how to apply my knowledge of circuits to real world examples of medical devices;
- I mainly learned a lot about how software can communicate with hardware;
- This […] taught me how to combine both hardware and software into one large working system to be able to get a reading off of a human ;
- I gained a deeper understanding for the power of an analog to digital conversion;
- I learned a lot of little things;
- I learned to use common sense;
- to always be as patient as possible, despite obstacles;
- I learned how a heart works, how to quantify how a heart works;
- I learned what a heart beat looks like in terms of the arterial waveform;
- I learned what oxygen saturation is, why it is useful;
- that Hemoglobin’s absorption spectra can allow us to calculate how much of it is oxygenated;
- How light absorption can be used to calculate oxygen concentration using the Beer-Lambert Law;
- I also learned a lot about the Beer-Lambert Law;
- I also learned the relationship between exercise and heart rate and respiration and heart rate;
- that light goes much farther through human tissue than I once thought;
- I also learned a little bit about light absorption and extinction coefficients;
- I learned that some signals from the body are very finicky to acquire and patience is a necessity when dealing with them;
- I learned that the best way to get started is to research and plan ahead some, but ultimately one must just start;
- I learned a little bit about the range for biological signal acquisition, how to design a two stage amplifier, and the approximate strength biological signals can be read from the skin;
- I learned how to write notes in a cautious way;
- I learned how to be patient with myself in creating a circuit, as it takes time and it is okay to make mistakes;
- I learned that understanding the information in the datasheet is very important.
- I gained more confidence using datasheets and manuals;
- Also learned that instrumentation amp (AD620) has weird input impedance effects and it also leaks current out of the inputs;
- I became much more comfortable with making filter circuits and reading/characterizing bode plots;
- One thing I learned […] is that if you stare at and wrestle with something for a really, really long time, you will eventually figure it out;
- I learned that getting the right results doesn’t mean your method is correct;
- I also learned how signal processing is complicated and how troubleshooting requires a lot of critical thinking to determine the problems;
- I learnt a lot actually. [It] helped me understand the importance of the sequence of events […] in circuit design with materials I’d never worked before;
- I learned I need to do a better job standing up for myself, and letting others know when they are making major mistakes;
- I learned a lot about […] the importance of setting expectations early on [and] I think that if I had been upfront about what I expected from my group members that I would have gotten results from people;
- I also learned how to work in a team better and make sure we communicate about what is happening;
- I learned that good teamwork makes [a] project a lot of fun!;
- I learned how to be patient with myself and my group members during this process;
- I also learned that sometimes what we plan will not always work […]; and
- I learned […] how important [] an instrument [] can be.
- Pay attention to every single detail;
- Noise is the enemy;
- Test by applying a known signal;
- Double check every single component before rushing to get results;
- Communicate better with software[/hardware] engineers about what exactly our inputs/outputs are; and
- If we were more patient, we would […] go[] down a different […] route that would […] save[] us.
- I would have set my expectations higher right of the bat for my team and let them know that;
- I would have thought […] more openly and not constrained myself to a specific way and function to build it in;
- I would have taken a greater caution in the design process and carefully determine the best components to use;
- I would have conceded earlier in the project […], instead [of] being stubborn.
- I would be more assertive;
- I would try to be more assertive and make sure we don’t move on before one part […] worked;
- I wouldn’t let [someone] steamroll the hardware aspect. I can make good design choices and I need to let them be heard;
- I think I would just make sure to have a better plan from the get-go and communicate it to everyone in the team, since I think we were at different pages when we started. I think this would have helped keep everyone on the same page since sometimes we weren’t all sure on what exactly was going on in different parts of the project;
- I’m always trying to work better with groups/teams, and I think I should have put in some more effort to be cooperative;
- I actually would ask for help more from classmates;
- I’d come in better prepared with more knowledge about the circuitry being used so that I could make more meaningful contributions and be more involved in the circuit design process;
- I would spend more time on the research and planning phase;
- I think we were too attached to our initial plans, making me reluctant to start over again;
- I would likely stay less hesitant on trying new things in the beginning […]. I think I had somewhat an unjustified fear in how to proceed and try new things, but many of our initial ideas [are] steps in the right direction;
- Speak up more about the initial design that I created that we ended up going with at the end only after we wasted time;
- I will try to minimize the noise as much as I can also I will use good quality of wires, components, and breadboard;
- I would add a Voltage follower to the circuit to reduce the current going through the entire circuit;
- I would also take more time to test that each individual system component was operating as expected before jumping ahead to the next thing;
- I would try to be more organised and systematic about my work;
- I would try to integrate the software earlier so that we could identify the problems earlier;
- I would help more with the hardware, which would help the team completing the hardware and would help me learn about an area I am not proficient;
- I would try not to pay as much attention to the bells and whistles of the program but instead work on making it as robust as possible in terms of what it’s foundationally supposed to do;
- I would have tried to perform more testing of the LabVIEW sooner […] this would have allowed me to better understand the flaws;
- I would probably have tested our software with a signal from the function generator instead of waiting on our hardware team to make the hardware;
- I would have advised my team to input a signal from the function generator into the LabVIEW code to test the code at an earlier time;
- I would keep in mind that the capacitor takes a while to charge and not jump to the conclusion that the circuit set up is wrong;
- Use smaller capacitors. That would save like 5 hours of debugging and make our device easier to use;
- I will get smaller capacitor to reduce the saturation time;
- I would try to double check and finalize all calculations prior to constructing the circuits and moving forward;
- I would constantly double check components, breadboards, and measurement tools; and
- I would take Barry’s advice of sometimes just starting over on a new breadboard when it’s been 30 mins and you are fairly certain the circuit is built correctly.
- N. A.
- M. A.
- H. A.
- K. A.
- B. A.
- A. B.
- J. B.
- M. B.
- A. B.
- J. C.
- J. C.
- J. D.
- S. D.
- S. D.
- T. E.
- L. F.
- J. G.
- I. G.
- M. G.
- N. H.
- N. H.
- H. H.
- I. H.
- S. H.
- D. J.
- S. J.
- R. K.
- S. K.
- D. K.
- E. K.
- H. L.
- L. L.
- A. L.
- J. L.
- M. L.
- L. M.
- B. M.
- K. N.
- B. N.
- L. N.
- S. N,.
- B. P.
- N. P.
- R. P. M.
- R. P.
- A. R.
- S. R.
- A. R.
- R. R.
- M. R.
- L. R.
- N. S.
- J. S.
- J. S.
- C. S.
- A. S.
- M. S.
- A. S.
- T. S.
- A. S.
- M. T.
- H. T.
- P. V.
- K. W.
- J. W.
- A. W.
- L. W.
- P. Y.
- C. Y.
- There are those of humanity;
- There are those of ingenuity;
- There are those of creativity (“This was my first “open ended” lab experience, so the whole planning, implementing and testing process was a learning experience for me”);
- There are those of reckless abandon (“I had no idea what concepts were at work so it was cool to see how the device actually works”);
- There are those of mechanism (“This […] was honestly the first time that I was able to see how long it took for large capacitors to charge up”);
- There are those quietly seeking (“This module helped me learn more than I originally thought it would”);
- There are those loudly fulfilling (“I filled a lot of holes in my knowledge of hardware but found it incredibly fun”);
- There are personal achievements (“In addition to these personal gains, I acquired knowledge of the heart”)
- There are interpersonal achievements (“I also improved my patience”); and
- There are those of persistence (“I practiced debugging the circuit for hours. It is an interesting task and I hope I can master it one day”)
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N. A., M. A., H. A., K. A., B. A., A. B., J. B., A. B., J. C., J. C., J. D., S. D., L. F., J. G., I. G., N. H., H. H., I. H., B. M., S. H., S. J., R. K., S. K., L. L., A. L., J. L., M. L., L. M., K. N., B. N., R. P., A. R., A. R., L. R., N. S., J. S., C. S., M. S., A. S., T. S., A. S., M. T., H. T., P. V., J. W., A. W., and P. Y.
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H. A., J. C., D. J., L. M., S. R., and A. S.
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N. A., H. A., M. A., A. B., S. D., H. H., I. H., S. H., D. J., S. J., D. K. M. L., B. M., B. N., L. N., B. P., R. P. M. A. R., A. R., S. R., N. S., J. S., J. S., A. S., M. T., H. T., P. V., L. W., P. Y, and C. Y.
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H. A., B. A., N. H., R. K., L. N., M. R., and J. S.
And the “I Didn’t Expect to Read That Phrase Today” Award goes to
Seung-min Park et al for their use of “analprint scan” in Figure 1 of their paper “A mountable toilet system for personalized health monitoring via the analysis of excreta“, seen below. This goes to show that we can be identified many different ways, some you might not ever have thought about until someone brought the term “analprint”1 into your life.2
- The “distinctive feature of the anoderm”.
- Those ever more curious among you can refer to Figure 5b, where you’d see for yourself that “[a]mong 11 participants […] video clips of the anus […] were acquired “.
An interview on mechanical ventilator production with Nolan Finley
I’m particularly a fan of the thumbnail image they have chosen. Really shows off my game face.
Questions to ponder on responsibility
- Who are you and to whom are you responsible?
- What are your personal responsibilities during these times of COVID-19?
- Medical decision-making requires a coordinated effort of a patient, their family, their healthcare provider, their healthcare system, etc. How should we delineate each’s responsibilities? In times of extraordinary burden (e.g., end-of-life-care, pandemics), how/does each’s role change?
- “The word “responsibility”,” we are told by Turoldo and Barilan (2008) “appeared for the first time in 1787 in a text attributed to Alexander Hamilton, in reference to the government’s obligation to answer […] questions raised by the parliament.” To whom are the governments of the world responsible? How are they held to account?
- When a “leader” of a nation was asked “do you take responsibility?” for a lag in testing for COVID-19 of that nation’s residents, they answered, “No, I don’t take responsibility at all because we were given a set of circumstances – and we were given rules, regulations, specifications – from a different time.” To what extent does historical happenstance and circumstance alleviate/compel the burdens of responsibility? Put differently, how ought we bear “the sins of the father”?
- Who is to blame for the empire (of liberty!) erected over the bodies of Native Americans and upon the backs of enslaved blacks? How is past injustice atoned?
- Today marks the 26th anniversary of the Rwandan genocide in which over 800,000 Tutsis and those that tried to protect them were murdered, mostly with machetes. Documents reveal, 16 days before the attacks the United States government knew of an imminent “genocide” to be committed but did not intervene. Does the U.S. bear any culpability for failing to act on its intelligence? More broadly, do the more powerful (nations on earth) have a responsibility to help those less powerful?
- A general gives an order, a soldier pulls a trigger, a person dies. Who is responsible?
- Does culpability exist in the absence of free will? Are the coerced culpable?
- Whence comes the responsibility of parent(s) to child(ren)? When does it begin? When/Does it end?
- Does our species have a duty to reproduce?
- Is the earth humanity’s dominion? Must human beings be stewards of the realms they occupy, of the earth? Do other animals have obligation(s) to their environment?
- Are our cities designed responsibly?
- Many contracts contain a “force majeure” clause in which both parties are freed from liability/obligation under extraordinary circumstances (e.g., insurrection, epidemic, acts of the gods, etc.). Do you believe that our times have triggered these clauses?
- On the eve of the American Civil War, minister Theodore Parker claimed “I do not pretend to understand the moral universe, the arc is a long one, my eye reaches but little ways. I cannot calculate the curve and complete the figure by the experience of sight; I can divine it by conscience. But from what I see I am sure it bends towards justice.” What bends this moral universe? How/Can it be made to bend faster?
- When history is written, will it be said our times were just?