Follow Our Journey Week by Week
a journey of a thousand miles begins with a single step
Week Two
Potential Interview Questions:
For doctors:
When was the last time you diagnosed a patient with a TBI? How did you make the diagnosis?
What do you believe to be the most obvious indicators of TBI?
Are you familiar with concussion tests? Do you have any concerns over the accuracy of these tests?
Are the symptoms of TBI different depending on how patients acquire them (car accident, sports injury, etc)?
For global health experts:
What are the most important factors when designing an LRS device?
Do you think current methods of diagnosing TBI are sufficient for LRS? Do you think there is a need for an additional diagnostic method?
Besides cost, what factors determine the success of a device for LRS?
For EMTs:
How often do you have to take patients to the hospital for suspected TBIs?
For patients:
What was the process of getting diagnosed with a TBI like for you?
Were you concerned about the cost of diagnosis?
Elevator Pitch: We a team of engineering undergraduates prototyping a device to quickly and cheaply diagnose a clinically significant traumatic brain injury (TBI). This device could be used in hospitals and clinics in low resource settings and by first responders in high resource settings where CT scans are not widely available. We are looking for field experts to advise us on our design.
Week Three
Top 5 Diagnostic Solutions From Radial Thinking (see chart above)
CT Scan
MRI + PET Scan
Glasgow Coma Scale
Blood Test
Functional Analysis Test
Human Centered Design Evaluation
We identified 3 main constraints in our radial thinking session that apply to Low Resource Settings (LRS) and EMTs in High Resource Settings (HRS) because we believe these are currently the settings most lacking in sufficient diagnostic tools for TBIs
Size/Portability
Efficiency
Cost
We evaluated each of our top solutions in within these constraints using these preliminary metrics. We plan to update these metrics with knowledge gained from future expert interviews
Size/Portability: Should be small enough to be reasonably carried by one person
Smaller than 8x8x5 in
No heavier than 5 lb
Efficiency: Should be a reasonable first-pass diagnostic for TBIs that could be used in LRS or by EMTs in HRS to determine if further treatment, which may be costly and difficult to access, is required
Should take no longer than 10 minutes to complete
Should diagnose TBIs with reasonable accuracy (we will determine a definition for reasonable accuracy through future interviews)
Cost:
Under $150 to manufacture
Under $0.10 per use
Preliminary Product Design Specifications
1 General Overview and Design Guidelines/Approach
This section describes the principles and strategies to be used as guidelines when designing and implementing the system.
1.1 System Overview
We aim to create a device that performs functional analysis on patients to diagnose clinically significant traumatic brain injuries (TBIs). It will serve as a first-pass diagnostic that could be used by emergency medical technicians (EMTs) or health care providers in low resource settings (LRSs) to determine if more expensive and potentially difficult to access diagnostics, such as CT scans, and further treatment are needed. This functional analysis will be performed through a series of tests designed to test memory (“Simon” game, story memory, and picture memory described below in section 2.1) and physical symptoms of TBI (shape, fine motor skills, and gait tests described below in section 2.1). The patient will be guided through these tests by the device, which will also record and process the results of these tests in order to diagnose the patient.
1.2 Assumptions / Constraints / Standards
To be applicable in rural LRSs and for EMTs, our device should be relatively small. We determined that a device smaller than 8x8x4 inches and no heavier than 5 lb would be reasonable. It also should be inexpensive so that it can serve as a reasonable first-pass alternative to other available diagnostics. We determined that the device should then cost no more than $150 and no more than $0.10 per diagnosis. If possible, diagnostics performed by the device should be quick, to make them more appealing to patients. We determined that the diagnostic should take no more than 10 minutes, including both the test itself and We plan to adjust these constraints based on feedback from future expert interviews.
2 Architecture Design
This section outlines the system and hardware architecture design of the system that is being built.
2.1 Logical View
The device will be a single box containing a screen, a raspberry pi, an accelerometer, and 5 buttons (4 directional and one “enter”) and a knob that will be used to interface. It should also have two Velcro straps large enough to strap the device to a patient’s thigh. It will perform a series of tests as a single sequence to test memory and physical symptoms of TBI. The scores from these tests will be saved and used in the final diagnosis. These tests will be:
A “Simon” game in which a random sequence of color-coded lights corresponding to 4 directions (up, down, left, and right) will be shown and the patient will then have to input this sequence using the directional buttons. The patient will be scored on their accuracy in repeating this sequence, and this process will then be repeated 5 times. The speed and accuracy of the patient’s responses will be recorded.
A story memory test in which the patient will read (or read aloud if they are unable to read) a short story containing 10 randomly generated details (ex. John may give Jane a ball in one version of the story and a toy car in another). The patient will then be asked to recall 5 of these details (which 5 will be determined randomly) from a list of possible answers for that detail (ex. they may be asked whether John gave Jane a ball or a toy car). The accuracy of the patient’s responses will be recorded.
A picture memory test in which the patient will be shown an image, allowed to look at it for as long as they please, and then shown an image identical to the other aside from 5 objects in the image having their color changed (ex a Jack’s shirt may be blue in the first picture, but red in the second). The subject will then be asked to identify which objects in changed color. The accuracy of the patient’s responses will be recorded.
A shape identification test in which subjects will be shown images of 4 simple shapes (ex. a square, a circle, a triangle, and trapezoid) corresponding to the 4 directional buttons and the name of one of those shapes, and asked to push the directional button corresponding to the name shown. This is repeated 10 times. The speed and accuracy of the patient’s responses will be recorded.
A fine motor skills test in which subjects will be shown a filled circle with a bright marker at one point along its edge, corresponding to a brightly colored grove in the knob, and another concentric, hollow circle around the first circle. Another marker will then be shown on the outer circle, and the patient will be prompted to rotate the knob, which will rotate the inner circle on the screen, until the two markers are at the same position. The speed and accuracy of the patient’s responses will be recorded.
A gait test in which subjects are asked to walk 10 feet in a straight single direction with the device strapped to the patient’s thigh. The accelerometer will collect data during this walk and this data will be saved.
The device then will compare the results of these tests to a set of normal results from the subject if one exists, and to population data to determine if the subject’s results align with results from TBI patients.
2.2 Hardware Architecture
The device will require the following components:
A screen large enough to display the interface, at least 4x4 inches, no more than 7x7 inches
A knob at least 2.5 inches in diameter that can record rotational position for the fine motor skills test
A small computer to control the device. A raspberry pi 2 would suffice
A plastic housing no larger than 8x8x5 inches
The specifics of this section will be updated further in the design process.
2.3 Software Architecture
The software will be a python script that carries out the tests described earlier, and will perform statistical analysis to determine if the subject has likely suffered a TBI. The specifics of this section will be updated further in the design process.
2.4 Performance
The device should:
Take no more than 10 minutes on average to administer the test and deliver a diagnosis
Be able to remain attached to the thigh for 30 seconds while the patient is walking once strapped
Be able to diagnose TBIs with at least 90% accuracy, with at least 80% of errors being false positives
Be able to perform diagnoses with or without normal (pre-injury) data from the patient
Be able to perform diagnoses without normal data with at least 85% accuracy, with at least 80% of errors being false positives
Be able to perform diagnoses with normal data with at least 90% accuracy, with at least 80% of errors being false positives
The specifics of this section will be updated further in the design process, after feedback from expert interviews.
Week 4
Design Review 1
Feedback Analysis from Design Review 1 Presentations
On February 21, 2019 we had our first design review! We presented the need and scope for our project to other BE428 design teams and received feedback from them. In total there were 23 responses, and overall it was positive! The comments provided great suggestions on what we can improve on and what we should make more clear. Outlined below is a summary of what was said.
Major Concerns/Comments
Although most responses liked the functional analysis device proposed, they were confused about the possible solutions listed, as well as our thought process behind picking the device.
It was difficult to understand exactly what the device does, and how it compares to the standards today.
Direct goal is not to increase diagnostic rates – change needs statement.
There were not enough statistics.
How did we pick the PDS numbers?
Define a quality score
It was unclear why undetected TBI is dangerous.
Is it possible to condense the device, possibly into an app?
Suggested Contacts
Interviewing athletes and coaches about TBI
Physical therapy/trainers
Psychologists and trauma doctors.
Formatting
Slide transitions were distracting – add a lighter theme
Avoid block text slides, font too small
Include slide numbers
Takeaways
In the future, we should explain the methods that are currently tested better to show how a functional analysis device can be useful. We also need to do more research and get statistics on how tests incorporated in the device correlate to injuries. We should also ground the project in India, getting specific examples on how TBI is treated and detection rates. We should also try to get an interview of a medical professional from India. If possible, include a sketch of what we would think the device looks like. Our needs statement should be changed to better reflect what we are trying to do.
Overall, the presentation went well, and we got a lot of good feedback to improve our project!
Interview Updates
We are in the process of scheduling Interviews with various health professionals.
In the coming week we’ll be interviewing an EMT from BU fitrec, talking about how they are trained to treat TBI in an emergency setting.
In two weeks we will have an interview with an MD.
In three weeks we have an interview scheduled with a BU global health professional.
Week 5
Short Summary of the team's past experience with CAD
The team has four members, namely, Olivia Salazar, Faiz Parvaz, Brannon Cox and Anshul Gupte. Only Faiz Parvaz has had experience with CAD in the past working with Creo Parametric for a whole semester of Fall 2018. The other members of the team have had no experience in CAD at all due to which all responsibilities requiring CAD knowledge and experience are directed towards Faiz Parvaz.
Professor Cabodi did give a short presentation in class on the basics of Solidworks which was very helpful to all the group members in getting a start with the individual assignments. The lecture by professor Cabodi briefed us on various features like Extrude, rounding off, shell, design tree, drawing and dimensioning.
Updates on prototype design
Our prototype design consists of a device which has various features that give a sense of the persons motor and sensory skills. It consists of a screen which will be used to display various colors via LED lights as well as keep a track of the person's score. The device has 5 buttons, four of them are for answering the color or direction appearing on the screen and one of them is to "enter". The above functions will be used as a test of the person's sensory skills. It also has a screen right in the center of the device which can be used to measure the angle at which the user is holding the device. There are two knobs attached to the sides of the device which are for push/pull and twisting which gauges the person's motor skills.
The pictures to follow are handmade sketches and CAD drawings of our initial prototype design:
Isometric View on CAD
The picture above is an isometric view of our initial prototype design made on CAD with the help of CREO Parametric. The different colors help to easily identify the various features and functions present in the device.
Drawing on CAD
The above picture is the drawing of our model on CAD with all the dimensions included. It gives the isometric, top, front and bottom view of our device. This drawing helps to understand the design of the device better as it gives the depth, height and length of all the buttons, screen and knobs present on the device.
Materials, machines and tools that we plan on using
For the main framework of our device we plan on using translucent plastic as LED lights can penetrate through this material. It is required to choose a material which allows LED lights to penetrate as there will be LED lights below the buttons that will light up in a random sequence for the "simon" test. The small screen located right above the center of the device will be LCD(Liquid Crystal Display). The buttons for the directions and letters will be made of silicone. The internal functions of our device would be based on "rasberry pi". It is a credit card sized computer that we plan on syncing all the inputs and outputs with. A gyroscope would be linked to the rasberry pi for the balance test as well. For the push/pull and twisting knobs we will be putting various applications of the spring loaded mechanism. A 3D printer will be required to 3D print the main framework of our device which can be accessed at EPIC.
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Initial Prototyping Strategy
Our initial prototyping strategy consists of using a cardboard box for the main framework of the device.
We also plan on using construction paper for wrapping it up, lettering and on deciding the colors that will suit the device.
Scissors and cutters will do the job of making the required holes.
Toilet paper rolls will be used for making the side knobs.
A ruler will be used for the exact dimensions to get an exact feel of the device and to get an estimate of how portable the device will be after is is made.
Interview Transcripts
Interviewer: Faiz Parvaz
Interviewee: Dr. Shahzad A Parvaz MD, Psychiatry
Short bio/background: Practicing Psychiatry for 20 years in Terre Haute, Indiana, USA
Interview Setting: Interview conducted over Skype
Time and date of call: 7:00PM on 23rd February, 2019
The interview focused on asking the doctor about the various types of symptoms a person shows after going through a TBI and the different ways used by the doctor before coming to any kind of conclusion. The interview also requested the doctor to give some examples of his previous encounters with TBI patients and the ways in which they showed behavioral changes after any sort of injury that gave them the TBI. The doctor was kind enough to address all questions. He also gave examples of his past cases and described the procedure that was put in line by him after he was suspicious of them having a TBI. The interview took place for 45 minutes and the following are some dialogues from the interview that were exchanged between the interviewer and the interviewee:
Do you usually diagnose TBI's in patients or do they come for treatment to you after they have been diagnosed with a TBI?
The patients usually come to me with some issues involving their anger problems, disturbed sleep, memory problems, etc which leads me to dig deeper into their past to figure out if they had any sort of injury involving their brain, symptoms of which may have started appearing now. Therefore, most of the cases are unaware of the TBI they might have and i diagnose them most of the time, but i also have patients who come to me for medications after they have had a concussion or any sort of brain injury.
What do you believe to be the most common indicator of TBI?
There is something known as cognition which i believe is really common. It is a huge word and means a lot of things. It involves thinking speed, your ability to think fast, recall information, analyze thinks and apply the things you have learned in your past,make judgements about life and control impulses. All of this comes under cognition and TBI affects cognition a lot. For example, people become really impulsive and tend to make irrational decisions without thinking through.
Can you give an example of a patient who you detected with TBI?
Yes, it was this man who came to me about 3-4 months back with his wife. His complain was that he has been having difficulty remembering things and memorizing small things that everyone does on a day to day basis. His wife was also talking about him and complained that there are certain days in the house where he keeps forgetting the small tasks given to him by her. He was also having depression and emotional problems. After some sessions with him and a couple of tests, i was able to diagnose that he was having TBI.
Are you familiar with the concussion test and what are your opinions on the accuracy of these tests?
Yes, i am familiar with the concussion test. It is basically making a person go through a set of questions immediately after he has incurred an injury in order to get a judgement on how well is his brain functioning. I personally don't think that it is the most accurate way to detect a TBI but definitely helps one get a small understanding of the type of injury.
For the future we have the following interviews scheduled as of now:
Interview with the Global Health professor Eldred from Sargent College - 25th March, 2019
Interview with Kevin who works as a psychologist for Steelers - Date TBD
Week Six
Manufacturing methods
Early works-like prototypes will be fabricated using methods discussed above in week 5, notably using FDM 3D printing to fabricate the plastic components or our device. When scaling up for mass production, we plan to use injection molding to fabricate these components. We decided on injection molding because it is inexpensive aside from the fabrication of the mold, meaning that it would be much more cost effective in the long term than FDM or other 3D printing methods.
Sterilization
We intend to sterilize our device with Ethylene Oxide, as other methods with similar sterility assurance levels, such as autoclave and UV radiation, would likely damage and deform the plastic components of our device, and it would be able to effectively sterilize the portions of the device’s surface that would be shaded when undergoing radiation sterilization.
The initial operating manual for our device using language of design is shown to the right.
Week Seven
Incorporating Arduinos and Actuators:
We plan to use an Arduino to prototype our device. The Arduino will be programmed to run our tests (i.e. light up the LEDs in a random order) and record the user's results. These results will then be displayed on the attached LCD screen. Pressure sensors will be included in each of the buttons and knobs, which will then transmit a signal to the Arduino indicating whether or not the patient pressed the correct sequence. The level will also have an imbedded motion sensor to detect the gait of the patient and to determine if they can walk properly. At this time, we do not plan to include any actuators in the prototype, as the user will control each of the buttons manually.
Response to Feedback from DR II:
Issue with slides: In the future, we will cut down on the amount of words on each slide and we will review the slides more thoroughly before turning them in. We will also be sure to include larger photos
Interviews: We are currently working on scheduling additional interviews (see below)
Improving instructions and better explaining tests: First we will have two simple physical tests, followed by a longer test to evaluate mental cognition:
The first test will be to evaluate the user's ability to twist and pull the knobs. Each knob will light up individually until the user twists or pulls it. The Arduino will record the user's ability to perform these tasks and how long it took to complete the tasks
The second test will be to evaluate the user's ability to walk properly. The user will hold the device in front of them with both hands and walk in a straight line for 20 paces, then turn around and walk an additional 20 paces. The Arduino will use the motion sensor to record the user's ability to walk in a straight line without staggering
The final test will test user's memory and attentiveness. At first, the colored buttons will light up in sequences of three, and the user will press the buttons in the same order as the lights. As the test goes on, it will become more difficult by incorporating the knobs on the sides of the device and having longer sequences that the user has to repeat. The Arduino will use the pressure sensors to determine the user's ability to complete the task and the speed at which the user is able to complete the task. This test should indicate whether or not there is an issue with cognition, which can then be used to diagnose TBI
After this test, the user's score will be presented on the LED screen
Please see the image below for visual instructions
Baseline and calibration: Before this device could be used in clinical trials, baseline data would have to be gathered. This device would have to be tested on a number of people with and without a TBI. The average score for each group will then be used to determine the range of scores which indicate a clinically significant TBI and which range of scores indicate normal function. We can then use this data to present a diagnosis with the final score at the end of the tests. We estimate 100 participants from each group should give a sufficient range of data
Additional Interviews
Completed Interview: Kevin Wildenhaus
Interview details:
Interviewer: Olivia Salazar
Phone interview on March 19
Kevin has been a team psychologist for the Pittsburgh Steelers since 2001
Do you think the NFL and other sports organizations check to see if players have sustained a TBI frequently enough?
A few years ago the NFL instituted a new rule where independent Neurologists are on the sidelines of every game and do immediate evaluations. The NFL is also sponsoring multiple research studies on concussion, TBI and CTE. They have developed programs and a trust fund for former players, invest in helmet safety, and changed the rules that now prohibit helmet to helmet contact.
Do you think most TBIs are diagnosed in sports, or do many go unnoticed?
I am not an expert but estimate many go undetected, especially in sports like soccer.
It is common for high school athletes to undergo an annual concussion test. Is this also the case in professional sports players?
No. Professional sports team like the NFL use the IMPACT test as a baseline for players to make comparisons on re-testing post-concussion but this is not done typically in schools.
What is the general procedure when a player is suspected of sustaining a TBI?
During a game the independent neurologist will determine if there is cause for a concussion, declare the player either is out or needs further evaluation in the locker room, and the team is required to take away his helmet and not play him
Do players have to take time off if they have been diagnosed with a TBI?
Yes, the NFL puts the athlete in a concussion protocol and they are monitored and re-evaluated and must be medically cleared before they can return to practice or competition.
What would be the most important aspects of a diagnostic device that could be used on the field during games after players have taken a hit?
There is no litmus test for diagnosing concussion. Diagnosis is made on observable symptoms, self-report and cognitive status assessment. A definitive test would be very valuable, if not immediately, certainly as part of the subsequent concussion protocol.
Upcoming Interviews:
Professor Kaytlin Eldred: professor of global health at Sargent College
Interviewer: Olivia Salazar
In-person interview scheduled for March 25
Dr. Abaya Kumar: doctor in India
Interviewer: Faiz Parvaz
Date TBD
Week Eight
On Tuesday the 26th, The team met for a Midsemester reality check with Professor Cabodi to get feedback on the progress so far. We talked about what equipment we possibly need and critical functions that need to be demonstrated for our "works-like" prototype.
Our needs statement specifies the need to create a device that detects TBI more affordably and faster than a CT scan to improve diagnostic rates in India. Our proposed solution of making a portable functional analysis device will satisfy these needs. The device will be designed to be used on the go, and give recommendations to the user in around ten minutes after doing a series of tests. In this way, it will be faster, more affordable, and more accessible than a CT scan. Furthermore, with our focus on language of design, the device can be used with minimal difficulty in foreign countries.
For the next prototype, we would want to have the buttons and level test programmed and implemented into an Arduino Mega/Uno. A simple Simon Game with the buttons and the screen would also further demonstrate the function of the device. These would be the critical functions to demonstrate for our works-like prototype. The equipment needed would be:
Arduino Mega/Uno
4-Buttons
Arduino compatible screen
Accelerometer sensor
Breadboard and wires
In the meeting we also talked about the obvious objection to the solution we are proposing. The foundation of our device is based on the tests that it administers in order to determine if the patient has a TBI. The tests are therefore a limiting factor in the device. Furthermore, a rating scale is necessary to grade the user and recommend treatment. It would be extremely difficult to gather the clinical data necessary to make the rating scale for this project. The device in its completed form would need to be tested in a controlled setting by people who have TBI, and those who do not. However, the tests that are incorporated in the device tests cognition and basic mental function, which are signs that health professionals look at when they are diagnosing TBI, and there is research that shows functional analysis tests can detect TBI.
Initial FMEA
Interview with Kevin Wildenhaus
Phone interview conducted by Olivia Salazar on 3/19
What is your official job title?
Team Psychologist
How long have you been working with the Steelers?
Since 2001
Have you worked with any other professional sports teams?
I also work as a consultant to the Pittsburgh Penguins of the NHL. Prior to working with the Steelers I worked with the Detroit Lions. I have also worked with many professional and amateur athletes and college and school teams.
Do you think the NFL and other sports organizations check to see if players have sustained a TBI frequently enough?
A few years ago the NFL instituted a new rule where independent Neurologists are on the sidelines of every game and do immediate evaluations. The NFL is also sponsoring multiple research studies on concussion, TBI and CTE. They have developed programs and a trust fund for former players, invest in helmet safety, and changed the rules that now prohibit helmet to helmet contact.
Do you think most TBIs are diagnosed in sports, or do many go unnoticed?
I am not an expert but estimate many go undetected, especially in sports like soccer.
It is common for high school athletes to undergo an annual concussion test. Is this also the case in professional sports players?
No. Professional sports team like the NFL use the IMPACT test as a baseline for players to make comparisons on re-testing post-concussion but this is not done typically in schools.
What is the general procedure when a player is suspected of sustaining a TBI?
During a game the independent neurologist will determine if there is cause for a concussion, declare the player either is out or needs further evaluation in the locker room, and the team is required to take away his helmet and not play him
Do players have to take time off if they have been diagnosed with a TBI?
Yes, the NFL puts the athlete in a concussion protocol and they are monitored and re-evaluated and must be medically cleared before they can return to practice or competition.
What would be the most important aspects of a diagnostic device that could be used on the field during games after players have taken a hit?
There is no litmus test for diagnosing concussion. Diagnosis is made on observable symptoms, self-report and cognitive status assessment. A definitive test would be very valuable, if not immediately, certainly as part of the subsequent concussion protocol.
Have you worked with players who have sustained a TBI?
That has not been part of my role.
Week Nine
Lessons learned from the EWB lecture:
When working on a project that includes implementing a device in low-resource settings, it is important to make sure the community is a stakeholder. It is also important to make sure they approve of the solution you are suggesting
It is impossible to predict all of the possible failure modes while testing in a lab. Because of this, testing prototypes in the place they will be used should be done as soon as possible to figure out unpredicted issues, such as goats destroying the device
There may be unexpected cultural differences that arise if you come from different cultures, such as the community in Zambia not wanting to boil water
If the solution you propose is inconvenient or one that the community does not like, it probably won't be used
Please see the updated FMEA below:
Interviews:
Completed Interview: Kaytlin Eldred
Interview Details:
Interviewer: Olivia Salazar
Interview Date: In-person on March 25
Professor Kaytlin Eldred teaches global health at Sargent College
What are the most important factors when designing an LRS device?
Expense
Training—how hard it is to train individuals on how to use the device
Languages—various languages and dialects are spoken. Even in Boston, you would probably need Arabic, Portuguese, Spanish, etc. In a low resource setting in Guatemala, you might need Mayan dialects. If there is a voice command, you would definitely need different languages.
Electricity—Would it need to be plugged in or run on batteries? If you are taking it in to people’s homes without electricity or using it outside, it would have to run on batteries.
Durability
Size & weight—in a super LRS and you want people to travel with it, they might not be traveling with cars. In that case, it would need to be light enough and small enough to be put in a bag to carry.
Are you familiar with TBI diagnoses in various settings? Do you think current methods of diagnosing TBI are sufficient for LRS?
No
Do you think there is a need for an additional diagnostic method?
Eldred: What’s the current method?
Salazar: CT scanners are the current gold standard for diagnosing TBI
Eldred: Those are hard to get in the field
Do you know how widely available CT scanners are in LMICs?
Most city centers in LMICs will have hospitals with CT scanners, but that is not a low resource setting. CT scanners would very rarely be available in low resource settings, such as rural areas of LMICs
Besides cost, what factors determine the success of a device for LRS?
All the factors I mentioned earlier would still apply
We were thinking about using visual instructions to make the device language neutral. Do you have any tips for that?
Pictures are really helpful. I have an example I could give you of a hand washing station that uses pictures instead of words.
(She then showed the image below)
So it’s very simple. The hand shows black stuff on it with a frowning face, so that obviously means something is on your hands and it’s not good. Then it goes through all of the other steps. I would say something similar to that, where the images are simple but you go through every step would be good. Just make sure to go through every step
Upcoming Interviews:
Fe Cajiga, a senior studying BME who has had a concussion
Interviewer: Brannon Cox
Date: In-person sometime in the next week (date TBD)
Dr. Abhaya Kumar, a doctor in India
Interviewer: Faiz Parvaz
Date: TBD
Image of visual instructions from Professor Eldred:
Week Eleven
Lessons Learned From Diagnostics Lectures
Diagnostic tests are tests that determine whether or not an individual who is suspected of being ill actually has a given disease or condition. Similarly, screening tests determine whether or not a seemingly healthy individual is potentially ill, or at risk for developing a given disease or condition.
Measurements in diagnostics can be made via direct visual inspection, but most often they are made by detection and amplification of some signal. Often times, this signal is chemical (as in a lateral flow strip test) and the amplification visual (as with the antibody-coupled gold nanoparticles used in many lateral flow strip tests), but measurements can also be made using fluorescence, voltage, ultrasound, and many other methods.
When diagnostics fail, they may fail such that they may fail to deliver a diagnosis or bring harm to the patient, and much like failures in other medical devices these should be limited by design as much as possible, but they may also deliver an inaccurate diagnosis, a false positive or false negative. These failures are the results of statistics and thresholding, and they are unavoidable to an extent. Rather one has to choose a proper threshold for diagnosis depending on whether the test is a diagnostic or screening one, favoring false negatives for the prior and false positives for the latter.
Completed Interview, In-person with Fe Maria Cajiga Pena on 4/21
Interviewer: Brannon Cox
When were you diagnosed with a TBI? How severe was the diagnosis?
2014, Grade 2 concussion
How did you get the TBI that lead to your diagnosis?
Hitting my head against the airbag during a car crash
What was the process of getting diagnosed like for you (like what were the steps)?
Was taken to the doctor a couple of hours after the car accident. I remember that the doctor asked a bunch of questions and had me do some motor coordination things and looked into my eyes.
How long did it take to be diagnosed?
A couple of hours
Did you have to have a CT scan done? If so, what was that like?
No I did not
Were you concerned about the cost of diagnosis?
I was not concerned about the cost because I knew my insurance would cover it.
How long did it take you to recover from your TBI?
It took a week of me just staying at home not being allowed to use my phone read or do anything that involved and then another week of me taking it slowly at school before I felt normal again.
What were the most noticeable symptoms for you?
The most noticeable was the increase in migraines. I also noticed that my brain felt a little jumbled in the sense that it took me longer to do things such as math problems or read and I got distracted easily.
Week Twelve
Lessons Learned the practicum
On the 23rd we had a practicum on diagnostic devices. We were given a device and were asked to explain what it was used for, how it works, and who would be the target audience. The diagnostic devices varied in function but overall were using a signal and amplified it as a detection mechanism. Some lessons learned:
The devices had different target audiences, and that shaped the complexity of the diagnostic itself in terms of instructions, and the number of steps that need to be taken. The devices also used the detection methods we studied in class as a foundation, and sometimes deviated slightly from them. Creating an FMEA gave a better understanding of how the device was meant to be used, and provided insight on False positives/Negatives. False results also had varied consequences depending on the type of diagnostic test.
Case Study summary
On the 25th we had an ethics case study that looked at the use of a medical device that was brought to market without being properly tested. The Case study was about a company that sourced Teflon from a manufacturer to be used in medical device applications inside the body. They patented the implants and gave it to doctors to be used in procedures, specifically TMJ surgery. However, over time complications arose and many of those procedures failed over time.
The Class was split based on the parties that were involved in the case study. Some were the doctors, the inventors, the manufacturer, etc. We then came up with a perspective on what went wrong, and who was at fault. Overall, the inventors and the company that developed the procedures did not take the appropriate steps to test their devices before selling them. Specifically, the Teflon was not meant for Load bearing applications, which is what it was being used for. Furthermore, they ignored the manufacturers warning that the Teflon should not be used for these applications. The Case brought many perspectives on who should take responsibility when a medical device fails.
Updates on projects
The Group is working hard towards the Final presentation, which is on May 2nd. We are designing a frame for the diagnostic device, and are reviewing the feedback we received all semester. We are making sure that the device we designed fulfills our need statement, and technically shows the scope of our product design specifications. We are finalizing our presentation and look forward to it in the coming week.
Interview Transcript on 4/25/19
Akash Gupte -Medical Student, EMT, worked on an Ambulance Responding to Emergency Calls.
Interviewed by Anshul Gupte
Have you ever responded to a patient who had a Traumatic Brain Injury?
Not specifically, but I had to test for cognition once or twice.
What do you look for when testing for a Traumatic Brain Injury?
If there are obvious signs of trauma then we usually test cognition, basic function like
Confusion of situation – disorientation
Incoherent Speech
Muscle movement – lack of coordination
Concussions have specific symptoms, but they can manifest over time, and it takes a CT scan to fully diagnose if they have one or not.
What do you think of a Functional analysis device that is portable, and would test for TMI
IT would be helpful but keep in mind
Misdiagnosis would be very detrimental, Take False Positives and Negatives seriously.
Doctors should get the final decision.
What do you think of this device (shows picture and scale)?
Size should be a selling point
Ambulances are small, and a lot of equipment need to fit inside it. Keep in mind that a box like this needs to fit somewhere.
Make sure the device is durable, and can withstand a drop
What do you think of the diagnostic tests we are including?
Preferably you should include more than just memory and dexterity. The Gait test is good.
There could be other injuries that could make the user fail tests. Head injured patients are not the most reliable in terms of recounting what happened. Patients with TBI can be confused, combative, or unresponsive, they may not follow instructions carefully and intoxication can make everything more difficult.
These are some challenges that should be addressed in a device like this.