Team:Purdue/Human Practices

Human Practices

As we ambitiously set out to develop a COVID-19 diagnostic device, our team turned to academic and industry professionals and individuals affected by COVID-19. Join us on the journey through the evolution of our project via our impactful and intriguing conversations.

12 years in regulatory affairs at Pfizer for Biotechnology Products with an overlap in medical devices

Frederick Gates

Before we began designing our microfluidic device, we spoke to Dr. Gates regarding safety regulations for diagnostic devices. Here are some highlights from our interview with him:

Question #1: What are the biggest domestic and international barriers or bottlenecks in getting a diagnostic device on the market?

The regulatory process varies between countries and getting approval for a diagnostic device can range from a month to a year. In order to increase your chances of regulatory approval, your proposals must include information regarding key players and methods of manufacturing the device, the science behind the device, the control of the test kit, design controls, and validation assays.

Question #2: Who are the key players (FDA, NIH) in the regulatory process?

The main player in regulating medical devices and diagnostics is the FDA. FDA CFR Title 21 Section 820 outlines the requirements for medical devices.

Question #3: Are the individual components of the device tested such as electrical, biological, etc., or is the device tested holistically?

Each component of the device is tested independently. In your case the biologics, electrics, and mechanics.

Question #4: What is the average amount of time needed for a diagnostic device to enter the market?

Standard FDA review is 12 months in order for a diagnostic device to enter the market. However, COVID-19 has accelerated approvals for the diagnostics related to the virus.

Question #5: What are Important Regulatory affairs factors we should consider for our project?

Include the controllability of standards, quantifying every aspect, and making sure the source of your reagents is of good quality and standard.

Question #6: In your experience what do diagnostic devices fail to address?

The pressure to approve testing is leading to a deficit of quality. Current tests have 50% false results rates and would not be on the market if there were not a crisis and an urgent need for any kind of test at all.

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Interview conducted on 5/21/2020

Integrated HP

• Include space for a control in the design of the microfluidic chip


• Read FDA CFR Title 21 Section 820 outlines the requirements for medical devices to make sure our device design does not violate any of the criteria (see Proposed Implementation)


• Took his advice to make this a two-year endeavor so we can conduct validation assays(see Phase 2)

Electrical and Computer Engineering Professor at Purdue University. In the area of bioengineering systems, Prof Mohammadi is involved in the fabrication and characterization of nano- and microfluidic devices for the detection of chemical agents and biomolecules.

Saheed Mohammadi

One of our teammates came across Dr.Mohammadi’s research and we decided to reach out to him to learn more about his experience with microfluidics and get his thoughts.

After our conversation with Derrick, we began designing our chip. After designing the first iteration of our microfluidic device on CAD we decided to meet with Dr. Mohammadi. He was able to provide us with more technical information regarding the different technologies available for actuation such as automatic syringe pumps and offered his assistance during the fabrication process. Dr. Mohammadi also referred us to his colleague Dr.Werely.

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Interview conducted on 6/05/2020

Mechanical Engineering Professor at Purdue University. Published in Lab on a Chip journal and has taught microfluidics courses at Purdue.

Steven Werely

Taking Dr. Mohammadi’s referral, we reached out to Dr. Werely to get his thoughts on our current design and ask questions regarding microfluidics in general.

After presenting our project to him, Dr. Werely made some interesting points. He brought up how current methods of testing require the patient swabs or samples to be shipped out to labs in order to be tested. The shipping process can result in mix-ups. Another point he mentioned is that our chip could be disposable and contain unique patient barcodes that can be scanned to view and save results of the test along with being unique to each patient to avoid mix-ups and keep track of cases. After showing our initial CAD Model to him the following suggestions were made by him:

• Include more valves as the device will contain air before all reactions take place which will need to be pushed out


• There is a lot of “dead volume” in the design so to minimize it shorten the length of the channel connecting the chitosan capillary to the RPA chamber. The less dead volume the better.


• While the chip may be small, the associated machinery such as syringe pumps and actuation mechanics will be the size of a shoebox which is something to keep in mind if our objective is to make this portable.

• We can either heat the entire chip or attempt to heat a portion of the chip so we may need some electrical components for heating that can maintain the 2 temperatures.


• We can reach out to him regarding chip fabrication or developing a 3D printed model.

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Interview conducted on 6/12/2020

Integrated HP

• Led to the development of iteration 2 of our chip which was reduced in size significantly, contained more valves and had significantly less “dead volume.” (Iteration 1)


• Knowing the use of mechanical components may hinder our long term goal for the chip to be accessible even from someone’s home led us to look into other methods of fluid actuation such as manual rotation


• We began thinking about methods of heating and decided the best way to heat our chip would be through a custom-designed electrical circuit (see Engineering Design)

Purdue iGEM alumnus and current Ph.D student in bioengineering at Virginia Tech and has fabricated microfluidic devices to study immune cell interactions.

Nidhi Menon

Ms. Menon talked to us about our second iteration microfluidic chip design. She sent us various literature on mixing in microfluidic devices and spoke to us regarding modeling fluid flow in our device as well as methods of fluorescence detection for our chip. Her advice is as follows:

• She sent us several papers on different methods of mixing in microfluidics via patterned channels


• Should use COMSOL once the final design has been determined to model fluid flow throughout the device


• Ms. Menon also discussed spectrophotometers for fluorescence detection and potential drawbacks

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Interview conducted on 7/20/2020

Integrated HP

• Began finalizing chip dimensions (25mm x 25mm) and continued fluid flow modelling using microfluidics laws such as Poiseuille flow or Darcy’s law


• Looked into alternative methods of quantification and detection of biological products besides fluorescence


• Looked into mixing alternatives

Purdue iGEM alumnus, Ph.D student at Boston University. Currently uses tools of synthetic biology and microscopy to visualize cell-to-cell communication and to develop frameworks of decision making within these multicellular communities.

Mark Aronson

After a successful meeting with one of the alumnus we decided to reach out to more. We reached out to Mr. Aronson and met with us regarding our approach to modelling.

He explained that the purpose of modelling is to answer a question. In our case we explained we are trying to determine the minimum RNA concentration required for our diagnostic test to accurately detect the viral RNA. In pursuit of this Mark advised us to develop a simple model of our chitosan capillary system.

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Interview conducted on 7/24/2020

Integrated HP

• Began designing a chitosan membrane efficiency assay


• Began designing an Argonaute efficiency assay


• Scrapped our previous python mathematical based model of fluid dynamics and began modelling chitosan adsoprtion


• Began designing a model and experimental set up to gather more data on RT-RPA

Biomedical Engineering Professor at Purdue University. Recently developed a paper-based COVID-19 diagnostic test using CRISPR

Dr. Linnes

After speaking with many faculty researchers with specialties in microfluidics we decided to reach to one of our very own professors, Dr. Linnes, who recently developed a COVID-19 paper based diagnostic test. We discussed our assay and chip design and received tips on troubleshooting when testing our device.

• Pumps/valves that often leak explore acoustofluidic approaches such as using a phone buzzer which is a convenient way to cause the fluids to mix through vibration


• You may not need to 3D print the chip and could instead laser cut/use xurography (craft cutter) for much of the channel portions which is faster to design and make


• Use cheaper materials and hydrophilic material such as 3M double sided hydrophilic film and tape. Hydrophilic material will help actuate the fluid without mechanical pumping

• Air bubbles form in high temperatures and can hinder imaging results. They can also be used to emulate a valve mechanism


• Iteration 2 microfluidic chip design looks good

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Interview conducted on 7/28/2020

Integrated HP

• Settled for the design of the second chip. Conducted research on mixing via vibration and settled on using that system for our chip. Exploring the use of hydrophilic film for the chip design to help with fluid actuation


• Determining solutions for possible pressure build up and bubble formation in the system to prevent poor results. Included a outlet on top of the RPA chamber in our iteration 2 microfluidic chip design to account for pressure build up and bubbling.

cRNA at a well funded hospital in Texas

Radha Venkat

As diagnostic device design began to take form, we began to think about who would benefit from our diagnostic device. In an effort to explore the possible impact of our product we spoke with a health professional to assess the medical center’s needs for rapid COVID-19 diagnostics.

• As a cRNA Ms.Venkat currently works with COVID-19 patients in the obstetrics unit. Throughout the interview Ms.Venkat highlighted the gravity of the situation via case by case examples of patients and nurses who have been infected and discussed her hospital's safety regulations and testing process..


• In her hospital, it is mandatory for anyone entering the hospital to be tested for COVID-19.However, Ms.Venkat clarified that not all hospitals have enough resources to test everyone that enters.

• Patient samples for COVID testing are collected via nasal swabs and results for each test come back within 30-45min at her hospital


• Ms.Venkat also mentioned that despite having the resources to test everyone that enters the hospital, they do not re-test any employees that tested positive and instead allocate those tests for new patients as they must be conservative regarding their use of tests.

• When asked what an optimal runtime would be for a diagnostic test Ms.Venkat said that anything between 35min-1hr would be a good time as anything shorter than that has potential to yield false positives or negatives as seen with the whitehouse 13 min COVID-19 tests.


• As a cRNA working with COVID-19 positive patients and as someone who witnessed its drastic effects, she strongly believes rapid testing at the moment can’t undo what has been done. However, she believes the development of a rapid multiplex diagnostic test such as ours can help prevent similar situations from occurring in the future.

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Interview conducted on 7/25/2020

Integrated HP

• Indicated that Hospitals are in need of large quantities or affordable tests. From this need we identified hospitals as one of our potential end users. ( see Proposed Implementation)


• From this interview we determined that the optimal runtime for our diagnostic device should be between 35min to 1 hour.

Lorenzo Mcghie is a 34 years cloud engineer consultant for Deloitte who lives in Odenton Maryland and has taken a COVID-19 test before in June

Lorenzo Mcghie

With many countries reopening and workplaces and universities opening, we decided to speak with an individual, who was recently required to get tested before heading back to the workplace, to gather information on his testing experience.

Question #1: Tell me a little bit about yourself (name, age, where you live, and current occupation)?

My name is Lorenzo Mcghie I am 34 years old I live in Odenton and I am a cloud engineer consultant for Deloitte.

Question #2: How has COVID- affected you personally?

COVID has tremendously impacted me. I am working from home, I have to take several precautions as we all are, CDC precautions like wearing masks not touching contaminated surfaces and lysoling a lot of surfaces. Can’t hang out with friends, meetings are limited, can’t really go out to bars or associate with people in the manner that I used to. It has also affected my Wife and I’s travel plans. We were supposed to see family in Jamaica but due to travel restrictions we had to cancel our flights.

Question #3: Have you been tested for COVID before? If yes can you describe the testing process such as the method of testing(nasal swab vs saliva) and how long it took for you to get back your results?

Yes I did have to get tested for COVID. I participated in a protest in DC in March and June and out of precaution I decided to get tested for COVID. I made an appointment with CVS online. I believe I went on Monday June 8th and went to the CVS drive thru. The lady handed me a package and demonstrated how to go about the test. I reached into the package there was a long swab with a line or an indicator to how far it was to be inserted into my nose. She demonstrated how long and how to do it. I inserted it into my nostril and twisted multiple times for 15 sec in each nostril and placed into a capsule and placed that into a ziploc bag and placed that ziploc bag into a mail like compartment on the outside of CVS. I received my results digitally on Friday June 12th (4 days after the date of testing).

Question #4: Did you or anyone you know experience any barriers(religious, political, financial, etc..) in getting access to a test?

There weren’t many barriers. They were minimum barriers if any. I’d say just locating a facility near you that can test at the time you want to test and the long lines at the drive thru but I wouldn’t say there was anything abysmal to me.

Question #5: What role do you believe availability and access to rapid diagnostics or testing plays/played in the spread of COVID-19?

I believe if we had rapid testing that would reduce the spread because there’s a lot of discussion amongst experts even Dr.Fauci and a lot of health experts that an individual can get tested on Monday and if they go about their life for 5 days or however time it took before the virus is able to be detected in the human body, which is approximately 5 days plus. During the time period from the 5 days they can be tested to the 5 day period of waiting, there’s a 10 day gap in which they could spread the virus. Whereas rapid testing would be able to identify an individual within 30min and that individual will know they can’t go to certain places and that they need to communicate effectively. Rapid testing would play a significant role in reducing the spread of COVID if tests were more widespread.

Question #6: How do you feel about a self administered test vs one conducted by a health professional?

I feel that personal conducted tests are a bit better. You just need someone to watch you and identify that you are doing it the right way cause you can limit the pain inflicted on one’s nostril as opposed to a personal experience of a friend I spoke with yesterday where the instrument or swab was directly jammed into one’s nostril with no regards for the better angle to limit pain and suffering.

Question #7: Do you have any personal recommendations regarding how testing could be improved?

Maybe something as simple for the layperson like a pregnancy test where, hey! it’s two lines or if it looks like this or if it looks like that you are positive. Something a lay person could fully understand. America does have various educational levels and people of different abilities to comprehend things of that nature.

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Interview conducted on 8/06/2020

Integrated HP

• Indicated a preference for easy to read results such as pregnancy test suggesting we explore methods of communicating our results in a universal and simplistic manner


• Indicated willingness to self adminster a diagnostic test if provided with instructions or guidance. This indicates potential market of direct consumers if we are able to make the test self administrable.

Omar Gillani is a 35 year old Project Manager for a consulting company and a Martial Arts school owner who lives in Wharton Virginia

Omar Gillani

After speaking with individuals who have administered COVID tests and have personally been tested as a precautionary measure, we had the opportunity to speak with a very brave individual who tested positive for COVID and was willing to share his experience.

Question #1: How has COVID- affected you personally? (Part 1)

I tested positive for COVID in May. While I was sick I had developed costochondritis(inflammation of the cartilage in the upper ribs that causes severe chest pain) and it caused a substantial amount of pain where I was essentially on bed rest the entire time I was sick. It was difficult to move. I am an asthmatic but it did not cause me any difficulty in breathing and luckily my asthma was not exacerbated. I also never had a fever. The costocondritis was the most painful but I also developed pericarditis( the inflammation of the pericardium or heart sack). As of the 12th of August(today) the costochondritis is completely gone but the pericarditis is still something I am being treated for. Most importantly, one of the biggest things that I feel has affected me right now is the cognitive or neurological impact the virus had.

Question #2: How has COVID- affected you personally? (Part 2)

While I was sick it was more severe to the point where I had severe dyslexia and I was unable to focus.I always believed I had ADHD before but this was on a completely different scale it was the difference of black and white. In the middle of sentences I would start blanking out in the sense I would completely forget what I was talking about. Sometimes it would come back to me sometimes it wouldn’t. My Primary Care physician has been stumped as I got a brain MRI a couple weeks ago and it came back completely normal. Nothing seemed worrisome at all and he put me on some ADHD medication. My heart situation is still sensitive but the whole issue with my cognitive and neurological aspect I still struggle with. It has deeply and heavily affected me at work to the point where I was put under performance review as my client didn’t understand the extent to which I had been affected by the virus. That opinion has since changed and overtime and my condition has slowly been getting better. It is getting easier to hide it even though I am still struggling right now.

Question #3: Can you describe the testing process such as the method of testing(nasal swab vs saliva) and how long it took for you to get back your results?

Around May 14th I started feeling sick and went to the hospital on the 19th to get checked out and on the 21st of May is when I got my positive result. In about 3 and half weeks I had gotten over the virus and around 5 weeks after my positive results I tested again and first it came back positive and then it came back negative the day after. The method of testing was the nasal swab test conducted by a nurse.

Question #4: Did you or anyone you know experience any barriers(religious, political, financial, etc..) in getting access to a test?

I surprisingly had 0 issues getting access to a test. I know of one person who mentioned one month prior to me getting sick and my sister as well, now that I remember, that their doctors were not allowing them to get tested. I believe this was around April when testing was more serious and I don’t think they were doing nasal swabs at the time. Their doctors were turning them away even though they had many of the symptoms.

Question #5: How was your recovery from COVID-19 assessed?

I volunteered on my own to get retested after recovering. They did not require it at all. They went by the last day I had felt any symptoms and then they went a minimum of 14 days that they asked me to continue to quarantine myself, and it was after that time frame that I volunteered to get retested.

Question #6: What role do you believe availability and access to rapid diagnostics or testing plays/played in the spread of COVID-19?

I think in the beginning, quote on quote I got lucky when I got tested because at that time it didn’t appear that there were any issues with availability. When I got tested it was at an urgent care clinic and there was a line of about 4 people there in their cars waiting to get tested. And it was the moment that they had opened it up and I thought it was going to be jam packed but it wasn’t. But what I heard from my sister and colleague from another organization, was again despite their symptoms including fevers, body aches and pains and … I apologize I can’t remember clearly what all of their symptoms were but their doctors were telling them that they didn’t qualify for testing. And I think because in April here in Virginia testing was scarce.

Question #7: How do you feel about a self administered test vs one conducted by a health professional?

I guess it depends. If I have to stick a giant needle into myself i'd rather have a professional do it or if anything i'd trust my wife to do it. Same thing with the nasal swab it felt like it when all the way up to my brain. If it is something simple then I would absolutely be ok doing it myself.

Question #8: Do you have any personal recommendations regarding how testing could be improved?

(laughs) Good question. (pause) I don’t know actually. I don’t really quite know what I would really say about that.

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Interview conducted on 8/12/2020

Integrated HP

• Indicated that nasal swab experience was unpleasant reaffirming the saliva based design of our diagnostic device is optimal


• His story was powerful and embodied our motivation behind choosing this project