The core of all our Human Practices work was engaging in a two-way dialogue with our stakeholders along the entire journey.
We always spoke directly to the people involved (stakeholders, clinicians, field experts) first and asked whether there was a need for our project before developing it further. Then, we created feedback loops so that they could make sure we had correctly understood their values and needs when integrating them into our design.
Our approach to integrated Human Practices
Integrated Human Practices maximise two-way communication in creative ways such that the outcomes benefit all the involved parties.
To demonstrate how our team responded to Human Practices reflections, research and engagement, we have created an interactive timeline that can be found in our integrated Human Practices page. This shows how our Human Practices activities impacted the project purpose, design and execution, with reflection points along the way. We had to think about how the project may affect society and how society affects the direction of our project.
We tried to promote inclusivity between different research groups by creating a space for collaboration. The Baker Lab’s development of modular biosensors could be joined with our university’s research on bacteriocins. The creation of this new biosensor would in turn benefit from meaningful collaboration with researchers working on luminescence detection and signal interpretation.
Below we have summarised the key elements of successful Human Practices activities based off iGEM’s guidelines. We have also created a learning resource that encourages Human Practices, specifically patient and public involvement and engagement.
Defining Human Practices
'The study of how your work affects the world and how the world affects your work.'
- Peter Carr, Director of Judging
It is about being responsible synthetic biologists, examining the positive impact of our work.
3 Principles:
1. Reflective: What values and needs are we prioritizing and which ones are we compromising? Which sustainable development goals are we targeting?
2. Responsible: Communicate honestly how our work could impact the world. Are there any negative impacts?
3. Responsive: Listen and learn from the stakeholders and others you engage with. Close the loop between designed and desired.
Cycle:
Brainstorm societal issues linked to ideas, getting feedback from stakeholders.
Document progress.
Go out of the lab.
Adapt.
Examples of things to do:
- Send out surveys to get feedback from customers and discover where there is demand for our product, and what issues we need to solve.
- Visit hospitals to get details.
- Document and follow the whole chain of production. Gather real-world arguments for taking the project in a particular direction. We may have assumed the issue was at one step of the production line, but upon further analysis, it was even more significant in other steps.
Examples of feedback loops:
- Researching policies and practices.
- Designing and/or documenting new frameworks and tools.
- Enabling equal opportunity in scientific practice.
- Engaging with stakeholders, users, and other experts.
- Developing new philosophical and ethical insights.
- Assessing the impact and feasibility of potential products.
Encouraging Human Practices
Interactive timeline
The interactive timeline provides insight into our project's development through extensive stakeholder engagement, showcasing how our efforts in human practices have influenced the project plan and design. It meticulously weaves together all aspects of our initiative to ensure it contributes substantially and responsibly across defined realms: necessity, scientific approach, implementation, safety and ethics, legal compliance, and business strategy. Moreover, it elucidates the experiential process of integrating the project into the real world.
Lets start with the journey!
| Bac2Glow - iGEM 2023
Stephen Lewin
P&G (Procter and Gamble)
6th April 2023
We learnt about the methods used by the industry for bacterial testing in the production line and in finished product testing of cosmetics. We understood the requirements for high speed and accuracy, especially at the industrial scale. We began brainstorming ideas for our design and what advantages it would provide.
Reflection Point
Leigh Wilson
Centre of Developmental Neurobiology - King's College London
22nd June 2023
To address her advice about incorporating feedback into our design, we will always state the exact purpose of our discussion at the beginning, so that whoever we are engaging with understands the genuine space for contribution. Then, we will always reflect on the contribution of the individual/organisation we reached out to and consider the implementation of their advice into our design. Finally, we will always consider the outlook, which will include next steps for us and may often involve scheduling a follow up meeting to review how we have implemented their feedback. Laying out this action plan for each discussion in human practices will make the co-devising process more dynamic and two-sided. Her suggestions will shape the way we will conduct our human practices work.
Stephen Lewin
P&G (Procter and Gamble)
24th June 2023
Following our previous conversation with Stephen, we compiled a summary of our competitor analysis, which allowed us to identify that our project idea differed to commercially available solutions in terms of speed, readability of results and specificity to different bacterial strains. We concluded that Bac2Glow and systems such as MOBA Sentinel microbial monitoring, can perfectly supplement each other. MOBA system needs to perform reference analysis on the bypass flow, which is done in a manually-sampling manner, perfectly suitable for the use of our Bac2Glow system. Instead of using the slow conventional culturing methods or other methods requiring further purchase of equipment, Bac2Glow has the unique advantages of being cheap, rapid, and easy to operate and read results (thus there is no need to invest in hiring well-trained professionals and buying equipment to perform the test). In addition, the species-specific detection by Bac2Glow helps MOBA system to overcome one of its biggest caveats. Even without automation, in the rare instances where MOBA or a similar system gives a positive result, Bac2Glow can be used for immediate identification of the strain, without needing to wait for days for results to appear on a plate.
Reflection Point
Dr. Laurence Leaver
GP Associate Director of Pre-clinical Studies for Health & Welfare at Oxford University, and Senior Tutorial Fellow for clinical medicine at Green Templeton College
26th June 2023
We discussed current methods for bacterial diagnostics and potential applications of our technology in hospitals. We believe that our technology would be particularly useful for point of care diagnostics, especially in emergencies and low resource settings where rapid and cheap but accurate diagnostic kits are needed. We may consider making biosensors for the detection of hospital acquired infections or sepsis. The advantage is that the modular nature of our biosensor would allow us to easily switch the bacterial binding domain so that it has a different strain specificity.
Reflection Point
Adriana Zarrelli
Former Regional Emergency Adviser for UNICEF
30th June 2023
Adriana brought to our attention the issue of water contamination in emergency situations and the global scale of the need for clean drinking water. We realised our kit could be adapted for testing drinking water in low resource settings, a new target market we hadn’t considered. This would require the production of a cheaper product than if our kit were aimed at industry water testing. It would also mean we would not need to pass it though clinical trials, reducing experimental/approval time. Making a kit that tests water samples may also prove less problematic than a patient diagnostic kit due to fewer ethical considerations. We would not need to recreate patient samples to test our technology on and could more easily access some contaminated water samples.
Christopher Hentschel
CSO - Cube Labs
7th July 2023
The purpose of our conversation was to have our idea challenged and to receive advice on how to scale up and commercialise our technology. We may need to reconsider our partnership with the Baker lab if we want to commercialise our product due to the patent behind their biosensor. If Bac2Glow was aimed at low resource settings for point of care diagnostics, we could mediate collaboration between the Baker Lab and NGOs, providing the necessary research and experimental work for the project to come together. From the Baker Lab’s report, it seems that the signal is strong enough to be detected by a phone camera, but we are uncertain whether it will be strong enough to be detected by the naked eye. We will research ways to make the signal more intense, potentially by nanoparticle formation.
Reflection Point
Diana Silva
Senior R&D Microbiology Manager - Unilever
11th July 2023
Diana gave us insight into the process of bacterial testing in industry. We will research the legal requirements for industry testing, as this determines which microorganisms need to be identified, in what volume and with what sensitivity. Governments put limits for the acceptable amounts of bacteria in their products, so Bac2Glow must have an even lower limit of detection and should be able to quantify the bacteria in the sample.
Reflection Point
Christopher Hentschel
CSO - Cube Labs
12th July 2023
We had a scientific discussion regarding our project with Christopher and asked for legal advice in terms of patenting. We could add the basic biosensor structure as a new part in the iGEM parts registry for future teams to use. If we are thinking of commercialising Bac2glow, we would need to find an agreement to partner with the Baker Lab for production. We should bear in mind that any company we partner with, for example Lumina, may require additional agreements for IP.
Peter Dobson
Scientific Advisor at Zanma., Previously Professor as Oxford University
18th July 2023
At the end of the seminar presented by Peter, Delphine went to speak to Peter in private to ask for specific advice related to our project. She set up a meeting with him and the whole of the Oxford iGEM team to properly introduce Peter to our project and have a more in-depth conversation.
Dr Laurence Leaver
GP Associate Director of Pre-clinical Studies for Health & Welfare at Oxford University, and Senior Tutorial Fellow for clinical medicine at Green Templeton College
19th July 2023
From conversations with Dr Leaver, there doesn’t seem to be a great need for a rapid bacterial testing kit in a GP setting. It has been made clear to us that there are many reliable methods already in place. Also, it would be ideal to be able to test for many bacterial infections at once, so we are considering developing a multiplexing system – possibly by making a lateral flow kit with multiple bands.
Reflection Point
William James
Professor of Virology and Tutor in Medical Sciences, University of Oxford
19th July 2023
Looking at Hutano Diagnostic’s technology inspired us to reach out to companies that have already developed phone software for detecting and interpreting the light signals that our biosensor will produce.
Mohammed Amro
WASH Cluster Coordinator - UNICEF
20th July 2023
We spoke extensively about the global water contamination crisis, especially in warzones and areas of extreme poverty. We have identified the best use-case for our technology: rapid bacterial detection in water, for emergency settings. In these cases (areas that face warzones, poverty, natural disasters) there is an urgent need for fast and accurate results on water quality. The kits that are used at the moment rely on membrane filtration and culturing, which gives results after 24-48 hours. This is the problem we would like to address with our project.
Reflection Point
Reem Abu Shomar
23rd July 2023
Senior specialist in public health and management.
Focal Person for the Palestinian Water Authority in the WASH Cluster. Carrying out her PhD on the detection of antimicrobial-resistant bacteria and resistance genes in water supplies at healthcare facilities.
Peter Dobson
Scientific Advisor at Zanma., Previously Professor as Oxford University
26th July 2023
We now have contacts with the CEO of HR Wallingford who will be able to share expertise on water related research. We will arrange a meeting with him. We could use magnetic beads to increase the concentration of pathogens in water samples, in case we encounter challenges with detection limit.
Reem Abu Shomar
Senior specialist in public health and management.
8th August 2023
We sent her a document we had written compiling our research and the outcomes of our interview so that she could review it and correct any potential errors. We felt this was important to ensure we and were engaging with our stakeholders and had all the correct information.
Bruce Tomlinson
CEO - HR Wallingford
18th August 2023
After a brief description of our project and vision, Bruce invited us for a site visit of HR Wallingford. During this visit we will further discuss our project and ask for suggestions on ways to develop it.
Dianna Silva
Rodney Hodge
Unilever R&D Colworth
11th September 2023
Diana and Rodney explained the importance of legal compliance and validation of new water testing methodologies. They also gave insights into the sampling plans Unilever R&D follow. We signed a confidentiality agreement before having our call so are unable to share further details of our conversation. However, from the conversation, we now know what to prioritize in the designing of our final biosensor product.
Bruce Tomlinson
CEO - HR Wallingford
21st September 2023
We were fortunate enough to be invited for an on-site visit to HR Wallingford at the Howbery Park site. Following our conversation with UNICEF at the beginning of September, we learnt the importance of testing and validating our results using wild strains of E.coli instead of lab strains. Bruce kindly offered to put us in contact with people that could supply us with wastewater/untreated water samples to test our kit on. We spoke about their projects on flood forecasting and warning systems and saw synergies with our vision for water quality data processing for monitoring and predictive applications.
Stephen Lewin
P&G (Procter and Gamble)
6th April 2023
Purpose
We would like to discuss our ideas about new methods for rapid bacterial detection. Drawing upon internship experience of our team members, we believe there may be a need for rapid microbial testing in the industry. We would like to understand more about the testing methods they use and what are the challenges they currently face.
Contribution
Stephen confirmed that researching accelerated bacteria testing methods is an area where P&G is interested and active in. He told us to identify how our idea would differ and provide advantage to the already commercially available technologies. He mentioned the use of automated water testing systems for instantaneous microbial detection and told us to look into these.
Implementation
We learnt about the methods used by the industry for bacterial testing in the production line and in finished product testing of cosmetics. We understood the requirements for high speed and accuracy, especially at the industrial scale. We began brainstorming ideas for our design and what advantages it would provide.
Outlook
We will continue doing market research and competitor analysis in bacterial testing kits, starting with the names of brands mentioned in our conversation with P&G. An example is MOBA detection system.
Leigh Wilson
Public Engagement Manager at the Centre for Developmental Neurobiology - King's College London
22nd June 2023
Purpose
We would like to ask her to share her expertise as a public engagement professional on the most effective way to conduct patient and public engagement and involvement.
Contribution
She told us some key points to keep in mind when seeking feedback on our project ideas. Once we have decided who we want to speak to and why we want to engage with them, below are some of the key points we need to consider:
What are the aims of the group?
Will there be genuine space for the outcome of interactions to be incorporated into your plans?
It's important that people don't feel as though it is an extractive exercise and that there is a true element of co-devising or production.
If you are more interested in conducting a survey to harvest views and opinions on your product, then that falls more under market research.
She also guided us towards some useful resources, including the NCCPE website (general PE) and also, a PPI guide (from Oxford Uni) as a good starter read.
Implementation
To address her advice about incorporating feedback into our design, we will always state the exact purpose of our discussion at the beginning, so that whoever we are engaging with understands the genuine space for contribution. Then, we will always reflect on the contribution of the individual/organization we reached out to and consider the implementation of their advice into our design. Finally, we will always consider the outlook, which will include next steps for us and may often involve scheduling a follow-up meeting to review how we have implemented their feedback. Laying out this action plan for each discussion in human practices will make the co-devising process more dynamic and two-sided. Her suggestions will shape the way we will conduct our human practices work.
Outlook
We feel more confident in how to approach our human practices work. As shown on this page, we began to think about the purpose, contribution, implementation, and outlook of all the conversations we had.
Stephen Lewin
P&G (Procter and Gamble)
24th June 2023
Purpose
Following our previous conversation with Stephen, we have compiled a summary of our competitor analysis, which allowed us to identify that our project idea differed from commercially available solutions in terms of speed, readability of results, and specificity to different bacterial strains. We would like to discuss our findings with Stephen.
Contribution
We realized that in industry settings, MOBA (SUEZ/Sentinel Monitoring system) could be used to detect the presence of any bacterial strain in real time, but bacterial plating is also carried out to test water samples from the production line. Therefore, we concluded that our solution can be used in conjunction with MOBA or as a replacement for plating, as it provides rapid and specific results that are easy to interpret.
Some of the disadvantages of MOBA are its relatively slow sampling rate, the large upfront cost, the expensive and large equipment, and the post-purchase maintenance. Furthermore, it uses laser-induced autofluorescence, which is unable to distinguish biotic and abiotic particles in liquid, let alone different types of pathogens (e.g., bacteria vs. viruses). Bac2Glow, on the other hand, should allow highly accurate detection of different species and strains of bacteria.
Since our project is not developed into a commercial product, there is no automation yet (unlike MOBA, which is a fully operational system), but this is something that we could potentially implement in the future.
Implementation
We concluded that Bac2Glow and systems such as MOBA Sentinel microbial monitoring can perfectly supplement each other. MOBA system needs to perform reference analysis on the bypass flow, which is done in a manually-sampling manner, perfectly suitable for the use of our Bac2Glow system. Instead of using the slow conventional culturing methods or other methods requiring further purchase of equipment, Bac2Glow has the unique advantages of being cheap, rapid, and easy to operate and read results (thus there is no need to invest in hiring well-trained professionals and buying equipment to perform the test). In addition, the species-specific detection by Bac2Glow helps MOBA system to overcome one of its biggest caveats. Even without automation, in the rare instances where MOBA or a similar system gives a positive result, Bac2Glow can be used for immediate identification of the strain, without needing to wait for days for results to appear on a plate.
Outlook
We agreed to keep in contact so that when our project and experimental work takes off and has been developed further, we can initiate discussions again.
Dr. Laurence Leaver
Senior Tutorial Fellow for clinical medicine at Green Templeton College, University of Oxford
26th June 2023
Purpose
We would like to discuss current methods for bacterial diagnostics and potential applications of our technology in hospitals. This two-way dialogue with a clinician should help us understand whether we can address a need in the healthcare and diagnostics sector.
Contribution
Dr. Leaver said that in primary care, there is some merit in point-of-care testing to confirm bacterial infection. An example would be if a patient has not responded to first-line treatment, other opportunistic infections may be complicating the previous use of antibiotics.
He mentioned that it would be useful to know what is causing a urinary tract infection. Dipstick for leucocytes or nitrite testing is useful in suggesting an infection is present, but it doesn't tell the doctors which one. In this scenario, he said that point-of-care testing might be of use, as knowing it is enterococcus rather than E. coli would change the management. But even then, it may not be that helpful because 90% of UTI infections are caused by E. Coli and what we really need to know is the antibiotic sensitivities, not the species of bacteria present.
With regards to rapid test kits, Dr. Leaver mentioned that despite rapid antigen testing is already available for strep in sore throat, it is of low value, in part because 20% of the population carry strep in their throats even when it is not causing disease. He said that similarly, testing sputum is a problem because of contamination from upper respiratory commensals (which may also cause disease).
For sexually transmitted infection, he said that this is not the GP's remit, but GUM clinics would be interested in such tests. For septicaemia and meningitis, Dr. Leaver said our tech might be helpful - although there are already rapid antigen tests available for many pathogens.
We expressed our concern for what seemed to be a long-time delay for getting results. He replied confirming that most of the time, GPs can send a sample to the lab and get a result in 48h but this delay is generally not a major problem, and if it was, they might be sending the patient to the hospital for a second opinion anyway.
Implementation
We believe that our technology would be particularly useful for point-of-care diagnostics, especially in emergencies and low-resource settings where rapid and cheap but accurate diagnostic kits are needed. We may consider making biosensors for the detection of hospital-acquired infections or sepsis. The advantage is that the modular nature of our biosensor would allow us to easily switch the bacterial binding domain so that it has different strain specificity.
Outlook
We could change our design by immobilizing our biosensor to create a lateral flow-style system, as this format of rapid antigen testing has been very successful in healthcare.
We would like to understand whether our kit could be used to prevent the over-prescription of antibiotics, which is a critical contributing factor to antimicrobial resistance.
Due to Dr. Leaver's busy schedule as a GP, we agreed it would be most time-efficient for us to come up with a list of questions to send him, and he could consider them in his own time, rather than conducting a live interview.
Adriana Zarrelli
Former Regional Emergency Adviser for UNICEF
30th June 2023
Purpose
As UNICEF deals with a variety of humanitarian crises, we would like to ask what their most pressing concerns are in bacterial testing. We decided to start by reaching out to an informal contact we already had - Adriana is a former staff member who occupied the position of regional emergency adviser. We are going into this discussion with an open mind, as we would like to see if there are other applications for our technology outside of industrial water testing or patient diagnostics.
Contribution
Adriana brought up the issue of water contamination in emergency situations. In war zones or areas that have faced a natural disaster, access to safe water is one of the first essential services to be disrupted, making the population, especially the poorest ones, very vulnerable to infectious diseases. She said this is a pressing concern because of the frequency of the need for clean drinking water and the global scale of the problem (everyone needs clean water every day!).
She provided us with contacts in UNICEF to investigate this further.
Told us about the WASH cluster and who to reach out to there.
Implementation
We realized our kit could be adapted for testing drinking water in low-resource settings, a new target market we hadn't considered. This would require the production of a cheaper product than if our kit were aimed at industry water testing. It would also mean we would not need to pass it through clinical trials, reducing experimental/approval time. Making a kit that tests water samples may also prove less problematic than a patient diagnostic kit due to fewer ethical considerations. We would not need to recreate patient samples to test our technology on and could more easily access some contaminated water samples.
Outlook
We will prepare questions and contact the specialists in UNICEF and WASH that Adriana introduced us to.
We will research the current methods used for testing contaminated drinking water.
Christopher Hentschel
Chief Scientific Officer, Cube Labs
7th July 2023
Purpose
As Cube Labs is a venture builder in the healthcare and technology space, we would like to hear their thoughts on our idea and whether it could become a startup. We will present our project as a generic bacterial detection device that can detect bacteria and produce a luminescent signal, in a variety of settings.
We would like our idea to be challenged and to receive advice on how to scale up and commercialize our technology.
Contribution
Christopher is particularly interested in developing products that are public goods as well as commercial products and so was interested in our mission. He is also involved in consultancy in both the private and public sector for innovation.
He told us about an organization in Geneva that has a similar aim to us and is a public-private partnership for diagnostics and is called FIND, URL: https://www.finddx.org/
He said that he knows many companies developing commercial diagnostics, but fewer are interested in products that are aimed for public good use.
We discussed the finances of our project. He was interested in understanding what kind of funding we had received to support our research and what our target market was. If we see applications for Bac2Glow in low resource settings, we will need to consider the cost of goods/consumables.
When we mentioned the Baker Lab’s modular biosensor, he had many questions about the Baker Lab technology and their IP. We discussed the type of patent the Baker Lab had, and how they allowed us to use their patented biosensor for the competition.
He expressed concern that if the ligand is present in low amounts, we may not get a strong enough signal. We discussed ideas to amplify the signal; combining the binding of the biosensor to the bacteria with the spontaneous formation of a nanoparticle would cause many biosensors to aggregate.
We also spoke about the potential application of our kit in the industry for routine quality control testing of water in the production line, food, and finished products. He said that there is a lot of testing done on food, especially on meat, so we would face a lot of competition.
Implementation
We may need to reconsider our partnership with the Baker lab if we want to commercialize our product due to the patent behind their biosensor. If Bac2Glow was aimed at low resource settings for point of care diagnostics, we could mediate collaboration between the Baker Lab and NGOs, providing the necessary research and experimental work for the project to come together. From the Baker Lab’s report, it seems that the signal is strong enough to be detected by a phone camera, but we are uncertain whether it will be strong enough to be detected by the naked eye. We will research ways to make the signal more intense, potentially by nanoparticle formation.
Outlook
We should consider what the cost of our kit would be. Bac2Glow consists of a protein, which should have lower production costs than making an antibody or circuit board-based kit.
We will research FIND and consider contacting them for information, such as metrics for the cost of a kit like ours.
We will send Christopher the Baker Lab’s publications so that he can better understand the science behind our project and can help us understand their patent and any IP issues we may face.
Diana Silva
Senior R&D Microbiology Manager, Unilever
11th July 2023
Purpose
To be thorough in our understanding of bacterial testing in the industry, we would like to speak to another organization (in addition to P&G) to get another point of view. Our previous conversation was based on testing in the cosmetics production line. In this conversation, we would like to talk about testing in the food production line.
Diana has a master's in biological engineering, and her PhD was on molecular methods to detect microorganisms, so we would like her to share her expertise as well as her experience from working in R&D at Unilever.
Contribution
Diana told us that Unilever R&D looks at trends in science and technology to decide where to direct their innovation for the future. They may also help develop manufactory practice guidelines, etc. For example, in relation to our project, they are responsible for deciding the requirements for how frequently the factories should be sampling their products for bacterial presence as well as which sampling methods should be used.
We asked for help in defining the target microorganisms for our kit and the current limitations they experience. In order to do this, she told us we would need to sign a confidentiality agreement to give them more freedom to share specific information.
Implementation
We will research the legal requirements for industry testing, as this determines which microorganisms need to be identified, in what volume, and with what sensitivity. Governments put limits for the acceptable amounts of bacteria in their products, so Bac2Glow must have an even lower limit of detection and should be able to quantify the bacteria in the sample.
Outlook
We will wait to hear back from their legal team so that we can sign a confidentiality agreement while we prepare a list of questions before our second meeting.
Christopher Hentschel
Chief Scientific Officer, Cube Labs
12th July 2023
Purpose
He has read the Baker Lab’s report, and so we would like to have a scientific discussion with him and ask for legal advice in terms of patenting.
Now that he has a better grasp of our technology, we would like to ask for some introductions to other similar startups he has worked with.
Contribution
In terms of innovation and IP, he said that as he had suspected when we had last talked, they have a strong patent with some rights reserved for the US DoD because of the way the Baker Lab’s project was funded. However, he believed this wouldn’t affect our project unless something purely 'commercial' comes out of it.
He also suggested there may be synergy between our iGEM project and the technology developed in one of the Cube Labs companies, namely Lumina. He suggested we look into their work so we could discuss this further when we next spoke.
Implementation
We could add the basic biosensor structure as a new part in the iGEM parts registry for future teams to use. If we are thinking of commercializing Bac2glow, we would need to find an agreement to partner with the Baker Lab for production. We should bear in mind that any company we partner with, for example Lumina, may require additional agreements for IP.
Outlook
We have scheduled another call to discuss partnership with Lumina and other luminescence-based biosensor companies/start-ups.
Peter Dobson
18th July 2023
Purpose
The Doctoral Training Centre in Oxford was holding a seminar on ‘How to boost your research’. We attended it with the aim of seeking advice on how to improve and develop our idea.
Contribution
It seems as though many projects and companies fail due to poor understanding of their target market - often their technology is great, but the innovators haven’t found the right application for it.
We learned about closed vs open innovation, the latter of which seeks ideas from outside. We also learned about innovation timescales and technology readiness levels (TRLs).
The seminar also gave practical advice on ways to reduce the time gap between idea generation and realization, which questions to ask during the development stage, and crucially, how to lay out a business plan and slide deck.
Implementation
At the end of Peter’s seminar, we went to speak with him in private to ask for specific advice related to our project. We set up a meeting with him for a later date so we could have a more in-depth discussion with the whole of our iGEM team present.
Outlook
We feel reassured that our extensive market research (industry vs healthcare) is crucial for a successful project.
We have better insights into what makes a successful pitch deck and how to make a business model, which will help us make a more effective presentation at the Jamboree.
We will prepare a brief presentation for our following whole-team meeting with Peter.
Dr. Lawrence Leaver
GP Associate Director of Pre-clinical Studies for Health & Welfare at Oxford University, and Senior Tutorial Fellow for clinical medicine at Green Templeton College, University of Oxford
19th July 2023
Purpose
We sent Dr. Leaver a list of questions. We have been considering immobilizing our biosensor on a strip to make a lateral-flow-style kit as this has proven to be highly successful in other areas of diagnostics.
Contribution
Below are the questions/answers:
Q: Do you think there would be applications for an at-home LFT kit for bacterial infections? Are there certain widespread bacterial infections that would benefit from rapid, cheap, at-home testing (like during Covid times) before coming to the hospital?
A: Not for general practice as a whole, but there may be certain patient groups for whom such an approach might be useful - for example, patients with cystic fibrosis might need to know if they have pseudomonas. There might be a role for home testing for MRSA prior to elective admission - but I think the hospitals would prefer to do swabs in the clinic to be sure the swabs have been collected properly.
Q: Are there other conditions that have similar problems to UTIs, where most are caused by one bacterium except a small proportion (e.g 90% E.Coli vs 5% enterococcus as you mentioned earlier)? Would a rapid test specifically for the less prevalent species be useful?
A: I wonder if it would be useful to have a good test for the presence of dermatophytes in skin rashes - sometimes it is difficult to know if a rash is eczema or fungal (in the case of flexures, groins, and axillae) or psoriasis vs. fungal (for scaly scalp). Conjunctivitis in contact lens wearers - it might be useful to know they do not have pseudomonas (which requires a quinolone) - if it can be confidently excluded, the patient should be fine with chloramphenicol eye drops - but the cost/risk of the different drops is only marginal, so it would have to be a very cheap and easy test to be worthwhile. Presence of candida in otitis externa might be helpful (but would not be used very often - maybe once every 6 months per GP - and not if the GP has to pay for it).
Q: What are the cons for rapid antigen tests for bacteria that are currently being used?
A: We don't use any. RAT for strep. in throat swabs is common in other countries. I think there is a reasonable body of evidence saying that it’s not very helpful - too many false positives (colonization) and false negatives (swab not taken properly). We use pH testing for bacterial vaginosis - seems reliable.
Implementation
There doesn’t seem to be a great need for a rapid bacterial testing kit in a GP setting. It has been made clear to us that there are many reliable methods already in place. Also, it would be ideal to be able to test for many bacterial infections at once, so we are considering developing a multiplexing system – possibly by making a lateral flow kit with multiple bands.
Outlook
We asked Dr. Leaver for advice on lateral flow style kits and multiplexing in patient diagnostics. He introduced us to Dr. William James.
William James
Professor of Virology and Tutor in Medical Sciences, University of Oxford
19th July 2023
Purpose
Dr. James was introduced to us by Dr. Leaver to discuss lateral flow kits in patient diagnostics.
Contribution
He shared a link to a paper about ‘Nano plasmonic amplification in microfluidics to enable accelerated colorimetric quantification of nucleic acid biomarkers from pathogens.’
Dr. James founded Hutano Diagnostics – a diagnostic tool for early disease prognosis, diagnostics, and management. Their patented modular LFD platform can simultaneously detect up to 20 different biomarkers (antigens and nucleic acids). We could use a similar concept, but with different colors of luciferase instead of gold nanoparticles.
Their platform is paired with a smartphone reader which scans and interprets the results.
Implementation
Looking at Hutano Diagnostic’s technology inspired us to reach out to companies that have already developed phone software for detecting and interpreting the light signals that our biosensor will produce.
Outlook
We will develop some designs for the hardware of our kit to multiplex our biosensor.
We will research companies that have developed ways to detect luminescence signals with a phone camera.
We need to further investigate the application of Bac2Glow in water testing to identify which strains to target.
Mohammed Amro
WASH Cluster Coordinator, UNICEF
20th July 2023
Purpose
Mohammed was introduced to us by Adriana as a field expert on water safety in emergency settings. We wanted to understand more about the need for more efficient bacteriological testing.
Contribution
We spoke extensively about the global water contamination crisis, especially in warzones and areas of extreme poverty.
He shared the water quality mapping activity proposal made by WASH and UNICEF. Under this proposal, they would be testing faecal and total coliforms as part of their biological water tests.
He also shared the statistics of their E.coli test results to give us an idea of the extent of the problem.
Implementation
We have identified the best use-case for our technology: rapid bacterial detection in water, for emergency settings. In these cases (areas that face warzones, poverty, natural disasters) there is an urgent need for fast and accurate results on water quality. The kits that are used at the moment rely on membrane filtration and culturing, which gives results after 24-48 hours. This is the problem we would like to address with our project.
Peter Dobson
University of Oxford
26th July 2023
Purpose
We arranged a whole team meeting to properly introduce ourselves, our project, and ask for advice and connections into the industry.
Contribution
Peter said he could introduce us to Bruce Tomlinson, the CEO of HR Wallingford, who could provide insight into water-related innovation.
For phone camera detection of luminescence, Peter told us about i-sense, who are developing digital tools to track, test, and treat infectious disease using smartphone-connected diagnostic tests. This would be very useful for the final stage of our product.
Peter suggested we read Ozcan’s research into optical methods to improve the sensitivity of absorption-based lateral flow tests by background removal. We would like to understand if there are applications for this in luminescence detection.
Implementation
We now have contacts with the CEO of HR Wallingford with whom we will meet, so that he can share his expertise on water-related research. Peter also told us we could use magnetic beads to increase the concentration of pathogens in water samples, in case we encounter challenges with detection limit.
Diana Silva - N&I R&D Microbiology Manager
Unilever R&D Colworth
11th September 2023
Purpose
To understand how our technology can be tailored for industry water testing. We wanted to learn about the challenges Unilever faced with their current water testing kits and therefore what they were looking for in new technologies. We also wanted to know what may have prevented Unilever R&D from adopting other new technologies on the market.
Contribution
Diana and Rodney explained the importance of legal compliance and validation of new water testing methodologies. They also gave insights into the sampling plans Unilever R&D follow. We signed a confidentiality agreement before having our call, so we are unable to share further details of our conversation.
Implementation
We know what to prioritize in the designing of our final biosensor product.
Outlook
We feel more confident in the direction we would like to take our project and prepared to answer questions at the Jamboree.
Bruce Tomlinson
CEO of HR Wallingford
21st September
Purpose
Following our conversation with Bruce in August, our team was keen to meet him in person. We wanted to gain a better understanding of the work carried out at HR Wallingford and to discuss ways to develop our project.
Contribution
HR Wallingford is involved in researching and designing smart water solutions for communities and industries. Their global vision means that impact and sustainability are at the heart of their work.
We were fortunate enough to have Bruce give us a personal tour of HR Wallingford. He told us about the vast and exciting areas of water-related research they are involved in. We visited their physical modelling facilities for water that they use to educate, investigate, and innovate across the marine and coastal sectors.
The focus of their projects is to understand the behavior and influence of water on communities and industries. Despite their work being more based on physics and engineering rather than bacteriology, we found areas of potential collaboration.
Implementation
Following our conversation with UNICEF at the beginning of September, we learned the importance of testing and validating our results using wild strains of E.coli instead of lab strains. Bruce kindly offered to put us in contact with people that could supply us with wastewater/untreated water samples to test our kit on. We spoke about their projects on flood forecasting and warning systems and saw synergies with our vision for water quality data processing for monitoring and predictive applications.
Outlook
We will keep in contact and will reach out for some water samples when we are ready for product testing and validation.
We believe that the data our kits provide on water quality will one day be able to be combined with their flood prediction systems. If governments can track and predict the movement of contaminated water (from leakages and floods), this will guide the choice of which water source to use during emergency situations, reducing response times.
Reem Abu Shomar Interview
WASH Cluster
23rd July 2023
Introduction
I am a senior specialist in health and management and have a masters’ degree in public health and a BSc in medical technology. I have over 20 years of professional experience in health management, medical technology, monitoring and evaluation, and quality improvement, working as the focal person for the Palestinian Water Authority in the WASH cluster. I am expecting to finalize the requirements for my PhD degree in water technology in September this year. My thesis is about detecting antimicrobial-resistant bacteria and resistance genes in water supplies at healthcare facilities.
Current testing
Could you briefly outline the types of bacterial testing you carry out in emergencies?
We have two main approaches for detecting microbial contamination: medical or environmental screening/surveying. For the environmental surveys, like water testing, the currently used methodology depends on having a sample, filtering it, and culturing it on agar to detect coliforms, whether faecal or total coliforms. [Note: Fecal coliforms include E.Coli and non-faecal include Enterobacter and Klebsiella]
How efficient are the environmental tests? Do they have any limitations?
The tests for microbial contamination based on culturing are done to assess compliance of water quality with the Palestinian national standards, but unfortunately, this is a limitation even for them, as they only test for the presence of coliforms. Pseudomonas, for example, would have to be detected through a second screening test as it is not a coliform. This is one of the challenges. In my thesis, I conducted a large survey which found water samples that contained Pseudomonas without testing positive for faecal coliform or total coliform – clearly a test for coliforms (E.Coli) alone is not comprehensive enough. Another huge limitation is the timing; culturing takes a minimum of 24 hours incubation time in a lab before giving results. Another downside is the time the actual sampling procedures take. There is a time lag between collecting the sample and transporting it to the laboratories where the tests are done. We may only be allowed to transfer it within half an hour, or if we have access to a cooling chain, we might be able to transfer it within two hours to the laboratory. In most areas even two hours is difficult to achieve. So, this is another challenge - we would need a rapid transport system, or even better an on-site detection system. Rapid testing would be very helpful for this. Another issue is also the interruption in supplies and materials for detection and isolation of bacteria. Often different testing kit brands are received from donations which reduce the accuracy of the results, especially if you are using different surveys at different times.
How much time does it take for you to get results usually?
The time for results is usually two days. If it is environmental testing, we might then send it for more confirmatory testing or for biochemical identification.
How is the clinical testing different from the environmental testing?
Clinical testing requires the identification of the bacterial strain more than in environmental testing. The environmental tests usually only depend on the morphological appearance of the colonies on the selective cultured medium. This means they are more rapid, but this comes at the cost of accuracy and specificity. For us to identify the bacteria more accurately, we might need to integrate some biochemical testing, but this would take additional time, especially the incubation time required for the culturing of the bacteria. For the clinical testing, we might need three days to have the final diagnosis, while for environmental testing, only two days because we skip the biochemical testing.
Timing
Is there another more rapid testing method that you have considered using?
You may hear the terms ‘rapid testing’ or ‘on-spot testing’ being used in this field, but this just refers to testing the free residual chlorine after water treatment. Water service providers sometimes substitute bacteriological testing with testing the residual free chlorine after chlorination. But this method is not sufficient and not accurate enough because there are strains that are resistant to chlorine. Also, biofilms form that can hide bacteria and enable Pseudomonas to survive even in highly chlorinated environments. This is another challenge here in Gaza.
Have there been any efforts to develop a more rapid testing method?
From my experience, more rapid methods do not exist. For example, I’ve heard about a new technique that accelerates the incubation period and so also the time to get results, but it is not available here in Palestine and is still quite a slow method. Using PCR technology for routine testing is not cost-effective for such a low resource context and also not realistic given the interrupted and intermittent supply of reagents and other supplies. Even when PCR is available and the technology is here, you would need to maintain the supplies and to provide skilled personnel – doing PCR requires even more skills than for the microbiological tests!
I remember the American University of Beirut organized a webinar on ways to help people in remote locations, or in areas under conflict, to read and interpret the results of the microbiological tests. This would shorten the required time for interpretation, but from my perspective we need to have innovation within the testing methodology itself. If we manage to accelerate the detection with a rapid, on-spot kit, that would be very useful. Also, being able to identify other species like Pseudomonas and Enterococcus, Staph aureus in addition to Enter
--Reflection Point--
Project Direction
With the aim to improve bacterial detection, we began researching molecular methods for rapid detection and novel biosensor designs. We learned about research conducted at the Baker Lab and their recent publication on ‘de novo design of modular protein biosensors’. In the following couple months, we started to research binding targets on bacteria that could be incorporated into this modular biosensor. We learned about Prof. Colin Kleanthous’ research on bacteriocins at the University of Oxford and realised that this could be incorporated into the biosensor’s design.
--Reflection Point--
We would really like our project to be impactful and there seem to already be many robust methods that are commercially available for bacterial detection in the industry. We would like to explore other areas of bacterial detection that involve higher stakes and depend even more on rapid results. We began to think about bacterial diagnostics.
--Reflection Point--
We believe our technology has great advantages in emergency situations where rapid and cheap bacterial detection is crucial to save lives. We will reach out to NGOs to understand this better.
--Reflection Point--
In parallel to our lab work, we should research and test methods for signal amplification. At the moment, we have two ideas for nanoparticle formation that would cause the fluorescent, bound biosensors to come together.
--Reflection Point--
At this stage we have considered food, water and finished product testing in the industry, as well as patient diagnostics in healthcare. Next, we need to further understand the applications of our technology in emergency water testing.
--Reflection Point--
Since it is important to be able to test for multiple pathogens, we will identify several bacteriocins for our design. We could look into ways of multiplexing our kit.
--Reflection Point--
The Bac2Glow will be aimed at water testing in emergency situations.
iGEM 2023 JAMBOREE
Close the loop
To close the loop between what is designed and what is desired, we had multiple conversations with the same stakeholder to discuss whether we integrated their feedback in the right way. Moreover, we tried to involve multiple stakeholders from the same field to create a broader opinion on our project design and to validate the advice of single stakeholders. The combination of multiple meetings with similar experts and literature studies enabled us to critically reflect on our design at each moment of the design process.
Secondly, we tried to close the loop between what is designed and what is desired by proposing the implementation of !MPACT (Proposed implementation). In this section, you can read each step that is necessary to bring !MPACT into the real world and what design of !MPACT is eventually required. With the help of our human practices work, we propose how our design should be further improved and what actions we as a team should take to successfully introduce !MPACT to the market.
1. Why Businesses Need To See Customer Feedback As Make-Or-Break. Accessed August 23, 2022. https://www.forbes.com/sites/serenitygibbons/2018/09/20/why-businesses-need-to-see-customer-feedback-as-make-or-break/?sh=78a16e6b1083
2. Stilgoe J, Owen R, Macnaghten P. Developing a framework for responsible innovation. Res Policy. 2013;42(9):1568-1580. doi:10.1016/J.RESPOL.2013.05.008
3. Gibbs G. A guide to teaching and learning methods. Learning by Doing. Published online 1988:129. Accessed August 23, 2022. https://books.google.com/books/about/Learning_by_Doing.html?hl=nl&id=z2CxAAAACAAJ