Team:CCU Taiwan/Human Practices
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Overview
Superbugs can defeat even the most advanced and newest antibiotics. That's because every time someone uses an antibiotic, bacteria have a chance to adapt and become resistant. Already, some patients are becoming seriously ill, facing amputation and even death due to antibiotic-resistant infections. Companies that develop new antibiotics to combat superbugs struggle to get a return on their investments. We don't know precisely when our last antibiotics will lose their efficacy. We don't know which strain of superbugs will push us past the tipping point. It's time to implement a new solution to solve this problem.
At first, our team could only verify our ideas by reading research articles and collecting experimental data. Although both have credibility, there will inevitably be doubts about whether we are out of touch with the actual diagnosis and treatment situation. That's the reason we have to focus on IHP and obtain professional advice, to ensure that the solution we develop matches reality. Only by considering human needs can the products we develop be sustainable. It is better to design "with" our stakeholders rather than design "for" them; they can help us see from different perspectives, shaping the design of our project, making it functional and unique at the same time.
To ensure our conversations between experts and stakeholders are effective, we plan a five-step approach. These five steps are "Define the problem", "Discover the need", "Search for a solution", "Design our solution", and "Commercialize". Below, we summarize all the advice we got from various experts. Every suggestion played an essential role in our project's direction at every stage, a five-step approach to IHP.
Define the problem
To make sure the direction of our project does not deviate from the original assumption, we first invited Associate Professor Chien-Chi Liu to discuss the project with us and point out the blurry areas. This step clarified the relationship between the bacteria on the wound and the type of dressing. Different wound phases have different suitable dressings.
Associate Professor Chien-Chi Liu
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Dr. Chien-Chi Liu is an associate professor in the department of nursing, National Taichung University of Science and Technology. Prof. Liu’s expertise includes Pediatric care and Maternal and child health care. We visited Prof. Liu to make AgenT dressing fit real needs. |
During the interview, Prof. Liu suggested first that we should cite the references that we used to strengthen the persuasiveness of the argument. Second, she said that we should tell the audience which kind of bacteria we can tackle. Third, we need to specify the period of treatment, so the doctor can decide whether to use our dressing.
After the interview, we devised a chart to summarize which kind of bacteria we can treat and also cited the reference we used to convince our audience. We will also design an experiment to test the period of treatment in the future to prove the effectiveness of our dressing.
Discover the need
After determining the function of our dressing and ensuring that the AgenT Dressing will successfully fit the target audiences' needs, we collected opinions from the perspective of users and therapists to try to find the balance between them.
Miss. Yi-Rou Liu
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Miss Yi-Rou Liu is the director of Yien Home Care Office, an institution that focuses on long-term health care. Patients in the Yien Home Care Office often require dressings to cover wounds. The objective of the interview was to find out the practical uses of an antimicrobial dressing and the appropriate target audience of our AgenT Dressing. |
We presented our motivation and project to Miss Liu, who provided some insights and comments on our project. During the interview, she also showed us the dressings often used for wound care in the care center. Miss Liu compared the current dressings to ours and listed the pros and cons of our product. She hopes our product can be different from the current dressings that have a foul smell from the wounds because the foul smell is what caregivers are concerned about. We solve this problem by killing the bacteria that produce the foul smell, so wounds treated with the AgenT Dressing will not have this problem.
Dr. Wu Ting Jen
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Dr. Wu Ting Jen is a visiting staff of Tai Chang Long Dermatology Clinic. She has experience in treating skin infections and chronic wounds for more than 10 years. With rich experiences in dermatology, she can provide us with the most immediate regional clinical advice. |
In order to make sure our product meets the needs of doctors, we interviewed Dr. Wu to understand which kinds of patients will use our dressing from the doctor’s perspective and how she educates the public about avoiding drug-resistant diseases.
Dr. Wu mentioned that patients with cancer, diabetes, and deep wounds would have a high potential to develop drug-resistant bacteria. This helps us determine our target customer. Dr. Wu also introduced how she promoted health education to people. To avoid secondary infection of the wound, she said that the most important thing is to prevent the wound from contacting water. This idea made us consider the importance of waterproofing.
Dr. Wu also said that considering that most patients are from ordinary families, price is often the first concern of doctors. But if we could prove that the antibacterial effect of our product can penetrate deep into the wound and have a long-lasting antibacterial ability, we could convince the doctor to recommend it to the patient when they go home, even if it is expensive. Thus, our team will keep testing the antibacterial effect and estimating the price to make it more feasible for patients.
Search for a solution
In this stage, we met many doctors with front-line clinical experience and discussed how to treat patients' wounds with bacterial infections using an antimicrobial dressing, and prevent antibiotic abuse.
Chia-Yu Chi M.D.
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Dr. Chia-Yu Chi is an attending physician in Infectious Diseases and Vaccinology of National Health Research Institutes. Dr. Chi is also a pediatrician at National Cheng Kung University Hospital. Dr. Chi’s studies focus on virulence factors analysis in Staphylococcus. aureus and the difference between healthcare MRSA (HA-MRSA) and community-associated MRSA (CA-MRSA). |
We want to get more S. aureus information from the expert to clarify our customers and confirm our experiment design. Also, we sought the doctor's perspective on our antimicrobial dressing to understand what a potential user thinks.
In this interview with Dr. Chi, she lets us know more details about the difference between CA-MRSA and HA-MRSA, which helped us determine that HA-MRSA is our target. Moreover, she asked whether our antimicrobial dressing could solve the biofilm problem, which we had never thought of before.
Nan-Yao Lee M.D.
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Dr. Nan-Yao Lee is the director of the Infectious Diseases Department of National Cheng Kung University Hospital, a medical center of southern Taiwan. Dr. Lee is famous for working on the Antibiotic Management and Monitoring Project to control and avoid superbugs, antibiotic drug-resistant bacteria. |
To make our dressing fit reality, we consulted Dr. Lee to determine the patient and doctor's demands. As a senior attending physician, Dr. Lee gave us much feedback. For example, we have to compare products on the market and persuade people that our products have an advantage. Therefore, our team compared our product with the silver dressing on the market to show our product's advantages.
Dr. Lee also claims that if we follow four rules of using antibiotics, superbugs won't appear:
Dr. Lee also suggested that we could design the experiment to solve the problem of biofilms. He gave us two directions to deal with biofilm. One is to inhibit the formation of biofilms. The other is the lysis of the biofilm. These will help us plan for future experiments to make better progress.
According to Dr. Lee's advice, we have compared our product, "AgenT dressing" to the most similar dressing on the market. We used silver dressings and gauze with antibiotics for comparison because doctors frequently use them in hospitals.
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Types
Pros&Cons
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Silver dressing | Gauze with Antibiotics | AgenT dressing |
|---|---|---|---|
| Pros |
1. Broad-spectrum antimicrobial ability
2. Common antibacterial dressing |
1. Easy to get
2. Affordable |
1. Broad-spectrum antimicrobial ability [5][6]
2. Less chance to emerge drug resistance [7] 3. Keep wounds moist, with a high absorption rate of exudate [8][9] |
| Cons |
1. Concern about health effects [3]
2. Cause irritated reaction [1] 3. Can not be using on the wound of recovery stage [2] |
1. Easy to dry and hard to recover [4]
2. Easy to stick on wounds and painful while changing [4] 3. Easy to cause drug resistance (According to the interview with Dr. Lee) |
1. The cost is higher than Gauze with Antibiotics
2. Allergies is to be determined[10] |
First, silver dressing has a broad-spectrum antimicrobial ability. But it causes health effects when it accumulates in the body and causes irritation. The silver dressing also cannot be used on the wound during the recovery stage, as it will harm keratinocytes and fibroblasts cells.
Second, gauze with antibiotics is the easiest dressing for the doctor or the people who using the antibiotics given by the doctor, and it is also affordable. For wound care, wounds tend to recover better in a moist environment, but the gauze can stick to the wound causing pain for the patients while changing the dressing. According to the interview with Dr. Lee, when the dose of antibiotics is not enough or does not follow the doctor's instructions, it will have a high possibility of causing drug-resistant bacteria.
Third, AMPs, the antimicrobial agent we use in our product, have a significant broad-spectrum antimicrobial ability that not only can tackle bacteria but also some fungi. It also has a low possibility of causing drug resistance. Our product can keep wounds moist and has a high exudate absorption rate compared to the research we found. The cost of our product is a little higher than the cost of gauze with antibiotics but lower than silver dressing. Although references say that our AMPs should be hypoallergenic, we cannot exclude the possibility that our dressing may cause allergic responses. But we do have references saying that AMPs do not have side effects in the clinical phase.
To sum up, the design of our products is based on three topics: safety, broad-spectrum antimicrobial ability, and proper condition of wounds. We will put more effort into contacting other experts to make our product fit the needs of consumers.
Tak-Wah Wong M.D.
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Dr. Tak-Wah Wong is the professor of the Dermatology Department of National Cheng Kung University Hospital. Dr. Wong has lots of experience in the clinical treatment of skin infections. |
During this meeting, Dr. Wong let us know our comparison product, silver dressing, is widely used in clinical treatment. If our AgenT dressing could be better than silver dressing, our dressing could sell successfully! However, Dr. Wong thought our design of the AMP release mechanism still needs more experiment data to prove it is feasible, and this is what we are working on now.
Design our solution
After collecting clinical opinions, we began to focus on adjusting the operating mechanism of our dressing. In our search for references, we found a paper published by Dr. Huang addressing the thrombin cleavage sites, so we had an opportunity to interview a professor at CCU.
Hsien-Bin Huang Ph.D.
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Dr. Hsien-Bin Huang is a professor in the Department of Biomedical Science at CCU. The expertise of Dr. Huang is protein neuroscience, enzymology, and protein chemistry. He gave us two dimensions of his feedback. One is about the TAT, and the other is about the thrombin cleavage. |
First, in our project, we created two kinds of antimicrobial agents. One is for extracellular, and the other is for intracellular infection. There is a reason why we need to design an intracellular antimicrobial agent. When macrophages swallow S. aureus through phagocytosis, S. aureus can hide and increase within macrophages. Infected macrophages could then spread S. aureus from the wound throughout the body, and it would cause bacteremia and infective endocarditis. TAT is in charge of bringing the AMP into infected cells. However, Dr. Huang questioned whether TAT would only bring AMP into the phagolysosome rather than other organelles.
Second, in our project, we conduct a thrombin cleavage test to speculate the release rate of our antimicrobial agent. In our biobrick, we substituted GFP for AMP since AMP is a short peptide and is not observed easily on the gel. In contrast, GFP is a protein with a tertiary structure, and it might interfere with the structure of CBD beside the thrombin cleavage site. Moreover, it might impact the recognition of the thrombin cleavage site by thrombin. If thrombin could not identify the thrombin cleavage site, Dr. Huang suggested we could increase the length of the linker to reduce the interference between CBD and GFP.
Jong-Yuh Cherng Ph.D.
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Dr. Jong-Yuh Cherng is an associate professor in the Department of Chemistry and Biochemistry at CCU. His specialty is drug delivery, biopharmaceutics, and bioactivity evaluation. |
The antimicrobial agent's release mechanism is crucial in our dressing design, so we invited Dr. Cherng to advise us on the release mechanism and the modeling part.
During the meeting, Dr. Cherng thought our release mechanism was remarkable. However, he was worried that if AMP were connected with other peptides, the antimicrobial ability of AMP would decrease. We are working hard to confirm whether this is a problem.
Commercialize
In this step, we considered what kinds of challenges our dressing might face on the market. We explored this topic from different aspects such as pharmaceutical certification, biotechnology entrepreneurship, sales channels, etc. We believe these interviews will help us improve our patent application, collaborating with Startup Land at National Chung Cheng University.
Wang Yuchi, Ph.D. & Wan-Shiun Lou M.D.
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Dr. Wang Yuchi is the co-leader of the Regeneration Medicine Technology Division, Biomedical Technology and Device Research Laboratories, Industrial Technology Research Institute. |
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Dr. Wan-Hsun Lo is a researcher in the Regeneration Medicine Technology Division, Biomedical Technology and Device Research Laboratories, Industrial Technology Research Institute. |
The Industrial Technology Research Institute is Taiwan's largest industrial technology research and development institution. They help enterprises develop products associated with regeneration medicine.
We are so glad to have an interview with Dr. Wang Yuchi and Dr. Wan-Hsun Lo. During the meeting, we asked the experts about what preparations we need to take before launching the product on the market. The managers told us a lot of the details of how to get approval for the launch. For example, we should send our information to the Ministry of Health and Welfare to check what laws we should follow.
We asked not only about business aspects, but also asked some experimental questions to solve our problems, such as the standard for cytotoxicity. In our meeting with them, we got pre-launching precautions and got some suggestions related to experiments. In addition, we also realized what types of experiments we should add, such as allergy tests, to ensure the product would pass the certification.
Hsiao-Hui Fu Ph.D. & Mr. Juinn Lee
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Hsiao-Hui Fu Ph.D. received her Ph.D. in Life Science at National Tsing Hua University. Now she is the Chief Technology Officer of ConnSante BioTech Inc. |
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Mr. Juinn Lee received his M.S. in the Institute of Sociology at National Tsing Hua University. Now he is the Chief Executive Officer of ConnSante BioTech Inc. |
We had an interview with Hsiao-Hui Fu Ph.D., Chief Technology Officer, and Mr. Juninn Lee, the Chief Executive Officer of ConnSante BioTech Inc. They have much knowledge about biotechnology and entrepreneurship.
After researching and developing our product “AgenT Dressing", it is vital for our team to keep optimizing AgenT Dressing so it will sell on the market. Therefore, realizing the market for antimicrobial dressings is an essential step. We conducted a survey and wrote an entrepreneurship model of market sales for the future. To improve entrepreneurship, we had a meeting with Hsiao-Hui Fu Ph.D. and Mr. Lee.
Attracting attention is necessary to entrepreneurship. Dr. Fu and Mr. Lee suggested we emphasize the strength of AgenT Dressing more, such as TAT-AMP, which can kill both extracellular and intracellular bacteria, and provide more references to support the technique. Also, they proposed we ascertain the market and the competitors to ensure our product is competitive. After the meeting, we scheduled to consult the Center for Drug Evaluation in Taiwan and apply for a patent as our future work.
Dr. Jack Tsai
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Dr. Jack Tsai is the Chief Technology Officer of GEcoll Biomedical Co., Ltd., a gene-editing application company in Taiwan. One of their products is a specific-pathogen-free (SPF) rat for humanized collagen, the material in our collagen layer. |
Besides questions about collagen, we asked more questions about entrepreneurship because GEcoll Biomedical is a successful start-up biotech company. Dr. Jack Tsai not only shared his perspective on our product but also gave us advice to improve our entrepreneurship:
- He thought we should put market analysis and competitive product analysis at the beginning of our presentation.
- He reminded us that patents are essential, so we will get started to register patents.
- It is crucial to have an expert understanding of the market demand, something he emphasized many times.
Dr. Lance Chang
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Dr. Lance Chang is the Chief Executive Officer of Trade Wind Biotech Co., Ltd. (TWBIO). TWBIO focuses on developing a probiotic cell factory that provides a reliable and sustainable source for natural products, valuable compounds, and pharmaceuticals production. |
Our team and NCKU_Tainan visited TWBIO in July. We were pleased to have a deep conversation with Dr. Lance Chang about how the factory provides a sustainable source for natural products or compounds by synthetic biology techniques during the visit.
While discussing our future execution plans, Dr. Lance provided experience in building up a biotech start-up. For instance, Dr. Lance was invited to the National Aeronautics and Space Administration (NASA) to discuss the factory’s achievement in 2019. From his helpful sharing, we were highly impressed and encouraged to implement our project combining scientific and business approaches in the future. We will keep in touch with TWBIO for more entrepreneurship collaboration throughout and after the iGEM competition.
What we learned
1. Multiple perspectives
We are learning new things and different perspectives from experts. Every group has its concerns, and we have to empathize with their feelings to create products that meet their needs.
2. Well-prepared
Experts made us aware of many new things. We need to prepare data to support our concept adequately so that when facing unknown challenges, we are prepared.
3. Self-identification
Scholars are surprised that students would devote their efforts to this issue. We clarified our project's problems while having conversations with them and showing impact while defining students' roles in the world.
Conclusion
"Plans are nothing. Planning is everything." David Eisenhower.
Closing the loop only means we achieve our current stage goals. Once a new change occurs, we can follow this loop to revise our strategy in a rolling manner. In other words, we can start this loop at any time, to develop problem-oriented solutions.
We will collect more clinical resources and data in Taiwan or Asia, propose a value proposition that attracts international investors or major manufacturers, establish closer collaboration with international biomedical accelerators and educational organizations, and consider local needs. In line with international standards, we will continue to promote the prevention and control of superbugs to all age groups. We hope to become a new star in Taiwan's biotechnology innovation ecosystem.
References:
4. Introduction of common dressing types, Yunlin Christian Hospital.
9. The absorption test of our absorption layer.
