Our Integrated Human Practices strategy was developed and conducted based on a continuous two-way communication with our stakeholders. The two pathways of communication were:

Public Engagement: Public surveys were utilized in order to collect data on the citizens' level of awareness and their opinions regarding antimicrobial coatings in surgical and implantable devices. This information was helpful for the direction of our project and communication of public education.

Expert Consultation: We interviewed experts to provide a critical review of our proposed project's real world applicability, practicality and risk management. Their valuable suggestions enabled us to work on project design, predict challenges, and design the solution more practically.

Figure 1. Stakeholder Analysis Map

The primary step when conducting the Integrated Human Practices was to stakeholder map the surgical and implantable device ecosystem to determine whose opinions we should be listening to and paying the most attention to when it came to developing a solution and project.

We applied an Interest vs. Impact matrix to stakeholder map our system. As indicated in the stakeholder analysis map above, this space is characterized by an extensive, and interconnected, network of stakeholders. We will need to break this analysis up into the various identified groups.

The first category of stakeholders is the primary circle on the map – those whose interest and impact from this project is high. We need to focus a majority of our project efforts in and around these stakeholders and their concerns, as our solution is primarily intended for these audience and we will need to work closely with them to ensure our solution is feasible and ethical and, most importantly, a value to society.

This group is comprised of:

1. Patients (consumers): Those in need of surgery or those who need an implantable medical device
2. Doctors (surgeons in particular): The clinical decision makers and procedure performers
3. Hospitals: The actual environments the surgery/devices will be used in as well as providing other resources and support
4. Government organizations: Policymaking and setting of industry-wide standards and regulations

The next stakeholder group to analyze is those with the inverse relationship as the primary group – impact without interest, in this case experimental apparatus companies. These companies are those that provide the machines and devices that aid in the development and testing of products, they are vital to the innovation of novel ideas but have no particular interest in or say in our specific project.

We also identified a high interest group with low impact: food producers. Food is a space that could use antimicrobial coatings as well, and these companies are interested in the development of such products but not as much as our primary stakeholder group. The final group was transporters and overseas shipping companies.

According to World Health Organization (WHO, 2016), up to 7% of patients in developed and 10% in developing countries suffers a healthcare-associated infection (HAI) during their hospital stays. Hence, it is essential to develop effective strategies to prevent pathogen contamination of medical devices. These data demonstrate the significant impact of HAI today, and we aim to improve this situation. Before initiating our project, we made a questionnaire to assess public awareness of medical device coatings.

Table 1. Public Health Priorities for Medical Device Coatings

To better direct our project design and activities, we conducted a public survey of 257 teenagers and adults in Shanghai. The survey findings were as follows, and they directly influenced and modified the following human practices and project plan:

1. Significant Awareness Gap: 76.4% of the respondents had no idea of medical device coatings), which gave a decisive affirmation of the importance and direction of our educational work and helped to specify the types of contents to be designed to fill this knowledge gap;
2. Optimal Communication Channels: Offline events and short-video platforms were the two most favored communication platforms for the public (43.1% and 34.5% of the vote, respectively), and thus we devoted more attention and resources to science communication via these two channels;
3. Public Health Priorities: The public ranked antibacterial performance (average rank of 1.4) and biocompatibility (average rank of 2.8) as the two most important coating properties, which provided a great inspiration for us as the two indicators were exactly where our project focused the most on, and thus it helped to ensure the public were more likely to get the expected safety and efficiency from our project work.

This indicates that antibacterial properties and biosafety are the core directions of research and development, as well as clinical application. In the future, it is necessary to ensure these two performances while also taking cost control into account to promote the clinical transformation and market acceptance of the product.

Meanwhile, antifouling properties and abrasion resistance ranked relatively low, with average scores of 3.2 and 3.5, respectively. This indicates that although these properties are important in some applications, their overall attention is not as high as the former two. The importance of the price factor is the lowest, with an average ranking of 4.1. Only 13 people considered it the most important. It indicated that clinical safety is far more crucial than cost for medical devices.

Figure 2 Bar Chart of Factors Affecting

With respect to the market entry of new medical coatings, the area which received the most votes in public comment was biocompatibility (90.2%). This clearly places the biologic safety and non-toxicity of the medical coating as the main driver for future development. The second highest area of interest was continued anti-infective efficacy (61.8%), which similarly instructs us to maintain this aspect of the medical coating function. Economic concerns, such as price and stability of cost (~38%) were much lower on the list, but these will of course continue to play a role.

Overall, the public's emphasis on antibacterial properties and biocompatibility has affirmed our project direction, as these two aspects are the most significant characteristics of the mussel foot protein antibacterial coating.

Through a literature review, we have thoroughly explored the potential of mussel foot proteins (MFPs) for practical applications, and mainly focus on their antimicrobial and water repellent properties. It provides a direct theoretical basis for our program.

The mussel adhesion proteins had strong underwater adhesion properties and significant antimicrobial activity. A recent study (Kim et al., 2024) highlighted the efficacy of fusion proteins combining Mussel Foot Proteins (MFPs) and antimicrobial peptides. These constructs proved highly effective against Gram-negative bacteria such as E. coli and Klebsiella pneumoniae (MIC 4–8 μM), and were capable of complete sterilization in just 10 minutes. Furthermore, their excellent thermal stability and strong safety profile underscore their potential as ideal candidates for next-generation antimicrobial coatings on medical devices and implants.

In addition, drawing inspiration from mussels, Argenziano et al. (2023) developed a fully natural composite hydrogel from soy protein and plant-derived polyphenols. The material demonstrated remarkable underwater adhesion for over 15 days, coupled with excellent biocompatibility and significant antimicrobial activity. These combined properties make it a highly promising candidate for applications ranging from waterproof bioadhesives and advanced wound dressings to scaffolds for regenerative medicine.

Our initial research into the antimicrobial and adhesive qualities of MFPs and discovered that they meet a market need and target the problem of healthcare-associated infections justifying our decision to focus on MFPs as the keystone of our project.

Figure 3 Potrait of Prof. Liujie Huo

To ensure the feasibility, we interviewed Professor Liujie Huo. He graduated with a bachelor's degree from Tianjin University in 2008, majoring in Biotechnology. After completing his doctoral degree in 2014, he worked on the biosynthesis and exploration of peptide-based natural products at the University of Illinois at Urbana-Champaign in the United States. In 2018, he returned to China and established a research group at Shandong University, continuing to engage in related scientific research. Professor Huo emphasized the importance of large-scale production. Taking artemisinin as an example, he pointed out that relying solely on natural extraction is inefficient and costly. Therefore, he suggested transferring the target protein (such as mussel foot protein) to easily culturable microbial hosts for expression, in order to increase production and reduce costs. Professor Huo's suggestion undoubtedly supports our plan to solve the problem through synthetic biology. However, we are also eager to know if the extracellular synthesis technology has more advantages compared to the traditional E. coli fermentation technology.

Figure 4 Interview with Prof. Huo

He then made a direct comparison between the two of extracellular (cell-free) synthesis and recombinant protein production using engineered E. coli fermentation. He immediately pointed out that, from a theoretical standpoint, the cell-free method would produce a higher purity product. He then immediately juxtaposed that with the current issues with this approach: extreme cost and the low yields that have been obtained at this point in time (which are only at the laboratory scale). Because of that, the cell-free method is not currently a feasible option for industrial applications. As a more mature and practical alternative, he suggested the refinement of E. coli secretion engineering. Secretion engineering takes advantage of specifically designed signal peptides to direct the target protein for extracellular secretion (which avoids the need for cell lysis). This makes downstream processing much easier and reduces the purification costs by orders of magnitude.

Table 2 A Short Comparative Study between Cell-free Synthesis and Engineered E.coli Fermentation

Key Learning, Reflection and Improvement

This consultation session on recombinant protein production was a critical event for our team’s project, where expert guidance had a decisive impact on our primary decision-making. Prof. Huo’s feedback penetrated into our project on two levels:

1. Technical Direction: Focusing on Industrial Application

Following a discussion with Prof. Huo on our protein production strategy, our original plan was the extracellular (cell-free) synthesis method. However, upon consideration of the expert feedback, we shifted our focus from this direction.

Professor Huo emphasized, based on his extensive research experience, that this technology is far from mature for industrial application: the equipment and raw materials costs are high, the maximum yield is at the microgram level, and the overall technology is not well-developed.

After the expert evaluation, we found that using an extremely elegant but difficult to industrialize solution would not benefit the project. Therefore, we decided to take his advice: to perform the secretion engineering optimization of E. coli.

This decision for E. coli secretion engineering can not only circumvent the cell cracking problem in subsequent purification but also greatly simplify the downstream work and save costs at the same time. It also creates a sustainable application scenario for our recombinant protein in the future industry.

This choice, made after expert feedback, ensures that our project is grounded in a feasible, impactful, and economically rational solution.

2. Biosafety and Environmental Protection Consciousness: Strengthening Responsible Research Practice

Prof. Huo also gave us new insights into the safety and environmental protection aspects of our work.

He pointed out that the large and often ignored risk in our project is microbial leakage. Prof. Huo introduced to us the current state and trends of national and international regulations and standards in this field. In particular, he warned us about the handling of genetically modified strains in our project and the possible “gene leakage” caused by improper handling and disposal of these strains. From an abstract laboratory safety concept, this guidance from Prof. Huo made it more real and more close to us.

After the expert session, we think that just doing the lab work according to the manual is not enough, and in the field of responsible science, we need to identify and address the potential risks as much as possible. Therefore, we applied his advice in the following way:

In the standard operating procedure (SOP) we designed and carried out for our project, we incorporated a more stringent waste disposal method for our engineered strains. Specifically, we carried out chemical inactivation before autoclaving and disposal.

We also started to plan and implement a “Safety by Design” approach. For example, in the future, we will try to consider adding a kill switch or other biocontainment strategies into our system.

Clinical suggestions

To ensure our products meet the fundamental needs of clinical doctors, we invited several clinicians to share their opinions about the program.

Interview with Dr. Nei Zhang-Grounding Innovation in Clinical Reality: A Consultation on Safety and Strategy

Figure 5 Potrait of Dr. Nei Zhang

1.  Expert background

She is a quality control expert in hospital sensing, the head of the hemodialysis centre, and a core member of the hospital sensing committee at Zi Jing Hospital affiliated with Wuhan University of Science and Technology.

2.  Summary

To summarize, she provided three essential insights:

（1）Proof of the Clinical Problem. Dr. Zhang validated that hospital-acquired infections remain a stubborn and complex issue. She further demonstrated that conventional antibacterial materials (e.g. silver ions) are largely inapplicable because of their innate toxicity, poor biocompatibility, and uncertain long-term safety. Therefore, the project's clinical motivation and the necessity of a new solution were further validated since device contamination during production and clinical use continues to represent a serious risk for patient safety. 

（2）Approval of Mussel Protein Approach. She also recognized our mussel protein-based coating as a potential solution. The primary strength of our concept, she said, is that, as a natural protein, it does not have the toxicity and accumulation issues of artificial agents. She also recognized the practical value of a factory pre-coating approach, which can help prevent contamination before the devices reach the clinical setting. 

（3）An Implementation Roadmap. Dr. Zhang then provided an implementation roadmap from the bench to the clinic, which can be broken down into the following points: a) We need to emphasize a safety-efficacy balance to comply with the medical industry's rigorous requirements; b) We need to systematically address specific biocompatibility issues, including blood compatibility and allergenicity, by interdisciplinary efforts and dedicated testing; c) We need to plan for long-term clinical validation of the material's durability, safety, and economic viability.

Figure 6 Interview with Dr. Nei Zhang

3. Key Learning, Reflection, and Improvement

Dr. Zhang’s expert guidance has not only offered key improvements to our experimental design but has also steered a shift in our team’s foundational approach towards the research project at hand.

（1）Lesson: Paradigm Shift to a “Safety-First” Orientation

Whereas previously, our team had focused heavily on honing the antimicrobial efficacy of our protein with the implicit view that biocompatibility was an ‘afterthought’ or downstream problem, the consultant’s comments and revisions have reinforced the opposite perspective, that safety is the foundational premise for any medical innovation. This was crucial in moving from an academic lens to a more clinical and product-minded frame of mind.

（2）Insight: Natural Protein as the Project’s Core Value Proposition

Dr. Zhang’s decision to accept our MFP protein as a worthy topic for guidance crystallized a line of thought in our group. Namely, this material choice was not just a technical preference for our part, but rather our project’s core value proposition. It is the one technical decision which directly addresses the primary clinical concern of toxicity/biocompatibility that the professor emphasized. This has bolstered our determination to maintain the “natural” and “biomimetic” properties of this design throughout further design efforts.

（3）Enhancement: Converting Guidance into a Tangible Experimental Plan

In response to this interview, we have taken steps to convert the expert’s advice into specific, actionable, and measurable modifications to the project moving forward:

• Reposition Safety Assays as Priority Experiments: In response to her key “safety-first” insight, we have rescheduled the experimental time table for our project such that both MTT cytotoxicity assay and the hemolysis assay are both now redefined as Phase 1 experiments to be performed in parallel with initial protein expression and purification. The purpose of this rescheduling is to front-load our key biocompatibility measurements such that any safety red flags are caught as soon as possible.
• Expand the Scope of Biocompatibility Efforts: To be more preemptive in tackling her concerns about allergens, we have added the following research activity to our project’s to-do list: an in-silico screening of our antimicrobial peptide sequence against known allergenic epitope databases as a necessary first step to inform future protein engineering to reduce potential immunogenicity. This has made it clear to us that a biomimetic design is only as “natural” as the research and efforts we invest into the material at the design stage.
• Design a “Target Product Profile” (TPP): Inspired by the consultant’s clear research roadmap, we have gone a step further to concisely document our research vision as a quantitative, project-level “target product profile” (TPP) statement. This TPP will henceforth serve as our group’s north star for all critical decision making and helps our research efforts always to keep in check with the strict demands of a true clinical product.

Interview with Dr. Han Yu Song-A Surgical Perspective on Infection Prevention

1.  Expert background

He is the doctor of the General Surgery Department of Fudan University's Zhongshan Hospital.

2. Summary

The surgeon’s insights can be summarized into two categories:

• The Limitations of Existing Methods for Infection Prevention:
  He explained that conventional time-bound sterilization methods, current antimicrobial coatings, and prophylactic systemic antibiotics, all have serious limitations. Sterilization is operator-dependent, which makes it susceptible to human error and exogenous contaminants. Current coatings degrade over time, while systemic antibiotics have various side effects and can increase AMR.
• The Potential in a Novel Strategy:
  He pointed out that our MFP-fused with AMP coating is extremely promising, because it is more biocompatible and evokes less of an immune response than traditional chemical agents. He had a specific interest in combining this MFP coating with other antimicrobial agents for especially high-risk implants such as joint prostheses. He described the key benefits of this approach as follows:
  

Localized Treatment: The coating works locally at the surgical site, without systemic side effects.

Long-Term Release: It provides a long-lasting supply of antimicrobial protection.

Limited Resistance: By targeting the drug more locally and directly, this method could help prevent the emergence of drug-resistant strains of bacteria. He suggested that although systematic research into efficacy and degradation is still required, this technology represents an optimal solution for long-term and sustainable infection prevention.

Figure 7 Interview with Dr. Song

Key Learning, Reflection and Improvement

The surgeon’s focus on the limitations of current methods, especially their susceptibility to human error and time-dependency, was our most valuable insight. We realized that the most important value that our product can provide is not a new antibacterial mechanism in itself, but a more fail-safe system that greatly reduces the possibility of intra-operative contamination.

1. Reflection: Redefining our Product as a Process
   This realization caused a shift in our thinking. We began to consider our product not only as a material, but as part of the medical device manufacturing process as a whole. The idea is to supply the surgeon with a device that is already reliably sterile “out of the box”, thus eliminating one more variable from the complex equation of surgical asepsis.
2. Improvement: Centering on a Pre-Coating Strategy
   In light of this, we have solidified our central project implementation strategy as follows:
   Factory Pre-Coating as a Priority: We have designed our product around a pre-coating model that can be integrated into the device manufacturing chain. This directly responds to the surgeon’s expressed concerns, as it allows the antimicrobial layer to be applied in a controlled and sterile environment long before the device reaches the hospital.
3. Focus on Reliability: This pre-coating strategy is meant to make the hospital less dependent on manual, time-bound sterilization steps. This helps to reduce the margin for human error and improve patient safety from the start.

Interview with Dr. Li Qin-Pragmatics of Clinical Translation

Figure 8 Portrait of Dr. Li Qin

1.  Expert background

She is Dr. Li Qin, MD and associate chief physician from Shanghai Red House Obstetrics & Gynecology Hospital. Skilled in the diagnosis and treatment of gynecological tumors and complex and complicated diseases, with rich experience in individualized treatment of various gynecological cancers, and also proficient in minimally invasive surgery and the

management of complex endometriosis.

Figure 9 Interview with Dr. Li

2.  Summary

Dr. Li stated that in order for a product to successfully launch and transition into the clinic, it must meet with the following “test” (or 4 pillars of success):

• Patient Safety (No. 1 and Non-Negotiable)

The material must be safe above all, which means that it must be fully vetted and tested for carcinogenicity, as well as any other potential long-term adverse effects

• Convenience:

The product must be easy to use and implement, and it must be easy for clinical teams to use. The product should not require more effort than a surgeon’s team is currently using. It should also integrate well with clinical workflow.

• Inexpensive:

The cost must be controlled, keeping the cost of the product as low as possible.

• Approval:

It is essential to obtain regulatory compliance and approval.

3.Key Learning, Reflection, and Improvement

• Key Learning: Innovation Must Serve Pragmatism

Dr. Li’s advice was a powerful lesson in pragmatism. We learned that in the medical field, scientific novelty alone is not enough. A successful product must be holistically designed to meet the real-world constraints of safety, usability, cost, and regulation.

• Reflection: Adopting a Clinician-Centric Design Philosophy

This feedback prompted a shift in our team's mindset. We moved from a purely science-focused perspective to a clinician-centric one, where the needs and workflows of the end-user (the surgeon) and the ultimate stakeholder (the patient) are central to every design decision.

• Improvement: Integrating a Multi-Pillar Development Strategy

Dr. Li's "four pillars" have become a core part of our project's development framework:

Reinforcing Safety Protocols: We have expanded our safety testing plan to not only include standard cytotoxicity assays but also to begin preliminary research into protocols for long-term carcinogenicity assessment, firmly upholding patient safety as our primary design constraint.

• Optimizing for Usability:

We are initiating a "design for usability" phase, where we will model how our coating would be applied to different types of gynecological surgical instruments and assess how it might impact their handling and performance in a real-world surgical context.

Interview with Dr. Zhang Chao-Unique Needs of Pediatric Care

1. Expert background



Figure 10 Portrait of Dr. Chao Zhang

Associate Chief Physician of the Department of Dermatology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine; Member of the Pediatric Dermatology Group of the Dermatology and Venereology Professional Committee of the Chinese Society of Integrated Traditional Chinese and Western Medicine; Member of the Light Medicine Group of the Dermatology and Rehabilitation Professional Committee of the Chinese Rehabilitation Medicine Association. Has been engaged in clinical work on the front line of dermatology for 20 years. Mainly engaged in the treatment of allergic and inflammatory skin diseases such as eczema and atopic dermatitis in adolescents.

2. Summary



Figure 11 Interview with Dr. Chao Zhang

Dr. Zhang shared his in-depth and valuable insights on our technology application to children:

The children are a special group that our antibacterial material needs to address. On one hand, their thin skin barrier and developing immune system put them at a higher risk of infection, therefore, there is an urgent demand for antibacterial material for this population. On the other hand, the high vulnerability and vulnerability of this group also requires the materials to have the most stringent safety, especially for the materials of a novel biological technology.

In addition, he shared the following points:

Children are prone to post-operative infections and their skin microbiome may be out of balance and lead to inflammatory diseases.

Form is an important factor for our product. For some applications, gels or powders may be better forms for the materials.

The mono-protein films are very promising as the rejection rate is low. However, their safety, efficiency, cost, and environmental impact will need to be verified for the pediatric population.

3. Key Learning, Reflection, and Improvement
• Key Learning: The Responsibility of Designing for the Vulnerable

Our conversation with Dr. Zhang was transformative. We learned that designing for children is not just a matter of scaling down an adult product; it requires a fundamentally different approach, with safety and biocompatibility elevated to an even higher level of scrutiny.

• Reflection: A Strategic Pivot Towards a High-Impact Application Dr. Zhang’s insights inspired a strategic pivot in our project's focus. We realized that by addressing the stringent requirements of pediatric care, we could develop a product that is exceptionally safe and effective, with potential applications that could then be expanded to the general population.
• Improvement: A Multi-Faceted Product Development Overhaul This reflection has led to a comprehensive overhaul of our development plan:
• Adopting a Pediatrics-First Focus: We are now centering our research on pediatric application scenarios. This includes intensifying our biocompatibility and safety assessments to meet the highest possible standards.
• Developing Versatile Product Forms: Following his advice, we have initiated parallel research tracks to develop both gel and powder formulations of our protein, tailoring them for different medical needs, such as topical application on wounds.
• Initiating Clinical Collaboration: We have begun outreach to pediatric clinical institutions to establish multi-center research collaborations. This will allow us to test our product's real-world antibacterial efficacy and its impact on the skin microbiome.
• Integrating Sustainability: We are placing a greater emphasis on cost control and environmental performance in our production process to enhance the long-term feasibility and sustainability of our material.

Interview with Dr. Jun Hu-Regulatory Compliance and Sustainable Development

Figure 12 Portrait of Dr. Jun Hu

1.  Expert background

He holds a Ph.D. in Pharmacy and a senior professional technical title. He serves as the Director of the Shanghai Centre for Adverse Drug and Medical Device Reaction Monitoring.

2. Summary

Dr. Hu clarified the regulatory, environmental, and economic development of the mussel protein-based antimicrobial film:

Figure 13 Interview with Dr. Jun Hu

A clear regulatory framework and market access path: The product will be classified as a Class II medical device. It needs to follow standards for the source and quality of raw materials, production processes, key indicators, evaluation, and performance to go to market.

Project development can receive special funds, "green channel" technical review, and tax benefits: The government actively encourages the development of similar projects through various means such as special funds, "green channel" technical review, and tax policies.

Environmental responsibility: In the process of resource development, we need to shoulder the environmental protection responsibility. The government will impose sustainable development measures such as quotas and restrictions on the fishing industry.

Link the project to the local industrial system to provide economic benefits to the region: The project must take measures such as industry-academia-research integration to better contribute to the local economy and improve the added value of the region.

3: Key Learning, Reflection, and Improvement

• Key Learning: Innovation and Responsibility go hand in hand.

Dr. Hu's interview told us that innovation must be accompanied by responsibility, and scientific and technological innovation is not done in isolation from strict regulatory compliance and environmental and economic considerations.

• Reflection: Responding to Responsible Innovation

This interview helped me realize that the antimicrobial film project must be designed and executed with an eye toward meeting strict medical device standards, ensuring the environmental sustainability of its supply chain, and considering its fit into the local economy.

• Improvement: Incorporate a “Compliance by Design” Approach

To incorporate Dr. Hu's valuable suggestions into our project, we are adopting a “Compliance by Design” approach:

Aligning development with Class II device requirements: We have integrated the regulatory framework for Class II medical devices into our project timeline. As we progress through the R&D phases, we will be documenting and validating key performance indicators, such as raw material purity, antibacterial activity, and biocompatibility, to ensure that our data package will support market entry.

Emphasize sustainable sourcing: Dr. Hu's comments on environmental protection underscored the importance of using genetic modification to produce our mussel protein. This will help reduce environmental impact by minimizing the need for mussel harvesting.

Industry-academia-research integration as a commercialization strategy: We are in talks with academic and research institutions in Shanghai to integrate with the local industrial system. By tailoring our commercialization roadmap to government initiatives that support local job creation and economic growth, we aim to create a support network that could facilitate technology transfer and help our product to make the leap from clinical value to industrial value.

To promote the efficient implementation of the product, we interviewed experts and some related firms. We formulated a clear commercialization strategy, aiming to accelerate market access, enhance product value, and facilitate the smooth transformation of technology into industry.

Figure 14 Interview with Mr. Zhang

Interview with Dr. Zhang An Dong-R&D and Market Access Strategy

1. Expert background

An expert majoring in finance and accounting, specializing in the fields of healthcare, pharmaceuticals and chemicals.

2.   Summary

Strategy for Commercialization
Mr. Zhang advised the team on the 3 sides of a commercial plan: technology development, policy engagement, and payment/adoption.

Adopt a Unique Value Proposition on Technology
On the technical front, Mr. Zhang advised considering short-chain derivatives of the material along with AI-based protein design tools to minimize R&D costs and “avoid the patent minefield” while maintaining a high degree of novelty.

Tap into Special Projects by Local Governments for Policy
Policy-wise, the team needs to “learn to obtain quota” through active engagement with special programs offered by local governments that can fast-track approval and other go-to-market processes.

Emphasize Value/Outcome for Payment & Adoption
For the ultimate “payers” of our product (hospitals, insurers), we need to “convince them there is advantage in our technology/cost/effect” to replace existing products and generate savings in overall insurance spend.

3. Key Learning, Reflection, and Improvement
   
Key Learning
Mr. Zhang’s top piece of advice for the team was that high science or technical merit is not enough. Real success in the market demands a synchronized strategy that combines science, policy, and value presentation.


Reflection
A Project Team Should Look Beyond the Lab
Interviewing with Mr. Zhang marked a turning point in our iGEM journey. Our team members all had a change of perspective in looking at our plan in the field beyond the lab. For R&D, it is important to select candidate proteins with a clear idea of the patents in the space; for policy, to ensure the team is actively “learning to obtain quota” (policy/project approvals), and for payments, that the value of the coating in terms of health economics is clear-cut and measurable.

Improvement
Constructing a Multi-Pillar Commercial Plan

As such, Mr. Zhang’s insights became the new foundations for the team’s business plan:

AI-Assisted Protein Design: In the R&D phase, we will consider using AI-assisted protein design software from the start, reducing the chance of incurring excessive R&D costs by designing around existing patents.

Value Communication: We will be developing a value statement and health economics model to quantify the cost-savings potential of our coating due to reductions in revision surgeries and antibiotics.

Interview with Manager Wang, Shanghai Lu Feng Additives Co., LTD- Industrial Manufacturing and Quality Control

Figure 15 Interview with Mr. Wang

1. Company background

Shanghai Lufeng Additives Co., Ltd. was established in 1999. It mainly deals in metal surface treatment additives and offers a variety of processing services. With strong technology and quality certification, it adheres to the principle of customer first.

2. Summary

On 7.9, our team visited a coating factory in Bao Shang. We have gained a deeper understanding of the characteristics required for coating different parts.

The company we visited does not have any superior quality in its products compared to other companies in the market. This is because the quality levels of other coating companies in the automotive industry are similar. Therefore, they have no advantages at all. Unlike large companies, small companies like theirs can only rely on price advantages and offer products at lower prices. Our experience tells us that we must first ensure stable product quality, and second, have a price advantage. After our project was commercialized, although we are also a small company, the uniqueness of our mussel histone biological coating lies in the fact that in the medical industry we are involved in, its quality has an advantage. Our mussel histone biological coating can achieve rapid and uniform distribution, and is very thick and dense. It is highly efficient because it has both antibacterial and anti-fouling properties, and has strong adhesion. When used as medical equipment and implanted/into the human body, the rejection rate is very low. In addition, their company also mentioned: Due to their manual production line, the quality of their products is inevitably subject to some human errors, and they cannot guarantee stable, high-quality output. This will put them at a disadvantage when communicating with customers, or bring them some obstacles and troubles. The lesson we have learned from this is that in our future development, we will plan to adopt a mechanized production line to ensure stable, high-quality output.



Figure 16 Visit to Lufeng

3. Key Learning, Reflection, and Improvement

Key Learning

Quality Comes Before All

The interview with Manager Wang was an unvarnished lesson in operational reality. The biggest takeaway was that the most innovative, cutting-edge product will fail without consistent, high-quality manufacturing. Quality control is not a final step at the end of the process; it is something to be baked into the production process from day 1.

Reflection

Product Quality Is the Team’s First Priority

Witnessing the quality problems of a company without a significant technical advantage reminded us of the value of our core product — strong adhesion, uniform distribution, and high efficacy. We were energized to commit to protecting that value with a production process that would not allow it to be compromised.

Improvement

Commitment to “Quality-First” Design

This experience has informed major early decisions for our long-term planning:

Automation is a Non-Negotiable

We have decided to make early adoption of a mechanized, automated line a core commitment in the manufacturing plan. Manual labor and all of its associated problems are to be shunned and automated first, before even scaling.

Value-Oriented Brand Strategy

We commit to building our brand from day one around quality as a core value. In this way, we will be able to compete on the basis of superior clinical value, not price.

Figure 17 Portrait of Mr. Chen

Interview with Manager Chen-Global Logistics and Cold Chain Management

1.  Expert background

 Graduated from Xiamen University. In March 1997, he joined Maersk Line Ltd. and has held the position of General Manager of the Import Sales Department of Maersk (China) Line Co., Ltd. in the Greater China region ever since. At work, Chen Su is a pioneer, fully committed to his tasks, and attaches great importance to team building. He practices his love and dedication to the shipping industry with concrete actions. In 2009, as a global pilot of Maersk, he was the first in China to explore and establish the Marketing Department of East China and Central China, and innovatively promoted work such as telemarketing. In 2010, he actively explored and established the import sales department and the freezer and special Cabinet sales department in the East China and Central China regions, and was the first to practice the model of dividing import sales teams by industry.

2.  Summary

Shipping Considerations

Figure 18 Interview with Mr. Chen

The key considerations for our product, based on Manager Chen’s expertise, were the following:

Figure 19 Interview with Mr. Chen

Shelf Life Is King: The shelf life of the material is the most important factor that determines the price point and other factors of its shipping. With a shelf life of >40-60 days, it can be economically shipped by sea, and with a shelf life of <7 days, only air freight is an option.

Temperature Maintenance Is Mandatory

On the other hand, the constant temperature of the protein at 4 degrees is non-negotiable. It requires a constant cold chain from the initial loading in refrigerated containers through packaging, storage, and even the “last mile” local shipping.

Safety Compliance Is Non-Negotiable

Shipping something as innocuous as non-toxic biological material is still not something you can do willy-nilly and still expect to comply with global safety regulations. It still requires MSDS (Material Safety Data Sheet) certification.

3.Key Learning, Reflection, and Improvement

Key Learning

Shipping Is Part of the R&D

The one overriding point from this interview that has stayed with us is that shipping is no afterthought for R&D. In fact, it is a critical part of the R&D process itself, because the chemical and thermal stability of our product would set the ceiling for the entire distribution model in terms of profitability.

Reflection

The Team Sees the Blindspot It Forgot to Factor In

Manager Chen’s interview served as a reality check for the team. We had been so focused on the function of our protein in the body that we had not considered at all the lifespan of that protein and its stability once outside the body.

Improvement

Logistics and Stability Testing are Now Critical Focuses

As such, this meeting has resulted in some immediate changes to our R&D priorities and how we plan to make a name for ourselves in the market:

Shelf Life Verification

We have prioritized long-term stability of the protein as a top priority for R&D. The result of these tests will determine the entire downstream sales strategy.

Cold Chain Specifications

We have also started to work on designing a full cold chain transportation plan, including packaging requirements (vacuum insulated containers, etc.) and protocols for strict maintenance of 4 degrees Celsius.

Start MSDS Preparation

In the same vein, we have already begun the process of documenting the details required for MSDS preparation and safety certification for compliant shipping.

Interview with Mr. Li Li

1.   Expert background

Mr. Li Li, an expert in the food manufacturing industry with expertise in natural materials, allergens, and the safety regulations of contact materials.

2. Summary

Insights on Biomaterial

In addition to the comparison, Mr. Li provided several critical recommendations on how to best address our product’s safety and improve our practicality:

Natural Proteins Are Allergens

As potent allergens, natural proteins like ours are an intrinsic risk and need to be properly managed and disclosed.

Natural Is Not Necessarily Cheap

Natural protein extraction still requires large-scale and low-cost synthesis; it is a major technical bottleneck and hurdle in many real-world applications. This confirms our decision to pursue a fully bioengineered synthesis process.

Two Directions of Research for Practicality

Mr. Li provided us with a two-pronged approach to our R&D to increase our real-world practicality: “remove allergenicity” and “stability testing.”

Food Contact Material Safety Steps

Mr. Li also shared the processes for ensuring the safety of food contact materials as a parallel framework to follow in our R&D, including toxicological and physicochemical performance tests.

Key Learning, Reflection, and Improvement

Key Learning

Safety Is a Layered Concept

In many ways, the most important lesson from Mr. Li was what is considered “safe.” While our product is an alternative to toxic, industrial chemicals, there is a host of other issues we need to ensure are safe. One is allergenicity. The experience of another industry helped us get a model to emulate in terms of the level of scrutiny to bring to our safety testing.

Reflection

Going from Lab Curiosity to Real-World Application

This is where Mr. Li’s insights also came in as we continue to take our lab-scale idea and bring it to the real world. We have a clearer picture of the scientific and regulatory barriers we have to overcome to make our material actually useful in practice.

Improvement

Focus for R&D and Regulatory Standards to Be Added

On the basis of Mr. Li’s advice, we have decided to:

Prioritize De-sensitization and Stability Testing

To that end, we have refined our research focus to include specifically reducing the allergenicity of our MFP and rigorous real-world-like stability tests.

Build a Regulatory Testing Pipeline

We are also now in the process of borrowing from the framework of food contact material standards to build our own set of required toxicological and physicochemical performance standards to test and validate our product.

Sustainable development is the key to achieving the coordinated unity of economic growth, environmental protection and social well-being. It not only concerns the quality of life of contemporary people, but also the living environment of future generations. Only by making rational use of resources, reducing pollution and promoting green innovation can we ensure long-term social stability and the virtuous cycle of the ecosystem. Therefore, we consulted manufacturers and experts in this field. We also made a systematic analysis between our project and realization of SDGs. Please refer to our SDGs page for details.

Lecture with Dr. Tianle Liu

1.  Expert background

Associate professor, currently employed at Harbin Institute of Technology (SZ), holds a bachelor's and master's degree from Tsinghua University and a doctorate from the Hong Kong University of Science and Technology.

2.  Summary

He said that in recent years the United Nations had made the defense and promotion of sustainable development one of its core missions, focusing on addressing global challenges, inequality and environmental degradation, while promoting peace, prosperity and the well-being of all humankind, through initiatives such as the Sustainable Development Goals, The United Nations aimed to promote long-term solutions that balanced economic growth, social inclusion, and environmental protection.

Figure 20 Lecture with Prof. Liu

3.  Inspirations and suggestions

We adjusted the project's strategy following the lecture by the sustainable development expert. Firstly, we introduce degradable materials and green manufacturing concepts in product design, striving to reduce the carbon footprint while ensuring performance. In addition, we have begun planning and establishing a product Lifecycle assessment (LCA) mechanism to systematically measure environmental impact and ensure sustainability across all stages, from research and development through production, transportation, and disposal. Through these improvements, we will more deeply integrate the concept of environmental protection into the product value chain and achieve the unity of economic benefits and environmental responsibility. 

A field trip to Shanghai Lu Feng Additives Co., LTD

1.  Summary, Inspirations & suggestions

The environmental protection situation of their company has suffered a setback. They wanted to upgrade their equipment, but failed to pass the approval process because it did not meet the environmental standards. Their production steps caused severe pollution to the environment. Even with the installation of brand-new and highly efficient equipment, serious environmental pollution problems could not be avoided. The lesson we learned from this incident is that the government attaches great importance to environmental protection issues and has some policy requirements for small businesses. Our company's plan for commercialization will be located in Shanghai. We can take advantage of the policy advantages to apply for the simultaneous approval of environmental assessment and pollutant discharge permits, completing the entire process at once. We can also participate in the pilot project of environmental information disclosure to gain financing advantages. Our project has significant advantages in environmental protection. We use the method of biological fermentation to reduce the amount of pollutants generated, which are biodegradable, thus being more environmentally friendly. In addition, our project is different from others. We do not need 10,000 oysters to produce 1 milligram of oyster siphon protein. Our project can reduce the number of oysters used for the production of oyster siphon protein while also increasing the output. This meets the goal of Sustainable Development Goal 14: "Life below water".

Figure 19 Visit to Lufeng

Figure 21 Visit to Lufeng

Figure 22 Visit to Lufeng

Our IHP strategy served as a framework that would allow us to maintain real-world applicability, ethical awareness, and ensure a long-lasting impact of our iGEM project. From the very beginning of the design process, we have established a thorough stakeholder engagement plan that would enable us to collect different opinions from the public, our potential users, other scientists, clinicians, and industry professionals throughout the whole project and use that input to improve our final project and vision.

At the stage of the problem, we first surveyed the general public to check the awareness and opinion about antimicrobial coatings in medical devices to justify our project direction. The results of our survey, along with the literature research, have confirmed the severe gap in the public knowledge about medical device coatings and their potential as well as the public’s awareness of the need for antibacterial activity and biocompatibility in such coatings. The consultations with clinicians have confirmed the necessity and interest of our project as a solution for the problem of healthcare-associated infections which are very common.

During the solution design stage, the consultations with other scientists served to direct and diversify our design as we switched the protein production strategy based on expert feedback. We have ensured the project’s economic feasibility and, therefore, sustainability, by moving to a simpler and more easily scaleable strategy of E. coli secretion. The steps of safety control were also added during the process to allow responsible research and engineering, with particular focus on microbial leakage prevention and environmental harmlessness.

Clinical experts’ feedback on our initial idea became a major consideration when planning the implementation of our project. We determined to base our design primarily on the principles of safety and biocompatibility and not let the perfect be the enemy of the good when it comes to antibacterial effectiveness, as such priorities were set for us by our future users. Also, while the antimicrobial potential of the MFP-based coating is the most evident selling point of the project, our consultations allowed us to understand the importance of “clinically compatible” products. We do not expect our technology to be appreciated only for its antibacterial effect but for its simplicity, and, therefore, we have changed the implementation strategy to “factory pre-coating” in order to guarantee a sterile product “out of the box.”

The information we received during the consultations on policy and regulation, sustainability, and commercialization concerns was also a determining factor in the final strategy. Industrial experts and potential regulatory bodies have informed us of the strict policy surrounding medical devices, both nationally and internationally, as well as their environmental impact and life cycle, so we have made sure to consider all of those factors in our final design. It has also been communicated to us that the market is key, so we took into account all the potential risks and solutions regarding the market introduction of our product as well as decided to also consider the idea of a simpler, not “cutting-edge” but still reliable and efficient antimicrobial solution that would require less risk and investment to be released.

The IHP strategy also led us to the conclusion that our project had major overlaps and points of connection with some of the UN Sustainable Development Goals (SDGs) that need to be considered. In particular, we determined that our decisions around the environmentally friendly production of the MFP-based coating and careful waste disposal would positively contribute to SDG 12 (Responsible Consumption and Production) and SDG 14 (Life Below Water) and reduce the potential negative impact of the project on our environment. As our project’s selling point is also the patient safety provided by the MFP-based coating’s antibacterial activity, we have also contributed to SDG 3 (Good Health and Well-being) by solving a common issue of healthcare-associated infections and providing a straightforward method for their reduction.

In summary, the IHP strategy allowed us to achieve a final design that would combine innovation with public needs. We were able to find potential use-cases and confirm interest and need for our product through expert consultation. We have also considered the global sustainability and health objectives that our project supports and have a better understanding of the potential economic and market-related issues that we need to consider. Therefore, we can see our project as a ready-to-implement innovative and sustainable solution that needs additional development and testing to be commercialized successfully.

Reference:

1. World Health Organization. (2016). Guidelines on Core Components of Infection Prevention and Control Programmes at the National and Acute Health Care Facility Level. https://iris.who.int/bitstream/handle/10665/251730/9789241549929-eng.pdf?sequence=1
2. Kim, D. Y., Oh, Y. B., Park, J. S., Min, Y.-H., & Park, M. C. (2024). Anti-Microbial Activities of Mussel-Derived Recombinant Proteins against Gram-Negative Bacteria. Antibiotics, 13(3), 239. https://doi.org/10.3390/antibiotics13030239
3. Argenziano, R., Viggiano, S., Esposito, R., Schibeci, M., Gaglione, R., Castaldo, R., Fusaro, L., Boccafoschi, F., Arciello, A., Della Greca, M., Gentile, G., Cerruti, P., D’Errico, G., Panzella, L., & Napolitano, A. (2023). All natural mussel-inspired bioadhesives from soy proteins and plant derived polyphenols with marked water-resistance and favourable antibacterial profile for wound treatment applications. Journal of Colloid and Interface Science, 652, 1308–1324. https://doi.org/10.1016/j.jcis.2023.08.170

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