Each year, Healthcare-associated infections (HAIs) affect millions of patients globally, with over 1 million deaths attributed to implant-related infections in the United States alone [1]. These infections not only devastate patient outcomes but also impose staggering economic burdens on healthcare systems, increasing treatment costs and prolonging hospital stays. Compounding this crisis, the implantable medical device market is rapidly expanding at a 6.1% compound annual growth rate (CAGR) from 2024 to 2030 [2], meaning the risk of infections will only escalate as more devices enter clinical use. While antimicrobial coatings are critical for mitigating this risk, their current limitations leave a dangerous gap in patient safety.

 Despite the urgent need for reliable protection, existing antimicrobial coatings fail to deliver comprehensive solutions. Antibiotic-based coatings risk fueling antimicrobial resistance due to uncontrolled drug release, while silver-ion-based options often exhibit cytotoxicity and tissue irritation. Polymer coatings, though widely used, lack strong adhesion in wet physiological environments—leading to premature detachment—and frequently rely on chemical modifiers that compromise biocompatibility. Even advanced antifouling coatings typically focus solely on preventing bacterial adhesion without integrating direct antimicrobial activity, leaving devices vulnerable to biofilm formation over time. This landscape reveals a critical unmet need: a coating that unites strong underwater adhesion, broad-spectrum antimicrobial efficacy, and long-term biocompatibility.

 Mussel foot proteins (Mfps) address this gap through their unique, nature-engineered properties. Secreted by mussel byssus, Mfps contain DOPA and catechol groups that form robust chemical bonds with diverse surfaces (metals, polymers, ceramics) even in moist, bodily environments—overcoming the adhesion failure that plagues conventional coatings [10]. When engineered via recombinant expression in E. coli, Mfps can be fused with antimicrobial peptides and zwitterionic peptides, enabling dual functionality: killing bacteria on contact while preventing biofilm formation. Unlike animal-derived or chemically modified alternatives, recombinant Mfps are biocompatible, avoiding immune responses, and degrade into non-toxic byproducts. Moreover, scalable production via genetic engineering resolves the high costs of natural extraction, making this solution both effective and accessible.

In short, Mfps-based coatings rise to the challenge of HAIs by addressing the core flaws of existing options—offering a path to safer, more reliable medical devices that protect patients while aligning with the growing demand for high-performance implant technologies.

Lack of multifunctional designs

Earlier designs were primarily monofunctional and complied with the general idea of bacterial demobalisation and biological repellent. However, these strategies can distinctly struggle from some drawbacks that restricts their potential utility [3]. The inability to target both Gram-positive and Gram-negative bacteria, which creates a biofilm, simultaneously [4]. Moreover, studies revealed that antifouling coatings within our body is readily degradable and unstable, which may promote proliferation of any attached bacteria. Antibacterial coatings similarly ceases bactericidal activity due to the depletion of antimicrobial agents and the adhesion of dead bacteria [5]. By integrating Mfps with antimicrobial peptides and zwitterionic peptides (via induced expression), the coating achieves dual functions: direct bacterial killing and prevention of biofilm formation, addressing the one-sideness of conventional antifouling or antimicrobial coatings.

Lack of Biocompatibility

Implanted materials can be recognized by the patient's immune system as foreign bodies causing immune responses. A negative immune response can lead to adverse effects, including inflammation, interference with healing, fibrous encapsulation, and implant rejection. These reactions are driven by the activation of monocytes and macrophages attaching to the implant surface [6]. The likelihood of adverse effects depends on the immunomodulatory properties of the implant: chemical composition, surface topography, surface wettability, surface charge, release of bioactive molecules. The incidence of metal allergies are mostly responsible for immune response for metallic implants [7]. Dental implant failure can be triggered by poor oral hygiene due to accumulation of bacterial plaque [8]. A recent study pointed out that coatings can tackle implant-associated infection by discouraging bacterial adhesion, prevent biofilm formation or kill bacteria directly. Therefore, antimicrobial peptides are one of the coating substances used to avoid immune response [9] in two ways:

1. Reduce the possibility of bacterial infection
2. Prevent monocytes and macrophages attaching to the implant

Low Cost-effectiveness of adhesive proteins

Traditional extraction of adhesive proteins from natural mussels is inefficient and costly. The most direct way to obtain Mfps is extraction from the byssus gland, but they produce low Mfp content at high cost. Most of commercially available extracted Mfps are based on mefp-1 (Mytilus Edulis foot protein) due to its high content inside mussels (byssal thread and plaque regions). They are delivered at a concentration range of 1–10 mg/mL in acidic buffer solutions, as DOPA, which is the functional molecule for adhesive properties, is spontaneously oxidised in neutral or alkali environment [10]. However, a recent study estimated that 1g of protein requires around 10,000 mussels [11]. On the contrary, recombinant Mfp in E. coli (e.g., BL21 strains) reduces costs, shortens production cycles, and enables scalable manufacturing—overcoming the high price barrier of natural Mfps.

Why (we develop it ?)

To address the significant global health challenge posed by healthcare-associated infections (HAIs) and nosocomial infections, which contribute to high mortality rates, immense economic burdens, and clinical risks. Our goal is to replace the limitations of current antimicrobial coatings, which often lack sufficient adhesion, broad-spectrum efficacy, or biocompatibility, with a solution that combines these essential properties for better patient outcomes.

How (we produce it ?)

Leveraging genetic engineering, we design and produce a tandem expression system that includes three Mussel Foot Proteins (MFPs), one antimicrobial peptide, and one zwitterionic peptide. These sequences are inserted into plasmids and expressed in E. coli under optimized conditions (e.g., IPTG concentration, temperature, induction time). After expression, the proteins are purified using Ni-IDA affinity chromatography. We then validate the product through a series of assays, including adhesion, antimicrobial activity, and antifouling performance, ensuring that it meets the rigorous standards required for clinical applications.

What ( to produce?)

We produce a liquid antimicrobial reagent formulated as a coating for medical devices such as orthopedic implants, cardiovascular stents, and catheters. This coating provides long-lasting surface protection that reduces the risk of infections, lowers the incidence of healthcare-associated infections (HAIs), and significantly enhances patient safety in clinical settings. By harnessing the natural adhesion mechanisms of Mussel Foot Proteins (MFPs) and combining them with synthetic biology (recombinant production), our solution sets a new standard for medical device coatings. This breakthrough addresses key unmet needs in global healthcare, offering both improved clinical outcomes and a pathway to reduce reliance on antibiotics, ultimately contributing to the fight against antimicrobial resistance (AMR).

Figure 1. the Golden Circle

The global medical device coating market is expected to reach 5.17 billion US dollars in 2024 and may reach 8.7 billion US dollars by 2033 (with a compound annual growth rate of 6.8% from 2026 to 2033) [12]. Among them, the antibacterial sub-segment focused on mussel protein coatings accounted for 1.81 billion US dollars in 2024, with a target penetration rate of 10-15%. The EU MDR will impose restrictions on silver-containing coatings (currently being the major player in the market) in 2025, releasing 1.2 billion US dollars of alternative space [13]. The core driving forces include high hospital infection costs (each case over 40,000 US dollars) and the popularity of minimally invasive surgeries.

Regional layout: North America accounts for 44% of the share but has sensitive unit prices; China's centralized procurement requires a 30% price reduction and needs to bind with manufacturers such as Weiyi to achieve a volume of ¥0.8/cm [14]; Southeast Asia has a growth rate of 15%+ (such as in Thailand, dressings have a premium of $35 per sheet). DSM Biomedical monopolizes 30% of the hydrophilic coating market, with domestic companies such as Jiangsu Biosurf occupying the high-price sub-segment. Mussel coatings need to break through the cost bottleneck (target ≤ ¥50/gram, current ¥80/gram), through secretion expression processes and patent avoidance (such as K32A/R44H mutations), to replace traditional products with "biocompatibility + infection response" functions. Three-stage strategy:

1. Short-term use mussel protein/polydopamine hybrid coatings to enter China's catheter centralized procurement
2. Mid-term seize the post-EU MDR high-end market
3. Long-term jointly build a green energy factory in Yunnan (electricity price ¥0.3/kWh).

The global potential scale from 2025 to 2030 is 8.4 - 12.6 billion US dollars. Cost control and clinical data are the key to large-scale production.

Figure 2 PEST Analysis

Political

Regulatory acceleration

• China
  • The "Special Approval for Innovative Medical Devices" by the drug regulatory authority exempts animal testing, but mandates chemical characterization (ISO 10993-18), and the testing cost is ≥ ¥3 million. [14]
• Europe and America (If we plan to expand our market)
  • The FDA's "Breakthrough Device Designation" (such as the N8 Medical tracheal tube) can shorten the approval process by 50%, but it is subject to the requirement of obtaining both GMP and ISO 13485 certifications. [15]

Policy support

• China
  • The "Open Competition and Lead-by-Example" program provides targeted funding for biotechnology projects (with a maximum of ¥500 million per project), e.g. the supporting fund for the Shandong Medical Device Consortium amounts to 1.2 billion RMB [16].
• EU
  • The EU's Horizon Europe program has included synthetic biological coatings in the priority direction of green medical technologies, with a 30% research and development tax rebate [17].

If we plan to enter the markets of Europe and the United States in the future, then we can first try to launch a campaign in Canada (with an approval cycle of 6-8 months) to accumulate clinical data, and then proceed to apply for FDA/EU MDR certification.

Economic

Trend of global interest rate divergence

• Europe and America
  • The Federal Reserve's benchmark interest rate remains at 5.25% - 5.5% (2025Q2)
  • financing cost for corporate bonds has reached 6 - 8% (suppressed capital expenditures) [18,19,20,22]
• China
  • LPR has been lowered to 3.45%
  • interest rate for policy-based loans (such as the "Synthetic Biology Special Loan") can be as low as 2.8% [21]

Priority can be given to applying for Chinese policy-based funds.

Currency exchange rate

• Euro - RMB: depreciate by 8% in 2024. The cost of EU's imports of coating equipment from China will increase by 10% [22]
• THB - RMB depreciate by 5% in 2024. The demand for medical devices in Thailand is shifting towards lower-priced Chinese products (such as mussel dressings) [23]

Switch to euro pricing for exports to Europe + set up assembly plants in Southeast Asia (such as in Thailand) for local production to avoid exchange rate losses.

Social

Demand

• Developed countries: Patients are willing to pay a 15% premium for "zero infection" medical devices [24].
  • Europe and the United States: but the acceptance rate of genetic engineering materials is only 48%.
• China: Patients are willing to pay a 15% premium for "zero infection" medical devices, the acceptance rate of genetic engineering materials is 68% [25]
• Emerging markets: Manufacturers of domestic catheters in countries like India and Brazil are primarily focused on cost controllability (target unit price <$0.8/cm) [26]

Patient-doctor information cognition

• Doctors
  • Doctors place greater trust in traditional silver ion due to insufficient evidence of the long-term safety of synthetic biological coatings. For instance, the study of 'Infection and the Chronic Wound: A Focus on Silver.' by Warriner R, Burrel R published in 2005, reveals the clinical monitoring of silver-containing coatings in the specturm of medical treatment [27].
  • Primary care doctors need even greater simplicity in their procedures.
• Patients
  • 32% of the patients mistakenly believed that "natural extraction" was superior to "recombinant expression" [28].
  • Need more education on "Non-antibiotic antibacterial mechanism"

Technological

Competitor product

• DSM's Hydropass™ --> Hydrophilic + antibacterial composite coating, but dependent on silver ions (restricted after 2025) [29].
• Tianjin University "Super Coating" --> Anti-fogging + Antibacterial + Adhesive in one (effective period inside the body is < 6 months) [30].

Figure 3 Porter Five Forces

Bargaining Power of Suppliers (Medium-high)

The patent monopoly of genetically engineered strains is a significant factor in the synthetic biology industry, particularly with the development of high-yield mussel protein expression strains that rely on CRISPR editing. Meanwhile, major players like GenScript, Integrated DNA Technologies and Twist Bioscience control the global synthetic biology component library, including plasmids and promoters, with procurement costs accounting for over 30% [31]. Additionally, the suppliers of fermentation tanks and microfluidic coating equipment are dispersed, with companies like Sartorius and GE Healthcare providing key equipment [32]. However, high-end equipment often needs to be imported, with delivery cycles typically taking around six months. This combination of patent control and scattered equipment suppliers poses both financial and logistical challenges in the field.

Bargaining Power of Buyers (High)

The large equipment manufacturer is facing pressure due to China’s centralized procurement policy, which forces significant price reductions, requiring package pricing for "coating + equipment" with discounts of up to 30% [14]. Similarly, international medical groups may demand the sharing of intellectual property rights, adding another layer of complexity. Public hospitals, through Group Purchasing Organizations (GPOs), are driving centralized bidding that results in large order volumes exceeding one million units. However, the profit margin has been severely compressed to just 15% [33].

To mitigate these challenges and ensure a stable business relationship, we propose signing a five-year exclusive supply contract with the equipment manufacturer, which will guarantee a steady purchase volume and provide both parties with long-term security and mutual benefit.

Threat of New Entrants (Medium)

The threat of new entrants in the market is considered medium due to several significant barriers. Technically, the modification efficiency of DOPA must exceed 90%, and mastering the secretion and expression technology is crucial. However, this technology is patented by Tianjin University and the Shenzhen Institute of the Chinese Academy of Sciences, which limits access for new entrants [30]. Additionally, there are certification barriers, as obtaining ISO 10993 certification for medical devices costs over 3 million yuan and takes up to 18 months [14], creating cash flow pressures for new companies. Furthermore, capital barriers are substantial, as the B-round financing amount for synthetic biology enterprises saw a 40% decrease in 2023, making it even more difficult for new players to secure the necessary funding [34].

Threat of Substitutes (High)

The market features several coating technologies, each with its own advantages and drawbacks. Silver ion coating, with a low unit price of ¥0.5/cm, holds a dominant market share of 58%, but it is subject to the EU MDR 2025 expiration date due to concerns about cytotoxicity [13]. Polydopamine coating, which has a simple process and is ready to use as a spray [35]; however, it suffers from weak adhesion [35,36]. Antibiotic coatings are highly effective, with an antibacterial rate exceeding 99.62% [37], but they pose the risk of accelerating drug resistance, capturing a small proportion of the market.

In terms of disruptive threats, the market is facing challenges from innovative technologies such as Tianjin University’s "Super Coating," which integrates an anti-fog function and targets the endoscope market [30], and Biocoat's HYDAKIN® series, a nano-silver and hydrophilic polymer-based inorganic nano-coating that has received priority FDA approval, posing a significant competitive threat [38].

Rivalry Among Existing Competitors (High)

The market for medical coatings is heavily influenced by the monopoly power of international giants, which dominate key segments. DSM Biomedical, a top three player from the Netherlands, commands a substantial market share in hydrophilic coatings [29]. Its integration with Medtronic’s supply chain has solidified its position, making it difficult for other competitors to gain significant traction in this space [39]. SurModics, based in the USA, holds a powerful edge in the drug-loaded coating technology domain, with patented innovations that cover 50% of the cardiovascular device market [40]. These patents create a significant barrier to entry for newer companies, as they impeded competitors from using similar drug-delivery coating methods, maintaining a tight grip over the industry.

On the domestic front, innovative enterprises are beginning to make waves, particularly in the areas of novel medical coatings. Weigao Group, a chinese enterprise based in Weihai Torch Hi-tech Park, Shandong, is a major player within the medical device manufacturing industry, as well as the manufacturing of coating. Their core competitive products (coating) consist of Hydrophilic & lubricious coatings on catheters, guidewires and stents; Antimicrobial silver-ion and nano-silver coatings; Custom drug-eluting layers for cardiovascular and orthopaedic implants With 12 billion RMB revenue across all divisions in 2023, they are undoubtedly an objective figure [43,44,45]. Their distribution channels extend to well-known players like Yunnan Baiyao and Guoda Pharmacy, positioning them as a key player in the Chinese market [41,42]. Meanwhile, Jiangsu Biosurf has made strides in the cardiovascular segment, where their cardiovascular anticoagulant coating has been granted a Class III medical device certification. The product commands a premium of 40% over traditional coatings, showcasing their ability to leverage advanced technologies to gain a competitive edge [46].

However, conflicts arise due to the technical iteration and pricing strategies employed by both international and domestic players. On the performance front, DSM Biomedical has launched its Hydropass™ antibacterial and hydrophilic composite coating [29], which poses a direct threat to the differentiated market for mussel protein-based coatings, particularly in applications that require antibacterial properties. This new product erodes the competitive advantage that innovative coatings like mussel protein had in the market [39]. On the pricing side, domestic manufacturers are engaged in a price war, particularly with silver-containing coatings. Prices for these products have dropped by as much as 40%, putting immense pressure on profit margins and squeezing the grassroots market where these products are predominantly sold. This creates challenges for smaller companies to maintain profitability while competing against the dominant players.

Figure 4 SWOT Analysis

Strengths

Mussel adhesive protein coating technology boasts significant multi-functional integration capabilities, as a single coating can simultaneously achieve three key functions: surface adhesion (containing DOPA and catechol groups), antibacterial (focusing on common bacterias in hospitals), and anti-fouling (credit to zwitterionic peptide). This thus effectively addresses complex nosocomial infections as healthcare-associated infections and infection due to formation of biofilm on medical implants. Its core advantages lie in strong adhesion and broad applicability: credit to DOPA groups, the coating can firmly adhere to the surfaces of medical materials like metals, ceramics, and polymers (e.g., PU, silica gel) [10]. Moreover, it maintains high stability in humid environments, far outperforming physically adsorbed coatings (typical cases include gel materials developed by the Massachusetts Institute of Technology and Freie Universität Berlin). Meanwhile, the coating exhibits excellent biocompatibility; studies by Tianjin University have confirmed that its hemolysis rate is <0.1% and cell survival rate is >99%, which greatly reduces the risk of immune rejection for implanted devices and makes it safer than traditional chemical antibacterial agents [30]. Additionally, the raw materials use biosynthetic proteins (such as γ-polyglutamic acid), which are biodegradable, avoiding microplastic residues and toxic accumulation, and thus aligning with the trend of green medical materials.

Weaknesses

The main bottlenecks faced by this technology are the lack of long-term stability data: existing studies focus on short-term in vitro tests (<30 days), while there is a lack of verification of long-term (>1 year) antibacterial properties and adhesion in vivo, which restricts confidence in its application in implanted devices. Besides, its antibacterial mechanism relies on physical effects (where positive charges destroy bacterial membranes) and does not involve the release of antibiotics, so it has a weak antibacterial effect on devices with formed biofilms and struggles to cope with highly drug-resistant strains.

Opportunities

The global market for implantable devices is growing at an annual rate of >12% (e.g., cardiovascular stents, artificial joints). As the number of surgical operations increases, antibacterial coatings have become a rigid demand. Meanwhile, China's volume-based procurement policy has accelerated the process of domestic substitution, thereby creating a broad market space for mussel adhesive protein coatings. Moreover, technology integration can further expand application scenarios: compounding with organic guanidine salts developed by the team of Li Peng from Xi'an Jiaotong University can enhance anti-biofilm capabilities, while combining with polyethylene glycol supramolecular materials from East China University of Science and Technology can extend its use to new fields such as surgical sutures and wound dressings. Additionally, both policy support and technological innovation provide strong impetus: the National Natural Science Foundation continues to fund projects on "antibacterial and anti-fouling biomaterials" (e.g., 51403173) to accelerate technology transformation, and breakthroughs in synthetic biology (such as those by Boyin Biology) have enabled large-scale production of recombinant proteins, thus solving the pain points of traditional processes.

Threats

The rapid iteration of alternative technologies constitutes the primary threat. For example, the organic guanidine salt coating from Xi'an Jiaotong University has broad-spectrum bactericidal properties, and the lipoic acid-polyethylene glycol material from East China University of Science and Technology has self-healing capabilities. The emergence of various chemically synthesized antibacterial coatings may therefore seize market share. Meanwhile, regulatory barriers continue to rise: medical device regulations in China, the United States, and Europe require the completion of full ISO 10993 biocompatibility evaluations and animal experiments (with a certification cycle >3 years), and such complex approval processes are unbearable for small and medium-sized enterprises [14]. There are also risks in the supply chain: recombinant proteins rely on genetically engineered bacteria for expression, yet fermentation capacity and purification processes have not yet been standardized. As a result, differences in performance between batches may affect product consistency.

Figure 5 Product Introduction

Price

The production cost of mussel foot protein coatings varies significantly by preparation method, with three primary routes defining the market. First, natural extraction relies on large biological resources—approximately 10,000 mussels yield just 1g of protein—making commercial products like Cell-Tak™ (Mefp-1/Mefp-2) and MAP™ (Mefp-1) prohibitively expensive at over $10,000 per gram [11]. Although Zhejiang Ocean University has improved purity using acetic acid extraction coupled with RP-HPLC, the multi-step purification process further elevates costs [48].

Second, recombinant expression offers a more cost-effective alternative: Tianjin University’s E. coli-based "Super Coating" reduces raw material costs, though low yield (<50 mg/L) due to host growth inhibition remains a bottleneck [30]. Fortunately, 2024 advancements in SUMO fusion technology have boosted purification yields by 30%, lowering production costs to $500–1,000/g.

Third, biomimetic synthesis stands out as the most economical route. UC Santa Barbara’s catechol-based primers (P3/P4) achieve adhesion comparable to natural proteins at just 15% of recombinant costs [47]. Similarly, Tianjin University’s simplified protein structures have driven costs down to $100–300/g, a figure far below those of natural extraction methods. [30]

Figure 6 Our Key Technological Advantage

Technology

Natural extraction and modification technologies center on enhancing the inherent properties of mussel foot proteins. For instance, Zhejiang Ocean University identified Mfp-3 proteins containing 20–25 mol% DOPA, which exhibit strong adhesion to metals; their 2024 development, MFP-20, further showcases unique antioxidant adhesion capabilities under Fe³⁺ and low-pH stress conditions. Meanwhile, German researchers have achieved over 90% conversion of tyrosine to DOPA using microbial tyrosinase, a breakthrough that not only improves efficiency but also paves the way for industrial-scale production of these modified proteins [48].

In recombinant expression, prokaryotic systems have advanced notably. Tianjin University, for example, optimized E. coli expression to develop multifunctional coatings that integrate adhesion, antibacterial, and antifogging properties [30], while Nanjing Tech successfully enabled the soluble secretion of Pvfp-5p through chaperone co-expression. In contrast, eukaryotic systems such as Pichia pastoris offer the benefit of enabling native DOPA modification but face limitations due to low yields (<20 mg/L) and inconsistent glycosylation, which thus hinder large-scale application.

Biomimetic synthesis, on the other hand, leverages catechol chemistry to replicate the functional properties of mussel proteins. UC Santa Barbara’s P3/P4 primers, measuring just 1 nm in thickness, enhance the adhesion of PMA resin by 10 times, thereby serving as a non-toxic replacement for traditional toxic dental silanes [47]. Building on this progress, Tianjin University’s "Super Coating" integrates multiple key functionalities—over 95% antibacterial resistance, over 90% light transmission for antifogging, and exceptional biocompatibility (with hemolysis rates <0.1%)—all of which are achieved through precise control of the isoelectric point (pI≈10) [30].

Figure 7 Purtiy and Performance Indicators

Purity

Purity levels differ significantly across production routes. For naturally extracted products—exemplified by Zhejiang Ocean University’s RP-HPLC purification process—purity is typically limited to ≤85% due to the inherent complexity of protein mixtures in natural sources [48]. In contrast, recombinant expression achieves higher purity: Tianjin University’s combined ion-exchange and SEC purification yields >95% purity, which has been elevated to >98% with the 2024 advancements in SUMO-tag removal. A persistent challenge for this route, however, remains endotoxin control (<0.05 EU/mg) [30]. Meanwhile, biomimetic synthesis, such as UC Santa Barbara’s production of P3/P4 primers, achieves the highest purity (>99%) through crystallization. This exceptional purity, however, comes at the cost of compromised protein functionality [47].

Specifications

Key performance parameters exhibit significant variation across formulations. In adhesion strength, recombinant Mefp-3 combined with DOPA leads at 2.5 MPa—approaching epoxy resin levels—followed by UC Santa Barbara’s P3 Primer (1.8–2.2 MPa) and Tianjin University’s Super Coating (0.5–1.2 MPa). Regarding antibacterial efficacy, Tianjin University’s Super Coating excels, exceeding 95% effectiveness (ISO 22196 against *S. aureus* and *E. coli*), surpassing the P3 Primer’s 70–80%. For antifogging performance under vapor stress, both Tianjin’s Super Coating and the P3 Primer perform well, achieving >90% and 85–90% light transmission, respectively [30,47,48].

All formulations meet stringent biosafety standards for biocompatibility and stability [14]: hemolysis rates range from <0.1% to 0.5% (well below the 5% threshold), and cell viability exceeds 95%. However, notable differences exist in in vivo stability: UC Santa Barbara’s P3 Primer exhibits the longest functional lifespan (>24 weeks), followed by recombinant Mefp-3 + DOPA (>12 weeks) and Tianjin’s Super Coating (>4 weeks). [30,47,48]

Product

Technology Roadmap

Figure 8 Basic Production Process

Figure 9 Project Structure

• Core Product: Liquid antimicrobial reagents formulated as coatings for medical devices, leveraging recombinant Mfps’ unique properties: strong underwater adhesion (via catechol groups), broad-spectrum antibacterial activity (fused with antimicrobial peptides), and biocompatibility (avoiding immune responses).

• Quality Assurance: Validated through adhesion tests, antibacterial assays, and antifouling analysis(?)

• Packaging: Sterile vials (10mL/50mL) suitable for industrial coating processes, with labels indicating batch number, expiration date, and storage conditions (2-8℃).

• After-Sales Service: Contact or give us feedback on our official accounts in Little Red Note, Douyin, and E-shops on TaoBao. We provide refund service to customers, if they encounter any problems with the quality or quantity of the product. We will review direct evidences that proves our liability during production, packaging and delivering that cause any issues with the quality and quantity of our product. We accept refund after we validated evidences.

Price

• Pricing Strategy: Value-based pricing, considering the technology’s uniqueness (solving adhesion and biocompatibility flaws of existing coatings) and cost structure.

• Cost Basis: Capitals (such as machinery), human resources (employees, managers), Supply cost (materials used in E. coli culture such as IPTG), power such as electricity, rent for the factory, parts of initial research and development investment (cost of R&D), purification cost fo the mfp-fusion protein, buffers and insulating materials that carries the protein, and maintenance cost for the overall facilities such as environment for bioreactor, for regarding the safety of employees and manager, avoid leaking accidents.

• Price Positioning: Initially mid-to-high (e.g., $15-25/g for bulk orders) to reflect R&D investments and clinical value (reducing infection-related medical costs), with gradual reductions.

Place

• Direct partnerships with medical device manufacturers for integrated coating during production.

• Distribution via specialized medical suppliers to hospitals and clinical centers, aligning with the product’s application in clinical medicine.

• Logistics: Cold-chain transportation (2-8℃) to maintain protein stability, with storage guidelines provided to partners.

• Expansion Path: Start with high-demand segments before expanding to cardiovascular and dental devices.

Promotion

• Publish clinical validation data in peer-reviewed journals and present at industry conferences to highlight efficacy

• Collaborate with key opinion leaders (KOLs) in orthopedics and interventional cardiology to endorse real-world applicability.

• Emphasize the technology’s “natural + engineered” advantage—using marine-derived Mfps via green biotechnology (recombinant expression) to address antimicrobial resistance and coating detachment issues, aligning with global healthcare trends toward safer, sustainable medical devices.

• Activities:

1. Offer free samples to top 5 medical device manufacturers for trial testing, with discounted rates for early adopters to accelerate market penetration.

2. Holding exibition or summit meeting to introduce the advantages of our product.

Having known through preliminary research and communications with stakeholders, contemporary antimicrobial coating to tackle Healthcare-Ahossociated Infections (HAIs) and bacterial infection during postoperative recovery to patients faces deficiencies. Hence, we sought to demote the risk of nosocomial infection through a strong underwater-adhesive, broad-spectrum antimicrobial, and highly biocompatible coating. We identified biomaterial manufacturer, Medical device Manufacturer, hospitals/medical institutes, and Medical research institutes and laboratories with the strongest demand for our antimicrobial coating.

Biomaterial and Medical Device Manufacturers

Manufacturers apply antimicrobial layer during processing. Our Multi-funcitonal protein coat ensures contamination during transportation and subsequent processes are inhibited, parts maintain sterilised and hence safe and ready for implantation. We provide our mfp fusion protein in a liquid medium that can soak or be brushed onto the parts needed to be sterilised. Automation is possible Compared to other common ways manufacturer may use, which is mainly physical and chemical, our protein coating is more stable and persistent.

Hospitals and Clinics/Medical Institutes (Central sterile supply department)

Through our investigation on the market growth of non-metal antimibrocial coatings, we discovered that Hospitals (particularly Outpatient Surgery Center and Central Sterile Supply Department) are our potential customer. Non-metal antimicrobial coating can be applied on surgical instruments and equipment, diagnostic and monitoring equipment, and medical furniture. Those are common mediums in hospitals that contacts patients directly during surgeries, diagnosis and nursing, thus sterilisation of these mediums through antimicrobial coating is profound to reduce risk of bacterial infection

Medical Research Institutes and Laboratories

Through our research about the market, they frequently utilise bacteria in experiments, thus contamination on the surface of medical devices occurs occasionally at undesired situations. To prevent contamination from happening, antimicrobial coating are applied. [49,50,51,52]

Figure 10 Business Canvas

Customer Segment: Biomaterial manufacturers, Hospitals, Medical Device Manufacturers, Research and Medical Insstitutes, Patients

Value Preposition: High yield, Persistent, Broad-spectrum antimicrobial, improbable rejection, biodegradable

Channels: Social Media (Little Red Note, Douyin), Our Network, E-shop

Revenue Streams: Biomaterial & Medical Device Manufacturers, Hospitals and Medical Institutes, Arrangements and Deals with Biomaterial Manufacturers

Customer Relationships: Long-term relationship and cooperation with suppliers, Transactional relation with manufacturers

Key Resource: Laboratories and equipment for R&D, Initial financial supports from investors, raw materials, External corporations for up-scaled production, intellectual support from SubCat Staffs, Factory space for up-scaled production, Expertise on antimicrobial coating

Cost Structure: R&D, Certification, Marketing and Branding, Upscaling, Transportation, Salary and Wage for employee

Key Partners: Recycling company/organisation, related experts (SubCat staff, Interviewee)

Key Activities: Receive CDE, ISO 10993 Certification for Production License, Acquire Fundamental funding, Produce test samples, Assessment of adhesion, antifouling and antimicrobial abilities, Product upscaling, Market Research and Create distribution channel, Branding and Advertising on Social Media.

‌Phase 1: R&D(6 MONTHS)

iGEM

Proof of Concept:

• Preliminary Research
• Engineering - 3 cycles of DBTL
• Analysis of results

Phase 2: Systematic production

Market Research:

• Identify Market & Customer Demand and Structure
• Confirm Marketing Strategy

Production:

• Agreements with suppliers
• Purchase Required Equipment
• Obtain Products

Find Distribution Channels

‌Phase 3: Sales

Marketing:

• Customer Profiling
• Create Tailored Promotion Method
• Advertise

Branding:

• Establish Brand Image
• Advertise

‌Phase 4: Adjustments according to the market

[53,54,55]

Figure 11 Milestone and Timeline

This table shows the core financial data of our mussel adhesive protein antibacterial film business over the next five years. This fully reflects the typical development path of "early investment and cultivation - mid-term scale profit - late explosive growth". In terms of revenue, the first two years are the start-up stage. The revenue growth mainly relies on the steady increase in product price from 500,000 yuan to 550,000 yuan and the sales volume rising from 20 kilograms to 25 kilograms, with an annual compound growth rate of 0.3 for both. This indicates that during the market cultivation period, the enterprise has achieved basic revenue accumulation through small price increases and sales volume growth.

By the third year, the enterprise will reach a turning point. Both the price and sales volume will increase significantly simultaneously. The unit price will rise from 600,000 yuan to 800,000 yuan, and the sales volume will rapidly increase from 30 kilograms to 65 kilograms. Thanks to the dual drive of price and sales volume, the revenue will grow rapidly from 18 million yuan to 520 million yuan, entering a stage of explosive growth.

On the cost side, in the first two years, due to large initial expenditures such as equipment investment and market promotion, fixed costs rose from 29.2 million yuan to 49.2 million yuan. Coupled with the pressure from variable costs, the company's net profit was negative for two consecutive years (respectively -10.22 million yuan and -1.02 million yuan). Especially in the second year, the promotion expenses were as high as 2.1 million yuan, further exacerbating the financial burden.

From the third year on, fixed costs tended to stabilize. Although variable costs increased with sales volume, the scale effect gradually emerged, and marginal costs declined. The enterprise achieved its first break-even point and recorded a positive profit (net profit of 2.77 million yuan). In the following two years, driven by the sustained high growth of revenue, the profitability rose significantly, with net profits reaching 187 million yuan and 253 million yuan respectively, fully demonstrating the remarkable benefits brought by economies of scale and cost dilution.

Overall, the future development logic of our project is clear and distinguishable: in the early stage, we will establish market and brand awareness through high investment; in the middle stage, we will enhance the scale effect by expanding production and sales; and in the later stage, we will achieve a profit explosion. However, what we need to pay attention on is that there are abnormal fluctuations in some cost data such as depreciation expenses in certain years, which still need to be further improved and calibrated to accurately analyze the intrinsic relationship between cost composition and growth path.

Our team is a group of talented high school students from one of Shanghai's top high schools, participating in the iGEM competition. With the support of prestigious academic resources from the Chinese Academy of Sciences, as well as valuable partnerships with renowned hospitals and research institutions, the team is well-equipped to tackle innovative challenges in synthetic biology. Their collaborative efforts combine academic excellence with real-world application, aiming to make a significant impact in the field of healthcare and beyond.

This project focuses on the field of surgical and implantable medical devices and has established an ecosystem network of stakeholders covering the entire industrial chain. The core demand side comprises patients who require surgical treatment or device implantation as end users. Medical teams, led by surgeons, undertake clinical decision-making and operational functions, while hospitals at all levels provide medical scenarios and resource support. The supply chain links show significant cross-industry characteristics: fishery practitioners provide biological raw materials such as mussels, experimental equipment manufacturers drive technological innovation, and professional transportation companies and cross-border regulatory agencies ensure the compliance of logistics. In the industrial collaboration dimension, government health departments lead industry regulation through policy formulation and standard setting, and medical-grade food producers supply supporting consumables.

Figure 12 Stakeholders

The most noticeable long-term effect of our product is a reduction in the risk of infection from bacteria and viruses on medical devices, while also enabling more efficient use of these devices,given our unique 3-in-one feature. Mussel foot protein, in particular, exhibits excellent underwater viscosity, water resistance, malleability, and durability. This creates an effective coating for medical devices that come into direct contact with body fluids, ensuring the coating adheres securely and safely.

Meanwhile, by integrating Mfps with antimicrobial peptides and zwitterionic peptides, the coating can significantly mitigate the risk of contamination that can arise from contact of medical devices, addressing a critical issue that contributes to over one million fatalities annually due to bacterial infections linked to implanted medical devices. Furthermore, our 3-in-1 design consolidates multiple complex procedures into a single, efficient step, thereby reducing the complex and burdensome steps associated with traditional coating and antibacterial processes.

The indirect impacts are significantly cheaper prices and faster production span compared to traditional methods of extracting Mfps, thereby perhaps lowering the price and provide more accessible and affordable medical coatings.

However, there are also some long-term consequences we need to consider. For instance, if mussel foot protein-derived or polymer fragments from laboratory sources are released into rivers or the environment, toxic chemicals and waste may accumulate, resulting in pollution of food chains and ecosystems. Furthermore, although biological coatings reduce rejection, the absence of comprehensive clinical testing means that we cannot guarantee that excessive or prolonged contact with MFps will not provoke an immune response; consequently, the long-term effects of exposure remain unknown. [56,57,58,59]

Figure 13 Long-term Impacts