Wound Closure Strip Manufacturing Plant Project Report 2024

The demand for wound closure strips is increasing due to several key factors. Firstly, there is a growing number of surgical procedures being performed globally, with approximately 310 million major surgeries conducted annually. This figure is projected to increase by about 5% per year, necessitating effective wound closure solutions to reduce surgical site infections and promote faster healing. Additionally, the prevalence of road accidents and injuries significantly contributes to this demand; for instance, in the U.S., nearly 41,000 fatalities were reported from motor vehicle crashes in 2023, while the National Safety Council estimated that around 63 million individuals sought medical attention for injuries that same year. This highlights the high incidence of cuts and lacerations requiring effective management.

The ageing population also plays a crucial role in increasing demand, as individuals aged 65 and older are more prone to chronic wounds and injuries. By 2030, it is estimated that this demographic will represent about 20% of the global population, further necessitating user-friendly wound management solutions, such as wound closure strip.

Other elements to consider while establishing a wound closure strip plant include raw material sourcing, workforce planning, and packaging. The production of wound closure strip relies on several key raw materials, such as adhesives and nylon. Adhesive materials comprise of pressure-sensitive adhesives that provide strong bonding while being hypoallergenic to reduce skin irritation. 3M's Steri-Strip™ features a breathable adhesive strip reinforced with polymer filaments, enhancing its reliability for closing incisions and lacerations. Reinforcement materials such as nylon or polyester filaments are often incorporated to improve the tensile strength of the strips. These reinforcements help the strips withstand tension and movement without tearing, making them suitable for surgical and minor wound closures.

Moreover, to help stakeholders determine the economics of a wound closure strip plant, project funding, capital investments, and operating expenses are analyzed. Projections for income and expenditure, along with a detailed breakdown of fixed and variable costs, direct and indirect expenses, profit and loss analysis, enable stakeholders to comprehend the financial health and sustainability of a business. These projections serve as a strategic tool for evaluating future profitability, assessing cash flow needs, and identifying potential financial risks.

However, challenges such as disruptions in raw material availability, primarily polyethylene terephthalate (PET) or nylon, alongside increasing energy costs, which have surged by over 30% in recent years, may threaten supply stability. To combat this, manufacturers can explore alternative sources for key ingredients. This can reduce dependency on fossil fuels and mitigate supply chain risks.

About Wound Closure Strip

Wound closure strips, also known as adhesive strips or tapes, are used to approximate the edges of wounds, promoting healing while minimising scarring. They are particularly effective for small, non-exudative wounds under minimal tension. The strips are easy to apply, comfortable for patients, and do not require follow-up for removal. However, their effectiveness can be compromised by moisture, and they are less suitable for hairy or highly mobile areas. The use of adhesive strips dates to the 1500s when Ambroise Paré created sticking plaster for facial wounds. This method evolved into modern microporous tapes like Steri-Strips.

Properties of Wound Closure Strip

Wound closure strips possess a porous structure, which allows for air circulation and drainage of wound exudate, reducing the risk of maceration and infection. These strips are made from materials like artificial silk and reinforced with rayon fibers, which results in a high tensile strength, providing strong adhesion and even tension distribution across the wound edges. Furthermore, their hypoallergenic adhesive minimises skin irritation while ensuring reliable adhesion. Additionally, some variants feature moisture-resistant properties, enhancing durability and effectiveness in various environments. Their breathable and permeable design also allows the skin to breathe while keeping light wounds protected.

Manufacturing Process of Wound Closure Strip

The production process of wound closure strips begins with material selection, where appropriate components such as microporous tape and hypoallergenic adhesive are chosen. Next, the materials are prepared by cutting the tape to the desired dimensions. The adhesive is then applied to the tape surface, followed by a quality control inspection to check for defects and ensure adhesion strength and porosity. Once approved, the strips are packaged in sterile conditions to maintain hygiene and labelled with product information, usage instructions, and expiration dates before being distributed to healthcare facilities and pharmacies.

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Making of Wound Closure Strips

1. Introduction

Wound closure strips, also known as adhesive sutures or Steri-Strips, are used for non-invasive wound closure. They are typically applied to close small, shallow wounds and provide support to surgical incisions without the need for sutures. This document outlines the industrial process of manufacturing wound closure strips, including the chemical reactions involved.

2. Materials Used

• Polymer Substrate: Typically made from materials like polyethylene terephthalate (PET) or nylon.
• Adhesives: Pressure-sensitive adhesives (PSAs), often made from acrylate or silicone-based compounds.
• Backing Materials: Can include paper or a polyester mesh.
• Reinforcement Filaments: Optional fibers for added strength, such as nylon or polyester.

3. Manufacturing Process

Step 1: Preparation of Substrate Material

The polymer substrate is prepared by extrusion or coating methods, using polyethylene terephthalate (PET) as the base material. PET is synthesized via polycondensation of terephthalic acid (C₈H₆O₄) and ethylene glycol (C₂H₆O₂).

Chemical Reaction:

n C₈H₆O₄ + n C₂H₆O₂ → PET + 2n H₂O

Step 2: Adhesive Coating

Pressure-sensitive adhesives (PSAs) are applied to the substrate. The most common adhesives are based on acrylic or silicone.

Acrylic Adhesives:

Polymerization of acrylic acid derivatives, such as butyl acrylate (C₇H₁₂O₂) and methyl methacrylate (C₅H₈O₂).

Polymerization Reaction:

n C₇H₁₂O₂ + m C₅H₈O₂ → Poly(acrylate adhesive)

Step 3: Curing Process

The adhesive is cured using UV radiation or thermal curing, depending on the adhesive type. In the case of UV curing, photoinitiators are used to trigger the cross-linking process in the adhesive polymers.

Step 4: Application of Release Liner

A silicone-coated release liner is applied to the adhesive surface to prevent the adhesive from sticking to unintended surfaces.

Step 5: Cutting and Packaging

The wound closure strips are cut to the desired size and shape, and then packaged in sterile conditions to prevent contamination.

4. Chemical Reactions

Silicone Adhesives:

Silicone adhesives are often formed from polydimethylsiloxane (PDMS) chains, cross-linked with vinyl-functional siloxanes in the presence of a platinum catalyst.

Cross-linking Reaction:

PDMS + Vinyl-functional siloxane → Cross-linked Silicone Adhesive

5. Quality Control

The wound closure strips undergo several quality control checks, including adhesion strength, sterility, and biocompatibility testing.

Applications and Drivers of Wound Closure Strip

The wound closure strips market is driven by the growing demand for innovative solutions, the increasing preference for sterile and non-invasive wound closure methods, and the diverse applications across end-user segments. Zip ties, ZipStich strips, Bandgrip, and Micro-anchor Skin Closures are leading products in this market, offering effective closure for lacerations and surgeries. Trauma centers, biotech companies, and orthopedic clinics are major end-users. Advancements in flexible and reinforced strips, particularly in surgical settings, have changed wound closure techniques. The market is also witnessing a surge in the adoption of sterile wound closure strips, driven by the need to reduce infection risks in healthcare facilities. These strips are used for laceration closure and dressing wounds in surgical, trauma, and chronic cases, catering to the healthcare industry.

Key Features of the Wound Closure Strip Production Cost Report

A detailed overview of production cost analysis that evaluates the manufacturing process of wound closure strip is crucial for stakeholders considering entry into this sector. Furthermore, stakeholders can make informed decisions based on the latest economic data, technological innovations, production process, requirements of raw materials, utility and operating costs, capital investments by major players, pricing strategies, and profit margins. For instance, the cost-effectiveness of adhesive wound closure strips, averaging USD 7.54 per laceration compared to USD 24.11 for sutures and USD 28.77 for tissue adhesives, drives increased demand from healthcare providers seeking to reduce operational costs. Their faster application reduces labor expenses and improves patient throughput, enhancing market positioning for manufacturers. 

Below are the sections that further detail the comprehensive scope of the prefeasibility report for a wound closure strip production plant:

Market Dynamics and Trends: Growth factors such as the increasing prevalence of surgical procedures and rising healthcare expenditures significantly affect market conditions in the wound closure strip sector. In 2024, approximately 51.4 million surgical procedures are projected to be performed in the U.S., while 30 million surgeries are estimated in India annually. Understanding these trends helps businesses align their production plans with demands and trends in the wound closure strip market. Additionally, regions like North America  and Asia Pacific present substantial growth opportunities due to expanding healthcare access and awareness.

Profiling of Key Industry Players: Leading manufacturers like 3M, Smith & Nephew, Medline, and Dukal LLC are included in the wound closure strip report. 3M offers Steri-Strip Antimicrobial Skin Closures, which are reinforced with rayon threads to prevent infections. Dukal LLCoffers a range of sterile and non-sterile wound closure strips in various sizes, such as 1" x 4" and 1/4" x 3". Their focus on sterile products is driven by the need to reduce surgical site infections. Dynarex Corporation provides reinforced wound closure strips made with polypropylene fibers, which are particularly effective for securing skin lacerations.

Additionally, players are focusing on improving their market presence by increasing their production capacities, engaging in mergers and acquisitions, and investing in technologies. In July 2019, BandGrip partnered with OrthoIndy to innovate micro-anchor skin closures, aiming to heal wounds up to 50% faster than traditional methods. This technology uses a breathable, reinforced adhesive that securely grips the skin, enhancing patient comfort and reducing complications. The micro-anchor system allows for quick application and intuitive removal, streamlining the healing process. This collaboration highlights the potential for advancements in wound care through strategic partnerships in the medical device industry. Companies are investing in research and development to create advanced products such as zipline closure systems that provide non-invasive solutions for skin lacerations.

Economic Analysis: Capital expenditure (CAPEX) analysis provides stakeholders the knowledge about required investments in advanced technologies, efficient machinery, and necessary infrastructure. Investing in high-capacity mixing equipment, such as a continuous mixer or high-shear mixer, can improve production efficiency by 20-30%. Investing in energy-efficient systems, such as combined heat and power (CHP) systems could reduce energy consumption by up to 30%, as these systems use waste heat from production processes to generate electricity and provide heating. 

Historical, Current, and Forecasted Price Trends

Fluctuations in wound closure strip prices are influenced by several key factors, particularly the costs of essential raw materials such as polyethylene terephthalate (PET) or nylon. In September 2024, PET prices experienced a notable decline of 2.5%, driven by falling crude oil prices and weak downstream demand, with U.S. prices averaging around USD 1.47/kg. This trend reflects a broader pattern, where PET prices in North America rose from USD 1.037/kg in January to USD 1.071/kg in March 2024, before stabilising amid supply chain adjustments. Conversely, nylon prices have shown variability due to fluctuations in crude oil and natural gas prices, impacting production costs and availability. Understanding the dynamics of raw material costs is important for maintaining competitive pricing and profitability in the wound closure strip market.

Financial Investment Overview for Wound Closure Strip Manufacturing Facility

Establishing a wound closure strip manufacturing facility requires a comprehensive financial investment that encompasses various elements critical to the project's success. The following sections detail these components:

• Raw Materials: The primary raw materials include PET and nylon, which are essential to produce wound closure strip. Additional costs may arise from catalysts, which can contribute an extra 5-10% to overall material costs.
• Utilities: Key utilities needed to produce wound closure strip, such as electricity, steam, and process water along with their cost assessments help investors to develop more accurate financial models and budget forecasts, ultimately enhancing profitability. In wound closure strip market, energy costs are significant, typically representing around 10-15% of operating expenses. This includes electricity and water necessary for the manufacturing processes.
• Labour: Personnel costs must be factored in, covering wages for skilled and unskilled workers involved in production and administration.
• Packaging: Expenses related to packaging materials and processes are crucial, as they ensure the product is safely transported and presented to customers.
• Transportation: Costs analysis associated with the logistics of delivering raw materials to the facility and distributing finished products to markets enable investors to select suitable location for manufacturing facilities, improve supply chain strategies, and negotiate better terms with suppliers and distributors.
• Land Acquisition: The purchase or lease of land for the facility is a substantial upfront investment as it aids stakeholders identify areas with lower land acquisition costs and favourable zoning regulations, ultimately reducing initial capital expenditures.
• Construction: Building the manufacturing plant involves significant capital expenditure, including site preparation, construction materials, and labour.
• Machinery: Investment in specialized machinery for mixing, foaming, and curing processes is essential for efficient production.

Profit Margins and Pricing Strategies

Projected profit margins and effective product pricing strategies improve overall profitability. Manufacturers might target a profit margin of around 20-30%, achieved through strategic pricing based on raw material costs and prevailing market demand. Effective pricing strategies should consider fluctuations in raw material prices and competitive positioning within the market.

Regulatory Frameworks and Environmental Considerations

The establishment of a wound closure strip manufacturing facility must comply with various regulatory frameworks that govern production standards and environmental impacts. In the United States, the Food and Drug Administration (FDA) regulates medical devices under the Federal Food, Drug, and Cosmetic Act, requiring manufacturers to adhere to Good Manufacturing Practices (GMP). This includes rigorous quality control measures, documentation, and validation processes to ensure product safety and efficacy.

For example, wound closure strips like 3M's STERI-STRIP must undergo premarket notification (510(k)) if they are deemed substantially equivalent to an existing product. In the European Union, manufacturers must comply with the Medical Devices Regulation (MDR), which mandates comprehensive clinical evaluations and post-market surveillance to ensure ongoing safety. Facilities must also obtain a CE mark, indicating conformity with EU safety standards. Compliance with these regulations not only ensures legal operation but also enhances product safety and marketability.

Key Questions Addressed:

• What are the detailed unit operations for wound closure strip production?
• Who are major technology licensors with their process evaluation?
• How are raw materials or catchem procured and what are their cost implications?
• What utilities are essential for production and what will they cost?
• What are the labour requirements and how does this affect operational costs?
• What packaging solutions are optimal for cost and efficiency?
• What logistical arrangements are necessary for efficient product distribution?
• What are the estimated land and construction costs for a new wound closure strip plant?
• How can profitability be maximised in the wound closure strip market?
• What pricing strategy should be adopted for wound closure strip to remain competitive?

This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the wound closure strip industry.