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Technologies

Developable/Fully Collapsible Internal Cutting or Gripping Mechanism

ID: 2018-047 Developable/Fully Collapsible Internal Cutting or Gripping Mechanism

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Invention Market Information
Commercialization and Marketing Report
Entrepreneur Plan

Marketing Report: Cylindrical Shaft with Curved-Link Four-Bar Mechanisms

I. Technology Description

This report focuses on a novel technology: a cylindrical shaft that houses two curved-link four-bar mechanisms. This mechanism can be actuated to perform tasks such as cutting, gripping, or squeezing objects inside of a cylinder. When not in use, the device resembles a simple cylindrical tube with a constant inner and outer diameter. The mechanism is actuated by rotating the inner cylinder relative to the outer cylinder.

Here’s a more detailed breakdown:

  • Structure: The mechanism consists of two concentric cylinders. A four-bar mechanism, a type of crank-slider, is fitted to the outer cylinder's diameter and thickness. The individual links of the mechanism have the same curvature as the outer cylinder, though this is not a requirement for operation. The outer cylinder is link 1, and the inner cylinder is link 4.
  • Function: Rotating the inner cylinder relative to the outer cylinder actuates the mechanism. Other rotating actuators could also be used. Link 3 could be the bottom blade of scissors, or one side of a gripping tool, while link 2 could be the upper blade of scissors or the other side of the gripping tool.
  • Operation: A single shaft can enter a workspace through a confined entrance, allowing a tool at the end of the shaft to perform a function. The tool can be partially retracted to allow the mechanism to perform tasks such as cutting, gripping, or squeezing. For instance, in minimally invasive surgery, the tool could enter a body cavity, grip tissue, retract it into the tube, and then cut off a biopsy sample. The mechanism can be placed at the end of the tube with a portion of the cylinder wall cut away, enabling the scissors or grippers to reach an object without needing additional tools.
  • Concealment: The links are constrained to a radius of curvature of the actuating cylinders and to a shape that will fit inside the cylinders when fully collapsed, so that the moving links are completely concealed when the mechanism is closed.

The shape of the links is flexible as long as the distance between the pins remains constant and the links do not interfere with each other. The depth of links 2, 3, and 4 does not alter the mechanism's function. Link 1 can be a full cylinder that extends above and below the mechanism.

II. Advantages Over Existing Technologies

This technology offers several key advantages compared to current solutions:

  • Reduced Procedure Time: Minimizes tool changes, speeding up procedures in confined or remote workspaces.
  • Reduced Trauma: Decreases the need for multiple entry points, limiting damage to the workspace boundary.
  • Minimized Tissue Damage: Limits interaction between blades/grippers and body tissue, since the only tissue interacting with the blades/grippers is that which is drawn into the inner diameter of the cylindrical shaft.
  • Simplified Control Systems: Reduces the number of shafts needed to enter the workspace, thus simplifying the control system.
  • Lower Procedure Costs: Reduces the costs of procedures by minimizing tool changes, simplifying control systems, and lowering overall equipment expenses.

III. Target Markets and Applications

This technology has broad applications across multiple sectors, including:

  • Medical and Surgical Industry:
    • Minimally Invasive Surgery (MIS): Ideal for procedures like laparoscopies and biopsies. The tool can reduce trauma and speed up recovery times.
    • Biopsy Procedures: The device can grip tissue, retract it, and cut a sample with a single device.
    • Endoscopic Procedures: Can cut polyps and remove foreign objects.
  • Robotics and Automation:
    • Robotic Arms: Can be integrated into robotic arms for precise handling and manipulation in confined spaces.
    • Automated Inspection Systems: Can be used for inspection tasks in hard-to-reach areas.
  • Aerospace and Aviation:
    • Maintenance Operations: Useful for maintenance inside aircraft engines and other complex structures.
    • Satellite Servicing: Useful for complex tasks without extensive tool changes.
  • Manufacturing:
    • Precision Manufacturing: Suitable for assembling small components in restricted areas.
    • Quality Control: Can aid in precise manipulation during testing.
  • Defense Sector:
    • Bomb Disposal: Can be used for manipulating devices with minimal disturbance.
  • Oil and Gas Industry:
    • Pipeline Maintenance: Can be used for cutting obstructions or retrieving objects from pipelines.

IV. Competitive Analysis

The following represents main competitors and alternative solutions:

  • Minimally Invasive Surgical Instruments:
    • Da Vinci Surgical System: While advanced, requires multiple entry points.
    • Laparoscopic Tools: Traditional tools that require separate entry points and tool exchanges.
  • Flexible Endoscopes with Tool Channels: Lack the mechanical complexity of the four-bar mechanism.
  • Articulating Instruments: Offer articulation at the tip but may not integrate multiple functionalities within a single tool.
  • Robotic Catheter Systems: Do not integrate complex mechanical tools directly into their shafts.
  • Industrial Robotic Arms with End Effectors: Require larger operational areas.
  • Manual Tools with Integrated Mechanisms: Lack the seamless integration of the cylindrical shaft mechanism.

This technology offers advantages over competitors in terms of:

  • Efficiency: The ability to perform multiple functions within a single tool reduces the time needed for tool changes.
  • Minimally Invasive Access: The cylindrical design allows the instrument to enter a workspace through a single entrance point, reducing trauma.
  • Safety: Reduces unnecessary contact with tissues outside the immediate area of interest.
  • Simplicity: Reduces complexity of control systems by requiring fewer shafts to enter the workspace.

V. Market Size and Growth

  • Total Addressable Market (TAM): The global market for medical devices and robotics/automation is estimated to be several billion dollars annually.
  • Serviceable Available Market (SAM): The SAM, which focuses on specific segments where the technology can compete, represents a multi-billion dollar opportunity.
  • Growth Potential: The market for minimally invasive surgical tools is projected to grow at a CAGR of around 9% from 2021 to 2028. Emerging trends, such as increasing demand for MIS, robotic surgery, flexible endoscopy, and industrial automation are driving this growth.

VI. Marketing Strategies

To reach customers effectively, a multi-channel distribution strategy is recommended:

  • Direct Sales:
    • Target hospitals, surgical centers, and medical device manufacturers.
    • Offer demonstrations and trials to showcase capabilities.
    • Provide customization options.
  • Distributors:
    • Partner with medical device distributors to reach healthcare institutions.
    • Collaborate with industrial equipment suppliers for non-medical applications.
  • OEM Partnerships:
    • Integrate the mechanism into larger systems or devices through OEM collaborations.
  • Online Platforms:
    • Establish an online presence through a dedicated website or platforms like Alibaba.
    • Use digital marketing strategies like SEO and targeted ads.
  • Trade Shows and Conferences:
    • Participate in industry-specific events to showcase the product and network with professionals.
  • Educational Institutions and Research Labs:
    • Engage with universities and research institutions that focus on mechanical engineering or biomedical innovation.
  • After-Sales Support Channels:
  • Provide after-sales support through maintenance services, training, and technical assistance.

VII. Key Marketing Messages

  • For Medical Professionals: Emphasize the technology's ability to reduce patient trauma, speed recovery, and improve surgical precision.
  • For Industrial Clients: Highlight the technology's versatility, efficiency, and ability to perform complex tasks in confined spaces.
  • For All Target Audiences: Position the technology as a cutting-edge solution that saves time, reduces costs, and improves safety.

VIII. Pricing Strategies

Consider a combination of the following pricing strategies:

  • Value-Based Pricing: Set prices based on the perceived value to end-users, such as improved surgical outcomes and efficiency gains.
  • Cost-Plus Pricing: Calculate total production costs and add a profit margin.
  • Penetration Pricing: Initially set lower prices to gain market share.
  • Skimming Pricing: Initially set higher prices for early adopters, then reduce prices later.
  • Bundling and Subscription Models: Offer the mechanism as part of a bundled package with complementary services.
  • Tiered Pricing Structures: Offer different versions of the product with varying features.

IX. Intellectual Property (IP) and Barriers to Entry

  • Patent Protection: The innovative aspects of the mechanism, such as the concentric cylinder design and the four-bar linkage system, are likely protectable by patents. A patent search and freedom-to-operate analysis is strongly recommended.
  • Barriers to Entry:
    • Technical Complexity: Developing a similar mechanism requires advanced engineering skills and precision manufacturing capabilities.
    • Proprietary Technology: Trade secrets and proprietary knowledge related to optimal materials and assembly techniques could further protect this technology.
    • Regulatory Approvals: Medical applications require time-consuming and costly regulatory approvals.
  • Market Entrenchment: Early entrants may establish strong relationships with key stakeholders.

X. Financial Considerations

  • Funding Opportunities: Explore government grants (NIH, NSF, DoD), private foundations, industry partnerships, venture capital, and crowdfunding.
  • Development Costs: Consider R&D, materials, manufacturing, regulatory compliance, IP, marketing, training, and a contingency fund.
  • Return on Investment (ROI): A high demand market segment like minimally invasive surgery may offer substantial returns. Cost savings through operational efficiency can enhance net profit margins.
  • Breakeven Time: Breakeven may occur within a few years post-market entry, depending on development progress and market penetration.
  • Recurring Revenue: Establish recurring revenue through maintenance contracts, support services, and software updates.
  • Liability Risks: Consider liability risks in medical settings and ensure adequate insurance coverage.

XI. Regulatory Compliance

  • Medical Applications: FDA approval in the U.S. and CE marking in Europe are crucial for medical devices. Compliance with ISO standards (e.g., ISO 13485, ISO 14971, ISO 10993) is essential. Clinical trials may be required.
  • Industrial Applications: Compliance with machinery directives and OSHA regulations may be needed.

XII. Conclusion and Call to Action

The cylindrical shaft mechanism with two curved-link four-bar mechanisms presents a unique opportunity for entrepreneurs. Its innovative design, versatility, and broad applications position it for significant market growth. This report provides an actionable plan to guide product development and marketing. Entrepreneurs are encouraged to pursue this technology by securing funding, conducting a thorough freedom-to-operate analysis, developing prototypes, implementing targeted marketing strategies, and establishing strategic partnerships to bring this technology to market effectively.

I. Initial Steps: Understanding the Technology and Market

  • Deep Dive into the Invention: The student should begin by thoroughly understanding the technology. This includes:
    • Mechanism Functionality: Understanding how the rotation of the inner cylinder relative to the outer cylinder actuates the four-bar mechanisms to perform actions like cutting, gripping, or squeezing.
    • Unique Features: Clearly defining the unique aspects, such as the ability to conceal the mechanism within a cylindrical shaft, and the multi-functional capabilities of the tool.
    • Customization Options: Exploring the flexibility in link design and how the mechanisms can be adapted for various applications.
  • Identify Target Markets: Determine which industries and applications will benefit the most from this technology.
    • Minimally Invasive Surgery (MIS): Due to the technology's ability to minimize trauma and reduce the number of entry points, MIS should be a primary target.
    • Robotics and Automation: The mechanism's precise manipulation capabilities could be valuable for robotic assembly lines and other automated processes.
    • Other Industries: Consider applications in aerospace, manufacturing, and even areas like veterinary medicine, where precision and minimal invasiveness are needed.
  • Analyze the Competition: Research existing tools and technologies that perform similar functions.
    • Identify Competitors: Look into established technologies like the Da Vinci Surgical System, laparoscopic tools, and flexible endoscopes.
    • Understand Weaknesses: Note the limitations of current solutions, such as the need for multiple entry points, complex tool changes, and potential for increased trauma.
    • Highlight Advantages: Focus on how the cylindrical shaft technology overcomes these limitations through its unique design, simplified actuation, and reduced invasiveness.

II. Protecting the Invention and Developing a Business Plan

  • Intellectual Property Protection: Secure intellectual property (IP) rights for the invention.
    • Patent Search: Conduct a comprehensive search of existing patents to determine if the technology infringes on any existing IP.
    • File Patents: If the invention is novel and non-obvious, file for patents to protect its unique aspects.
    • Trade Secrets: If manufacturing processes or techniques are unique, consider protecting them as trade secrets.
  • Create a Detailed Business Plan: Develop a comprehensive plan to guide the startup’s development.
    • Executive Summary: Briefly describe the invention and the market opportunity.
    • Market Analysis: Evaluate the size of the potential markets and identify target customers.
    • Competitive Analysis: Outline the strengths and weaknesses of the invention compared to competitors.
    • Marketing and Sales Strategy: Develop strategies to reach target customers.
    • Operations Plan: Detail the manufacturing and production processes.
    • Financial Projections: Estimate the costs for development, manufacturing, and marketing, as well as potential revenue and ROI.

III. Prototyping, Testing, and Regulatory Approvals

  • Develop Prototypes: Create working prototypes to refine the design.
    • Multiple Prototypes: Build various prototypes to test different materials and designs.
    • Stress Testing: Perform rigorous testing to evaluate the performance, durability, and reliability of the mechanism.
  • Regulatory Compliance: If targeting the medical field, navigate the necessary regulatory pathways.
    • FDA Approval (USA): Understand the requirements for medical devices, which may include 510(k) premarket notification or premarket approval (PMA).
    • CE Marking (Europe): Ensure compliance with the EU Medical Device Regulation (MDR).
    • ISO Standards: Adhere to relevant ISO standards such as ISO 13485 for quality management and ISO 14971 for risk management.
    • Clinical Trials: Depending on the device's classification, conduct clinical trials to prove safety and efficacy.

IV. Securing Funding and Launching the Product

  • Secure Funding: Explore various funding options.
    • Government Grants: Apply for grants from agencies like the National Institutes of Health (NIH) or the National Science Foundation (NSF).
    • Private Foundations: Seek funding from foundations focused on medical technology or engineering innovations.
    • Venture Capital: Engage with venture capital firms that specialize in medtech startups.
    • Industry Partnerships: Partner with established companies in the medical device or robotics industries.
  • Strategic Partnerships: Collaborate with key players in the target markets.
    • Medical Institutions: Partner with hospitals or surgical centers for clinical trials or pilot programs.
    • Medical Device Companies: License the technology to established manufacturers.
    • Robotics Firms: Collaborate with robotics companies for product development.
  • Manufacturing and Scaling: Develop efficient manufacturing processes.
  • Precision Manufacturing: Ensure high-quality production of complex components.
  • Economies of Scale: Optimize manufacturing processes to lower costs as production volume increases.
  • Marketing and Sales: Reach potential customers through various channels.
    • Direct Sales: Directly approach hospitals, surgical centers, and medical device manufacturers.
    • Distributors: Partner with medical device or industrial equipment distributors.
    • Online Platforms: Establish an online presence to reach a global audience.
    • Trade Shows and Conferences: Participate in industry events to demonstrate the technology.
  • Post-Launch: Monitor performance and provide support.
    • Maintenance and Support: Offer maintenance contracts and technical support services.
    • Upgrades and Training: Provide upgrades and training programs to enhance the user experience.
    • Continuous Improvement: Gather feedback and make iterative improvements to the technology.

V. Monitoring and Iteration

  • Track Key Metrics: Monitor sales, market share, customer satisfaction, and other relevant metrics to evaluate the performance of the startup.
  • Adapt and Evolve: Be willing to adapt the product and business strategy based on feedback from users and changes in the market landscape.