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Technologies

Developable/Fully Collapsible, Multiplying Cylindrical Shaft for Medical Instruments and Other Applications

ID: 2018-045 Developable/Fully Collapsible, Multiplying Cylindrical Shaft for Medical Instruments and Other Applications

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Invention Market Information
Commercialization and Marketing Report
Entrepreneur Plan

I. The Technology: A Revolutionary Approach to Confined Space Access

This invention is a cylindrical shaft that ingeniously incorporates a curved-link four-bar mechanism. This mechanism allows the shaft to deploy secondary shafts or tools alongside the main body, all through a single entry point. Imagine a simple tube that can expand and present multiple functional tools, cameras, or devices when inside a workspace. When not deployed, the mechanism retracts, leaving a smooth, cylindrical profile.

Key Features:

  • Multiple Deployments: Numerous secondary shafts can be deployed along the length of the primary shaft.
  • Single Entry Point: Enables access to a confined space, then expands to allow deployment of tools.
  • Versatile Functionality: Tools can be held, pointed, oriented, and actuated, making it suitable for diverse tasks.
  • Concealed Mechanism: The mechanism retracts fully, maintaining the simple cylindrical form of the shaft when closed.
  • Compliant Mechanisms: The use of compliant segments can replace pin joints to allow for innovative manufacturing techniques such as planar CNC routing and die cutting.

II. Advantages Over Existing Solutions

Current cylindrical shafts typically only allow one tool at the end, especially when the tubes are small. This invention allows multiple tools to enter a workspace through a single entrance. This technology offers significant advantages by:

  • Reducing procedure time by minimizing the number of tool changes.
  • Minimizing trauma by reducing the number of entry points needed.
  • Simplifying control systems by requiring fewer shafts and controllers.
  • Lowering costs by streamlining procedures.

This invention can revolutionize industries needing precision operations within confined areas.

III. Target Markets

This technology's versatility opens doors to several key industries:

  • Medical Devices: Focus on minimally invasive surgery (MIS) tools, stents, and dilation devices. The ability to deploy multiple instruments through a single incision can significantly reduce patient trauma and improve surgical outcomes.
  • Industrial Automation: Target robotic arms, inspection tools, and maintenance equipment that need to operate in confined or hard-to-reach spaces.
  • Aerospace and Defense: Applications in aircraft maintenance, satellite repair, and drone technologies that require compact yet powerful deployment mechanisms.
  • Consumer Electronics: Explore integration in compact devices requiring expandable components such as retractable cameras or sensors.

IV. Commercialization Plan

This plan focuses on a phased approach, starting with a strategic entry point and expanding to other applications:

  1. Phase 1: Focus on the Medical Device Market
    • Regulatory Approval: Begin the regulatory approval process for medical applications, such as FDA clearance or CE marking, which will likely require clinical trials.
    • Strategic Partnerships: Collaborate with established medical device companies through licensing agreements or joint ventures. Leverage their existing distribution networks and regulatory expertise.
    • Pilot Programs: Initiate pilot programs with hospitals or medical research institutions to validate the technology's effectiveness and gather feedback.
  2. Phase 2: Expand to Industrial and Other Applications
    • Targeted Outreach: Focus on industries such as aerospace, automotive, and robotics, where precise tooling is needed.
    • OEM Partnerships: Collaborate with original equipment manufacturers (OEMs) to integrate the technology into their product lines.
    • Custom Solutions: Offer customized versions of the technology for specialized industrial applications.
  3. Phase 3: Broad Market Penetration and Diversification
    • Global Expansion: Extend reach into global markets.
    • Consumer Applications: Evaluate opportunities to integrate the technology into consumer electronics.
    • Continuous Innovation: Invest in R&D to improve functionality, explore new applications, and integrate emerging technologies.

V. Marketing Strategy

A multi-channel approach is essential for reaching various target audiences:

  • Educational Content Marketing: Develop content to educate potential users about the technology and its benefits. Use blogs, infographics, and interactive web content to explain complex concepts in an accessible way.
  • Trade Shows and Conferences: Attend industry-specific events to showcase the technology, network with potential clients, and gather market feedback.
  • Demonstration Videos and Webinars: Create detailed demonstration videos showcasing how the mechanism works and its advantages over existing solutions. Host webinars with experts to discuss the technology's applications and benefits.
  • Partnerships with Key Opinion Leaders (KOLs): Collaborate with leading surgeons or engineers to endorse the product and build credibility.
  • Digital Marketing: Use social media platforms for B2B engagement and implement SEO strategies to ensure that relevant audiences can easily find information about this innovation online.
  • Pilot Programs: Offer pilot programs to early adopters to validate performance and collect feedback.
  • Case Studies: Develop case studies across various industries that demonstrate successful implementation of the technology.

VI. Pricing Strategy

A multi-faceted approach will be best for pricing:

  • Value-Based Pricing: Especially in the medical sector, where the technology offers significant benefits like reduced trauma and recovery time, premium pricing is justifiable.
  • Cost-Plus Pricing: Calculate the manufacturing cost and add a markup to ensure profitability.
  • Competitive Pricing: Analyze prices of competitive devices and solutions.
  • Tiered Pricing: Offer different models at different prices to cater to different market needs.
  • Subscription/Leasing Models: Consider leasing for industries where large capital expenditures may be an issue.

VII. Intellectual Property Strategy

  • Secure Patents: Obtain patents to protect unique aspects of the technology, including its mechanism and applications.
  • Trademarks: Secure trademarks for the brand name and any unique identifiers.
  • Licensing: Develop a licensing strategy to leverage IP across multiple sectors.

VIII. Financial Considerations

  • Funding Sources: Explore funding opportunities such as government grants (NIH, NSF, DoD), SBIR/STTR programs, venture capital, and angel investors.
  • Cost Management: Carefully manage development, manufacturing, and regulatory costs.

IX. Recurring Revenue Opportunities

  • Maintenance Contracts: Offer maintenance contracts for regular inspection and repair.
  • Support Services: Provide technical support for users.
  • Upgrade Packages: Offer upgrades as the technology advances.
  • Software Updates: If software is part of controlling the mechanism, provide software updates.
  • Spare Parts: Sell spare parts.
  • Training and Certification Programs: Train users to ensure safety and proper use.

X. Key Takeaways for Entrepreneurs

  • Focus on a Strategic Entry Point: Start with a specific application to establish credibility and market presence.
  • Build Partnerships: Collaborate with existing companies to leverage their resources and expertise.
  • Prioritize Intellectual Property Protection: Secure patents and trademarks early to protect your competitive advantage.
  • Adapt to Market Needs: Remain flexible and adapt to changing market conditions and feedback from users.
  • Be Patient: The regulatory approval process may take time; persistence and thorough planning are critical.

Highlight Value Proposition: Emphasize the technology's ability to reduce trauma, simplify procedures, and lower costs, as these advantages will resonate with users.

Phase 1: Laying the Foundation (Months 1-6)

  • Step 1: Deep Dive into the Technology & Design Specifics
    • Mechanism Mastery: Thoroughly understand the curved-link four-bar mechanism within the cylindrical shaft, including how its dimensions, materials, and curvature affect its actuation and expansion. Analyze how the links move, and how the slider rotates.
    • Concentric Cylinder Understanding: Study the design of the two concentric cylinders, how they fit together, and how the mechanism is housed within the outer cylinder.
    • Material Properties: Investigate suitable materials such as stainless steel, titanium alloys, or advanced polymers, considering strength, flexibility, and biocompatibility (for medical applications).
    • Compliant Mechanism Exploration: Explore the potential of compliant segments to replace pin joints, focusing on how this impacts manufacturability via methods like planar CNC routing or die cutting. Understand how to design bistable or multistable systems.
  • Multiple Mechanisms: Consider how multiple secondary shafts or mechanisms can be integrated along the length of the tube.
  • USPs Defined: Clearly articulate your USPs: single-entry point for multiple tools, reduced trauma, simplified control, cost-effectiveness, and the ability to add different functionalities (cameras, lasers, etc.).
  • Detailed Documentation: Create technical documentation with detailed drawings of the mechanism's components, dimensions, and assembly, as well as flowcharts illustrating its actuation.
  • Step 2: Intellectual Property Protection with Tech Specifics
    • Targeted Patent Search: Specifically search for patents related to curved-link four-bar mechanisms, expandable shafts, compliant mechanisms, and multi-tool deployment systems. Check both utility and design patents, particularly those covering medical devices.
    • Patent Filing Strategy: Secure patents for core innovations such as the specific curved-link design, actuation method, the use of compliant segments in the mechanism, and its application in minimally invasive surgery or other identified areas.
    • Trade Secret Identification: Document and protect proprietary manufacturing processes, such as material preparation or specific CNC machining techniques required for precision.
    • Trademark: Select a brand name that communicates the technology's benefits and secure it along with your logo.
  • Step 3: Laser-Focused Market Research
    • MIS Procedure Identification: Focus on specific MIS procedures where your tech's single-entry point capability provides the most benefit, e.g., surgeries requiring multiple instruments, 3D vision, and precise tool deployment.
    • Targeted Customer Interviews: Interview surgeons and medical practitioners to understand their needs, challenges, and what they value in surgical tools.
      • Understand what existing surgical tools or techniques are being used and what their drawbacks are.
    • Industrial Applications Assessment: Investigate other high-potential areas where a single entry point with multiple tool deployment has value, such as in pipeline inspection, or robotics where confined space operation is key.
    • Competitor Deep-Dive: Analyze your competitors, such as traditional laparoscopic instruments or robotic surgical systems. Understand their limitations.
  • Step 4: Business Plan Tailored to This Tech
    • Value Proposition Details: Quantify how much time the technology saves in procedures by reducing tool changes, how it reduces trauma compared to existing solutions, and cost savings for hospitals or industrial users.
    • Initial Licensing Model: Focus on a licensing model initially, targeting companies with expertise in medical device manufacturing, as this approach will help you with regulatory hurdles. Develop royalty strategies.
    • Detailed Financials: Project R&D costs (including prototyping and testing), manufacturing costs (considering material selection and volume production), and regulatory expenses. Project revenue based on licensing fees and potential sales. Determine the breakeven point and the time to get there.
  • Funding Needs: Define how much initial capital you need and where you can get it from, including government grants (NIH, NSF) and venture capital firms.

Phase 2: Development and Validation (Months 7-18)

  • Step 5: Precision Prototyping and Testing
    • Functional Prototypes: Create functional prototypes that demonstrate the smooth operation of the mechanism, the expansion of the secondary shaft(s) and how the different attachments (cameras, lights, lasers etc) function.
    • Use methods like 3D printing to rapidly prototype different iterations of the mechanism.
    • Surgical Simulation Testing: Conduct testing in simulated surgical settings to ensure that the mechanism functions correctly, that the tools deploy effectively, and that it causes minimal disruption.
    • For industrial applications, test in relevant industrial environments.
    • Material Durability and Wear Testing: Conduct stress testing to evaluate the durability of the chosen materials and how well the mechanisms will perform with repeated use.
    • Iterative Design: Based on testing, refine your design, adjust link dimensions, change material composition, or make changes to the actuation system.
  • Step 6: Regulatory Pathway Specifically for Medical Applications
    • FDA/EMA Consultation: Begin the regulatory process by consulting with the FDA (if targeting the US market) and/or the European Medicines Agency (EMA) and identifying the required pathway for approval.
      • Prepare for a 510(k) premarket notification or PMA, based on the risk assessment.
    • Biocompatibility Testing: Conduct biocompatibility testing according to ISO 10993 standards, if the device will contact human tissue.
    • Sterilization Standards: Ensure your device meets ISO 11135 or ISO 17665 sterilization standards.
    • Electrical Safety: If your device has electrical components, ensure that it complies with IEC 60601-1 and EMC standards like IEC 60601-1-2.
    • Risk Management: Conduct a risk assessment following ISO 14971 to identify potential hazards.
    • Clinical Trials: Prepare for clinical trials, if required, to demonstrate safety and efficacy.
  • Step 7: Strategic Partnerships and Licensing
    • Targeted Partner Outreach: Prioritize medical device companies that have expertise in surgical tools, strong distribution networks, and experience with regulatory approvals (e.g., Medtronic, Johnson & Johnson).
      • Consider OEM partnerships where your tech is integrated into another company's product line.
    • Licensing Negotiations: Develop licensing agreements that clearly outline royalty rates, exclusivity terms, and other key provisions.
    • Collaboration Agreements: Consider collaborations with companies who need your tech, but can also provide value, such as companies in the robotics or automation industries.
  • Step 8: Pilot Programs in Medical Settings
    • Hospital Selection: Partner with hospitals and surgeons specializing in MIS procedures to participate in pilot programs, gathering real-world performance data.
    • Training and Support: Provide training and technical support to the medical staff using the technology during the pilot program.
    • Data Collection: Collect detailed data on the device's performance, efficiency gains (reduced time), safety outcomes (reduced trauma), and any user feedback for iterative improvements.

Phase 3: Launch and Growth (Months 19+)

  • Step 9: Multi-Channel Marketing Approach
    • Surgical Community Outreach: Attend medical conferences and trade shows, conduct webinars, and develop high-quality videos demonstrating the technology in simulated surgery environments.
      • Highlight the value of reduced trauma and faster recovery.
    • Key Opinion Leader (KOL) Endorsements: Collaborate with surgeons who are leaders in their field to endorse the technology through testimonials, publications, or participation in trials.
    • Digital Marketing: Utilize a professional website with detailed technical information and videos, social media (LinkedIn for B2B), and SEO to reach potential customers.
    • Develop targeted content marketing to educate users about the technology.
  • Step 10: Scalable Manufacturing & Distribution
    • Manufacturing Partners: Establish partnerships with manufacturers who have experience with precision CNC machining or other techniques required to produce the components consistently at scale.
    • Quality Control Systems: Implement strict quality control procedures during production to maintain high standards and adhere to regulatory requirements.
    • Distribution Channels: Work with existing medical device distributors to reach hospitals and surgical centers.
    • Consider a direct sales approach, if you are focusing on select hospitals, or for sales of components.
  • Step 11: Financial Management & Monitoring
    • Monitor Costs: Use financial tracking software to ensure that your budget is not exceeded.
    • Pricing Strategy: Use a value-based pricing strategy, where you justify your pricing based on reduced costs and improved outcomes.
    • ROI and Breakeven: Track sales, revenue, and costs, and monitor your progress towards reaching your financial goals.
  • Step 12: Continuous Improvement and New Tech
    • Ongoing R&D: Invest in research and development to improve the functionality of the mechanism, explore new compliant mechanism designs, and add new features (improved sensors, etc.).
    • User Feedback Loop: Establish a system to gather feedback from users to help guide your R&D, leading to improved performance and new features.
    • Upgrade Packages: Develop upgrade packages for existing clients, offering new functionality.
    • Software Updates: If applicable, provide software updates for your technology.