Our clinical group has extensive experience in designing and conducting early stage healthcare technologies.  We have the capabilities to offer a complete clinical testing and verification pathway from production ready prototype to acute and chronic animal experiments to first in man and feasibility clinical trials with the highest clinical research standard.  We are familiar with the regulatory pathways and its overall impact in bringing a product to market.

The core of our development process is a systematic roadmap to identify, strategize and execute need-driven, value-based medical innovations. We customize our process around specific project needs to achieve maximum efficiency, efficacy and cost savings to deliver a successful product.   

Interventional Concepts has the ability to support medical innovators in the following areas of its medical device product development:

1. Project Planning

The Planning Phase is composed of plans and strategies that validate and address the need identified by the innovator. The plans and strategies will serve as an organized roadmap for the Development and Delivery Phases.  

Objective:

To validate and address the need identified by the innovator

Deliverable: Project Plan Report

A clear and concise report will be generated including all the elements needed for the development of a medical device that is successful clinically, commercially viable, technically feasible and meets regulatory requirements. The elements are separated in sections in order to sequentially validate the need and address it. Please see Appendix I for additional details.

2. Investor Presentation

Integrating the components within the Planning Phase will yield a clear and concrete “pitch” plan that will explain the innovators vision and compel investors, partners and employees to invest in the project.

Objective:

To prepare innovators to present and defend the opportunity to potential investors and partners.

Deliverable: Investor Presentation

A slide presentation will be generated including topics required to convey the opportunity and address typical investor requirements.  Please see Appendix II for additional details.

3. Clinical

We will focus on gathering the technical requirements that are generally required for submission to the different regulatory bodies. Our goal will be to compile a dossier for submission to Colombia's INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) so that a first-in-human clinical study is conducted in a qualified clinical research center in Colombia.

Objective:

To demonstrate the device's safety and efficacy in humans, and as a result, generating clinical and commercial value.

  • Clinical Trial Set-up
    • Site(s) selection
    • Coordination of budget(s) with selected site(s)
    • Site introduction
    • Pre-trial visit
    • Drafting of clinical trial agreement (CTA) and interactions with site's legal counsel(s) and administrative staff.
    • Protocol approval
    • Site initiation visit
  • Clinical Study Management
  • Clinical Study Monitoring
  • Logistical Services
    • Legal representation
    • Import of medical products into Colombia
    • Product storage
    • Product management
    • Domestic shipments to/from site
    • Product disposal/return
    • On-going reporting
  • Project management
  • Regulatory Management
  • Technovigilance
  • Patient recruitment campaign
  • Adjudication of adverse events
  • Clinical Product Readiness
    • Regulatory consulting services in preparation for submission to regulatory bodies.
      • Product Labeling
      • Product IFU
      • Medical Reporting Process
      • Establishment Registration
      • Quality System Registration
      • Non-Clinical Device Testing
      • Mechanical System Testing
      • Screw Testing
      • Corrosion Testing
      • Biocompatibility Testing
      • End-user (cadaver) test
  • Clinical Study Design
    • Literature review
    • Power calculation (# of subjects in the study
    • Study protocol
    • Investigator's manual
    • Patient's informed consent
    • Case report form (CRF)
    • Statistical analysis
    • Data management

 

4. Continued Full Project Execution

Additional to the mentioned services we can provide full product execution. We can manage every element to ultimately reach a value event goal, whether it is commercial sales or acquisition.


Appendix I

PHASE II - Addressing The Need

  • NEED
    • Stakeholder Analysis
    • Value Proposition
  • MARKET
    • Identify Advantages
    • Pricing Strategy*
  • REGULATORY
    • Identify FDA class
    • Identify FDA pathway*
    • Identify Out of US pathway*
  • REIMBURSEMENT
    • Reimbursement Analysis
    • Identify Payers
    • Evaluate Strategic Options
    • Identify Proxy Devices
  • CONCEPTS
    • Generate Concrete Concepts
  • R&D
    • R&D Plan
    • R&D Milestones Identification
    • Prototyping
    • Testing
  • INTELLECTUAL PROPERTY
    • Freedom To Operate Analysis
    • IP Implementation Plan
    • Provisional Patent Submission
  • OPERATIONS
    • Operating Plan
    • Financial Model
    • Staffing Plan
    • Market Model*
    • Cost Projections
    • Proxy Company Analysis*
  • QUALITY
    • Quality Plan*
  • CLINICAL STUDIES
    • Pre-Clinical Strategy
    • Clinical Strategy
  • BUSINESS MODEL
    • Business Model
    • Incorporation*
    • Legal Documents*
  • SALES & MARKETING
    • Sales and Distribution Model
  • FINANCIAL
    • Financial Model*
    • Identify Comparable Companies
    • Funding & Capital Milestones
    • Company valuation
    • Identify Investors
  • MANAGEMENT
    • Assign Management team

*Using publically available data. Exclusive of any external service fees.

PHASE I - Validating The Need

  • NEED
    • Need Statement
    • Disease state Analysis
    • Existing Solutions Analysis
    • Gap Analysis
  • MARKET
    • Market Analysis
    • SWOT Analysis
  • REGULATORY
    • Initial Assessment
  • REIMBURSEMENT
    • Initial Assessment
  • CONCEPTS
    • Generate Initial Concepts**
    • R&D
    • R&D Initial Activities
  • INTELLECTUAL PROPERTY
    • IP Landscape Evaluation**
  • CLINICAL STUDIES
    • Initial Clinical Plan
  • FINANCIAL
    • Initial Cost Projections
  • MANAGEMENT
    • Assign Management team
  • DELIVERY
    • Exit strategy proposal

 


Appendix II

Presentation Outline (typical slides for a thorough and effective presentation)

  1. Cover Slide
  2. Elevator Statement
  3. The Clinical Need
  4. The Solution
  5. The Market
  6. IP
  7. R&D
  8. Regulatory Strategy
  9. Clinical Studies
  10. Reimbursement
  11. Business Model
  12. Marketing and Sales
  13. Financial Information
  14. Exit Scenarios
  15. The Ask
  16. Management Team
  17. Closing Slide
  18. Timeline: History, Milestones, and Prior Funding
  19. Value Proposition (detailed for key stakeholders)
  20. Detailed Financials (revenue and expenses breakdown)
  21. Break-even Analysis (base-case versus bare bones case)
  22. Pipeline of Potential Clients (with likelihood of closing each one and potential revenue)
  23. Capital Structure (ownership of founders and current investors)
  24. Competitors (capital raises/investors)
  25. Headcount (numbers of employees, projections, key hires needed)
  26. Proprietary Aspects (not included in core deck)

Questions to be considered when generating pitch deck

  1. Elevator Statement
    1. What is the core problem the business is trying to solve?
    2. What is the solution it has developed?
    3. What key benefits will the solution deliver to its target customers?
  2. The clinical need
    1. What is the need being addressed?
    2. Why is this need important?
    3. How is the need currently being addressed (if at all)?
    4. In what ways are current solutions inadequate?
  3. The solution
    1. What is the proposed solution to the need?
    2. How will it be used (and by whom)?
    3. How does it better address the need than what is currently available?
    4. What is the value proposition?
  4. The Market
    1. Who is the target customer?
    2. What is the market size?
    3. How fast is it growing?
    4. Who are the primary competitors?
    5. How will the company differentiate itself from the competition?
    6. What are the barriers to entry?
  5. Intellectual property
    1. How will the company protect its IP?
    2. How strong is its IP positions?
  6. R&D Strategy
    1. How will the company prove (or has it proven) that the solution is technically feasible?
    2. What are the risks that must be addressed and how will they be mitigated?
    3. How will the product be manufactured and where?
  7. Regulatory Strategy
    1. How will the company get its product cleared/approved for the market?
    2. What will be required to demonstrate safety and efficacy?
  8. Clinical Studies
    1. How will the company collect safety and efficacy data?
    2. Where will the studies be performed and who will be the key investigator?
    3. What other endpoints will be studied and why?
  9. Reimbursement
    1. What is the reimbursement pathway?
    2. What codes will be used?
    3. How much resistance is anticipated?
  10. Business Model
    1. How will the company make money, including its anticipated pricing and margins?
    2. What will be the timing and frequency of revenue realization?
    3. What volume of business is needed to make the model viable?
  11. Sales and Marketing
    1. Why will customers be compelled to use the product?
    2. How will the company close sales?
    3. How will the product reach customers?
  12. Financial Information
    1. What are the company’s financing needs?
    2. What does it intend to do with the money raised (according to what timeline)?
    3. How (and when) will it generate a return for investors?
  13. Exit Scenarios
    1. How are investors most likely to achieve liquidity for their investment?
    2. When is an exit most likely to occur?
  14. Management Team
    1. Who are the key individuals that make up the company?
    2. What specific qualifications do they bring to bear?

Common questions asked by investors

  1. Technology or service concept
    1. Is the product/service concept clear? Does it make sense?
    2. Is there sufficient proof of principal or evidence of feasibility?
    3. Are there adequate proprietary aspects – patents, trade secrets, or other barriers to entry?
    4. Can it be manufactured at a reasonable expense?
    5. Are there regulatory issues?
  2. Market size and dynamics
    1. How large is the market, realistically? What is the actual addressable population?
    2. Does the company have a realistic potential to obtain substantial revenues in the market?
    3. Is the decision making of purchasers and users well understood?
    4. Are there reasonable marketing and sales costs? Sales cycles? Distribution systems?
    5. Are the business relationships between referral sources, purchasers, providers, and consumers well understood?
    6. Does the company have a strong competitive position?
    7. Is the technology/service consistent with market, regulation, and reimbursement trends?
  3. Management team
    1. Is the management team smart? Are they knowledgeable about this business?
    2. Does the management team have a proven record, particularly in this business?
    3. Do managers have high levels of honesty and integrity? Can they be trusted?
    4. Do they have reasonable expectations for the business, particularly for the difficulties of product/service development, rate of company growth, capital requirements, ultimate business size and profitability?
  4. Business model and financial requirements
    1. What are realistic revenue and expense projections for the company?
    2. How much capital will be required to reach positive cash flow?
    3. What are realistic expectations for the timing and sources of this cash?
    4. What are the realistic exit opportunities for investors in this deal?
  5. Exit scenarios
    1. How are investors most likely to realize an exit? What scenario seems most likely?
    2. For acquisition candidates, what companies are most likely to be interested? What other acquisitions have the made recently? Does the company have an established relationship with one or more of these companies? Why would these companies acquire a technology in the space rather than developing it themselves?
    3. What timeline is most realistic for achieving an exit?
    4. What are the major factors likely to influence whether or not the exit is realized?
  6. Valuation and deal structure
    1. Will the valuation of the investment in this deal afford a high probability of substantial return (40 percent or greater internal rate of return)?
    2. Will the deal allow for enough capital to be put to work to make the investment worth the time and effort?
    3. Who will be the co-investors? Are these parties good to work with?
    4. How can this investment be structured to minimize the technological and financial risk?
  7. Business planning and teams
    1. What will be the equity ownership of each of the founders?
    2. How will equity and stock options be distributed to key employees?
    3. What is the process through which these decisions will be made?
    4. What will be the responsibilities of the founders and early employees?
    5. What roles will the founder and early employees play as the company evolves and grows?
    6. Who will be the CEO (and will they be an interim CEO to be replaced by a permanent CEO)?
    7. What are the desired attributes of early employees?
    8. How and from where will important hires be recruited?