Stage I

Product Ideation and Concept Development: define the product and the intended use by the Company and the transferring to a Outsource Manufacturing Partner (OMP) draft design, prototypes, and/or component-assemblies.

Stage II

Intellectual Properties: Copyrights, IP Strategy, Due Diligence, Patents, and Trademarks.

Stage III

Initial Product Design: Product design ideas and goals are developed during this stage to arrive at a working design that will meet the specifications of the product by developing a project chartering process to define the objectives, scope, specification, deliverables, and timing of the development effort, all of which will be distilled into a detailed plan which will include refined specifications and risk analysis.

Stage IV

Process Formation: with a fixed product design in place, create project documentation and engineering drawings and the implementation of a change management process which integrates industry best practices into the development process.

Stage V

Manufacturing: Manufacturing will be increased to capacity necessary to fulfill requirements. In addition to production of a market-ready product, this stage will include the exploration of venues to improve project efficiency through in depth cost reduction analysis and, if feasible, the development of specialized hardware.

Stage VI

Reimbursement: As shifts in healthcare financing continue to influence the decision-making processes of physicians, facility administrators, it is critical to prepare reimbursement strategies, educational programs, marketing materials, patient advocacy, and financial “value analysis” sales tools.

Stage VII

Regulatory : Premarket - Premarket regulatory strategy development, project management, regulatory design, software and process verification and validation, biocompatibility review, sterilization validation review, internal audits, procedure development, labeling review and quality system management.

Submission: Submission services include dossier generation, liaison and negotiation with government agencies or in-country agents and securing clearances as well as U.S. Agent for foreign establishments.

Post-market: Post-market services includes responding to FDA inspection observations (483) and warning letters, Notified Body observations, complaint and vigilance handling, Medical Device Reporting, recalls, adverse event management, advertising, off-label promotion and post–market surveillance.

Stage VII

Commercialization Plan:

  • Complete basic research to investigate the new market, evaluate and quantify competitive products, verify market size and market potential.
  • Validate the product concept from perspective of the hospital and physician.
  • Quantify the unmet needs, determine how the hospital/physician would use the product and how it would impact his/her practice (+/-).
  • Determine Market Positioning and Product Messaging. Position against competition.
  • Develop the value proposition.
  • Generate a Marketing
  • Strategy. Develop a Strategic Business Plan or Product Launch Plan.
  • Develop Advertising and Promotional Plan.
  • Establish Action Items for Product Commercialization

Stage VIII

Investor Offering

Stage IX

Exit Strategies: Develop short term and long term exit strategies analyzing both “go it alone” and Strategic Partner Strategies.