Regulatory Pathways

  • Regulatory Assessment: is a 510(k) or a PMA required?
  • 510(k) content creation: assemble the required components to support a 510(k) submission
  • PMA pre-submission strategy and FDA meeting prep: scheduling and conducting a pre-submission meeting with the FDA to investigate / discuss submission timing and strategy
  • Study design and PMA submission prep: draft study protocol creation and creation of a modular shell submission package
  • Label writing and marketing claims: draft proposed, desired claims, indications and instructions for use. 
  • PMA panel prep and presentation creation: from creation of the pivotal data presentation to Q&A back-up slides, and mock panel practices, V² can help you prepare for panel
  • Audit prep and managing an inspection: SOP review and mock inspection ‘drills’

Design and Development

  • From idea to market : Working with Clinicians and Manufacturers to assist in making your concept a standard of care.
  • Background and patent research: Understand you and your competitor’s products and opportunities. Maintain/develop Intellectual Property to ensure market exclusivity and understand the competitive landscape.
  • Market assessment: Identify market demographics to forecast product costs/opportunities.
  • Manufacture-ability assessment: Ensure your design success by understanding the Materials and manufacturing technology available.
  • Prototyping and engineering resourcing
  • KOL prototype assessments
  • Design History File creation from concept to transfer to Manufacturing
  • Process and Product Validation

Product Launch Support

  • Development of approved claims-based sales & marketing materials: avoid regulatory conflict by assuring that all marketing and promotional materials remain “on-label”
  • Customer Selection, training criteria guideline development: ensure optimal outcomes and a sustainable business plan by essentially protecting results via careful distribution
  • Customer and Sales training: fully brand all training materials, while maintaining labeling accuracy and best clinical practices focus
  • Advisory Board organization and implementation: KOL physicians and patient groups convened to provide feedback on sales and marketing activities and new plans
  • Press Releases and social media messaging: V² consulting can assist you with protecting your brand and reputation in the marketplace.

Clinical Study

  • Literature Searches, reviews, summaries, white papers; V² can provide comprehensive and concise snap-shots of a clinical topic, treatment modality or surgical intervention to aid you in decision making and strategic planning in the area.
  • Medical writing / editing: Submission-ready manuscript preparation, from ‘scratch’ or from your draft.
  • KOL expert opinion access: Manuscript review, challenging clinical case advice
  • FDA labeling review: maintenance of on-label training and promotion
  • Clinical Pathways; Best-Practice clinical applications

Key Opinion Leader (KOL) Development

  • Physician and Sales training development: Working with leading clinicians, V² Consulting can create a comprehensive training program customized for physicians, mid-level providers and industry professionals; from life seminar programs to on-line learning modules.
  • Course content creation; utilizing an extensive KOL network, current, best-practices and clinical standards, presented by leading KOL faculty
  • Live event production: conference style events to lunch-and-learn modules
  • Webinars; individual training: live coaching sessions and programed instruction options
  • On-line learning modules