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

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.

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

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