- 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.
- 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