Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

• Advertising and Promotion
• The basics of intended use, adulteration and misbranding
• Understanding what constitutes a “claim”
• Knowing the contours of on and off-label including the new “Coronia” decision
• Dealing with a 510(k) general intended use statement in making specific use claims
• Explaining direct-to-consumer advertising
• Help seeking/reminder ads
• Dissecting a fictitious ad
• Social media
• Off-label dissemination/Unsolicited requests
• FDA enforcement
• Anti-kickback Statute
• The purpose and scope of the statute
• The kinds of promotional activities/remuneration it covers, e.g., consulting payments including stock/options/royalties, referral marketing, co-marketing, grants, discount, rebates, physician-owned distributorships, etc.
• Outlining the Safe Harbors which permit certain forms of remuneration
• OIG/DOJ enforcement
• False Claims Act/Reimbursement
• What is a False Claim?
• The interplay between a false claim and off-label promotion or dissemination
• How to make a false claim—advice, services, promotion
• What to do to avoid liability
• OIG/DOJ enforcement
• Physician Sunshine Payment Act
• Understanding definition of what is reportable
• Information required for reporting
• Exclusions
• Fines/penalties
• State Advertising and Promotion Laws and Reporting
• Establishing a compliance program
• Expectations of the Office of Inspector General
• Code of Conduct/Compliance program
• Compliance Officers and Committees
• A Code on Interactions with Health Care Professionals
• What subsidiary standard operating procedures an organization should have

• Covering “Graduate-level” Promotional Topics: the three buckets of “promotion,” “dissemination” and “communication”
• The issues in promoting a specific claim with a general intended use in a 510(k) device with workshop
• How to conduct lawful off-label dissemination including what is “disseminable,” can sales reps disseminate, how to do it procedurally
• Engaging in “communications” activities such as use of corporate website, public relations/press releases, use of consultancies, market research, grants for continuing medical education and physician initiated trials, notices of availability for physician and patient recruitment, publication planning, exhibiting at medical conventions, etc.

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.