Course "Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

Course Description:

This seminar will help medical device marketing professionals to better understand the myriad statutes and regulations that confront and impact their business. It will provide a comprehensive look at the dos and don’ts with regard to the following regulations:

  • The Federal Food, Drug & Cosmetic Act as it relates to advertising and promotion.
  • The Anti-kickback as it relates to remunerative relationships with those who purchase or prescribe your products.
  • The False Claims Act as it relates to seeking reimbursement for your products.
  • The False Claims Act as it relates to seeking reimbursement for your products.
  • HIPAA.
Day one of the seminar will begin with a high level discussion of advertisement and promotion requirements for medical device marketing including 510(k) submission and approval. It will also review the Anti-kickback Statute, False Claims Act/Reimbursement, Physician Sunshine Payment Act and State Advertising and Promotion Laws and Reporting. Attendees will learn to establish a compliance program in order to avoid FDA and OIG/DOJ enforcement actions, fines and penalties.

On day two, the instructor will focus on the promotional side of marketing a 510 (k) device, covering the three buckets of “promotion”, “dissemination” and “communication”. Attendees will learn the issues in promoting a specific claim and how to conduct a lawful off label dissemination and how to engage in different “communication” activities.

Learning Objective:

  • Understand the depth, breadth and overlap of the laws affecting promotion.
  • Know how to comply with and navigate the regulatory/legal landscape.
  • Understand how to engage in off-label dissemination/responding to unsolicited requests.
  • Know the issues and potential liabilities surrounding reimbursement communication strategies.
  • A structure for analysis of how to “whiteboard” a promotional strategy.
  • Understand recent FDA enforcement emphasis involving advertising and promotion and reimbursement.
  • Learn the importance and contents of a compliance program.

Who will Benefit:

This seminar will be beneficial for the following medical device personnel:

  • Senior executives of medical device companies
  • Medical device marketing management
  • Sales management
  • Regulatory affairs - vice presidents, directors and managers
  • Attorneys (In-house or outside counsel)
  • Compliance management
  • Clinical affairs management

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 1:30 PM)

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.

Meet Your Instructor

Mark DuVal
President, DuVal & Associates, P.A

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.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

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