Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media: One and a Half-day In-person Seminar

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.