Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media: One an (Marketing Your Medical Device)
|Event Date/Time: May 16, 2013 / 8:00 am - (PST)||End Date/Time: May 17, 2013 / 1:00 pm - (PST)|
|Abstract Submission Date: May 16, 2013||Time: 07:00:00 - (PST)|
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.
- 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
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.