ASQ Biomedical Ohio Discussion Group Presents

Medical Device Off-Label Promotion and Advertising Controls - Scott Blood

March 18, 2017, 8:30 am – 12pm |Fluke - 6045 Cochran Rd. Solon, OH

The medical device industry has been a regulated industry since the Pure Food and Drug Act was introduced in 1906. Regulation has been incrementally strengthened and refined as time has gone by and the industry has become more technologically advanced. One tenet of our regulated industry that has bene in place from the very beginning is establishment of consumer protection through the restriction of a company’s ability to promote products outside of their scientifically-validated approved indications for use. Included in this restriction is the sharing of certain types of data that companies can share with potential customers and their patients.

This talk will focus on some examples of misbranding and the consequences of those actions. The audience will also learn about how FDA can enforce regulation. Of course, it is not all negative and scary. The audience will also learn what they CAN do. And better yet, what they can bring back to their companies to better protect themselves and stay out of trouble. The talk is designed as an interactive exploration of the balance between regulation and enforcement, and best practices and effectively running your business in our regulated environment.

Please bring your own examples and questions.

Scott Blood

Scott Blood brings more than 20 years of professional experience and leadership in quality, regulatory, operations, and product design for life sciences companies. He is currently the Vice President of Quality Assurance and Regulatory Affairs at Solace Therapeutics, a medical start-up in the urology space located in Framingham, MA. Prior to joining Solace, Scott operated his own organization, providing Quality and Regulatory consulting services by establishing quality systems, resolving compliance problems, representing firms in FDA inspections and Notified Body audits, developing sterilization, cleaning, and design and process validations, and constructing regulatory strategies for early-stage life sciences companies. Prior to establishing his own organization, Scott has held leadership positions in Quality, Regulatory, and Operations at companies such as NinePoint Medical, Candela Corporation, InfraReDx, Inc., Fossa Medical, and PercuSurge, Inc. up through its acquisition by Medtronic AVE. Scott is the past Chair and currently the Education Committee Chair of the Biomedical Division of the American Society of Quality (ASQ). He is past Chair of the New England Biomedical Discussion Group of the ASQ, a former member of the Board of Directors of the Massachusetts Medical Device Industry Council (MassMEDIC) and a frequent lecturer on quality, clinical and regulatory topics relevant to the medical device industry. Scott is a Certified Quality Engineer and a Certified Quality Auditor through the American Society of Quality. Scott holds a BS degree from Wentworth Institute of Technology and holds Graduate-level certificates in Manufacturing and Management from University of Massachusetts at Lowell.

Tentative Agenda

8:30 – 9:00 Registration and Networking – Continental Breakfast

9:00 – 9:15 Welcome and ASQ Biomedical Division Overview

9:15 – 9:55Fluke Overview and High Level Tour

10:00 – 11:00Medical Device Off-Label Promotion and Advertising

11:00 – 11:15 Break

11:15 – 12:00Workshop

Cost - This is an outstanding mini conference for $10

RSVP - Email to allow for appropriate planning to

0.3 RUs for this mini conference