I am at Advamed 2009 Conference in Washington D.C. capturing content by Flip Video, Apple Video and putting thoughts on Twitter. @ubiquity check out #advamed and #advamed09. I will work to blog various sessions I sit in. This blog will be cleaned up as I have Internet connections, so be kind with any spelling or run on sentences. 
Tuesday October 12th, 2009:
I sat in on a session called: Bringing medical devices to the U.S. market.
Great information and will post thoughts and info.
I moved to a second session as I wanted to hear what was said on social media. It is interesting that they are talking to this group as if they have never been on a blog before.
Crisis Prevention & Risk Mitigation 101: 5 things Every company must be prepared for:
We have 5 panelists who are talking on a variety of topics.
- Brett Berty: Sr. Recall Strategist, Stericycle, ExpertRECALL
- Christian Haller: General Manager: MPR Product Development
- Don Houghton: Director of Crisis Contact Center, Academic Network
- David Bartlett: Levick Strategic Communications
- Willie Bryant: Former FDA Senior recall coordinator, Steri ExperRECALL
Recall Communication Strategy by David Bartlet of Levic Strategic Communications:
I enjoyed listening to David and I see he even has a book. If I had a medical device recall and needed a spokesman, this would be the guy.
- Get out in front of the story: Who better to tell the story than you. Don’t let others tell your story, good or bad.
- Think like your audience: Are you in the medical device business or the safety business.
- Choose the right spokesperson: Someone who knows how to say, “I don’t know”.
- Understand the importance of the online blogs: It is not your father’s media anymore. There is no such thing as the new media. There is the media and the “old” traditional media. Treat bloggers like journalists. Journalists turn towards bloggers for info. If your not playing in that arena, your dead before you begin. The people you are trying to reach are not being reached through old media.
- Ensure your statements match regulatory actions:
- Know the regulators and stay in touch:
When a recall happens you need to think of the following.
Apologize: Don’t grovel, emphasize with your audience about the future not about the past. What your doing to make this right. The more you defend yourself you send the message that you are trying to defend against something.
Describe what happened: Don’t let the story dribble out. We have all seen the stories that should have been a one day negative story and was dragged on for weeks.
List steps you are taking so FDA and your team understands direction.
Advise consumers: Give public something they can do, they can control to solve the problem. They were reassured and started to relax. Thing about the emotional predicate with the audience your trying to reach. They want to make sure they are doing something to be involved.
EColi in Ground Beef: If you cook a hamburger to 160 degrees to kill all bad things you will be eating charcoal briqets, not many people do, but knowing about this makes you feel better with decisions you are making.
Provide frequent updates: Continuously update information and don’t be afraid I don’t know. Practice saying this: “We don’t know that yet, we are trying to figure it out and you’ll be the first to know when we have figured it out. ”
Present a human face: Remember you are communicating with real people, just like you. Remember the crisis is about them, not about you. It is understandable for you to worry about you, the millions of dollars your spending or losing but it is magnificantly irrelevant. Think patient first then the company or there could be no company in the future.
FDA Recall Audits with Willie Bryant who was the former FDA Sr. Recall Coordinator.
Here is a quick review on what happens with FDA recall audits. Lets hope you don’t have this happen.
An audit is an inspection by FDA, audit checks and status reports. The Investigation Operations Manual (IOM) is the guidance to FDA investigators.
Class 1 & @ recalls “should” have an inspection to determine the “root cause” of the problem(s).
In most cases for devices or pharmaceuticals, inspection is after notification to FDA and the public. May be immediate (class 1) or months later.
The FDA inspector will be looking at key areas and asking questions:
- Review complaint investigations for adequacy.
- Injury/Illness complaints reported under MDR?
- Has the manufacturer taken appropriate corrective action? If not, get timetable!
- Investigate all areas, control points, and circumstances which may a bearing on product deficiency including batch records, processing logs and other related logs.
- Industry conducts “effectiveness” checks, FDA conducts “audit checks”
- Class 1 recalls: FDA expects 100% documentation of consignee notification and appropriate reponse.
- Documentation of notifications, responses and returned product important to justify termination of recall.
- Weekly, bi-weekly, or monthly depending on recall circumstances and FDA desire for info.
- Critical to FDA’s evaluation of recall and your request for follow-up.
Reference: FDA’s Investigations Operations Manual, Subchatper 7.2 Recall Notification/Inspection
You can download for free on FDA’s website.
Brett Berty, Sr. Recall Strategist for Stericycle ExpertRECALL: Going to talk about comman mistakes that people make when making a recall. Have done over 1500 recalls for companies.
Three Goals of any recall:
Protect the Public
Protect Your Brand
Recall Lifecycle: 7 Steps to consider.
So many companies do not even have a plan about what they would do if they get a recall. Practice, Practice Practice.
1: Preparation: What are you doing right now to be prepared for recall. Do you have team in place? SOP in place? Do you understand your roles and responsibilities? Do a mock recall and get everyone together and watch decision making process? Everything you think is right will be wrong.
2: Target / Consignee Identification:
3: Notificaton Management: Who are your customers? How does the notification work? Can’t just email out to a list? If you sell through distributor, will they give you a list, will they notify their customers.
4: Response Management:
5: Product Processes:
6: Remedy : Have to know what the remedy will be before you send out recall info. You may need to send out recall before having an remedy but control this with proper press release and communication as David Bartlett from Levick Strategic Communications discussed.
7: Resolution Management:
Additional questions to ask:
What is my call to action. Keep the call action simple. Here is what you need to do and here is what we are going to do.
The big take away: Have a plan, practice your plan, re-work your plan, prepare and have a spokes person and train your executive team on what to say and how to say it.
More info to follow as I continue to listen and meet some amazing people.
Greg Olson :: Ubiquity
Ubiquity specializes in generating demand for life science companies.
Greg@ubiquitygroup.com 303-962-8700
