Reimbursement by Private Payers
Audio Conference - July 27, 2006

Medical device manufacturers need private health plans to provide reimbursement for their products. Find out who the private payers are and the criteria they use when deciding whether or not to provide reimbursement for specific medical devices.

---Comments by Participants---  

"This teleconference was very helpful in learning the basics for working with private payers."
   Beth Guevara, Respironics

Clinical Studies for FDA and CMS
Audio Conference - June 1, 2006

Both FDA and CMS want clinical data-more often than ever, on more products than ever. Yet clinical studies cost a fortune. And they take forever.

Find out ways to do one clinical study that works for both FDA and CMS?

---Comments by Participants---  

"The audio conference was clear and informative."
   Patricia vonHelmst Davis, Boston Scientific

Preparing a 2006 Timeline For Getting Reimbursement
Audio Conference - December 6, 2005

CMS is unforgiving. It sets strict deadlines for coverage, coding, and payment applications. If you miss a deadline, your application could be delayed a year or more. Find out if you know the rules.

---Comments by Participants---  

"The topics offered are always unique, timely and relevant - much more so than those offered by other organizations. This is where I look first for educational opportunities."
   Sandra Bryant, Sanuwave

Meeting the Challenges in Implementing
ISO 13485, QSR and Risk Management
Audio Conference - November 22, 2005

Ed Kimmelman, Convenor ISO 13485 Working Group, recently presented an audio conference on the actions that firms can take to meet some of the challenges in implementing 13485, QSR, and risk management. The audio conference recording contains information that firms can implement immediately.

---Comments by Participants---

"The training was well organized and technically perfect. The presentation provided good background for daily use and training of colleagues."
     Konrad Schmitt, Ethicon GmbH

"The information presented was worth the time and money."
    Harbant Grewal, R2 Technology, Inc

"Good conference for anyone associated with compliance training. "
    Maclean Dan-Jumbo, US Surgical

Calculating the Cost of Poor Quality
Audio Conference - November  17, 2005

Firms spend a tremendous amount of money on product complaints, testing, and rework activities that fail to enhance product quality. If firms calculated the cost of poor quality (COPQ), this would allow them to appreciate the magnitude of these expenditures and lobby management for more resources for preventive action.

---Comments by Participants---

"This program outlines the basic 'big picture' model to introduce management to the concept of the cost of quality and the savings 'good' quality practices can bring to the bottom line. By providing these basics, you will set the framework to show the value that the quality function will bring to every aspect of the business."
    Mark Swanson, Medtronic, Inc.

"A practical approach for the application of a very valuable management tool."
    Benno Dunn, Cyberonics

Integrating a CMS Reimbursement Strategy
into Your FDA Planning Process
Audio Conference - August 11, 2005

Medical device regulatory professionals spend years learning the FDA product clearance process. Many times they believe that getting reimbursement for their product is someone else’s job. This is wrong. Medical device firms may now have to satisfy CMS in structuring their clinical trials, conducting their post-approval studies and implementing their product launch strategies.

---Comments by Participants---

"I am currently working on developing a protocol for a new device. After participating in this conference, I know now that I have an opportunity to further refine and define my study to potentially meet the needs of both FDA approval and CMS approval, which will save my company some time and money in the long run. Well worth the 1.5 hours out of my schedule today. Thanks!"
    Tami Womack, Guidant

"After just this 90 minute conference, I now feel comfortable in describing to others in my organization the scope of CMS reimbursement, including -

• how to approach evaluating whether a particular planned medical device might be appropriately be pursued for CMS reimbursement
• the major factors to address in a development plan that would assure the best chance of achieving CMS reimbursement status."
      Leonard Berman, Pall Lifesciences

"The conference was a great way to start feeling comfortable with CMS for someone with regulatory background in just one afternoon."
    Meagan Bailey, Becker and Associates Consulting