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Trilogy Tidings
October 2010 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
in this issue
The Folding Chair
Industry Responds to FDA
Combined FDA/CMS Review?
Resources from our Archives
What does Trilogy do?

My monthly topics are usually determined either by what I've been engaged to do for a client or by what I download from "the cloud". This month it's both.

It's hard to imagine anyone who is not convinced of the critical importance of listening to one's customers today. But there may be some doubters out there (not you, of course). I offer some thoughts and suggestions on this topic.

The industry has begun to respond to FDA's findings on the need to alter its 510(k) device clearance track. I also bring you up to date on that saga. Finally, FDA and CMS may someday combine forces to speed clearance and coverage decisions for medical devices; how about that!

Regards,
Joe

Change Ahead
The Folding Chair
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Don Peppers, founding partner of Peppers & Rogers Group, related this story in 2008:

A sales manager at Siemens AG often carried a folding chair into internal meetings. At first, the other sales representatives in the meeting were puzzled. "Who are you expecting to join us?" some asked. "Shouldn't we just get some more chairs brought in here?" others suggested.

"No", the manager replied, "this is my customer's chair. I brought it into the meeting so my customer can sit right here and listen to our discussion."

The simple presence of the folding chair always changed the character of the conversation. It reminded everyone of the importance of customers and caused all to ask, "What would our customer say?" and "How would our customer react?"

What a great way to emphasize the critical importance of accounting for customer views in your business decisions! (Wish I'd thought of it.)
We do a lot of voice-of-the-customer work at Trilogy, so I decided to share some of our accumulated wisdom (we claim, you decide) on this subject. You will find my thoughts here. They include 10 hints that will help make your VOC program a smashing success. Or, if you're so inclined, you can view and listen to my presentation on this topic.
I'd be pleased to discuss your own VOC needs with you and support those needs as you see fit.
But beware! Your VOC initiative may not be enough. You must also be on the alert for game-changers, hard-to-detect market upsets in the works that not even your customers see coming. This topic is nicely covered in the September issue of Drug Delivery Technology in an article by Derek Hennecke.
Industry Responds to FDA
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FDAThe first official reaction to the agency's proposed changes to the 510(k) process was released by AdvaMed on September 15, 2010. That reaction was largely based upon a study commissioned by Battelle Memorial Institute (one of my alma maters) that analyzed publicly available information from FDA and companies with affected products. The Battelle study (which is available here) demonstrated that of the nearly 47,000 medical devices cleared by FDA via the 510(k) process since 1998, only 0.16 percent were involved in a serious recall event.

AdvaMed's CEO, Stephen J. Ubl, summarized his organization's position: "These studies reinforce the fact that the basic structure of the 510(k) process is sound. So we believe FDA's recommendations should be targeted, focusing on a small number of specific device types where changes will result in a clear public health benefit without creating new hurdles for the vast majority of 510(k) devices".

While a "serious recall event" may not be the only criterion to consider in the effort to reform the 510(k) process, it seems to me to go a long way toward convincing the agency to tread lightly in its reformation.
Combined FDA/CMS Review?
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And here's a piece of good news from Washington: On September 16, 2010 FDA and CMS proposed a pilot project for devices which could ultimately result in tandem review by FDA and CMS to speed up coverage decisions. You will find a nice summary of the rationale and a list of questions posed to industry in a joint memorandum from the two agencies. Then, if you want the real skinny, check out the views of my associate, Ed Berger.

It's about time! Let's get on with that initiative, the sooner the better.
Resources from our Archives
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Check out our Reading Room to view my published articles, presentations and white papers on a variety of topics.
And, you can examine an archive of my prior newsletters (since February 2007).
What does Trilogy do?
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Trilogy Associates facilitates business growth and renewal through commercialization of new products, providing the following services:
  • Opportunity assessment
  • Business planning and enterprise growth strategies
  • New-product conceptualization, commercialization and marketing
  • Market research and competitive assessment
  • Business development and partnering
  • Market and technological due diligence
  • Assessment of the therapeutic and diagnostic potential of novel technologies
  • Design of efficient and effective development strategies for early-stage biomedical products
  • Business and technical writing/publishing

Inquiries to establish whether and how we might support your business initiatives are always welcome. Contact us.

Contact Information
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ContactInfoJoseph J. Kalinowski, Principal
919.533.6285
LinkedIn Profile: www.linkedin.com/in/trilogy
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