Exclusive: IAMERS chief and former senior FDA staffer talk reseller market challenges

Exclusive: Chefe de IAMERS e desafios sênior anteriores do mercado do reseller da conversa do staffer do FDA

por Brendon Nafziger, DOTmed News Associate Editor | July 26, 2012

DOTmed News: Why do think the UDI has the potential to be the "open door" that regulations on the medical equipment remarketer industry can come through?

Diana Upton: We don't know what they're going to do in terms of regulation, but this would certainly be their opportunity.

Casper Uldriks: When the whole issue of single use and reuse came up in 1997, one of the things that the agency discussed behind the scenes that we didn't share with anybody was that the easiest way to regulate an industry group like IAMERS is labeling. Anytime you're using labeling it's easy to expand the scope (of regulation). There are two reasons for this. One, the language in the regs is so vague, you can interpret it as you want. Two, it's a matter of enforceability. It's easier to enforce labeling violations.

Why are you concerned about the UDI public database in development, at least for resellers?

Upton: I fear that this (UDI) database is somehow or another going to give market access to larger companies and put them at an unfair advantage. If the data is open to everyone, a larger company would find it easier to analyze the data than a smaller company would. The more personnel you have, the more you can do.

How would a bigger company use the database to its advantage?

Uldriks: Let me give you an example. I had a sister who worked for Kellogg. She recently retired. She developed a worldwide database, she was analyzing what the other cereal companies were doing, and (the analysis) went out on a daily basis. The same capacity is here for large medical manufacturers to create daily updates to know what's going on. Smaller companies can't do that.

Upton: They could know where their competitors' customers are. Think how easy it would be to say, "The XYZ clinic just bought a used MRI from the ABC company, and the product was this old, so we can analyze and determine when they might be in the market again." They gain market access, the ability to know what their completion is doing with their customers, and it also puts them in a position to know where every single piece of gear is.

Uldriks: They can also do regional forecasts. If you understand the regional medical area (such as turnover), you can pretty well predict what else is going on there in the next year or so.

Will the UDI database really be that granular?

Upton: I think it would have to be, to be meaningful.

Uldriks: It wants to know where everything is, and when it gets there. As Diana just said, in terms of confidential commercial information, what a goldmine!

When does all this take effect?

Upton: The implementation of this for Class 2 devices, which is what IAMERS members would be selling, would be 2014 or 2015. That's what Jay Crowley (with the FDA) told me, and it's in that document.


(132) (5) (42) Don Bogutski In summary of the UDI discussion July 26, 2012 11:58 This interview should serve as a wake up call to IAMERS Members and non-members alike. We face a growing number of interested, well funded entities that see the vibrancy of our market for pre-owned systems, parts and iOS service. Their number and level of interest expands as the new healthcare market place shrinks. These parties understand that regulations are the most effective way to gain control over this valuable market segment. They are prepared to legislate and regulate us out of existence. If you participate within the frame work of used items, don't allow your company to be lulled to a certain death because the glacial pace of enactment and enforcement puts you to sleep. Individually we are too poor, too weak and too distracted to counter the OEM's momentum. There is no better way to engage this threat, then to become an ACTIVE IAMERS Member. Log inor Register to rate and post a comment Michael Wray More commentary on the UDI discussion July 27, 2012 02:54 When you realize what is happening globally and how these global changes are dramatically affecting small business players in all avenues of the economy here in the US You realize what is at stake. The very existence of our way of life. Our ability to make a living and what will happen when 3rd party service and sales go away. What you have here in the United States and around the world is Large Global Multi-National corporations who have billions of dollars to influence National governments throughout the world. They shut off used and refurbished markets through back door secret deals and shut off these markets through the National Health departments except for those large multi-national corporations equipment. In the US for years are industry pointed to 21CFR as some type of a way to provide a least a basic set of schematics access to calibration and some basic troubleshooting and repair information allowing manfacturer, end user, and 3rd party the ability to work on and repair equipment. In the early years of these regulations Manufacturers pretty much went along with these requirements. Today you will find most manufacturers give practically no information on the equipment. They limit access to everything but the most mundane and basic information. Many today do not even provide schematics of the equipment. They are not worried, they know that the FDA will not do anything. And on Capital Hill they have an army of lobbiest working to make it easier on themselves and harder on everyone else. From my perspective the only way foward is for legislation to mandate and reinforce the basics laid out in 21 CFR covering more in depth due to the nature of every thing being software driven.To provide a more level playing field for the end users and for 3rd party providers. Short of this and due to the way the FDA interprets 21CFR today. I do not see a long term way foward for this industry. And when the OEM's get rid of us. Watch equipment costs and repair costs skyrocket. We will go back to the days of $250,000.00 dollar CT contracts. And supposed saving in healthcare will be just a mirage. At the turn of the last century are forefathers saw monopolies as a bad thing something that needed to be broken up for the good of society. Today in healthcare you have a small handful of large multi-national global corporations that control a huge percentage of the medical equipment sold in this country and around the world. In most other parts of the world their is no other way to get service or sales except through the OEM. The United States is one of the final area's in the world that has a truly free exchange of medical equipment of all types and has many different people selling and servicing this equipment. Free enterprise with a truly neutral and balanced umpire. That umpire in our field is the FDA. From my perspective the FDA seems very tilted towards the OEM's.I think the point that Ms. Upton made in this interview reinforced that. These are my thoughts I would like to hear others. Thank you Michael Wray Log inor Register to rate and post a comment
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