by Paul Feuerstein, DMD
My recent trip to the International Dental Show in Cologne, Germany, was somewhat frustrating.
I saw many products and processes that were amazing, but not available in the U.S. Some were improvements to current devices, such as new versions of caries detection devices. The new ones looked like the devices we currently use with a new LED frequency or an improved method of detection. But I was told to "wait until we have approval."
Others, such as periodontal disease treatments, were using special solutions, low level lasers, or even specific frequency lights, but they will not be available in this country anytime soon, if ever. Some things I saw even seemed to be a bit dangerous, but I was assured they are being successfully used in a variety of countries.
Some companies were making new claims but offered no hard clinical proof. An example was a new "very short" implant from Italy that had 2.5 mm of thread. I was told, "It works. My father has had one for a few years."
As I asked how soon we might see some of these products in the U.S., company reps consistently told me that they were waiting for the FDA or something called 510(k) approval. This process — called Section 510(k) of the Federal Food, Drug, and Cosmetic Act — requires device manufacturers to register to notify the FDA at least 90 days in advance of their intent to market a medical device.
If the device is an update of an existing process, proof of the similarity can be presented. The agency evaluates this claim. Whenever it completes an evaluation, it can issue an OK. This is where many products get stuck. I've seen several early announcements of a product launched at, for example, the ADA meeting.
I'm then told it will have to wait for Greater New York, Yankee, Chicago Midwinter, or the next year's ADA meeting. Often, the FDA will return the application for further clarification.
When a new device or process is launched, it's a necessary nightmare, and it must go through "premarket approval" (PMA). Paraphrasing U.S. Code 360e, "The PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, demonstrating that it is safe and effective for its intended use."
In a study of more than 200 companies, "U.S. companies that navigated the 510(k) pathway stated that it took them an average of 10 months from first filing to clearance. Responses from those who had communicated with the FDA prior to making a 510(k) submission indicated that the total elapsed time from first communication to clearance … was an average of 31 months."
The shocker is the cost. The report further states, "According to the survey data, every additional month a company spends attempting to obtain the 510(k) costs nearly $400,000 per month and a total of more than $750,000 for a PMA product. These high expenditure levels may help drive higher prices for medical technologies when they finally reach the market, directly contributing to increased health care costs in the United States." This statement should give you an idea of why some of our products have such high costs for "just a little box with some wires."
As a result, I would rather not tell you about all of the cool things I saw at IDS, at least in print. I have leaked previews of some on www.dentistryiq.com, as well as on my Facebook dental technology page and blog. I watch my email every day to see if Company A has received approval so I don't have to go into a backroom at a dental meeting to see their product.
I should have a few terrific ones to tell you about as this year progresses. So, as they say, stay tuned.
References available upon request.
Paul Feuerstein, DMD, installed one of dentistry's first computers in 1978, teaching and writing about technology since then while practicing general dentistry in North Billerica, Mass. He maintains a website (www.computersindentistry.com), Facebook page (Paul-Feuerstein-DMD-Dental-Technology), is on Twitter (@drpaulf), and can be reached via email at [email protected].
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