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Can Dental Products be Evaluated Faster?
CAN DENTAL PRODUCTS BE EVALUATED EASTER?
G O R D O N J. C H R IS T E N S E N , D .D .S ., M .S .D ., P H .D .
Q ; am asked frequently by practitioners why evaluation of dental products by the profession is such a slow procedure. A new product comes on th e m arket, and m any m onths or even years pass before its clinical acceptability is confirmed. Couldn’t there be a faster, easier method? Shouldn’t this rapid evaluation of products b6 accomplished by some overall organization? W ouldn’t it be helpful for practitioners to know about products before they are m arketed? The problem sounds as though a solution would be simple, but th at is not the case. The following inform ation may help in understanding the situation and accepting it. C U R R EN T M E TH O D S ARE S LO W !
The cu rren t system of product evaluation in the United States is slow, but it represents private enterprise well. How does it work? The several stages follow: ™ A com pany develops a product and, before m arketing, most companies accomplish their own laboratory and clinical testing. Depending on its category, the product m ay or may not require governm ent approval or acknowledgment. ■" Frequently, before m arketing, a product is tested by dental schools or independent-testing orga nizations, and usually changes are made in the product by the
com pany as a result of the prem arket evaluations. ■■ At the time the product is marketed, it has probably had significant prem arket research, but m ost products have not been accepted by any official approving organization. ™ By this time, independent testing organizations or schools have prelim inary evaluations under way or completed. The practitioner buys the product if it appears useful, the advertising looks impressive, prelim inary research is promising, some wellknown clinicians or independent testing organizations support it and the com pany has a good reputation. Now the real clinical evaluation begins. The product is sold by the thousands and used by practi tioners for its intended purposes. If everything goes well during patient care as the m anufacturer has planned, the product is a success, but usually a few problems are discovered during patient care. These problems are reported to m anufacturers by practitioners and researchers, and they are corrected by the m anu facturer. Occasionally, major problems create more significant practi tioner and patient reactions, including lawsuits, withdrawal of the product from the market, or major modifications of the product by the m anufacturer. ™ At this time, independent
clinical testing organizations and schools have reported early study results on the product. « In addition, the product has received practitioner acceptance or rejection, and it m ay be providing financial success for its developers. Some m anufacturers, seeking Am erican Dental Association acceptance, have had research projects u n d er way at various academic or private institutions, and scientific data are starting to confirm or reject empirical observations of practitioners. If the product is a success, other m anufacturers are copying it and selling their own versions. Short-term success of the product has been confirmed by its use characteristics, and knowledge of the product has spread throughout the profession by m anufacturers, speakers or publications. ™ The successful product becomes a part of dental practice. Scientific publications about the product start to appear, usually confirming and supporting practitioner empirical observations. Discussion and debate about the product and its advantages and disadvantages are active in academ ic circles, and its clinical use has probably started in some dental schools. “ Enough scientific research has been completed to allow the product to receive provisional American Dental Association approval, confirming its acceptability. For the practitioner JADA, Vol. 122, April 1991
73
EATING RIGHT CAN HELP REDUCE THE RISK OF CANCER.
It can also help you reduce your weight.
A nd since a 12-year study shows that being 40% or more overweight puts you at high risk, it makes sense to follow these guidelines for healthy living! Eat plenty o f fruits and vegetables rich in vitam ins A and C —oranges, cantaloupe, strawberries, peaches, apricots, broccoli, cauliflower, brussel sprouts, cabbage. Eat a highfiber, low-fat d iet that includes whole-grain breads and cereals such as oatmeal, bran and wheat. Eat lean m eats, fish, skinned poultry and low -fat dairy products. Drink alcoholic beverages only in m oderation. For more information, call 1-800-ACS-2345.
AMERICAN “V CANCER f SOCIETY® 74
JADA, Vol. 122, April 1991
who is very conservative about using new concepts, this is the time to accept the new product. *■ By now, another concept is starting through the previously described cycle to replace or compete with the now acceptable product. ARE THERE A L T E R N A T IV E S ?
Yes, there are alternatives, but they may be worse than our current system. In several countries, government agencies evaluate new products, and they are not available for sale in those countries until they pass governmentally accepted research projects. This process for evaluation impedes use of new products for up to several years, and it places the burden of evaluating products on governmental agencies that may or m ay not represent practitioners. Dr. Christensen is Another fou nder and senior consultant, Clinical potential system Research of product Associates, Provo, Utah, and a w e llevaluation uses known le cturer in the councils and clinical practice of committees of dentistry- He has his m aster’s degree in professional restorative dentistry societies to and his do cto rate in education and evaluate new psychology. products and pass judgm ent on them rapidly. This system can work, bu t it is slower than our current system in the United States and is impeded by the norm al adm inistrative channels of large organizations. T H E C O N C L U S IO N ?
Our current system of product evaluation and acceptance in free
enterprise American dentistry has its challenges. It places a significant am ount of the evaluation burden on you and m e private practitioners. It leaves us in a state of confusion for a while after new products are introduced, and we m ust depend on m anufacturers, independent testing organizations and schools during the first stages of product use. Eventually, approval of a product by the American Dental Association confirms its usefulness. In spite of the weaknesses of our system, the known alternatives for product evaluation do not appear to be more attractive. The solution? Accept new products or concepts slowly, and use them on a selected few patients. Make accurate clinical records using brand nam es for product identification. Report problems with products to m anufacturers immediately. They w ant to know if their products work well or poorly. Be active in study clubs and continuing education dealing with new products and techniques. Yes, the system is slow, but the excitem ent of private evaluation of products is a stim ulation for you and me, and it is probably better than you thought. ■
G O R D O N J. C H R IS T E N S E N , D .D .S ., M .S .D ., P H .D .
Q ; am asked frequently by practitioners why evaluation of dental products by the profession is such a slow procedure. A new product comes on th e m arket, and m any m onths or even years pass before its clinical acceptability is confirmed. Couldn’t there be a faster, easier method? Shouldn’t this rapid evaluation of products b6 accomplished by some overall organization? W ouldn’t it be helpful for practitioners to know about products before they are m arketed? The problem sounds as though a solution would be simple, but th at is not the case. The following inform ation may help in understanding the situation and accepting it. C U R R EN T M E TH O D S ARE S LO W !
The cu rren t system of product evaluation in the United States is slow, but it represents private enterprise well. How does it work? The several stages follow: ™ A com pany develops a product and, before m arketing, most companies accomplish their own laboratory and clinical testing. Depending on its category, the product m ay or may not require governm ent approval or acknowledgment. ■" Frequently, before m arketing, a product is tested by dental schools or independent-testing orga nizations, and usually changes are made in the product by the
com pany as a result of the prem arket evaluations. ■■ At the time the product is marketed, it has probably had significant prem arket research, but m ost products have not been accepted by any official approving organization. ™ By this time, independent testing organizations or schools have prelim inary evaluations under way or completed. The practitioner buys the product if it appears useful, the advertising looks impressive, prelim inary research is promising, some wellknown clinicians or independent testing organizations support it and the com pany has a good reputation. Now the real clinical evaluation begins. The product is sold by the thousands and used by practi tioners for its intended purposes. If everything goes well during patient care as the m anufacturer has planned, the product is a success, but usually a few problems are discovered during patient care. These problems are reported to m anufacturers by practitioners and researchers, and they are corrected by the m anu facturer. Occasionally, major problems create more significant practi tioner and patient reactions, including lawsuits, withdrawal of the product from the market, or major modifications of the product by the m anufacturer. ™ At this time, independent
clinical testing organizations and schools have reported early study results on the product. « In addition, the product has received practitioner acceptance or rejection, and it m ay be providing financial success for its developers. Some m anufacturers, seeking Am erican Dental Association acceptance, have had research projects u n d er way at various academic or private institutions, and scientific data are starting to confirm or reject empirical observations of practitioners. If the product is a success, other m anufacturers are copying it and selling their own versions. Short-term success of the product has been confirmed by its use characteristics, and knowledge of the product has spread throughout the profession by m anufacturers, speakers or publications. ™ The successful product becomes a part of dental practice. Scientific publications about the product start to appear, usually confirming and supporting practitioner empirical observations. Discussion and debate about the product and its advantages and disadvantages are active in academ ic circles, and its clinical use has probably started in some dental schools. “ Enough scientific research has been completed to allow the product to receive provisional American Dental Association approval, confirming its acceptability. For the practitioner JADA, Vol. 122, April 1991
73
EATING RIGHT CAN HELP REDUCE THE RISK OF CANCER.
It can also help you reduce your weight.
A nd since a 12-year study shows that being 40% or more overweight puts you at high risk, it makes sense to follow these guidelines for healthy living! Eat plenty o f fruits and vegetables rich in vitam ins A and C —oranges, cantaloupe, strawberries, peaches, apricots, broccoli, cauliflower, brussel sprouts, cabbage. Eat a highfiber, low-fat d iet that includes whole-grain breads and cereals such as oatmeal, bran and wheat. Eat lean m eats, fish, skinned poultry and low -fat dairy products. Drink alcoholic beverages only in m oderation. For more information, call 1-800-ACS-2345.
AMERICAN “V CANCER f SOCIETY® 74
JADA, Vol. 122, April 1991
who is very conservative about using new concepts, this is the time to accept the new product. *■ By now, another concept is starting through the previously described cycle to replace or compete with the now acceptable product. ARE THERE A L T E R N A T IV E S ?
Yes, there are alternatives, but they may be worse than our current system. In several countries, government agencies evaluate new products, and they are not available for sale in those countries until they pass governmentally accepted research projects. This process for evaluation impedes use of new products for up to several years, and it places the burden of evaluating products on governmental agencies that may or m ay not represent practitioners. Dr. Christensen is Another fou nder and senior consultant, Clinical potential system Research of product Associates, Provo, Utah, and a w e llevaluation uses known le cturer in the councils and clinical practice of committees of dentistry- He has his m aster’s degree in professional restorative dentistry societies to and his do cto rate in education and evaluate new psychology. products and pass judgm ent on them rapidly. This system can work, bu t it is slower than our current system in the United States and is impeded by the norm al adm inistrative channels of large organizations. T H E C O N C L U S IO N ?
Our current system of product evaluation and acceptance in free
enterprise American dentistry has its challenges. It places a significant am ount of the evaluation burden on you and m e private practitioners. It leaves us in a state of confusion for a while after new products are introduced, and we m ust depend on m anufacturers, independent testing organizations and schools during the first stages of product use. Eventually, approval of a product by the American Dental Association confirms its usefulness. In spite of the weaknesses of our system, the known alternatives for product evaluation do not appear to be more attractive. The solution? Accept new products or concepts slowly, and use them on a selected few patients. Make accurate clinical records using brand nam es for product identification. Report problems with products to m anufacturers immediately. They w ant to know if their products work well or poorly. Be active in study clubs and continuing education dealing with new products and techniques. Yes, the system is slow, but the excitem ent of private evaluation of products is a stim ulation for you and me, and it is probably better than you thought. ■