The rapid growth of digital dentistry in the United States and Europe is hard to miss. Not only at the lab level but also on the clinical side as well. Dentists are even starting to generate their own digital outputs such as study models, splints and surgical guides, while their lab partners with them on design and the more complicated cases. This type of work is more efficient. It requires less visits from the patient and quite honestly is more profitable for both the dentist and their lab.
So, is it safe to assume this growth will spread rapidly on a more global basis? While it is inevitable as it was with zirconia, implants and other contemporary procedures, the speed to market for digital dentistry has some headwinds.
What digital dentistry brings to the market is much more efficient, environmentally friendly and cost saving processes. It streamlines the analog process but at the same time brings new materials and procedures directly to the patient’s mouth. More and more materials and equipment will require Medical Device status with the various regulatory bodies. Intra-oral scanners are a class II medical device, as are many resins such as splint, temporary and permanent crown as well as denture resins.
Our industry does not have a central regulatory body. The FDA covers the interest of the United States and is observed, at least for the short term, in other North and South American countries. The MDR now is in the process of regulating the European Union and while essentially both organizations are looking out for the best interest of the patient, they each get there through unique requirements. Other regions such as the Middle East, Australia and many countries in Asia have their own regulatory bodies with, again their own specific requirements. This lack of unity is very expensive for the manufacturers, dealers and various dental brands. The processes in each country as discussed are unique and the paperwork, mandated documentation and fees all contribute to extremely high cost. The bottom line is that while regulation is necessary, it is expensive.
The impact on the smaller dental markets in various countries will be a delayed offering in the latest digital technologies. Many companies will have to examine a return-on-investment based on the overall regulatory cost versus the amount of sales the country may deliver. Brands will pick and choose which markets they will do business in. The winners in most cases will be markets like the U.S. and Europe where you get more “bang for the buck” by having the regulatory requirement absorbed over a much greater opportunity for sales.
Many new pieces of equipment or material will be open to this level of regulation as a medical device. Each piece of equipment and material will be analyzed about which markets can provide the return to launch the products in. I have no doubt digital dentistry will be available on a global basis. The largest markets will have the benefit of launching the product first and, while most countries will have available intra-oral scanners, not all countries may carry the same brands. Local manufacturers will have distinct advantages.
So keep your eyes and ears open to the latest technologies driving our exciting industry. Do your homework on multiple brands. Look to the companies that can provide premium support in your own local markets and begin today to build your lab or practice into a digital solution.