From resins and floss to prosthetics, alloys, powered tools, and advanced SaMD digital devices, dental medtech plays a vital targeted role in the lives of everyone making their customary trip to the chair.
Like any medical device manufacturer, dental medtech companies are facing the squeeze of increasing competition, sharper regulatory scrutiny, and post-COVID economic downturn.
Only world class quality management and operational innovation can separate the strongest dental medtech manufacturers from the rest, and the strongest of the pack will have a critical role to play in lifting the quality of dental care to new levels across the next decade.
PREPARING FOR THE DIGITAL REVOLUTION
The highly fragmented nature of the dental industry has impeded the levels of investment in digital medical systems seen in other sectors.
With only around 15% of British dental clinics in consolidated private chains, a figure that drops to less than 10% in continental Europe, individual clinics have found it difficult to scare up the funds needed for investment in the latest digital medical systems.
But this is changing. Hub-and-spoke referrals, external investment models, resource pooling and greater affordability are all expected to give the dental world unprecedented appetite – and capacity – for digitization in the next 10 years.
Dental SaMD manufacturers will play a key role in serving this demand for greater automation and digitization of the dental care process, including more remote patient monitoring, AI-supported imaging and visualization of treatment options, and deeper data integration between clinics and labs.
And while CAD/CAM systems remain limited in dental laboratories, with only around a fifth of American and European clinics using them, increasing adoption of these systems will have a knock-on effect for analog hardware dental medtech, too. Manufacturing should and will become faster, simpler and more standardized, making outsourcing a less viable option and triggering a stronger in-house medical device manufacturing push.
Which brings us to…
QUALITY-CENTRIC DESIGN AND DEVELOPMENT
The digitization of dental care won’t be restricted to medtech manufacturing and innovative SaMD adoption.
Like the broader medical device market, and the wider life science world of pharmaceuticals and biotech, dental medtech manufacturers are increasingly realizing the advantages of digitizing their quality management systems.
Key results include strengthening and accelerating regulatory approval processes, eliminating product defects and variation, and getting to market faster.
Dental medtech generally falls under the medium-risk regulatory categories dictated by the FDA and EU, making airtight quality management and a controlled product design and development pathway vital.
Medical device quality management software eases the compliance burden associated with dental medtech development and marketization by:
- Centralizing quality information, such as design controls and SOPs, in a single source of truth
- Eliminating cumbersome manual paper-based quality management and accelerating access to data
- Unlocking visibility of root causes to allow targeted corrective and preventive actions (CAPAs) which slice device defects and faults
- Allowing the rapid construction of quality frameworks compliant with the demands of medtech standards such as FDA 21 CFR 820, ISO 13485, IEC 62304 and more
With digital quality management at the core of future dental medtech development, manufacturers will enjoy leaner, more cost-effective and safer product pathways with stronger clinical outcomes for patients.
Hand-in-hand with greater market consolidation and deeper investment, we can expect a new approach to dental medtech manufacturing that is more in-house, quality-driven, and digitized. The dental world has lagged behind other medical sectors in these key areas for several decades.
The ingredients are now in place to facilitate a rapid and far-reaching catch-up.
ABOUT THE AUTHOR
Alex Pavlović has worked in the quality and compliance space for 5 years, producing a range of industry content to help Qualio blog visitors understand the complex and highly regulated environments of modern life science.