Proclaim Health is a medical equipment manufacturer based in Mountain View, California. The company’s first product is based on pioneering a new 3D-printed oral health system for at-home use. The issue that Proclaim set out to solve was that many people don’t floss—or floss effectively, said David Hood, director of marketing for the dental professional channel at Proclaim Health. Gum disease is a widespread issue, with numerous studies showing links between gum disease and systemic health conditions, such as cardiovascular disease, diabetes, and many others. The company wanted to change that and create a product that would help people improve their oral health and overall health by revolutionizing at-home oral care.
Proclaim envisioned an entirely new way to clean between teeth that displaces traditional string floss or water flossers. It created the concept—the Proclaim Custom-Jet Oral Health System—that essentially pressure washes a person’s mouth in just seven seconds. The company wanted to tailor each system to the individual’s mouth based on dental scans for maximum effectiveness. With nothing like this on the dental tech market, Proclaim’s engineers brought its idea to fruition.
“We start with the dental scan and create each system to fit a person’s mouth and get the jets pointed in the right spots, at just the right pressure. There’s nothing else like this in the world today.”
- Brent Goldstein, vice president of software and digital-customized medical products, Proclaim Health
Courtesy of Proclaim Health
The Challenge
Which Partner Can Best Bring Efficiencies and Best Practices to Scaling Manufacturing?
Proclaim knew one thing—3D printing was the only way to create the patient-specific Custom-Jet Oral Health System. Injection molding wouldn’t enable a customized system for every individual. After talking with various 3D printer and services providers, Proclaim chose 3D Systems’ printing technology for this novel oral health system. In addition to advanced printing technology, 3D Systems’ Application Innovation Group (AIG) brought in-depth technical expertise and problem-solving skills as the team looked to optimize its approach, said Goldstein.
“We knew this would be a difficult product to scale, and we needed a partner that we knew could do it,” said Goldstein. “3D Systems has a lot of experience in medical device and mass custom manufacturing in orthodontics.”
Once engaged, the AIG team applied its application development engagement model, which studied the product design and functionality to determine how best to optimize technical, clinical, and functional requirements, which include things like surface quality, biocompatibility, translucency, and feature fidelity, against economic objectives.
The Solution
Unique Expertise for a Unique 3D Printing Application
Courtesy of Proclaim Health
Proclaim and 3D Systems worked closely together to optimize the system consisting of a mouthpiece and hydrostation unit. The mouthpiece is very complex, with eight different manifold capillaries that each break into multiple nozzles to direct and focus water jets into the right place of a specific person’s mouth.
Proclaim engineers chose 3D Systems’ Class 6 Accura® ClearVue biocompatible material for the application, and the team determined laser-based Stereolithography (SLA) to be the optimal technology to produce the device. A custom hydraulics test was also built using a 4x4x4 machine that attaches to the mouthpiece and pumps water through it just like the hydrostation would.
Once the product met the technical feasibility requirements and the design was fully optimized, Proclaim purchased a compact ProJet 7000 HD from 3D Systems to prove its product’s viability in the beta stage. Satisfied with early results, Proclaim then looked to the next stage of industrial scale-up and mass production. For this, they turned to In’Tech Industries in Minnesota and its fleet of 3D Systems SLA Large frame printers.
3D Systems recommended a seasoned contract manufacturer—In’Tech Industries Inc. of Minnesota—to bring the product across the finish line and eventually to market. In’Tech has a long track record in high-volume, custom manufacturing, having successfully mass-produced 3D-printed custom hearing aids, dental and orthodontic products, as well as other medical-grade solutions. The company has also collaborated with 3D Systems for more than two decades.
Industrial Scale-up to Production
The next phase involved transferring the learnings and optimizations from the compact, lower-power ProJet 7000 HD to the large-format SLA. 3D Systems served as a partner with In’Tech and Proclaim throughout the process. To build a successful prototype, In’Tech performed printing, class VI post-processing, assembly, hydrotesting, and high and low tolerance testing for the mouthpiece to pass. This process took about 90 days and was relatively seamless.
“At times, we had to lean on 3D Systems for support. We usually lean on them during the development process but also for optimizing the manufacturing processes. 3D Systems’ expertise extends beyond printers and materials, which is very valuable for us and our customers.”
- Roger Neilson Jr., co-owner, CEO and vice president of sales and marketing, In’Tech Industries Inc.
In’Tech has a full tooling, engineering, and molding facility, from which it provides resources for post-curing, finding better ways to finish the bottom part of the mouthpiece, and adding plastic parts so it can function and attach to the main device. Throughout the process, In’Tech engaged with 3D Systems and Proclaim to create the prototype and prepare for mass production.
Once the prototype underwent clinical trials and eventually received FDA clearance, In’Tech began production of the Proclaim Custom-Jet Oral Health System. When orders are received, In’Tech prints the custom mouthpiece to the custom specification for each customer, performs class VI post-processing, mills mating surface, attaches a collar, then hydrotests, cleans, packs and ships the finished device to Proclaim’s fulfillment center.
The Proclaim Custom-Jet Oral Health System is the first consumer product In’Tech has produced using 3D Systems’ Accura ClearVue material. With its business growing in production applications in the life sciences industry, In’Tech is also expanding more into printing with 3D Systems’ Figure 4® equipment and materials for medical-grade applications.
Courtesy of Proclaim Health
The Results
Excitement Builds for Oral Health Innovation
A clinical study was published showing Proclaim reduced gum bleeding by up to 82% and gum inflammation by up to 41% in just 30 days. Shipping of the Proclaim Custom-Jet Oral Health System began in February 2024. The novel oral health product has received significant buzz in the media and from the dental community for its custom, patient-specific innovation, and amazing results.
Being part of the team that brought such an intricate 3D-printed device to market is a source of joint pride for Proclaim, 3D Systems, and In’Tech. Neilson has ordered one for himself and is in awe of the innovative oral health device he helped bring to life that will clean so thoroughly in just seven seconds.
“A lot of dentists say, ‘Why didn’t I think of this?’ Many dentists want to try it for themselves and get a trial device for their practice.”
- Brent Goldstein, vice president of software and digital-customized medical products, Proclaim Health
