The solution consists of a tag that accommodates one of two possible high frequencies: 13.56 MHz RFID compliant with the ISO 15693 standard, or Near Field Communication (NFC) chips, also operating at that same frequency and compliant with ISO 14443. Historically, identifying dentures at nursing homes and hospitals has proved challenging, though essential. Nursing home personnel clean the false teeth, then return them to the proper patients, but there is always a risk that the dentures could end up missing or be returned to the wrong individuals. Additionally, dentures are frequently found on lunch trays and in bedsheets. “Dentures are lost regularly,” says Devon Howe, Nobilium’s president and CEO, “and this is a big problem in nursing homes and hospitals.”

He adds that the issue is severe enough that 27 US states have enabled laws to ensure that every set of dentures is identified with the correct patient’s name or some other unique ID. Compliance with these regulations may be spotty; however, according to anecdotal information Howe has heard, there are good reasons for that. Labeling dentures invades the privacy of a patient, for one thing. “Patients don’t want their names on their denture,” Howe says, simply because it can be embarrassing for others to learn that they have false teeth. In addition, he says, indelibly adding patient names onto dentures at the manufacturing lab requires the added cost of labor, and dental laboratories charge an extra fee for this service in many cases. This is an expense that dentists who fit the dentures to patients need to pay or pass on to the patient.

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This enables dental labs, dentists, and denturists to permanently assign the denture to its user via a digital certificate, eliminating the labor-intensive process of placing the patient’s ID to the denture surface. Additionally, using Syrma’s standard USB RFID scanner attachment, this new solution will enable personnel at nursing homes and other care facilities to easily match dentures with individual users following routine cleaning and maintenance. Such digitized recordkeeping also helps these facilities remain in compliance with HIPAA regulations protecting patient confidentiality. While 23 states currently mandate some form of physical ID on dentures, compliance has typically remained low due to the high added lab costs and patients’ general reluctance to be revealed by name as denture wearers.

“When it comes to leading-edge wireless tracking applications, RFID technology offers the perfect combination of convenience and reliability at reasonable costs. In light of our prior success with other RFID solutions across various markets, we’re pleased our design and manufacturing expertise helped enable Nobilium to bring their product concept to reality rapidly,” said Sreeram Srinivasan, Syrma’s CEO.

“These embedded RFID chips will significantly reduce the single largest cost factor associated with dentures, labor at the lab during manufacture. These are savings the labs will pass on directly to dentists and, in turn, their patients. Syrma’s team was instrumental in developing the tags, readers, and software into a combined solution that could pass the FDA’s rigorous clearance process,” said Devon Howe, President & CEO of Nobilium.

About Syrma SGS Technology

Syrma provides global OEMs with electronic manufacturing services (EMS), backed by strong engineering expertise, to reduce risk and costs on product designs and manufacturing. From RFID technology and power electronics to turnkey manufacturing services and custom magnetics, we deliver high-mix, flexible volume products for automotive, computing, industrial, medical, power, and telecom companies. Within the last decade, we’ve helped design, manufacture, and market more than 200M products worldwide. Syrma is a wholly-owned subsidiary of the Tandon Group, a technology holding group that has grown multiple technology companies since 1975.

For more details about Nobilium products, please visit www.dentureid.com.

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In nursing facilities, because most dentures lack user names, it’s often difficult to match individuals with their dentures after they’ve been routinely collected for cleaning and maintenance or misplaced. These facilities also face potential HIPAA medical confidentiality violations if a labeled denture is mishandled and user identity is exposed beyond facility personnel. With the high costs of custom-made dentures and their day-to-day necessity for the user, this common problem called out for an innovative technical remedy.

Challenges

The client looked at embedding miniature passive RFID tags into a denture, which could be wirelessly scanned, logged, and identified via a custom software app. They initially discussed this idea with us at a medical device tradeshow after learning of our past success with RFID tags, smaller and medical-grade tags combined with our own readers and software across multiple mobile tracking applications. Our product team then set about developing the necessary hardware and software to the customer’s specifications. Bringing the convenience of RFID technology to dentures meant tackling several unique requirements:

• Tags must be small enough to be embeddable within dentures while delivering full RFID function within standard denture materials.
• Embedded tags must be able to withstand regular exposure to oral bio-acids, as well as routine cleanings using standard dental cleaning products.
• All materials used in this application meet compliance with FDA bio-compatibility regulations.

Scanned dentures would be automatically linked to the client’s custom-developed proprietary website database, enabling dentists, labs, and patients to authenticate dentures via a three-part digital certificate containing every product unit’s unique identifier (UID) along with important patient data.

Solutions

Following a detailed analysis of the technical specifications, our hardware engineering team developed the optimal tag and reader combination. They determined a 5 mm epoxy-encapsulated ISO 15693 HF tag would withstand the long-term conditions of dental use and maintenance. These tags were paired with our standard plug-and-play USB RFID reader. We simultaneously assembled an in-house software team to execute the web and mobile app development and quality assurance for the client’s dentures ID solution. Our software team custom-designed the corresponding denture app.

The digital UID certificate formats were created using Microsoft .net 4.0 and SQL server development platforms without farming out software programming to a third-party vendor. QA included peer reviews, code reviews, and custom test development, along with regular project audits. Our software engineers recognized compatibility issues with later models of some name-brand smartphones during our initial project testing. The problem was traced to those phones’ internal wireless charging system, which blocked RFID reception.

To adopt this solution into a universal option for all mobile devices, our hardware team suggested including an NFC tag alongside the original ISO 15693 tag, which could prove equally readable by all mobile devices. Our software team devoted an additional three months to adapting a downloadable Android mobile app that could utilize the low-power NFC readers built into those devices. “The universal readability of the RFID chips is what makes this application so appealing. The real promise is that it’ll significantly reduce labor costs at the dental labs, and this will be a major selling point the labs can offer to dentists. We believe this represents a real milestone in the industry,” said the Company’s CEO.

Following successful prototyping and initial DFM planning for this innovative RFID denture ID solution, the client shepherded the system components through the FDA 510(k) premarket approval process for oral products. As RFID-based denture identification was essentially a new product category, the FDA required an especially lengthy and comprehensive series of applications, committee proceedings, and other administrative hurdles. Following final FDA clearance in October 2017, the client gave us the formal go-ahead for a full production order. Tags packaged with digital certificate instructions for dental labs.

Successes

We contribute our 40 years of design and manufacturing expertise spanning multiple diverse markets. We look forward to discussing how we can deliver world-class products for OEMs across the globe. We understand our home Indian market, familiar with its vast regulatory and selling environments. We foster growth opportunities within India through our strong technology incubation ecosystem. We also assist global OEMs in entering the Indian market by leveraging the local supply chain and favorable operating environments for cost reductions.

Our flagship Chennai location opened in 2006 and lies within a Special Economic Zone (SEZ) for electronics manufacturing, offering economic incentives for imports and exports. This primary facility is within 90 minutes of the Chennai seaport and 20 minutes to the international airport. Additional road and rail connectivity links to the rest of India and beyond and infrastructure advantages with faster import and export clearances. We also have labor force flexibility, both technical and manual, to scale to demand rapidly.

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