In recent years, specialty pharmaceuticals and other biotech products aimed at treating chronic diseases such as diabetes and chronic obstructive pulmonary disease have been on the rise. Concurrently, there has been an increased focus on self-care at home, with patients administering their own treatments, particularly injectable and inhalable drugs. Many of these self-administered drugs are supplied in connected drug-delivery devices, creating a valuable link between the patient and the medication, as well as between the healthcare provider and the patient.
Near Field Communication (NFC) technology, a short-range wireless technology, can be added to mechanical devices to create secure, easy-to-use patient experiences. For purely mechanical devices, passive or connected NFC tags, which can harvest energy from the NFC field generated by the reader (e.g., a smartphone), can add connectivity without requiring additional electronic components or a battery. Conversely, for devices already equipped with electronics and a power source, an NFC reader frontend or NFC controller can be integrated into the design.
Depending on the use case, patients may need to install a mobile app or use existing internet connectivity by tapping their smartphone to the device to launch a website that provides digital guidance. With a single tap, patients can check product authenticity, receive step-by-step application guidance, or maintain a digital regimen diary based on automated timestamps. A mobile app can perform simple data-processing tasks to display real-time information to the patient, or data can be sent to the cloud for more complex processing and analysis.
NFC can automate communication between a reusable drug-delivery device and a disposable drug container, such as a cartridge or pre-filled syringe. The device, equipped with an NFC reader, communicates directly with a passive NFC tag on the container. This NFC communication can verify the originality of the consumable, check the drug's expiration date, confirm the drug type and batch number, and read parameters that might require adjusting device settings. Additionally, the NFC reader can register dosage events, preventing consumable reuse. A delivery device can also provide sensor-based feedback to ensure medications are handled and dosed correctly in real time.
Studies from the World Health Organization (WHO) and others reveal that 50% of patients with chronic diseases are non-adherent to treatments, often missing doses, taking the wrong dose, or stopping treatment altogether. This is frequently due to a drug’s negative side effects, dose frequency, over-/under-dosing, or the usability of the delivery device. Connected devices can help patients better manage their conditions by providing immediate feedback during administration. Automated features can effortlessly capture key information such as injection dose, date, and time. Additionally, notifications can remind patients when their next dose is due or alert them when doses are missed. Collected data can be uploaded to a cloud-hosted service for complex data processing and shared with healthcare systems to keep clinicians informed.
It’s an unfortunate fact that counterfeit, adulterated, off-label, and diverted products have become increasingly widespread, to the point that the WHO describes counterfeits as “one of the urgent healthcare challenges of the decade.”
To reassure patients concerned about the security of their drug-delivery systems and prevent the use of wrong or fake products, manufacturers can implement authentication and authorization processes. Authentication verifies that a device or its medication is genuine, securing access to applications or data.
While identification validates serial numbers using online allowlists, NFC-based authentication performs enhanced checks based on an item’s NFC tag data and credentials, using secure cryptographic functions. Authorization can further verify attributes of each tag, ensuring rightful access to user data or the delivery system.
NXP Smart Technology Solutions
NXP offers well-matched Reader and Tag IC solutions to help customers design advanced, integrated systems that benefit from enhanced functionality, interoperability, and performance.
Our NFC authentication tags come with standard-based AES-128 cryptography. Popular tags include NTAG 424 DNA and NTAG 22x DNA (ISO 14443/Type 2 or 4 Tag) as well as ICODE DNA (ISO 15693/Type 5 Tag), supporting different operating distances and form-factor dimensions. Some tags support web-based dynamic NFC message authentication upon every NFC phone readout to prevent mass cloning. Others support a mutual authentication mechanism, ensuring only an authenticated reader can access sensitive tag data, protecting it against unauthorized access. Certain tags also come with enhanced status-sensing capability, measuring factors such as opening indication, fill level, or the completion of a mechanical function – even without a battery.
Our NTAG 5 (ISO 15693/T5T) connected NFC tags are versatile devices for use in or on systems with an electrical system interface to connect to an external sensor or microcontroller. In medical devices, our connected tags can help ensure a drug is within the right temperature window or control pressure in an inhalation device. They also support advanced memory-data protection with access rights.
All these NFC tags are supported by NXP’s latest single-chip NFC microcontroller, PN7642, which offers the highest integration level and the smallest footprint for adding NFC reader functionality, processing, and cryptographic security, even in small drug-delivery devices.
- NFC interoperability: ISO/IEC 14443-A communication, NFC Forum Type 4 Tag
- 416 bytes memory organized in an ISO/IEC 7816-4 file system: 32 bytes capability container, 256 bytes NDEF file, and a 128 bytes protected data file
- Common Criteria® EAL4 certification for hardware and software
- Standard AES-128 cryptography for authentication/secure messaging, or LRP wrapped AES operation for even stronger attack resistance
- NFC Forum Type 2 Tag and ISO/IEC 14443-A compliant
- Common Criteria AEL3+ (AVA_VAN.2) certified
- 7-byte UID, 50pF input capacitance
- Communication baud rate at 106kbpws
- Contactless transmission of data and supply energy (no battery needed)
- Operating frequency: 13.56 MHz (ISM, world-wide license freely available)
- Fast data transfer: up to 53 kbit/s
- High data integrity: 16-bit CRC, framing
- AES mutual authentication
- I2C target and controller channel
- GPIO and PWM
- Energy harvesting with configurable output up to 30 mW
- ARM Cortex M-33 core: 90 MHz, 20 kB user RAM, 180 kB user Flash
- NFC Forum-compliant NFC reader supporting read/ write and card emulation modes
- High output power 2W: 350mA maximum operating transmitter current with Dynamic Power Control (DPC 2.0) and Automatic Waveshape Control (AWC)
- Integrated DC/DC allows single 3.3V supply with max Tx power
The Future of Connectivity in Healthcare
Connectivity will continue to play an important role in maximizing the quality of healthcare for patients, especially those with chronic conditions. NXP has become a key technology provider in the field of connected drug delivery devices, leveraging high-quality, reliable products and an extensive partner network.
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