On-body delivery systems (OBDS) are changing the way patients receive medications, offering convenience, improved adherence, and new opportunities for long-term treatment outside of healthcare facilities. These devices attach directly to the patient’s body and deliver medicines over a set period, often through a needle or soft cannula. As technology advances, OBDS are beginning to incorporate connectivity features such as real-time monitoring, cloud integration, and artificial intelligence (AI), creating a new category of “connected OBDS.” While these innovations bring potential benefits, they also raise important regulatory considerations.
The drug delivery industry is projected to grow more than 25% annually over the next decade, driven in part by devices that improve drug bioavailability and target medications more precisely. OBDS are already used for high-value biologics like Avastin, Rituxan, and Herceptin, which treat various cancers. These systems help address challenges such as drug viscosity, large volume administration, and patient access to care. Unlike traditional subcutaneous injections, OBDS can deliver large doses over longer periods without requiring the patient to hold the device in place, making them particularly useful for biologics that are difficult to administer.
In comparison to self-administered autoinjectors, OBDS can reduce the risk of dosing errors by simplifying the administration process. Autoinjectors often require multiple preparation steps for each dose, which can lead to mistakes and underdosing. OBDS, while still requiring proper patient training, typically involve fewer steps and provide more consistent drug delivery.
The COVID-19 pandemic highlighted the importance of alternatives to in-clinic treatments. Programs such as the United Kingdom’s chemotherapy buses showed how shifting care outside hospitals could reduce infection risk for vulnerable populations. OBDS have similar potential to increase treatment accessibility, especially for patients in rural areas or those with limited mobility.
In the United States, OBDS are considered combination products, meaning they integrate a drug, device, and sometimes a biologic. The U.S. Food and Drug Administration (FDA) assigns oversight to the agency center that regulates the product’s primary mode of action. Depending on whether the device is primarily drug-, device-, or biologic-led, it may require a New Drug Application, a 510(k) clearance, or a Biologics License Application. While these pathways are well-established for current OBDS, the addition of connectivity features introduces new complexities.
Connected OBDS could transmit patient data directly to healthcare providers, enabling remote monitoring and potentially real-time adjustments to treatment. AI tools could analyze data from these devices to support clinical decision-making. However, integrating these capabilities raises concerns about cybersecurity, data privacy, and the need for transparent algorithms. The FDA’s Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan outlines how the agency may oversee connected devices, including principles for good machine learning practices, patient transparency, and real-world performance monitoring.
As OBDS become more sophisticated, clear regulatory guidance will be critical for their safe and effective adoption. This includes ensuring that devices meet rigorous design, quality, and cybersecurity standards while maintaining patient trust. The combination of drug delivery innovation and connected technology has the potential to transform chronic disease management, but it must be matched by robust oversight to ensure safety, privacy, and reliability.
EMMA International works with companies in the life sciences industry to navigate complex regulatory environments, including those involving advanced drug delivery systems. By providing compliance strategies and quality system support, EMMA International helps ensure that innovative products like connected OBDS can reach the market while meeting all applicable regulatory requirements.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
International Organization for Standardization. (2022). ISO 11608-6: Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems. https://www.iso.org/standard/72294.html
U.S. Food and Drug Administration. (2021). Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. https://www.fda.gov/medical-devices
