We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
In the rapidly evolving landscape of drug delivery, on-body delivery systems (OBDS) continue to stand out as a sophisticated integration of medical devices and pharmaceuticals, collectively referred to as "combination products." These devices provide unique benefits that allow patients to administer large volumes of medicine in the comfort of their home. The additional benefit of a pre-programed OBDS allows for drug administration at predetermined times and dosages with minimal user intervention, thereby supporting patient adherence and, by extension, supporting clinical outcomes.
West recently hosted a webinar with Dr. Di Wu on Navigating the Future of Drug Delivery with On-Body Delivery Systems: Harnessing Innovation for Enhanced Patient Outcomes and Regulatory Success. The webinar linked here reviewed the US and EU regulatory pathways and considerations for a successful regulatory submission. In review of the global landscape and feedback from the industry and West’s customers, below are answers to the most commonly asked questions around on-body delivery system requirements.
As drug delivery technology evolves, on-body drug delivery systems (OBDS) are emerging as a powerful alternative to traditional injection methods. From wearable injectors for biologics to patch-like devices for chronic therapies, these systems promise greater patient convenience and independence. But with innovation comes complexity, especially when it comes to human factors (HF) and usability.
OBDS devices aren’t just drug containers. They're wearable systems that patients must apply, wear, monitor, and eventually remove. This introduces unique usability risks not typically present in autoinjectors, prefilled syringes, or inhalers—risks that regulators are watching closely.
OBDS devices require users to select the correct application site and ensure proper adhesion to the skin. Misapplication can result in incomplete dosing, injection into the wrong tissue layer or even detachment. Adhesion must hold up against real-world factors like movement, body type, skin condition, perspiration, and body hair. Special consideration should be given to conditions that can be especially challenging for users with sensitive or fragile skin, commonly seen in elderly patients.
One of the biggest usability differences is passive wear. Once activated, OBDS devices operate over a pre-defined time, often out of sight and mind. This introduces risks to scenarios like:
Both FDA and EU MDR expect usability studies to evaluate these scenarios in realistic settings, not just lab bench-top simulations.
OBDS devices often rely on lights or sounds to communicate status, like whether a dose has started or finished. But these cues may be misunderstood or missed entirely, especially by users with hearing, vision, or cognitive impairments. Regulators emphasize the need for multi-sensory, intuitive feedback—and that labeling alone isn’t enough unless proven effective through testing.
With OBDS, safe disposal can be just as critical as safe use. Users may need to handle sharps, residual drug, or subparts of the device prior to disposal. Human factors evaluations must include removal and disposal tasks, ensuring users can complete them without injury, confusion, or environmental harm.
Some OBDS devices may require training at first use. This introduces training decay as a risk because users may forget instructions or important details for device use over time.
Both FDA and EU MDR expect usability testing to simulate first-time and if applicable, trained and delayed-use scenarios to ensure safety across real-world conditions.
Both the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR) emphasize the critical importance of human factors in the development and evaluation of medical devices and combination products.
The FDA requires that manufacturers demonstrate through human factors and usability that devices can be used safely and effectively by intended users, under expected conditions, without causing use errors that could result in harm. Similarly, the EU MDR mandates that devices be designed to minimize the risk of use error and account for the abilities and environment of users. Both regulatory frameworks view human factors as integral to risk management and require documented evidence of usability validation to ensure patient and user safety throughout the device lifecycle.
Software driven OBDS are designed to enhance monitoring and control. With software embedded in the device to continuously monitor / control drug delivery process, the software improves drug delivery consistency and provides alerts and notification to potential issues. The OBDS with software has a data log to store information about drug delivery. Data generated by on body delivery systems may be leveraged to support post-market surveillance activities, including issue investigation and trend analysis. When connectivity features are incorporated, systems may enable secure data exchange with external systems like mobile applications or healthcare provider portals.
To ensure the safety and effectiveness of software used in medical devices, OBDS with Software must comply with software/cybersecurity related regulatory requirement throughout product lifecycle. The manufacturer should demonstrate compliance with:
Guidance documents that support the software development include:
Drug-delivery device design should be an integral part of the entire product development process. Being the device constituent of a combination product that has interface with the end user, the design of the OBDS impacts the combination product’s usability. In addition, the materials of the OBDS interact with the drug product so that the device impacts extractable/leachable study as well as biocompatibility. In the early pre-clinical stage, the evaluation of the potential drug-delivery systems should consider factors like target patient population, route of administration, dose frequency, material compatibilities, and use environment. During clinical trial phases, the device should be integrated into the clinical trial design to ensure it meets the needs of the intended drug's use. Post approval, continuous monitoring of the device's safety and performance in real-world settings is crucial.
While it is not good to switch devices mid-trial, it is possible to change the drug delivery devices as the drug development process continues. For example, pharmaceutical companies may use prefilled syringes in phase I / II clinical studies, and shift to OBDS in Phase II trials and commercial launch. This “shift” should be planned carefully with a clear understanding of all potential implications. A proactive approach, involving early engagement with regulatory bodies, comprehensive risk assessment, and planning with all stakeholders, is crucial for minimizing risks, maintaining study integrity, and ensuring a successful outcome.
A platform approach can be used for OBDS development, and the data from platform development or generated for one drug product can be leveraged in the marketing application for other drug products. The performance and safety of the device can be impacted by patient population, use environment, drug property etc., which needs to be supported by verification/validation data. A platform cannot cover all drug properties and intended uses, therefore, a “blanket” approval for a drug delivery device that can deliver any drug is not practical.
Instead, the manufacturer can use a bracket approach to test device performances within pre-defined limits, such as temperature , drug viscosity, or other relevant attributes. When preparing for a new drug application, a gap assessment should be performed to determine if the drug’s intended use and drug property falls into the pre-defined platform requirements. Any additional product specific requirements should be evaluated and addressed, based on risk management activities, with actual drug products or mimic solutions that represent the new drug products as required.
English
Chinese
