ON-BODY INJECTOR AND AUTOINJECTOR DEVICE DEVELOPMENT
NOVO continues to build our resume in drug delivery device development for parenteral administration of drugs and biologics. This category of durable and single-use devices includes:
- On-body injectors
- Safety syringes
- Insulin pumps
- Infusion sets
- Primary container systems
- Companion mobile apps
- Microneedle devices
Drug delivery devices and related projects include disposable and reusable pen injectors, autoinjectors, primary packaging, safety syringes, needle hubs, infusion set inserters, lyophilized vials, vial adapters, and more. These products are generally high-volume, cost-sensitive components and devices. Drug delivery devices may be used for chronic conditions such as insulin-dependent diabetes, and in other cases the devices are single-use devices that deliver a drug or biologic and are discarded after a single dose of medication is administered. These devices may be applied by a trained health-care practitioner or a by the patient themselves. Because of the hands-on nature of these devices and the cost of the medications typically involved, attention to human factors design, user safety, and product reliability are of paramount importance to our clients.
DRUG DELIVERY DEVICE TECHNICAL AND DESIGN CHALLENGES
High-volume production, multi-cavity tools, automated assembly, machine vision inspection, and high reliability goals give rise to some of the challenges inherent to these product development efforts. In some cases, sterility and packaging issues present engineering challenges that are beyond the actual product design. Due to the tool cavitation and reliability goals, physical testing to establish reliability requires very large sample sizes and is extremely time consuming. This emphasizes the need for predictive analytical methods, such as simulation and tolerance analysis, in order to minimize the number of physical experiments required. Finally, the greatest of all reliability challenges is making designs intuitive enough that all users, regardless of possible dexterity impairments due to neuropathy or arthritis, are able to properly deploy the device.
There is a long list of potential requirements depending on the application protocol and the specifics of the drug or biologic being delivered. Requirements for these drug delivery devices may include miniaturization, high reliability, lower power consumption, usability, programmability, and wireless communications. Aseptic or sterile processing is typically required for the primary container filling and finishing. Custom packaging of the primary container may be necessary to facilitate preloaded and prefilled devices, prefilled primary containers loaded at time of use, or primary containers that are preinstalled and filled at time of use. Satisfying all of the requirements in a way that will meet regulatory requirements requires experience and a systems engineering approach to the design.
Some subsystems in on-body injector or pen injector devices require specialized knowledge of materials, processes, and regulatory requirements. Examples include battery power management, secure wireless communications, plunger drive mechanisms, needle-injection modules, primary containers, and fluid paths compatible with automated fill and finish lines.
Over multiple years and projects, NOVO engineers have designed hardware and software for drug delivery platforms in a wide range of configurations for a wide range of drugs and biologics. Our independent development team has a unique level of experience in this domain. We can provide comprehensive engineering support throughout the development lifecycle including custom mechanism and enclosure design, embedded system design, mobile and web applications. We will identify the most suitable materials and manufacturing methods to meet biocompatibility and toxicity requirements. In addition to a design tailored to your requirements, you can rely on us to provide comprehensive design verification documentation based on performance and reliability testing, environmental testing, screening tests for applicable standards, and simulation techniques as appropriate for each system.
LET’S TALK ABOUT YOUR PROJECT
Whatever your needs may be in the drug delivery device space, whether you are developing a pen injector, an on-body injector that is part of a body-area-network (BAN), an electroporation-enabled injection system or some exotic drug delivery platform, look to NOVO for the expertise you need. There is a strong chance we’ve developed a system or two that is relevant to your requirements.
If you want to discuss your project, contact us to set up an appointment.