THE MARKET OPPORTUNITY
NOVO continues to increase our familiarity with the drug delivery device category. Drug delivery devices we have developed 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. Often, these products are used to deliver parenteral medication for serious medical conditions, and although the products may be considered “low-tech,” they tend to have a disproportionate impact on the end users’ perception of the brand. Human factors, user safety, and product reliability are of paramount importance to our clients, who strive for defect rates measured in parts per million.
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.
THE ENGINEERING BEHIND GREAT PRODUCTS
NOVO has consistently employed a system-level approach to help our clients develop design solutions, experimental methods, analysis, and simulation appropriate to any drug delivery platform they are developing—whether at the component or system level. In most cases, a combination of custom hardware design, embedded system design, and analytical methods were employed in order to resolve the design or manufacturing challenges. Verification methods have included environmental testing, physical properties testing, and in vivo trials. Regardless of the technical challenges, NOVO engineers have consistently been able to provide designs that met the design requirements.