Leveraging Cross Industry Innovation to Revolutionize Drug Delivery
Challenge
Emerging biologic therapeutics present new challenges—and opportunities—for innovation in drug delivery devices. These drugs, used to treat rheumatoid arthritis, multiple sclerosis, and other conditions, can be viscous, and may require high volume doses to be effective. Even more challenging, they are delivered via self-injection, by patients experiencing physical limitations due to their conditions. Manually injecting viscous drugs is beyond some patients’ strength and dexterity, but enlarging the needle to make injecting easier causes more discomfort and distress for patients. Clearly, incremental changes to existing drug delivery systems are inadequate to address these challenges.
Solution
Battelle launched the Engineered Delivery Device Initiative (EDDI) in 2011 to reimagine the way delivery systems for biologic drugs are designed. A core team of experts in drug delivery device engineering, formulations, and human centric design looked beyond the medical device industry to identify novel ways to move viscous fluids with less effort. Reaching across Battelle for cross-industry expertise, the team created several solutions.
One solution drew principles from the oil and gas industry, where high volumes of viscous oil are flowed long distances through pipes with relatively small diameters by flowing the oil in a core stream through an annulus of water, which contacts the inside surfaces of the pipe. This “core annular flow” slipstream reduces friction between pipe, water and oil interfaces, allowing the oil to flow easily. Battelle engineers adapted this approach to an injector format, using miscible high viscosity and low viscosity solutions in a volume relevant to injectable biologic drugs
An additional solution utilized a gas-producing reaction to drive injection, replacing manual or spring driven force. Another solution incorporated human centric design research with rheumatoid arthritis patients into novel injector form factors.
Preliminary Concept Sketches
Using results from the contextual research as input to guide thinking, preliminary concept sketches were generated exploring a wide variety of potential design embodiments.
Form-Factor Concept Sketches
Concept sketches were generated to refine device form-factor, user interface features, and integrate with mechanism development.
CAD Exploration
Visual language approaches for the selected device form-factor were explored.
CAD Refinement
The selected visual language approach was transitioned to CAD software for further refinement.
Final Design Render
Final Design Render
Physical Model
Non-functional physical models were fabricated to communicate the final design approach and to evaluate specific features.
Physical Model
The non-functional physical models were fabricated in-house at Battelle, incorporating multiple materials to visualize the solutions.
Outcome
EDDI has been successful in creating innovation solutions to deliver biologic drugs. Battelle’s gas-producing technology to drive injection was licensed for commercial development. Our design research identified features to enhance ease of injector handling and stability that could offset dexterity and hand strength limitations. And finally, our “core annular flow” system demonstrated a significant reduction in the time required to push a viscous formulation through a 27 gauge needle, as compared to using the viscous fluid alone or by diluting the viscous liquid with the non-viscous liquid. This technology could also have applications in delivery device filling.