Iterations of Portal's Needle-Free Drug Delivery
Innovations and Iterations
In the consumer tech world, iterations happen very fast, though most inventions are not ‘one and done’ masterpieces: the Dyson cyclone vacuum cleaner made 5,127 prototypes. In the medical device world, development takes longer because of the appropriate and necessary regulations and need for safety. Using an agile approach, but with safety and reliability in mind, Portal has made tremendous technological advancement in the development of a next-generation needle-free injector through multiple iterations and prototypes.
Legacy Needle-Free Injectors
Needle-free technology was developed in the 1930s and according to the International Journal of Pharmacy and Pharmaceutical Sciences, the first needle-free injectors used mechanical compression to force fluid through a small opening. The high power in the first needle-free injectors was generated by a compressed gas, typically air, CO2, or nitrogen. The force generated pushed the medication fast enough to penetrate the skin, subcutaneous tissue, or underlying shallow muscle in order to deliver medication, such as a vaccine, in a fraction of a second. This quick delivery time allowed for fast turnaround in mass vaccination programs such as smallpox, polio, and measles but did not permit precise, high volume injections.¹ Along with the limited ability to regulate delivery volume and injection depth, cross contamination quickly became an issue for needle-free technology.² In 1986 an outbreak of hepatitis B, which is caused by exposure to infected body fluids, was traced back to the use of a needle-free multiple-use-nozzle injector.³ In response to the outbreak, the World Health Organization recommended that only the needle and syringe be used for immunizations until safe needle-free injectors could be developed.
Portal’s Start in Academia
Many years later in an MIT lab, professor Dr. Ian Hunter filed a patent to develop a “controllable jet injection device, based on a custom high-stroke linear Lorentz-force motor that is feedback controlled during the course of an injection”.³ In 2014, Portal licensed the technology used by Dr. Ian Hunter and his team at MIT to develop and commercialize an at home reusable needle-free injector. The motor in the device drove the cartridge directly, without the compressed gas that was previously used in needle-free technology. At the time, this technology required a lot of power, leading to multiple capacitors and a lot of space needed in the injector to hold them. But, at the time, this bulky device could not perform very large injections, only 0.3 mL maximum.
The First Iterations
The first steps in development, Portal Instruments Chief Architect Bobby Dyer explained, were “to prove that we could make a small device with all of the technology needed inside and the second was to prove we could less painfully inject medication into a human.” To meet the first objective, Portal built a handheld device called Tiffin that showcased the bulky device in a much smaller container. Simultaneously, Portal built a medical grade development injector called Bento Box which they used in a human clinical trial with saline to test pain and preference versus a pre-filled syringe. After seeing success with both Bento Box and Tiffin, Portal brought the technologies together and created a 1 mL handheld needle-free injector, Clinical Tiffin. This device was tested again in clinical trials.
Cartridge Development
Clinical Tiffin used a cartridge that was filled at the time of use. Bobby Dyer spoke of the challenge of that model, “As the business side of Portal moved alongside the clinical and technical work, it became clear that our injector was especially well-suited for biologics delivery and these were usually taken by patients with chronic conditions. However, patients took these medications at home and expected them to come in a pre-filled container. This led us to develop a whole new part of Portal that focused on developing a primary container for the drug; one that could fit into standard fill-finish lines, be single-use and disposable, and that could hold the drug for a long period of time.” Because Portal’s jet injector required a very narrow jet stream, years were spent iterating the nozzle and disposable cartridge design.
“I don’t think anyone has done more work on nozzle geometry than we have. We developed the primary container to fit the exact geometry of the device, which was a multi-year process. Building complex, disposable cartridges without having them break was a huge challenge”, Dyer said. Once Portal figured out the speeds, pressures, and diameters that would work best, they turned their attention to the next version of the device. Dyer went on to say, “After we entered into our first partnership, we were able to focus on finalizing the device for a specific patient population and testing the cartridge with a specific drug.”
Looking Forward
When asked where Portal stands today, Patrick Anquetil said, “In the consumer tech world, iterations happen very fast, though most inventions are not ‘one and done’ masterpieces. In the medical device world, development takes longer because of the necessary testing to the high reliability and quality standards, all driven by the need for patient safety. To think we have made such large strides in a short amount of time, it is something to be very proud of. This is no vacuum cleaner, we are putting a medical device into the hands of patients and we want to make sure it is safe before that happens.”
¹ PATWEKAR, S.L., et al. “NEEDLE FREE INJECTION SYSTEM: A REVIEW.” International Journal of Pharmacy and Pharmaceutical Sciences, https://innovareacademics.in/journal/ijpps/Vol5Issue4/7464.pdf.
² Taberner, Andrew, et al. “Needle-Free Jet Injection Using Real-Time Controlled Linear Lorentz-Force Actuators.” Medical Engineering & Physics, Elsevier, 13 Jan. 2012, https://www.sciencedirect.com/science/article/abs/pii/S1350453311003249.
³ Ziegler, Andreas. “Spritzen ohne Nadel. Science-fiction oder Renaissance einer totgeglaubten Arzneiform?” [Needle-free injection–science fiction or comeback of an almost forgotten drug delivery system?]. Medizinische Monatsschrift fur Pharmazeutenvol. 30,8 (2007): 297-303.
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