Insights from the 2014 Universe of Prefiled Syringes
The first question that popped into my mind when I arrived in Huntington Beach, Calif. on October 5 was, What is so big about the Universe of Prefilled Syringes? I mean, we are talking about injectable technology, which has been around for hundreds of years. Really, what would possess almost 1000 people to congregate at this PDA event year after year for nearly a decade?
Well, it didn’t take long for me to understand why this meeting has grown into one of PDA’s largest. The amount and breadth of research that goes into the development of new prefilled/autoinjectable devices is remarkable. Plus, the technological advances and opportunities offered by smartphones and other new technologies is even more impressive. And all of the advances and potential future offerings are meant to improve the patient experience, create safer injectable products and safeguard such products from inadvertent and careless mistakes by users.
Markus Bauss, President and CEO, ConnectMeSmart GmbH, offered a glimpse into the endless possibilities for the pairing of injectable devices with smartphone and mobile medical applications.
Bauss started off his talk by discussing and demonstrating the “talking vial” circa 2007—a device coupled with a microchip attached to a vial that can read information out loud about the medicine, including dose and frequency. That same year, he noted, also saw the launch of the smartphone revolution with the introduction of the Apple iPhone. Now, he asserted, there exists endless opportunities to use these devices to enhance and improve drug delivery, patient compliance, safety, dosing accuracy, and supply chain integrity, to name a few.
Many reusable pen injectors already have included embedded electronics for many years for dose setting and tracking of injection dates. Now, with available technologies and networks, these devices can include additional functionality such as integrated reminders and transfer of injection data to personal Web-based health records.
Other companies in the diabetes market are developing smartphone-based blood glucose metering, while others are combing the glucose infusion and metering technology into one small device. Several developing products such as Bee and Timesulin allow for the wireless transfer of injection data.
Similarly, BETACONNECTTM allows multiple sclerosis patients to program injection speed, needle insertion depth and set injection reminders for Betaferon® administration. This device also allows patients to upload their injection records to a website via bluetooth or cable.
Who hasn’t used YouTube to figure out how to change their oil, fix a hole in their wall, or do some other unfamiliar task? Well, now patients will be able to look increasingly at their smartphone to learn how to use their injectable product. No longer will they have to try to remember the often cursory training provided by their healthcare provider. Bauss demonstrated the NovoPen training app produced by Novo Nordisk.
And if you feel these technologies only can be applied to reusable products, you are wrong. Bauss also discussed how these solutions can be tailored to disposable products, too.
He closed his talk with a discussion of the regulatory landscape. Both the European Union and the United States regulate mobile medical applications. Of the 50,000 or more “mobile health” apps developed over the last few years, “only a couple of hundred have received certification by the FDA or CE approval in Europe as a medical device/medical product,” Bauss reported.
According to a 2013 U.S. FDA guidance, a mobile medical app is classified as such if it meets the definition of a device in section 201(h) of the Federal FD&C Act and either is used as an accessory to a regulated medical product, or transforms a mobile platform into a regulated medical device.
In Europe, the Medical Device Directive applies if the mobile app or app/device combination is considered a medical device, and then all other applicable rules for risk management, quality, etc. apply.
Bauss explained that while the marketplace for mobile medical applications is only in its infancy, it is already exploding as more and more smartphone users worldwide (already >1 bil.) are becoming increasingly comfortable using the technology for personal health monitoring.
He concluded: “Connecting smartphones with the help of modern connectivity standards to areas where drug delivery devices are used opens up a world of completely new applications, to support patients in taking their medications.”
Author Note: This is the first of a series of reports on the science and technology presented at the 2014 PDA Universe of Prefilled Syringes Conference in Huntington Beach, Calif., Oct. 6-7. Next time, we’ll look at how patient safety is driving the movement towards single-dose systems, though economics might present the biggest challenge to broader, worldwide implementation and acceptance.