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by Conor Devine
www.linkedin.com/in/conor-devine-0566b286/As Europe's dedicated pharmaceutical packaging and drug delivery event, Pharmapack is the industry's go-to place to kick off the year. At least that’s what the event website says and, after my visit, I’m inclined to agree. With 411 companies exhibiting their services in everything from primary, secondary and tertiary packaging to drug delivery devices or anti-counterfeiting systems, there was certainly plenty to see.
Thinking about the trends and where the industry may be going, a few things became apparent as I walked the floor:
As my colleague Jez Clements also noted at the recent consumer tech show CES in Las Vegas, the ‘Internet of Things’ (IoT) is most definitely here. The ability to track and log the amount of medication being taken by a patient, as well as the time of day (and sometimes GPS location…) – and uploading this data to an app or the cloud in real time – was offered in everything from eye droppers to blister packs. The claimed advantages of this additional functionality were most often the ability to either increase the efficacy of clinical trials or provide extra features to improve the user experience.
Many companies have clearly been putting the user front and centre in their design process. The innovations that stood out were those where human factors was obviously considered throughout the design process, resulting in user-friendly products which were able to hide complex functionality behind pleasingly simple features.
It was interesting to see how developments in the industry are enabling more and more drugs to go from requiring administration by a healthcare professional in a controlled environment to being able to be administered by the patient in the comfort of their own home. For example, a wearable injector – able to accurately administer large volumes of viscous drug, automatically, over extended time periods – is undoubtedly an extremely convenient and deskilled platform that has the potential for a wide array of uses.
I found the claim that smart packaging and connected devices can be used to dramatically reduce the pain of a clinical trial particularly interesting. Average costs of getting a drug through all phases of clinical trials are upwards of $1bn – so anything that can be done to reduce costs, increase results accuracy, remove unnecessary time sinks and/or gain crucial user insights in clinical trials has huge potential to benefit patients in the long term. Yet how do smart packages and connected devices claim to be able to do any of these things?
Mostly it is down to enabling cheap and accurate tracking of patient compliance, with some solutions offering the added bonus of encouraging better patient adherence behaviour, too. Compliance is a notoriously difficult thing to monitor and poor compliance can add a huge additional cost to trials, with larger populations being required than ideally necessary to achieve accurate results. Traditional compliance monitoring methods are either very costly, using pharmacological markers which also add extra complexity and time to a study, or unreliable – checking prescription records does not indicate drugs have been taken and patients often overestimate their compliance when interviewed.
Smart packaging enables the number of pills removed from the package, time of day, and sometimes even the GPS location of the patient, to be stored in a database and wirelessly transmitted to a smartphone in real time. Connected devices can go even further. As these devices are integral to administering the drug, they can state with confidence that a specific dose was delivered and automatically transfer data on where the drug was administered, how much and how ‘correctly’ too. If you factor in that the included smartphone apps can teach patients correct administration – using feedback from the sensors in the connected devices to offer personalised tips – then you can see how the time and effort in managing clinical trial patients drops off whilst adherence improves.
One of Schreiner’s smart packaging solutions at Pharmapack was a blister pack which has a printed electronic circuit integrated into the package. Removing a pill breaks an electrical connection and triggers the pill number and time to be stored in a database before being transmitted to a smartphone via Bluetooth or NFC. Similarly, Baswen’s IoT bottle cap uses an infrared sensor to monitor effectively the same thing but from a pill bottle. It has, however, added ‘adherence-improving’ functionality to its device by including a timer alert, linked to the user’s smartphone which reminds the user when their next prescribed dose should be taken. Simple, yet undoubtedly effective.
Ypsomed had a great example of a connected device. An add-on shell that attaches to any of Ypsomed’s auto-injectors, the SmartPilot platform has a multitude of sensors in the device which can detect that skin is present throughout the injection and if the injection procedure was undertaken correctly, partially correctly or very much incorrectly. Very useful information which is difficult to check – patients generally will assume they have injected correctly!
Meanwhile, Nemera’s offering of e-Novelia – a connected eye-dropper device – had some great, simple features that solve some of the main pain points when trying to drop liquid into your own eye. An ergonomically designed eye-piece ensures the device is held consistently in the right place on the face and a tilt sensor indicates to the user, via LED, when the device is vertical and ready to dose. It also had a plethora of extra features such as location tracking, drop detection and a connected app (of course!) but it was the simple, yet effective, human factors features that grabbed my attention.
But even with all this technology on show, it was clear to me that the crucial ingredient required to come up with the best solutions is putting the patient at the centre of the drug delivery development process.
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