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By CDP quality engineer, Stephanie Ward
Last week CDP travelled to Paris for Pharmapack 2017, Europe’s largest dedicated pharmaceutical packaging and drug delivery event.
The event covered a wide range of areas within the market; injectors, inhalers, packaging, primary containers, automation, manufacturing and testing. Innovation within the industry is shaped by many factors including regulatory requirements, new drug formulations and evolving user needs. Here are some of the key themes we noted during the show.
Drug delivery is not immune to the demand for more personalised data and interactivity
Connected devices were a key feature on many stands. These devices are designed to provide patients with information about their therapies and allow them to self-manage their treatment at home. For healthcare professionals (HCPs), benefits include being able to better monitor patient adherence to their treatment regimes. With increasing pressures on the healthcare system (increased life expectancy and an increase in chronic diseases), solutions that can enable home therapies will benefit both patient and healthcare providers.
For example, the 3M Intelligent Control Inhaler is designed to improve patient adherence and use competence of current inhaler technologies. The device is designed to ensure accurate dosage is delivered and give clear instructions on use through its integrated patient information. It logs information such as the inhalation profile of the patient to track progression of the disease. All of which can mean less costly trips to the hospital or unnecessary treatment escalation.
The parenteral market has also seen an increased number of connected devices being marketed. SHL’s ENYA platform is an add-on device to be applied to any multiple dose pen. Biocorp has a similar solution with their ‘EasyLog’ add-on sensor. These devices are designed to provide the patient with information about their treatment and allow them to log details including dosage, time, and date, via an app on their mobile phone.
This add-on approach is somewhat of a gap-filling solution between the traditional pen and a fully integrated connected device. The true aim is to deliver a device that, without any additional devices, is capable of informing the patient all of the information on their injection data they could need. Biocorp’s ‘DataPen’, seen at Pharmapack, demonstrates what technologies may be involved in such a connected device. Although we cannot be sure what is being used in the ‘DataPen’, such technologies as Bluetooth and wireless, electro-mechanical, sensor technologies, and Near Field Communication (NFC) technology could all be utilised in a connected pen device.
Cybersecurity and safety is an emerging area of concern for connected medical devices
Patient safety in a connected world requires real consideration. From a regulatory standpoint, the FDA has produced guidelines on cybersecurity for connected devices. Additionally, last month the FDA released a safety communication detailing how an implantable cardiac device is vulnerable to unauthorised access, possibly leading to ‘rapid battery depletion and/or administration of inappropriate pacing or shocks’.
While cybersecurity is a key consideration for manufacturers, something as simple as being able to use the device when the battery is dead could lead to foreseeable use errors. Some of the devices we saw at Pharmapack allow users to continue dialling and dosing when the logger is no longer working and logging usage data. As patients become more reliant on their devices to track their treatment regimes, this could lead to a situation of missed doses or miscalculation of dosage. It is important that risk management and human factors considerations are included early in the design development process for these devices. This will ensure that these risks are controlled in a manner that ensures user safety, while delivering all the benefits of a connected device.
Viscosity was another key theme
With the growing trend in larger molecular weight biologics over small molecular weight drugs, device manufacturers are looking for new ways to deliver more viscous substances that also allow for easier injections.
Delivery of these large molecules (e.g. monoclonal antibodies for cancers) can be an issue for the traditional delivery methods due to drug viscosity. Primary container breakage, the need for a larger needle bore (and therefore increased patient pain) and high injection forces are all factors that are shaping parenteral device design.
We saw a number of devices at Pharmapack whose primary feature was the ability to deliver viscous drug solutions. One example is Bespak’s VapourSoft® syringe — it uses a container of liquefied gas, that when released, provides energy in the form of a pressurised vapour delivering up to 2ml of 200 cPs in 10 seconds. For a more traditional delivery system, Ypsomeds YpsoMate 2.25 Pro has the capability to deliver up to 50 cPs in ≤15 seconds. However, these solutions do come with an increased size than a standard device - the YpsoMate 2.25 Pro is 11mm longer and 20 grams heavier than the standard YpsoMate 2.25 auto-injector.
Also seen was an interesting resurgence of polymers such as COC (Cyclic Olefin Copolymer) and liquid crystal polymers, which could see primary container manufacturers changing from the traditional glass PFS system to a polymer capable of withstanding the forces generated when delivering a viscous solution. These materials could see the high volume/high force needs of a biologic drug in a standard size pen. It sounds exciting, but I feel these are still early days for these materials in the primary container world and adoption will take time. The challenge is attempting to change the long-established industry standard of glass container systems. However, with the increased requirement for delivery of ever viscous solutions, this could be a challenge worth facing.
Packaging was consistent and relatively standard
A large proportion of Pharmapack was related to (unsurprisingly!) pharmaceutical packaging. This field hasn’t seen much evolution over the years. Got a solid dose? Blister pack! Injectable? PFS! We were a little surprised not to see too much in the way of innovation in this space at Pharmapack — apologies if you were exhibiting a game-changer and we missed it. In spite of the regulatory boundaries, we believe there’s a large scope for innovation in the pharma packaging space. CDP is working on a number of related projects that we look forward to sharing later this year.
If you’d like to discuss any of the areas we’ve highlighted here in more detail and how they might relate to something you’re working on, please get in touch email@example.com. We’d be happy to help.
See you next year in Paris!
Reflections on the recent Manufacturing Medicines Industry Partnership conference.
21 June 2018
The benefits of making medical devices intuitive to interact with as well as safe to use.
15 June 2018
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