The connected drug delivery device market is growing rapidly, with projections of over 20% growth in the market annually between 2023 and 2030, fuelled in part by increased self-administration outside healthcare settings. However, many pharmaceutical companies may not have a clear-cut understanding of their own and their patients’ specific needs when it comes to connected devices, and may not be used to thinking in device terms. This article will lay out the essential areas pharmaceutical companies should cover during decision-making and product development phases to get the most out of connected drug delivery devices.

As the industry as a whole moves towards ‘Pharma 4.0’, companies are looking at connectivity and the transfer of key data as a way to achieve competitive differentiation in a crowded market. This is of particular interest for biosimilars producers, where patents for original biologics will continue to expire in the next three to four years. The core benefits of patient support, adherence monitoring and reduced use errors offer an attractive advantage, but innovation in this domain must be grounded in market need, addressing key issues relating to therapy management, adherence and outcomes, or by enhancing the patient experience in a meaningful way. The link between adherence and improved outcomes is a key factor when considering cost and whether the market will pay for connectivity. In simple terms, connectivity for connectivity’s sake will not cut it.

When used as part of a patient support programme, connected devices are a key potential tool for improving patient engagement. Connectivity can be integrated into demo devices to aid with training, providing specific feedback to patients who are using the device for the first time or who are less confident in their ability to use it correctly. As remote monitoring becomes increasingly common, connected devices can offer greater guidance to patients, providing reminders, helping to prevent use errors such as incorrect device handling and inaccurate medication management, and providing visual feedback for injection site rotation.

‘Pharmaceutical companies stand to gain significant benefits from connectivity, with clear knock-on benefits for payers, patients and healthcare professionals alike’

With the increasing development of extended-release formulations leading to longer intervals between injections (eg, monthly injections), there is a risk of patients forgetting how to use their device correctly. In such cases, the additional guidance provided by connected devices may play a valuable role in maintaining compliance. However, pharmaceutical companies must consider the cost of connectivity when it comes to very infrequent or low-cost injections. There is no ‘one-size-fits-all’ solution and decisions must be made on a case-by-case basis for each disease and therapy.

Where improved outcomes can be shown to be a direct result of improved adherence via connected drug delivery devices, there are potential savings to be made across the healthcare system, including fewer consultations, interventions and additional prescriptions.

Thanks to the data collected by connected devices, it is possible to gather information on the timing and actual dosage (frequency and injected volume) of therapies, avoiding drug waste and ensuring more efficient medication usage. This is especially important in the context of the continuing rise in healthcare costs across Europe and the US as a result of more expensive (biologic) therapies, economic pressures and healthcare pressures relating to ageing and less healthy populations. It follows that a device must have a very strong value proposition or story if it is to be prescribed and reimbursed.

In the US, adherence information can be used as part of a value story to help drive payer reimbursement. Chronic care management outside a hospital setting is a key trend, and reimbursement rules are changing to cover remote monitoring of healthcare. This is a significant driving force behind the development of connected devices. With payers of all types demanding economic and clinical data to justify product reimbursement and improve the health outcomes of the populations they cover, data from connected devices can provide reassurance, particularly for novel drugs where less real-world data may be available. In rare diseases where populations are smaller, therapeutic targets are more specific and drug development for orphan status is expensive, adding connectivity to therapies will be an important strategy, allowing pharmaceutical companies to gather adherence and outcome data that can help drive reimbursement.

When it comes to developing connected devices, add-ons to pre-existing devices are likely to become more and more common. Such solutions may offer the benefit of a simpler regulatory pathway, as the original drug-device combination product has already been approved. Another benefit of a connected add-on is the flexibility it offers in terms of use with or without connectivity functionality, depending on the market and the patient group. This is of particular importance for accommodating different types of patients with different needs and levels of engagement.

However, fully integrated novel drug delivery solutions that accommodate connectivity features should not be ignored. They can take user needs into account early in the design development process, whereas there may be usability compromises with add-ons. The user experience is of vital importance as it determines engagement, with device design and configuration playing a major role. In addition, it plays an important role in ensuring the user interface – including any additional applications – is as intuitive as possible.

In both cases, environmental impact must be factored into decision-making throughout the complete life cycle of the device. Although infection control necessitates some single-use components, impact can be minimised through innovative, hybrid designs allowing for reuse of the main parts, especially the digital element – such as reusable auto-injectors with lifetime batteries, where only the safety syringe is disposable.

Data from connected devices might also be used to improve device performance once they are on the market. The detection of device issues and malfunctions is of great value for pharmaceutical and device companies from a quality perspective, allowing root cause identification and analysis for device errors. This can create an important feedback loop to improve device design.

Significant progress is likely in this area in the near future as novel technologies and sensors are increasingly used to capture data about device performance. Additionally, with the arrival of 5G technology, real-time data transfer from the device to the cloud will eliminate the need for a secondary device or application, providing manufacturers with valuable real-world usability data and enhancing the user experience.

The use of data from connected drug delivery devices could help transform clinical trials, with patient adherence data enabling sponsors to prove the value of the therapy on patient outcomes. The ability to carry out remote clinical trials removes geographic constraints and enables more diverse patient groups, as well as potentially opening up opportunities to trial therapies in a variety of markets. Wider inclusion in the clinical trial phase can, in turn, ensure device suitability for more diverse patient populations, thus contributing to healthcare equity.

Remote monitoring during clinical trials, in particular data capture by connected devices themselves, may also allow both patients and clinical teams to save time and effort. This method is much more convenient than the alternative paper or web-based forms – and potentially more accurate too. Where relevant, real-time data can also allow researchers to make corrections and treatment interventions during the clinical trial.

Pharmaceutical companies stand to gain significant benefits from connectivity, with clear knock-on benefits for payers, patients and healthcare professionals alike. However, they must establish a clear understanding of the objectives of connectivity and the concrete value that connected devices can bring early in the decision-making and device development phases.

References are available on request.

Michael Earl is director of pharmaceutical services at Owen Mumford