Connected drug delivery devices: what does the future hold?

The market for connected drug delivery devices is booming, with annual growth of 23.4% expected from 2023 to 2030 [1]. With their ability to collect a host of data relating to drug administration, these devices hold great promise for enhanced healthcare outcomes, by enabling more accurate adherence monitoring, increased patient support and reduced use errors. Michael Earl, Director, Pharmaceutical Services at Owen Mumford, explores in more detail how connectivity is poised to revolutionise the drug delivery sector so that both healthcare professionals and patients can leverage connected drug delivery devices to the fullest.

Enhanced patient experience

Given current trends in drug delivery, including the increasing importance of self-administration, a key benefit to connected drug delivery devices is their potential to improve patient experience and thus increase engagement and treatment adherence. Connected devices for subcutaneous delivery can offer greater guidance and support to the patient during usage, allowing them to manage their condition more independently thanks to guidance on key steps throughout the injection process and feedback to ensure devices are being handled and used correctly. Visual and audible notifications, for example, can help confirm start and end of dose delivery and injection hold times. In addition, automated patient reminders can be programmed into the device to provide the user with prompts for their upcoming injections. For new or less confident users, connectivity can also be integrated into a demo device with more specific guidance to assist with familiarity and training.

Connected devices are also expected to provide administration reminders and support as some medications move towards longer intervals between injection times. As patients use their devices less regularly, they may forget to use the device altogether or how to administer their injection correctly, all of this leading to worsening therapy compliance. In this case, connected devices can prove highly beneficial by providing healthcare professionals with data around the device use and success of medication delivery. As the stakeholders needs and technology underlying connected devices both evolve, the capabilities of the devices themselves will improve and provide enhanced benefits for all. Novel sensors for providing sensory feedback on device orientation already exist, and the future data capture possibilities are increasing. For healthcare professionals, closer monitoring of patient behaviour and device use opens the door for more targeted patient care and support with training and education where needed.

Harnessing savings from connected devices

• More efficient medication usage

Efficient medication usage has become a key concern as healthcare costs rise in many markets, particularly the US and Europe, due to more expensive biologic therapies, economic pressures including inflation, and healthcare pressures relating to ageing and less healthy populations.

Connected devices make it possible to reduce drug wastage by monitoring the frequency and volume of actual medication used by the patient. In addition, with connectivity facilitating improved remote treatment adherence and potentially better healthcare outcomes, there are savings to be made across the healthcare system – as consultations, interventions and additional prescribing may all be reduced. However, savings must be weighed against the cost of the connected device itself. Depending on the disease and the therapy, connectivity may not be cost-effective, for example in the case of low-cost injections.

• Driving reimbursement with adherence data

In Europe and in the UK, managing cost is a key driver in healthcare. This may limit the potential for more costly connected devices, requiring a very strong value proposition to be built around the device for it to be prescribed and covered by healthcare providers. However, in the US, adherence information can be used as part of a value story to drive payor reimbursement. We are already seeing payors of all types demanding economic and clinical data to justify device reimbursement and improve health outcomes [2]. In an environment increasingly focused on managing costs, connected devices are one way of providing such data, particularly for novel drugs where fewer data are available.

Two key areas of interest with regard to reimbursement are chronic care management moving outside of hospital settings, with the growing recourse to remote monitoring as a major driver for the development of connected devices; and expensive, novel drugs, where adherence and outcome data from connected devices can help drive reimbursement. Rare diseases, which by definition have much smaller populations, are another area where connected devices could provide important information on treatment adherence and associated efficacy.

Digitalising existing devices

While fully integrated solutions can now be found on the market, there is also the option to add connectivity functionality to existing drug delivery devices potentially enhancing existing administration options for patients. A key benefit of adding connectivity to an existing medical device is the flexibility it offers for different markets or patient groups. Platform devices that work with or without connectivity offer a way to accommodate multiple types of patients with different needs and levels of digital capabilities. As real-time data transfer becomes possible thanks to the emergence of 5G, connected devices can also send data directly to the cloud without the need for an app on a smart phone. This results in an improved user experience and greater attractiveness for some patient groups who are less familiar with digital technology.

Improving device performance

In an industry where quality is paramount, data on device performance captured by devices themselves can be particularly useful. Device error data can provide important feedback to manufacturers for detecting device issues and malfunctions, enabling root cause analysis and fixes to be implemented. Real-world usability data can also be gathered during clinical trials and guide device design, allowing for further improvements when usage errors are identified.

This is one area where significant progress is likely in the near future, as novel technologies and sensors are used to capture data on real-world use and device performance. This would be a rich supplement to the data gathered in human factors studies in a controlled setting, and allow manufacturers and healthcare providers to work together to improve the device design and user experience.

Benefits for clinical trials

Connected devices present a range of benefits for clinical trials, not least the ability to capture usage data in a quicker, more convenient and accurate way. It is likely that data from connected devices will increasingly be combined with other trusted sources of information, such as consumer health tracking devices, to build a holistic view of the patient, as well as the effectiveness of therapy and its impact on other health indicators. This information may then be used with payors to demonstrate the impact of the therapy on patient outcomes, potentially increasing the likelihood of payor reimbursement.

Remote monitoring also opens up new horizons for clinical trials, in addition to saving time and effort for both the patient and the clinical team. The possibility of carrying out remote clinical trials, thus removing geographic constraints, enables more diverse patient populations to be included in trials and potentially provides opportunities in other markets, which in turn contributes to healthcare equality.

Conclusion

Connectivity offers significant potential benefits for all parties involved, whether it be patients, healthcare professionals, payors or pharmaceutical companies. There is likely to be significant innovation within the connected device space, but this innovation will need to be grounded in market need, addressing key issues relating to therapy management, or by helping to enhance the patient experience in a meaningful way. There must be a clear under-
­standing of objectives and the concrete value that connected devices can bring at every level; to this end, the various stakeholders involved must cooperate if the potential benefits are to be fully realised.

Michael Earl, Director, Pharmaceutical Services at Owen Mumford

References
1. GrandView Research. (2022). Connected Drug Delivery Devices Market Size, Share & Trends Analysis Report By Product, By Route Of Administration (Parenteral, Inhalational), By Application (Asthma, COPD, Diabetes Management, Others), By Region, And Segment Forecasts, 2023 – 2030
https://www.grandviewresearch.com/industry-analysis/connected-drug-delivery-devices-market
2. BMJ, T Bartholomew, Use of adherence monitoring in drug contracts tied to outcomes: put patients first, March 2022