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On the road to connected drug delivery devices

Top three benefits and challenges, by George I’ons, head of product strategy and insights, Owen Mumford Pharmaceutical Service.

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The world over, the pandemic has added pressure to healthcare systems that were already struggling to cope with an ageing population and the rise in chronic illnesses. In doing so, however, the health crisis has also highlighted the value of teleconsultations and greater connectivity – both minimising the impact of growing demand and limiting the spread of infection within hospitals and clinics.

Patient self-management and remote monitoring are already in place for the management of certain conditions, including chronic respiratory conditions and diabetes – and the results have been encouraging.[1]

George I’ons

Prompted by these promising results, progress is now being made in the area of digitally connected drug delivery devices for injection. In fact, our own research expects the global market for connected drug delivery devices to grow exponentially from US$225 million in 2020 to US$706 million by 2025 – a CAGR of over 25 per cent.

While the demand for connected drug delivery devices is undeniable, key healthcare stakeholders, including payers, clinicians, patients and pharmaceutical companies, will have to collaborate for deployment in this area to be effective and deliver benefits.

As the line between “consumer” and “patient” becomes increasingly blurred with the rise of wellness products, expectations from potential users of digital devices may be much higher – as are the stakes for all those involved in the development and deployment of the device.[2] This article assesses the top three expected benefits from this new form of remote patient monitoring, and the main potential challenges that lie ahead for stakeholders.

BENEFIT #1 – IMPROVED PATIENT OUTCOMES

Clinicians can use data generated from connected devices to remotely monitor therapy adherence. Thanks to embedded electronics and sensors that report on the time, dose and site of the injection self-administered by the patient, clinicians can check that treatments are being carried out at the correct frequency and in accordance with the prescribed dosage. Some drug delivery devices already provide benefits such as dosage reminders and adherence tracking, achieved via connected technologies and associated apps. As a result, patients and clinicians can expect a better therapy success rate and better outcomes, or indeed better understand when and what interventions may be required.

BENEFIT #2 – DATA IS POWER

Thanks to the connected devices’ collected data, not only can patients strengthen their understanding of their condition and its management, but clinicians can also use this information to better support patients; they can tailor treatments to patients’ specific indicators and requirements, or provide necessary training and education. Personalised treatment plans hold great potential to improve health outcomes, as well as the patient experience.

BENEFIT #3 – CUTTING COSTS

For health insurance providers, the benefits of increased connectivity are also important. By helping patients to take greater ownership of their medication regime, and thereby encouraging adherence, connected devices may reduce the likelihood of patients requiring additional, potentially costly, healthcare interventions.

Pharmaceutical companies manufacturing costly injectable therapies such as biologics can also benefit from digital devices, as these can help reduce drug wastage through missed injections, and inaccurate dosing – thereby improving the success rate of the drug.

Connected devices also provide support to the growing number of pharmaceutical companies offering wider services related to their drug portfolio – including patient training and support, adherence monitoring and benefit tracking – as the automatic and remote access to adherence metrics and treatment outcomes can help to make these services more economical.

CHALLENGE #1 – INFORMATION OVERLOAD

When it comes to giving patients access to treatment and progress data, stakeholders will want to aim for a level of information that is useful and motivating. Too many notifications and an excessive level of detail may overwhelm and confuse patients, ultimately affecting the levels of compliance irrespective of the functionality of the device.

CHALLENGE #2 – RISK ASSESSMENT

While dosage reminders will help to encourage adherence, devices will need to undergo thorough Human Factors (HS) analyses to identify design elements that either create a risk for the patient or reduce the ease of use or comfort during injection. With connected devices, patients become the primary actors in their medication regime so it’s important that pharmaceutical companies select a device that has been designed with the patient in mind. Given the sensitivity around security of electronic health records, ensuring that devices are interoperable with standard clinical systems and provide robust protection from data breaches is key.

CHALLENGE # 3 – REDUCING WASTE

Finally, drug delivery device designers are under pressure to create environmentally conscious products. Choosing a sustainable design will therefore be important in the development of connected delivery devices. Hybrid designs – which combine a reusable connected ‘shell’ in which the electronics are embedded with a disposable device element – could greatly reduce a device’s carbon footprint compared to fully disposable devices.

CHALLENGE #4 – REGULATORY OBSTACLES

COVID-19 has shone a light on the importance of having a rapid regulatory approval process for new medical products so that patients can begin to reap the benefits. Regulatory authorities are exercising keen scrutiny of the tangible impact of digital technologies on patients.

For its part, the US Food and Drug Administration regulates manufacturers of any electronic product and has formally recognized several consensus standards related to wireless medical devices.[3] However, providing hard evidence of patient benefits is challenging without widespread deployment and adoption of these products.

As such, it is hoped that facilitating the use of non-traditional data sources such as real-world data within regulatory submissions could accelerate and enrich innovation and development in this area. This is already being trialled in Europe, where the European Medicines Agency recently released guidance on the use of digital technologies to support approval of medicinal products. Acknowledging that digital tools are increasingly used in clinical trials, the guidance provides advice on determining the validity of collected data.

As noted by the agency, the guidance reflects their current experience, and further considerations may be added over time. This reflects the wider industry view that there is a great deal more to learn to realise the full potential of digitalisation in healthcare.[4]

References

[1] See for instance, Impact of a diabetes remote monitoring program on medication adherence; Kiraat D Munshi, PhD; Kyle Amelung, PharmD, BCPS; Callie S Carter, PharmD; Roberta James, MStat; Bimal R Shah, MD, MBA; and Rochelle R Henderson, PhD, June 2021: https://www.jmcp.org/doi/pdf/10.18553/jmcp.2021.27.6.724

[2] Cambridge Consultants, CONNECTED DRUG DELIVERY DEVICES: THE REALITY OF DESIGN AND DEVELOPMENT: https://www.cambridgeconsultants.com/sites/default/files/uploaded-pdfs/connected-drug-delivery-devices.pdf

[3] US Food & Drug Administration, Wireless Medical Devices, 09 April 2018

[4] European Medicines Agency, Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products Status as of June 2020, 01 June 2020

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