Andreas Meliniotis, director of Device Development at Vectura explains how connected devices are helping patients better manage their medications and improve adherence.
Connection
The effectiveness of any treatment is a combination of many factors, most notably patient adherence to the dosage regimen and correct use of drug delivery devices by the patient. This means that a lack of compliance and/or patient use error can seriously compromise treatment outcomes.
Now, more than at any time in the past, it is possible to use relatively simple connected devices to track and report factors affecting adherence, giving healthcare providers specific and targeted data to inform decisions regarding any necessary modification of a therapy. As the availability of connected devices increases, so the effect of this data-driven therapy adjustment is likely to become increasingly apparent, which in turn will increase the desire to connect more therapies.
Connected drug delivery should be focused on areas where the impact can be greatest. For example, whereas insulin injections for diabetes have a generally high level of adherence due to immediate severe outcomes, an asthma maintenance therapy may exhibit poor adherence as there is no immediate decline in health. Using a connected drug delivery device for the latter can provide a high level of monitoring and therefore give an early trigger for intervention to prevent uncontrolled disease and eventually hospitalisation.
Some therapies can be affected significantly by user technique, and identifying this can have a dramatic effect on the efficacy of a treatment, particularly if it prevents a patient being prescribed a medication at a higher level to compensate for poor technique. A recent paper reviewing inhaler adherence states, “In the simplest way, adherence should be defined as how patients follow the medical prescription. However, numerous variables influence medication use, such as the route of administration, frequency of use, taste, response to therapy and adverse events.” [1]
Another example where feedback on medication effectiveness is key to correct administration is diabetes, where glucose levels are self-measured by patients to decide when to administer insulin. Where connected devices can provide feedback on medication effectiveness, this can be an important part of the self-administration process.
The ability of patients to self-administer, however, depends upon many factors; not least education and age. For some patient groups, there are smartphone apps connected to a drug delivery device that can be designed to both prompt the user to self-administer and guide them through the administration process by listing the critical tasks and providing pictures or videos to aid dosage. Such technology and interaction provides huge levels of guidance data to patients, and gives the opportunity to reduce user task errors and improve compliance as a by-product of connecting medical devices.
Connected devices can provide both feedback and metrics to encourage patients to comply. Gamification can be used to change patients’ mindsets, using an app or other feedback interfaces to encourage compliance, and there are suggestions to ensure long term compliance, constantly changing aspects, (i.e. new targets or ongoing metrics) can keep patients interested, and have a longer-term effect than more basic systems.
Currently, connected drug delivery presents as add-ons to existing approved combination products or medical devices. Good examples are pressurised metered dose inhaler (pMDI) add-on devices, which sense the user pushing the pressurised canister to release the medication. The functionality of such devices is limited as the base device has not been designed with connectivity in mind, so the options for communication between devices are restricted. Additionally, only the number of times the user has pressed the canister to release medication can be measured, but no indication as to whether the user has inhaled the medication, or whether the canister still contains medication can be registered. Without monitoring the usage and remaining doses, the system is far from providing true patient adherence information.
As time progresses, delivery devices are likely to be increasingly designed with connectivity in mind, which could open up possibilities for integrated connectivity or high functionality add-on devices, but extensive market research will need to be undertaken prior to the development of next-generation devices. User needs must be fully understood and a detailed target product profile (TPP) drawn up to ensure that the top level assumptions and requirements are considered. It is likely that the functions of such a device will be different or more complicated than initially assumed, and these details are important to ensure that the final design meets the user’s needs.
For any developer, the key is to focus on the user and the intended use, and to use these inputs to select a concept for development. Once a design is available, functional requirements can be tested, but again the developer must engage users for feedback and validate that their needs are met – and this is likely to be an iterative process to achieve a product which meets the original brief.
Ensuring that regulations are met when developing connected devices depends largely on the target markets and the type of device being developed. For instance, a 510k application with the FDA for the US market can be used if a predicate device exists, (i.e. one that is sufficiently similar to the test product) as a basis for the application. This would be appropriate for a medical device but not for a combination product. A combination product that includes a fixed connected device element would need to follow a more onerous new drug application (NDA) type route. The new EU Medical Device Regulation would apply to both medical devices and combination products for European markets.
The emergence of connected devices brings the industry to a potential turning point, and being able to measure ‘true adherence’ will be a first step towards fully unlocking the benefit of such devices. The ability to measure signals from the patient and automatically administer, or prompt administration of medication will provide a closed feedback loop that could ultimately optimise efficacy for individual patients, and ensure the robust continuation of medication, optimising patients’ treatments. Once the benefit can be clearly demonstrated, in terms of patient outcomes, better controlling of diseases and ultimately, lowering the cost of healthcare, more devices will emerge which increase patients’ benefits.
References:
1. Jose R. Jardim and Oliver A. Nascimento, The Importance of Inhaler Adherence to Prevent COPD Exacerbations