Reflections from PDA Universe of Pre-Filled Syringes and Injection Devices conference 2018

Senior members of DCA’s medical team attended the PDA Universe of Prefilled Syringes and Injection Devices conference and exhibition in Florida 8th-9th October. Here they share some high-level reflections from the presentations and discussions.

With the continued trend to create smart and connected products for all aspects of life, it was not a surprise that many of the papers at the PDA conference were focused on, or alluded to connectivity and smart functionality for injection devices in the future. This focus was further fuelled by Novo Nordisk’s announcement in the previous week that they are planning to launch a range of connected insulin pens in 2019 and have made a number of digital health partnerships as part of their initiative.

A key discussion point surrounding the addition of smart functions and connectivity to injection devices continues to be the value proposition - whether the extra costs of adding the functionality can be justified by the benefits they bring to patients and/or healthcare systems. A lot of this discussion to date and within the conference focussed on improving adherence to treatment regimens and the often-associated model of outcome-based reimbursement, where the pharmaceutical company’s compensation is linked in some way to treatment efficacy. Amongst other things, smart functionality can enable much more accurate tracking of adherence and therefore can provide both patients and HCPs with a new level of understanding on how they interact with the device and associated therapy. Although there is still some debate about how effective such connected device systems can be in sustainably improving patient compliance, it seems clear that they have an important role to play in informing consultations between HCPs and their patients. This is especially true in scenarios where the treatment is not working as intended. With clearer information about whether the problem is physiological or adherence related, HCP’s will be able to adjust their advice and prescriptions more effectively.

The value model is undoubtedly a key theme and will continue to be discussed as more evidence becomes available to support or challenge the benefits across various therapeutic areas, however, a number of additional linked considerations came through from discussions and the papers presented this year.

Imagine you have a chronic condition that you need to manage with medication and a combination of devices. In an ideal world, your condition would be managed with minimal input – allowing you to ‘disengage’ from the disease. However, one paper speculated that by seeking to add value for patients and HCPs, in some circumstances connected functionality may actually increase the amount of effort required by patients because of the need to engage with more complex devices and associated apps. If smart or connected functionality is to be successful, the challenge is to strike an appropriate balance between user effort and information management, ultimately providing a more valuable experience that is better tailored to the capabilities of individuals and the needs of their condition. One presenter proposed that to genuinely improve user experience and engagement, the pharmaceutical device industry needs to adopt behavioural modelling techniques that are widely used by companies operating successfully in the consumer digital space. Setting up experiences that are engaging and help to reinforce positive behaviour by making users feel successful is key, and something that developments must take into consideration when creating their connected device offering.

As pharmaceutical companies consider their connected offering, it is expected that many will develop bespoke interfaces or apps, through which information is presented to patients or HCPs. With increasing numbers of connected devices, there is a risk that there will be a proliferation of apps and digital platforms which are not cross-compatible and that become complex for patients and HCPs to manage. Whilst this may create market advantages in certain situations, it was discussed that a better model may be for all parties to use an open source approach, allowing device applications or data to be transferred, combined with, or interrogated by third-party applications, creating a digital ecosystem where users can access all their medical / device information in one place. In the example of diabetes care, such an open source digital ecosystem could allow exercise information (e.g. from a Fitbit) to be combined with diet information, blood sugar readings and insulin dose history to allow a comprehensive overview of information which helps patients review trends and better calculate dosage. In focusing on the goal of helping to improve patients’ lives, such digital ecosystems seem a pragmatic approach, but they will require some level of cross-industry interaction.

Adding connectivity to injection devices comes at a cost and this can be quite significant, for example when compared to the high volume disposable injection devices with which they are integrated. Even the simplest smart or connected functionality requires a number of components and specialist assembly considerations. This is currently a barrier to widespread adoption of connected or smart functions and as such, building the right value proposition is key.

This was discussed in various forms throughout the conference but what struck us is consideration of what may happen as the cost barriers reduce with the introduction of new generations of electronic components and power sources. Undoubtedly there will always be ‘soon to be released’ next generation components that offer new or improved functionality at a cost, but at the other end of the spectrum, basic level smart or connected functionality may fall to a price point where it can be integrated into every device and selectively turned on where needed or prescribed. Whilst this approach is clearly some years into the future, it offers advantages of minimising assembly variations, making the technology more universally available.

Overall, as one paper highlighted, when considering connected and smart functionality for future medical devices, we should think about the What, Why and Who. What, considering the requirements and how we are going to achieve them; Why, understanding the value model and business drivers for the extra costs when smart/connected functionality is added; Who, ensuring we understand who we are serving and that we are serving them appropriately with the additional functionality and associated interfaces.

If you are interested in how DCA can help you design the right product and deliver a great injection device to the market, please feel free to contact us to discuss your needs.

Written by Malcolm Boyd, Rob Veasey, Matthew Jones