From new opportunities in therapeutic areas and device sustainability, to the use of digital solutions and the rise in patient centric approaches steering new formulation decisions, there are a number of prevalent trends in the drug delivery space. I recently sat down with some of Team Consulting’s leading experts to discuss how these trends could shape drug delivery device and technology development in 2023.
Before looking at some of these specific trends, it’s worth highlighting one of the broader shifts in the sector that has been taking place in recent years. The strategically focused pharma companies have recognised the benefits of putting technology (including devices, digital solutions, wearable sensors, diagnostics and more) at the core of their long term vision to both improve patient outcomes and to gain a commercial market advantage.
It may sound like a small shift, but the pharma industry has in the past been culpable of not giving serious consideration to drug delivery devices and technologies until relatively late in the clinical development process. By consequence, this means that the real patient needs are not always uncovered, or when they are it is not always possible to adequately address them within short launch windows.
By not considering the device (and other supporting technologies) that will be used to deliver therapies and train users early enough, important decisions relating to aspects of the intended treatment will have already been fixed, such as formulation type, formulation physical properties, delivery volume and administration route. This often leads to a rush to use a relatively limited number of options for existing administration devices, such as IV infusion, commoditised pre-filled syringes or off-the-shelf devices. Whilst these devices can broadly meet the regulatory and safety requirements, the fact is that they will often be sub-optimal in the hands of the intended user group population. They often can’t fully meet the intended environment or lifestyle of the user which can lead to costly post-market issues.
Whilst there is always a need to get potentially life-changing therapies onto the market as quickly as possible, it is surprising to see that the pharmaceutical industry is still spending a huge amount of effort and funds on gaining regulatory approval for combination products that only partially meet the needs of users, whether they be patients or health care professionals.
Today, the trend is definitely shifting to involve focused delivery device expertise early in the therapeutic discovery and R&D process. By doing so, our clients, including those from many of the world’s largest pharmacos, have highlighted that they are able to better inform formulation decisions to be more appropriate for the expected use scenarios and technologies. They are also able to put the patient and by consequence, the device and the technology that is going to be used to deliver the therapy, at the centre of the drug development process and reduce post-market complaints.
There are lots of very interesting new and developing therapy areas to keep an eye on throughout 2023, but there has unquestionably been a spotlight on ‘biopharmaceuticals’ for a number of years. The European Medicines Agency (EMA) uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are “based on genes, cells, or tissue engineering.” These innovative medicines are used to treat the root cause of many complex diseases in areas such as rheumatology and oncology, but are also used in cardiology, dermatology, gastroenterology and neurology, among others. Within this field biosimilars also now have a very important role to play in the democratisation of healthcare, enabling more global access to treatments at a lower cost.
The major challenges in biologics however are both the high treatment costs – largely driven by complex manufacturing processes – and complications with transport/storage and drug administration. Factors such as a need for low temperatures during shelf-life storage and a requirement to deliver in high volumes, often by intravenous infusion, are all challenges that need to be addressed in the near future if these treatments are to be fully democratised.
To fully realise the opportunities in this space and to improve access for a wider range of patient and income groups there is a need to simplify the manufacturing processes and produce formulations that can be stable at higher temperatures, while also simplifying the therapy administration process.
The ‘market pull’ is for simple, at home, self-injection of therapies such as oncology treatments that would have previously only been available as a large volume infusion in a hospital or healthcare setting. This in turn has highlighted a drive for new delivery systems such as high-volume injectors and wearable, on-body delivery systems, that can meet the requirements for routine self-administration of more concentrated and viscous biologic therapies.
The key factor to developing devices to suit this need is through a combination of deep understanding of mechanical requirements and trade-offs to accommodate increased formulation viscosities and higher payloads. Careful behavioural science input into the device design is also key to ensure that the device solutions are easy to use as well as being safe and effective.
In 2023 we can expect to see a continued focus on novel technologies for delivery of higher payloads/viscosities for self-injection, as well as a continued demand for other low-cost devices to suit generic therapeutic applications for both the respiratory and injectables markets.
Speaking to Ben Cox, Head of Digital Design at Team, we identified a clear move towards hybrid healthcare and training in recent years, offering a key opportunity area in the drug delivery space.
“Over the past few years healthcare professionals (HCPs) have been noting a massive growth in digital tools, however these tools are not replacing in person care, rather they are augmenting it. Many of the digital approaches that were used at scale during the pandemic, such as telehealth in GP surgeries, have continued and have become an expected part of the patient journey. While these digital tools became mainstream through necessity, their continued use post-pandemic has been an important step towards increasing the adoption of other digital solutions more widely.
Previous concerns around patient access to the technologies required to enable digital solutions also appear to be diminishing, with the number of smartphone subscriptions worldwide surpassing 6.5 billion in 2022 and predicted to rise to 7.5 billion by 2027. The pandemic proved to be a steep technology learning curve for many populations, owing to the use of government issued apps requiring people to scan QR codes and upload test results digitally.
As smartphone usage continues to proliferate, the key for medical device developers will be to ensure that any digital experiences they introduce are easy to use, add value and are accessible to all user groups.”
Paul Greenhalgh, User Experience and Innovation Director at Team, discusses how device manufacturers are continuing to place an increased focus on the user when designing their devices.
“Having a device that not only functions effectively, but also provides a positive user experience plays a significant role not only in improving clinical outcomes, but also patient adherence. A human factors programme is much more than a regulatory tick box exercise – to develop products that meet the practical and emotional needs of our users, it is essential to adopt a truly user-centric design process. In line with this, pharma companies are placing increasing importance on the user experience and the need to understand their patient’s behaviours, beliefs and needs.
This could in part be related to the recent shift in many drug payment models from a focus on volume to a focus on value for the patient. These outcome-based contracts, whereby treatment payments are linked to positive patient outcomes, are encouraging drug manufacturers to take a more proactive approach to ensure and demonstrate the effectiveness of their products in the wild.
While the most important patient outcomes are of course health related, patient quality of life is also another key factor. In order to achieve both, pharmacos need to ensure that both the treatment and the device used to deliver it, meet their patient’s needs.”
Alastair Willoughby, sustainable engineering lead at Team, highlights how as sustainability has been increasing in importance across the medical device industry, the horizons that are being considered are widening.
“In recent years, many discussions around device development have been focused on material selection and incremental improvements to existing architectures and business models. As net zero targets begin approaching for pharma companies, healthcare providers and governments, more radical approaches are needed to achieve these in time.
Drug delivery is mirroring the wider world, with a trend towards not just product sustainability, but also the total impact, through scope 2 and 3 emissions. This is forcing all parties to look further afield at their supply base to understand the impact that those businesses have. In the device field, a wider consideration of reusable and re-processable devices, falling under the circular economy grouping, is again widening the horizon of what is possible and more importantly, what is actually needed by patients. Furthermore, consideration of the whole lifecycle needs to be planned in from the beginning of the development to ensure the maximum gains can be made, for example designing to minimise interim transportation packaging.
As new medical devices and technologies can often take upwards of 5-7 years to reach the marketplace, our expectation is that we won’t see any pivotal changes on this topic in 2023. However, we do expect that pressure will continue to ramp-up (particularly around new developments) to make sure that sustainable development strategies are included and documented as part of the planning process thus putting into action the groundwork for more sustainable devices in the future.”
Alastair Willoughby, Head of Mechanical Engineering and Sustainable Engineering Lead.
As we move into 2023, a common theme that remains central is the need to put the user and technology at the heart of new drug delivery opportunities to both improve product differentiation and to drive better long-term patient outcomes. With many pharmaceutical and biotherapeutics companies increasingly looking to the device and other technologies as the key unifier, we can continue to drive for better, more innovative health solutions. It will be interesting to see how these trends continue to shape the drug delivery market.
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