Putting medical devices at the centre of drug development
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.