What lessons does this offer for the industry?
It may appear strange to reflect on a drug product that did not meet market expectations 20+ years ago however, I suggest that the lessons learned are equally valuable today.
Numerous articles have been published regarding Exubera, identifying different reasons for why the product was not successful. The on-market inhaled insulin product, Afrezza, has demonstrated that there is a demand for inhaled insulin, but the market is not as big as was initially projected.
With this in mind, is there anything we can learn from this?
Clearly, the potential benefits of inhaled insulin do not outweigh the limitations of titration and larger device size, which could well be a perceived issue for a number of potential users. Conducting a user preference study, ideally with both general and needle-phobic users, would be useful to better understand why there appears to be a lack of widespread interest in the inhaled insulin route. Without this data, it is difficult to determine the real reason behind it.
As a medical device manufacturer, it is also important not to underestimate the existing, competing technologies on the market – competitors will likely resist and improve their offering.
Finally, there is a clear need to understand the regulatory pathway and closely engage with the regulatory authorities. Even after Exubera gained authorisation from the FDA, certain patient groups were excluded and the FDA recommended that patients’ lung functions were tested at 6 and 12 months after starting treatment with inhaled insulin.
What can device manufacturers do to help develop a successful new technology?
The importance of the KISS design principle for new technology
An important acronym for any technology developer, but probably more important for new technologies, is KISS: “keep it simple stupid”. This is a common design principle which states that designs and systems should be kept as simple as possible.
In the due diligence activity mentioned above, the device part of the combination product included electronics. This provided a number of opportunities to include, at very low or no additional cost to the device, additional features that would enhance the user experience. Despite the potential benefits of these features, many were not core features for inhaled insulin and may have been better suited to a gen 2 device, once the gen 1 had built up some market demand.
One example was confirmation of drug delivery to the lung. The device provided feedback that it functioned correctly, and therefore it could be assumed that the patient received the dose – where else could the drug go? However, the technical team felt that providing additional feedback that the drug had exited the device would provide extra reassurance to the patient. To explore this, we undertook a design activity to design a sensor in the device mouthpiece to confirm that the drug had excited the device. While this led to some interesting design solutions, the benefits to the user did not outweigh the development costs and technical risks.
Another example of potentially unnecessary features was device connectivity. It’s worth emphasising that this was 2002, meaning a long discussion was needed about what data should be captured and what value this would bring, as well as what patients would expect. Ultimately, this connectivity was a distraction from the core device for inhaled insulin and could have been included in a 2nd generation device. Once again, we need to consider the KISS acronym.
The future of inhaled insulin
The relative lack of success in inhaled insulin over 20 years ago and continued small market size to date suggests there may not be the appetite the industry once hoped for. However, this does not mean that the delivery route does not have potential. For anyone looking to innovate in the inhalable insulin space, they would do well to learn from the lessons of the past and focus on building devices with a clear user need, that keep things simple in the first instance, and that can truly beat the competition.