Change management in medical devices for patients

An increasing number of biologic drug patents are expiring, driving new development of biosimilar products. This in turn sheds light on the issue of changing drug delivery devices.

Biosimilar drug developers need to differentiate their offerings from originator products, and a novel drug delivery device may be an attractive option. After all, patients are used to changing brands of medications they are prescribed, so it’s tempting to think they won’t be surprised by a new drug delivery device from a different manufacturer.

But it is not so simple. If you have been using the same auto-injector for years, you may have difficulty coping with a new one or may be concerned about unfamiliar features. Patients’ trust is paramount – otherwise there is a risk that they will not use the new device and will lose important doses of medicines.

The stakes are high – especially given the growing trend for patients to self-administer medication at home (and therefore away from the watchful eyes of healthcare professionals). But if you do it right, it’s a win-win situation; patients are more likely to adhere to their treatment regimen if they find it easy to use the drug delivery device. This is not only good for the patient – it also benefits the healthcare system and pharmaceutical companies.

So how much change can patients cope with when it comes to their drug delivery device? The only way to find out is to test the new device with real patients. However, there is a surprising lack of research on the ease of device switching – so we decided to commission an independent study to assess the ease with which patients could switch between two different auto-injectors.

Two devices were selected for the study: SHL Medical’s three-stage, button-activated DAI auto-injector and our own two-stage, spring-loaded OMPS Aidaptus device, which does not require a button and is activated by the patient simply pressing the device against the injection site. In addition to being easy for patients to use, we designed Aidaptus to accommodate both 1ml and 2.25ml glass pre-filled syringes in the same basic device – with stopper detection technology and a self-aligning plunger that automatically adjusts to different fill volumes in each syringe.

We believe our device has benefits, but what about the patients who will literally be the center of attention? To be clear, our goal was not to compare the two devices (all study participants had been using the DAI auto-injector for at least three months). We simply wanted to know how easy it was for patients to switch from a familiar device to a new auto-injector.

The study involved 52 participants (34 women and 18 men), with an average age of 51 years (age range 16–75 years), split equally between the UK and the US. They were each asked to administer four injections into an injection pad placed on the table – starting with the DAI auto-injector and then alternating with Aidaptus.

They were given no help with their new device – only the user manual included in the box containing the device. We wanted to see if they could successfully inject themselves using the new Aidaptus auto-injector without external guidance and training. We were also interested in how long it took them to administer the injections, whether they actually read the instructions for use (or even skimmed them!), and how confident they were in administering the injections. Observing participants operating the new device certainly gave us clues about its ease of use.

All injections were performed successfully – even with an unknown device. Most participants only needed to examine Aidaptus once to successfully administer the injections, with the ability to switch between the two devices having no effect on gender. People over the age of 40 took slightly longer to receive injections with both devices, but still completed them successfully. Interestingly, on the second use, injection times – counted from the moment the autoinjector was placed on the pad and the participant began the injection process to the moment the device was removed from the pad – were similar for both devices.

Of course, while these results are interesting, they’re obviously just a start – we need much more user research to truly understand all the potential pitfalls of asking patients to switch to an unfamiliar drug delivery device. Nevertheless, we were comforted by the fact that the study participants handled everything calmly – even under pressure in an artificial testing environment.

And I would cheekily add that our results suggest that choosing an innovative two-stage biosimilar autoinjector instead of a traditional three-stage device may not be a step too far after all!