Safe self-administration devices: Beauty in simplicity
Research conducted on behalf of Owen Mumford Pharmaceutical Services showed that the market demand for at-home self-administration drug delivery is rising, due to the increasing prevalence of chronic conditions including diabetes, heart disease, and certain cancers.
Specifically, according to the research, the global safety syringe market is currently growing at a compound annual growth rate (CAGR) of 8.96%, while the global market for pre-filled syringes, which was valued at over $772m (€694.31m) in 2018, is expected to reach $1.13bn (€1.02bn) in 2023, growing at a CAGR of 8%.
Moreover, the market for safety-engineered pre-filled syringes is projected to be worth over $868m (€780.65m) in 2023, and to dominate the total pre-filled market, holding an approximate 76% share of the total pre-filled demand.
The above figures and the market trends they describe put the spotlight on patient safety, as well as on the manufacturers’ challenges in ensuring convenience, safety, and their own compliance with regulation.
These aspects become more important as the industry sees competition on at-home administration availability rising, although ensuring safety can become challenging, with faulty products posing a risk of recall for manufacturers.
Breaking down safety
Asked about the main safety features that manufacturers need to work on, George I’ons, head of product strategy and insight at Owen Mumford, explained that ease of use and ‘passive’ safety activation should be ‘at the top of the list’.
“Ease of use is an integral part of the successful device design process,” I’ons explained, adding that it is important to offer “reliable functionality while minimising the number of use steps required. There is beauty in simplicity!”
Regarding more detailed specifications, the product strategist cited “a fully automated delivery and needle retraction process, and complete needle shielding” as a major objective.
On a technical front, looking specifically at prefilled syringes, “it is also important that the device prevents the plunger rod from being completely removed, as this may lead to drug spillage, as well as opening the door to device re-use,” which is ‘clearly not a good idea’, according to I’ons.
Additionally, he noted providing cues (visual, audible and tactile) to alert the user that the correct dose has been successfully delivered, as an important feature.
Great design ‘more than the simply conceptual’
Speaking about the designer’s perspective, I’ons went on to explain other factors that a manufacturer needs to consider in order to get an idea successfully and safely on the market.
“Great design is much more than the simply conceptual,” he stated, adding that, in order for the user to receive high-quality experience, safety devices need to behave as intended during manufacture, assembly, final assembly and transit.
“You can have a great product concept, but value will be undermined if problems arise further down the production or supply chain,” he said, adding that the best performing design teams “combine the designers themselves with cross-functional operational teams early on,” to ensure quality in drug delivery.
According to I’ons, this collaboration helps to avoid unnecessary complexities that can present problems further down the development and manufacture process.
However, ensuring patient safety with self-administration also relies on the risk assessment processes that are now a stringent and mandatory part of device development testing.
“Fully automated (‘passive’) devices are preferable so that any room for patient error is eliminated and the needle is automatically retracted and shielded,” I’ons noted, adding that, on top of this, it is ‘paramount’ that the manufacturers pay ‘meticulous’ attention to clear instructions for use and training documentation – whether for the patient, the supervisory nurse or the carer.
Ultimately, he concluded that safe disposal routines are critical at the end of the lifecycle, whether that is “product size considerations (fewer bin collections), or collection services themselves.”
