A new grip-able sleeve for pharmaceutical autoinjector pens makes it easier for patients with reduced dexterity due to rheumatoid arthritis (RA) to handle the medical device and perform self-injections, which can help improve health outcomes. Adding the molded-rubber sleeve also doesn’t require pharma companies to incur time-consuming and costly packaging revalidation.

Noble, an Orlando, FL, company that provides drug delivery device training solutions, fulfilled a pharmaceutical client’s request to develop a product that functions in tandem with a pre-existing autoinjector to improve RA patients’ overall injection experience. The pharmaceutical company declined to participate in this article to maintain its privacy.

However, Josh Hopkins, engineering manager at Noble, answers Packaging Digest’s questions about the design and functionality of the autoinjector+sleeve.

When was the sleeve introduced into the market?

Hopkins: The sleeve was introduced into various markets in early 2019 and will continue to launch in global markets in the following years.

Why was it important that the grip feature be added on to the pre-existing autoinjector, instead of, say, incorporated into it?

Hopkins: Autoinjectors are typically selected as the drug delivery system in the clinical trial phase before a drug launch and are validated as part of the human factors testing for the drug delivery system. Changing the autoinjector form factor after a drug launch is a costly effort and incorporating a large ergonomic grip into an autoinjector design is typically not considered.

Adding a sleeve as an accessory and developed separately from the autoinjector was important, as it allows users to save the sleeve and dispose of the autoinjector after their injection process.

From the photo, it looks like the grip is sold separately and can be used multiple times. Is this correct?

Hopkins: Yes, the sleeve can be used multiple times and is not disposed after the user performs a self-injection.

Is the grip also sold as a kit with an autoinjector? Why or why not?

Hopkins: The sleeve is provided in various ways depending on how each individual market prefers to supply the sleeve to their patients.

How much does the grip cost?

Hopkins: We typically don’t disclose the sleeve price, as it is indicated for use for a specific autoinjector and patient population.

How does the RA patient (with reduced dexterity) insert the autoinjector into the grip?

Hopkins: The patient simply inserts the sleeve onto the top of the autoinjector and twists the sleeve to attach it. The sleeve was designed specifically with ease of attachment and detachment in mind for these patients.

How is the autoinjector removed from the grip?

Hopkins: When patients complete their self-injection, they can simply twist the opposite direction to remove the sleeve. Again, this simple detachment was created with patients with reduced dexterity in mind.

How is this grip more ergonomic, especially for RA patients?

Hopkins: The outer diameter of an autoinjector can be small, which can be difficult for patients with moderate to severe RA to hold and perform the self-injection. When the sleeve is attached to the autoinjector, it is easier for RA patients to grip the autoinjector, and they do not have to press the button with their thumb to activate the injection.

How is the autoinjector activated once the sleeve is on?

Hopkins: The autoinjector is activated by the patient using the sleeve and pressing firmly down towards the injection site.

Did you do any usability testing? If so, what were the results?

Hopkins: Noble performed the human factors testing during development and validated the sleeve during the final human factors testing. Patients had an overwhelmingly positive response to using the sleeve and preferred using the sleeve whenever they performed a self-injection.