Phillips-Medisize, insidecollaboration with your client, Ascendis Pharma,has recently been recognized with a third industry award for the Skytrofa autoinjector.
The Red Dot Award recognizes the outstanding design and positive impact of the drug delivery device. The device is designed to allow for convenient and efficient preparation and administration of Skytrofa, a growth hormone treatment for children. The Red Dot jury praised the device for its ease of use and optics, as well as convenient and safe process control with a reduction in pharmaceutical waste.
Traditionally, children requiring growth hormone treatments were given daily injections which often led to non-adherence to treatment, due to pain and/or bruising with the injection, as well as a fear of needles. The introduction of the Skytrofa auto-injector has reduced the frequency of injections to once a week, using a discreet needle.
The device has previously received thePharmaceutical package Healthcare Product Award for Patient Centered Design in May 2022 and theParenteral Drug Association (PDA) Innovation Award.in October 2022.
How the Skytrofa autoinjector works
Skytrofa is aLyophilized powder available in a double chambered single-dose prefilled cartridge containing lonapegsomatropin-tcgd in one chamber and water in the other.
The cartridge is designed for once-weekly subcutaneous injection with the Skytrofa autoinjector. The delivery device provides fully automated reconstitution of lyophilized drug, followed by a device-controlled manual mixing step. The device automatically dispenses the drug after inserting the injection needle into the skin.
Integrated electronics and software assist the user through the entire preparation and injection sequence and confirm that the full dosage is delivered.
By making the device reusable and refillable, Phillips-Medisize and Ascendis Pharma did away with itthe waste of disposable injector pens and batteries on a full charge lasting four weeks, with one weekly injection. The life of the autoinjector is approximately four years or 210 injections.
John Christensen, Senior Contract Development Project Manager at PhilipsMedisize, recently spoke MD+DI a demonstration of how the Skytrofa auto-injector works (see video below).
Design considerations for the Skytrofa autoinjector
Paul Erik Fabricius, director of front-end innovation at Phillips-Medisize, said there were several key considerations when designing this device due to the intended user population (parents of young children needing growth hormone therapy ).
The team wanted the design to be visually appealing to children and found that the device’s bright white and green colors made it more appealing to this user population.
“We wanted to facilitate this very complex preparation procedure in a simple and safe way,” said Fabricius MD+DI. “This means both physically handling the device—for example, it needs to remain upright during reconstitution to ensure the drug isn’t lost through the needle—but it also needs to have a good grip when injecting.”
Phillips-Medisize conducted numerous usability studies with more than 300 participants who helped shape the design of the device. Participants included a mix of experienced and novice users, trained and untrained users, healthcare professionals and healthcare professionals.
It was especially important to test the device with inexperienced and untrained users, Fabricius said, to ensure it was as intuitive and simple to use as possible.
“It’s a challenge because, if you imagine, when you see the device, you don’t have any reference because you’ve never seen a device like it,” he said. “So, you start out with no prior knowledge of how to use it, so pretty much anything can go wrong. But we tested it with naïve and novice users, and they all successfully got their dose.”
Some of the users in these test groups thought the device actually had no needle because the 31-gauge needle is so thin they couldn’t even feel it.
In addition to in-depth usability studies, Fabricius said it is crucial to maintain an open dialogue with the customer throughout the device design and development phase.
“This has been a key thing to success here because things have come up in the process where we needed to change things,” he said. “For example, that manual mixing step that John showed you, we didn’t think it was necessary at first. But it was simply because we could see that the drug was not homogeneous after the stable mixing step.”
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