A Shot of User-Friendliness

Originally Published MDDI June 2002

MEDICAL DESIGN EXCELLENCE AWARDS 2002

SimpleJect Auto-Injector System
Submitted by Amgen (Thousand Oaks, CA); manufactured by Owen Mumford Ltd. (Oxford, UK)

A few years ago, Amgen created a new, injectable medication for rheumatoid arthritis, Kineret, and realized that it needed a device that would facilitate the drug's adoption among the elderly. This patient population has great difficulty manipulating their fingers and gathering enough strength to perform even simple tasks, let alone pinching their skin while simultaneously inserting a needle at an angle. Studies also showed that some patients had a fear of needles. In other cases, patients weren't sure if they had administered the medication correctly.

To address these issues, Amgen joined forces with injection devices manufacturer Owen Mumford Ltd. to develop the SimpleJect Auto-Injector System, the first drug-delivery device designed to overcome both the physical and psychological difficulties encountered in self-injections of medicine for rheumatoid arthritis patients. "SimpleJect is the first device created to fill needs in this therapeutic area," says Craig Lester, Amgen's marketing manager. "One of our chief goals was to create a device that would help patients with rheumatoid arthritis regain some independence by being able to self-inject their medication. We also hoped SimpleJect's simplicity would encourage patients to continue to comply with administering daily doses of their medicine."

The device features an oversized, soft-rubber handle that is easy to hold, and a syringe-loading device that automatically removes the needle cover. A needle guard hides the needle during injection and sets the injection depth so that patients deliver the medicine to the subcutaneous layer of the skin (the optimal depth). After the injection, the device signals whether the patient has performed the injection correctly, then allows for disposal of the syringe into a sharps container without handling the needle. The entire process takes less than 60 seconds to perform.

"We designed this product from the ground up, thinking of every step—from opening the box the product is delivered in to inserting the syringe into the housing, to disposing of the syringe—and modifying each step to meet the special needs of a rheumatoid arthritis patient," Lester says.

The product went through five prototypes and five advisory boards made up of rheumatoid arthritis patients before a design was found that thoroughly satisfied users. Patients got to choose among 50 handle samples alone—testing different sizes, shapes, and textures to see which options were most comfortable.

"There are kitchen utensils that have been specially developed for people who have arthritis—that have oversized handles and such. That's basically the concept that we followed for developing our device's handle," Lester explains.

Amgen also determined that syringes would be delivered prefilled with the appropriate dosage of Kineret so that patients could simply drop them into the housing. Patients then place the device against the skin, causing the needle cover on the syringe housing to recoil to the appropriate depth, and press down on the handle to deliver the medicine.

Patients have found the device easy to use, and Amgen says it tested its directions as thoroughly as it did the device. In addition to showing medical office staff how to use the product so that they can tutor patients, Amgen provides a videotape, a toll-free number staffed by registered nurses, and a needleless practice syringe that patients can use to walk through the steps as often as they like before giving their first self-injection.

MDEA jurors cited the product's user-friendliness and its ability to restore independence to older patients who suffer from crippling arthritis as outstanding qualities worthy of recognition.

Copyright ©2002 Medical Device & Diagnostic Industry