Prototyping
Business Situation
Our client is a world-leading manufacturer of autoinjectors, pen injectors, and specialty delivery systems and has more than 1,000 employees worldwide. To simulate intravitreal injections into pre-term infants, Ergonomics Factory was tasked with specifying and providing a representative baby dummy. We have furthermore completed all activities relating to human factors engineering, user-related risk management, user interface design, and human factors formative and validation testing for one of our client’s key-important medical device design and development projects.
The Challenge
The global injectors company needed a dummy to represent a pre-term infant in all relevant aspects related to performing intravitreal injections. Intravitreal drug delivery has become a common standard for investigating and treating many diseases of the retina, including diabetic retinopathy, retinal vein occlusion, and age-related macular degeneration and, in this particular case, retinopathy of prematurity. The procedure places medication directly into the vitreous body. The company, as mentioned earlier, required an injection dummy that incorporated:
A body, head, and several facial features, including nostrils and mouth.
Eyeballs that were flexible, representative in terms of their resistance to needle puncture, and could be exchanged.
The option to allow simulated intubation to the nose and mouth.
In addition, the pre-term infant dummy needed to be:
Adjustable in height.
Re-usable through the exchange of eyeballs.
Portable so it could be transported to different study sites.
Delivered on time to support the completion of human factors studies.
The Solution
Ergonomics Factory first researched the characteristics the baby dummy needed to match. For instance, the different eyeball sizes, the materials required to imitate flexible and puncture-resistant tissue, and the correct structure for the dummy’s mouth and nose to support intubation simulations.
Outcomes
Our client now has a re-usable and portable pre-term infant dummy that can be used to simulate intravitreal injections within human factors formative and validation studies. The dummy has exchangeable eyeballs, can be adjusted in height, and allows the simulation of the real world setting for valid assessments of injection procedures and settings.
Benefits
Ergonomics Factory created a simple, effective solution for the client. The entire design and development process of the injection dummy was left to Ergonomics Factory, from analyzing the initial needs through the production and testing of the injection dummy.
There was no additional supplier management required; Ergonomics Factory completed all activities relating to Human Factors, Use-Risk Management, and User Interface Design, and made sure the baby dummy met all respective requirements and was provided on time for conducting the human factors studies.
The injection dummy is sufficiently representative of a pre-term infant regarding all intravitreal injection-relevant aspects, therewith supporting the ophthalmologists and assistants in the simulation of intravitreal injection procedures into pre-term infants and the collection of valid human factors study results.
Updates
The client has used the baby dummy during multiple human factors formative and validation studies. Ergonomics Factory continues to support the autoinjector manufacturer through our human factors engineering, user interface design, use-risk management, and user testing services.