Self-Injection Aid (SIA)
Janssen Pharmaceuticals are a global company tasked with conducting research and development activities related to a wide range of human medical disorders. Shore and Janssen enjoy a long standing, successful partnership.
In May 2018 Janssen Pharmaceutical Japan (JPKK) approached Shore to develop and launch a new reusable UltraSafe Grip Accessory device and needle shield remover, for use solely in Japan by Simponi Rheumatoid Arthritis patients. The challenge posed was to complete all development, engineering and launch activities inside 9 months, create & manage all documentation within Janssen’s own process and finally supply commercial units by December 2018.
The technical challenges alone in developing an intuitive and robust device that delivered against the strict cultural expectations of a very specific user group were complex. Add into the mix the firm deadline imposed to launch commercial units, and the project was a big ask in anybody’s language. It was a project which Janssen would only trust Shore to take on and deliver.
The key challenge was to create a simple, intuitive device that could be used time and again by patients of impaired manual dexterity and neuromuscular dysfunction.
Shore’s design allowed simple, safe location and removal of the UltraSafe X100L safety syringe.
Achieving an acceptable solution to the problem of needle shield removal was as a key driver in our development strategy. Shore’s innovative mechanism removed this problematic needle shield as a secondary function to closing the device.
Using Shore’s approved and flexible design process, our responsibility went beyond just development activities, and included all project management and documentation.
As an initial planning and definition activity we attended site visits and formative user research studies in Tokyo. Design inputs were agreed and signed off, giving a strong foundation for multiple rounds of quick, iterative development to be undertaken to investigate and test options for user assembly and automatic needle shield removal.
Here our Industrial Designers and Mechanical Engineers worked in tandem to develop a device that was easy to understand, offered an effective grip, housed the automatic needle shield removal mechanism and could be reliably put into production within the given timescales. Here the user studies and knowledge gathered in Japan really helped inform the fast development process.
Taking the finalised concept design, we then worked on the all engineering details to ensure all design requirements were met first time. Each individual component was created in careful consideration of their intended manufacturing and assembly method.
Our expertise in material selection, tolerances and finite element analysis (FEA) ensured that mechanisms and performance requirements were fully considered and reviewed before progressing to tooled prototypes.
Engineering prototypes were tooled and built through our approved moulders. Shore then conducted rigorous in-house engineering testing, evaluation and refinement in order to build a high level of confidence in the design solution prior to full production tooling.
As a final step to validate the design against the User Requirements before production, formal Human Factors studies were also completed in Japan using the prototype parts.
Full production tooling was procured and setup via our approved ISO 13484 suppliers.
Samples were built and we conducted final Verification Testing on over 300 units in order to verify that all the Technical Design Requirements were fully met. A formal Verification Report recorded the results and following review closed the loop on the complete Design History File allowing the device to enter the market.
As a result of our meticulous management, design process flexibility and medical expertise the project was successfully delivered ahead of schedule, less than 9 months after commencement.
Shore completed all documentation as required by Janssen’s SOP and conducted a commercial readiness Design Review, successfully bringing together two separate Quality Management Systems, allowing 5,000 SIA units to delivered on-time and within budget to the JPKK team
“Thank you for your great cooperation.
From 7th January our reps are delivering SIA to our customers. I want to express from the bottom of my heart how much I appreciate what you did”
Project Director, JPKK
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