I joined Unilife in August 2013 as a Product Development Engineer working for the Auto-Injection and Reconstitution business units. Working for such a fast-paced and agile company has enabled me to get involved in many projects and wear many different hats.
While working for the Reconstitution business unit, I developed four different Reconstitution devices and contributed in the development of additional three.
I developed four devices based on one of our existing platforms, customizing dose volume, overall size, activation mechanism, usability and ergonomics for a specific customer. The project required me to completely redesign ground-up the activation and safety mechanisms for these devices.
I followed a user-centered process starting with an initial exploration of feasible concepts based on both customer's and user's requirements. Initial sketching allowed me and my team to discriminate concepts based on our timeline and resources. I then did an concept CAD for each of them and created high quality renders to communicate the concepts with the team and the customer.
The finalist device concepts were selected based on how well they fulfilled the user requirements in combination with the results of analytical evaluations of the conceptual interface such as task and risk analysis that were part of the Human Factors Engineering activities performed for this project.
I performed the detailed design for each of these devices, including FEA simulations, spring design, material (thermoplastic resin) specification and DFM. I worked with vendors to design specialized resins and confirm the applicability of commodity resins, and all the selections were verified with comprehensive FEA simulations of the critical features and interfaces.
I used several low resolution SLA prototypes printed in-house to enable the discussion and help quickly refine both the mechanisms and the ergonomics of all the different components and sub-assemblies. Then high quality SLA prototypes to test the functionality and fit of the whole assembly and as tools to communicate the design intent with upper management and the customer.
Injection molded parts were made using prototype-level tools to assemble and test the complete production-equivalent devices. Testing included intensive and comprehensive technical and functionality testing, as well as usability and human factors testing in which a platform was selected.
One of the many hats I have worn during my time at Unilife is the one of Human Factors Engineer. This puts me in a very sweet spot in which I am both the mechanical and the usability engineer, which enables me to fully involve the user in the development process, as well as to quickly incorporate the findings and insights from usability evaluations into the design of my devices. The end result is a device that is safe, comfortable, usable and that fits within the user's lifestyle.
As the Human Factors Engineer, I am responsible for the Human Factors and Usability Engineering strategy for my business units, which establishes how the Human Factors Engineering (HFE) activities are integrated into Unilife's Product Development process.
Following this process, I have performed analytical evaluations for several of our platforms to identify the intended user and use scenarios, as well as the potential risks and hazards anticipated for such scenarios.
I have defined design and engineering specifications to ensure both durability and ease of use of our devices. Such specs are the result of combining human performance data with the output of our risk analysis process (task analysis, PCA and UFMEA). Human performance data is obtained from literature when available, or otherwise collected during studies I design and execute to capture user force exertions on specific user-device interactions. I have also been responsible for the design of the fixtures, sensors and apparatus required to obtain such user data.
Once the interfaces can be prototyped and tested, the physical device, the interface and the documentation are all evaluated by the intended user population and iterated to ensure the implemented measures of risk mitigation are effective and the device is usable and fulfills the user needs.
A thorough documentation of this process enables us to tell a sound story to both the customer, our top management and the governing bodies (FDA).