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Ensuring continuity: Human Factors consultant staffing during critical transition periods

Human Factors Engineering


Two human factors consultants climbing a snowy mountain


Business Situation


One of our international pharmaceutical clients faced a resource challenge when one of their Human Factors Engineer (HFE) left the company. A swift and effective solution was required to bridge the gap until a suitable internal replacement could be found. At that time, the HFE who left the company was in charge of the HFE-related activities for the development of an accessory for one of the company’s injection pens. To ensure the seamless and timely continuation of this project, a deep level of expertise regarding the device technology, respective user interface design requirements, as well as regulatory and process requirements was required.


The Challenge

Departure of a Human Factors Engineer

  • The departure of their HFE professional presented a major challenge as ensuring the seamless continuity of the HFE activities was required; The company had just finalized a formative study at that time and needed to assess the impact of the study results on the design of the accessory and the subsequent actions.


Ensuring Project Continuity

  • A replacement was needed that is able to quickly and seamlessly assimilate the project history, the company's quality system and respective design control processes, and integrate into the project team. The primary focus was on effectively managing multiple internal and external parties to ensure the project goals and timelines remained on track.


The Solution


Ergonomics Factory sent a HFE for a period of four months, who seamlessly took over ongoing HFE activities from the previous engineer. Our HFE took charge of the impact analysis of the previous study and design activities, supported the risk management, and took charge of the planning and execution of subsequent user studies with external test partners. Furthermore, our HFE ensured constant cross-functional alignment across the internal and external stakeholders and the integration of the different requirements into the project and the project strategy. The regular on-site presence of our HFE supported real-time engagement with the project team, fostering a deeper understanding of the ongoing activities, effective communication, and effective alignment with the project manager.


"Our team is impressed with the thorough contributions made by Ergonomics Factory’s Human Factors Engineer (HFE) during their four-month engagement with our project. The seamless transition from the previous engineer and the proactive approach to taking over ongoing HFE activities greatly benefited our project.


The HFE's thorough impact analysis of previous studies and design activities provided us with invaluable insights. Their support in risk management and the planning and execution of user studies with external test partners was instrumental in advancing our project objectives.


Moreover, their ability to ensure constant cross-functional alignment across internal and external stakeholders was a key factor in the successful integration of various requirements into our project strategy. The HFE's regular on-site presence facilitated real-time engagement with our project team, which fostered a deeper understanding of the ongoing activities, enabled effective communication, and ensured robust alignment with our project manager.


Overall, Ergonomics Factory's HFE significantly enhanced our project's outcomes and we highly recommend their expertise for any similar engagements."


Cara, Senior Human Factors Engineer


Outcomes


Within the 4 month project duration, our HFE effectively supported the project activities, conducted two formative user studies that provided critical insights into user interactions and the design of the device, the digital application, as well as the instructions for use, and established the required technical documentation in alignment with the cross-functional team.



Benefits


The partnership between Ergonomics Factory and our client ensured the seamless project continuation within time and budget, and delivered tangible outputs in the form of formative study protocols and reports, updated risk analysis and project planning, and aligned design decisions documented in the user interface specification.


Updates


After the handover of the HFE activities to the new internal HFE, Ergonomics Factory continues to support our client on multiple projects and various activities including regulatory remediation activities for legacy devices, as well as known use problems analysis and human factors expert reviews for new development projects.





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