Human Factors Engineering
Business Situation
A multinational pharmaceutical company with 60,000 personnel and operations in 65+ countries partnered with Ergonomics Factory to leverage our experience with design, control process improvement, and human factors engineering. Due to the client’s expanding range of device types, their medical device and drug-device combination project teams needed to implement and integrate a more efficient, flexible process reflective of the company’s growth trajectory.
The Challenge
As a world-class developer of self-administered drug therapies used by millions of patients all over the world, this global pharma company needed a streamlined, adaptive, up-to-the-minute human factors engineering process. A vital optimization aspect was verifying regulatory compliance and aligning with the organization’s standard operating procedures.
In addition, their new product development and patient safety projects required numerous cross-functional links between procedures, work instructions, and document templates.
The new and improved process would need to be:
Supportive of all in-progress activities and deliverables of existing and upcoming projects.
Fully compliant with the latest US FDA and EU MDR regulations and standards.
The Solution
Ergonomics Factory defined and optimized the human factors engineering procedure for the client’s design and development processes on time and within budget in less than two months.
" We realized it was time to consult with a human factors expert when we decided to optimize our procedures for supporting a more efficient and compliant design and development process for our growing and global pipeline of medical products. We chose Ergonomics Factory because of their technical and regulatory expertise and their experience in working with a broad range of different product types and organizations. It’s been over a year since they completed the optimization process, and our team is very happy with the new procedure and how well it integrates our human factors engineering activities and deliverables into our design control process. Most importantly, we can be confident that our human factors engineering process is fit for supporting the design and development of our upcoming product range, and that it is in compliance with the latest regulatory requirements."
Yu-Ting, Senior Usability Engineer, Medical Device and Combination Product Development
Outcomes
Our systematic improvements involved the integration of procedures with related processes and functions, including product specification, verification, and validation, leading to:
Lean standard operating procedures, work instructions, and templates.
Regulatory compliance and effective risk management processes.
Traceability between identified risks and risk controls.
Cross-functional stakeholder alignment.
Benefits
Reduced time and effort
Confidence in regulatory compliance
Reduced data integrity risks
Effective verification and validation planning
Updates
The client continues to work on additional improvements and developments to these four systems, within existing and new global projects. In addition, they plan to collaborate with Ergonomics Factory on future validation projects.