Human Factors. Risk Management. Design.
Ergonomics Factory is a Swiss-based, global consulting firm, specialized in the provision of expert human factors engineering, risk management, and design services to the MedTech and Pharma industry.
The challenge
Regulatory requirements:
Health authorities expect manufacturers of medical devices, in vitro diagnostic devices, and combination products to comply with regulatory human factors, risk management, and design requirements.
Compliant strategy:
The success of your projects depends on the early definition of the right strategy that optimizes the project development timelines and required resources while being in line with the regulatory expectations for your product type, intended use, and intended target markets.
Flexible and experienced resources:
Because each phase of the product lifecycle demands different levels of human factors, risk management, and design resources, the success of your projects depend on the timely availability of highly experienced specialists that are familiar with the project, the project team, as well as the relevant regulatory expectations.
What we offer
Project management services
We represent the human factors, risk management, and design role within your projects, i.e. we support you in defining the most suitable strategy, conduct the required human factors, risk management, and design activities in alignment with your cross-functional teams, create the required documentation, and support you in your health authority interactions.
Tailored project support
We support your project teams in the conduction of specific human factors, risk management, and design activities, including (but not limited to) regulatory strategy support, use-related risk assessment, development of user interface design concepts, creation of instructional and training-materials, development of hard- and software test samples, labels, and test equipment, conduction of formative and summative human factors studies, review of post-production information, and definition of the respective actions.
Compliance and training services
We help you review your human factors, risk management, and design procedures and help you ensuring regulatory compliance with the latest standards, regulations, and guidelines through the creation/update of your standard operating procedures, work instructions, document templates, and effective workshops, trainings, and coaching activities.
Your advantages
Get continuous on-demand access to highly qualified and experienced human factors, risk management, and design experts that accompany your project throughout the product development process.
Develop innovative solutions and implement effective risk control strategies to maximize the use-related safety, effectiveness, and user acceptance of your products.
Perform design validation activities with confidence, meet the regulatory expectations, and swiftly enter into clinical phase 3 studies and commercialization.
Off-load your project teams through outsourcing defined work packages such as known use problems analysis, development of instructions for use, labels, and training materials/videos, conduction of expert reviews and human factors studies, creation of project documentation including human factors summary reports and briefing book chapters.
Bring-in best-in-class expertise from our work with many of the world-leading MedTech and Pharma companies, SMEs, start-ups, service providers, and consulting firms around the globe on innovative solutions for patients, caregivers, laboratory experts, field service engineers, nurses, medical doctors, and healthcare managers.
Current project examples
Optimization of the human factors engineering processes of a multinational pharmaceutical company to ensure its regulatory compliance and efficiency.
MDR remediation for the autoinjector portfolio of a multinational pharmaceutical company.
Formative human factors study witha specific patient group to assess the acceptability of the required force for triggering a pressurized inhaler device that is equipped with a new valve system.
Creation of a dummy patient for the purpose of simulating use testing of an injection procedure within formative human factors and validation studies.
Development of instructions for use and on-device labels for a globally marketed autoinjector intended for emergency use through untrained patients and caregivers.
Human factors project management for a multinational MedTech company for the development of a globally marketed injection device used to facilitate the delivery of intravitreal injections into pre-term infants by specialized ophthalmologists.
Human factors validation study to demonstrate the use-related safety and effectiveness of a breath-actuated inhaler to be used by a specific adult risk group within a global clinical phase 3 study.
Interested in working with us? Get in touch.
Ergonomics Factory LLC, Switzerland
Mail: office@efty.ch
Phone: +41 213 11 11 00
