Expert human factors, risk management, and design solutions for the MedTech and Pharma industry.
Through our unique expertise in the complementary fields of healthcare human factors, risk management, and design, we are the one-stop shop for world-leading MedTech and Pharma companies, start-ups and service organizations in and outside of the EU.
Based at the lake of Geneva in Switzerland, we are perfectly situated in an international MedTech and Pharma cluster with direct access to highly specialized and experienced resources.
WHAT WE DO
We provide highly specialized and seamlessly integrated expert human factors, risk management, and design services to the MedTech and Pharma industry. Our service portfolio covers the entire product development process from concept design to approval including HF strategy definition, conduction of formative user studies, task- and risk analysis, device design, creation of instructions for use, labels, training videos, test samples, provision of regulatory support, performing human factors validation, and creating the required documentation.
WHAT DRIVES US
The unique opportunity to improve lives through our work constantly drives us towards our key objective:
Providing patients, caregivers, and healthcare professionals with safe, effective, and user-friendly solutions that are highly accepted by both users and health authorities around the globe.
We're thrilled by the possibility to make a difference and grateful for each and every opportunity to contribute to the development and approval of our clients' technology.
Bridge the gap between human factors engineering, risk management, and design to develop innovative and safe solutions that are more effective, easier to use, and receive wider user acceptance.
Optimize your development costs and timelines through effective design strategies and risk management.
Meet regulatory expectations and accelerate your approval processes through compliant human factors engineering and risk management processes.
From concept design to health authority approval.
Ergonomics Factory serves a wide range of clients including world-leading Medtech and Pharma companies, specialized service organizations and start-ups all around the globe for which we've been setting up compliant human factors, risk management, and design processes and strategies, managing all human factors related project activities, qualifying and managing suppliers, providing staff training, creating design solutions, performing formative and summative user studies, managing product risks, creating the required documentation, and supporting health authority interactions.
Our experts have been developing, testing and optimizing design solutions for auto-injectors, inhalers, point-of-care devices, medical analyzers, laboratory information systems, pre-filled syringes, vial-kits, and novel drug delivery systems. I.e. industrial design concepts, graphical user interfaces, training videos, instructions for use, packaging and labels, as well as study samples. We furthermore have been performing user studies and successfully supporting pre- and post-marketing activities and approval processes.
We possess significant experience in working with patients, caregivers, laboratory experts, field service engineers, nurses, medical doctors, and healthcare managers, and understand how to systematically incorporate specific user characteristics such as educational and training levels, gender, age, dexterity levels, comorbidities, and different cultural backgrounds into risk management and design solutions.
We are experts in analyzing, specifying, designing, and testing use scenarios and workflows for high-throughput laboratory sample processing and reagent quality control, laboratory information system management, point-of-care diagnostics, web-based medical information systems, implantable medical devices, as well as drug (self-) administration for chronic disease treatment as well as medical emergencies.
Our solutions are used in emergency vehicles, intensive care units, operating theaters, laboratories, doctor's offices, as well as in home and public environments. Characteristics these use environments include extreme weather conditions, varying noise levels, poor lighting conditions, presence of distractions, multiple stressors, and competing tasks, as well as potentially life threatening hazards.
We ensure the seamless integration of human factors, risk management, and design activities including cross-functional alignment. Our processes are tailored to design control environments, follow recognized consensus standards and current guidelines, and have proven to deliver safe, innovative and approvable solutions with outstanding usability and user acceptance.