OUR EXPERIENCE

We have a highly qualified and experienced team that has been delivering human factors, use-risk management, and user-interface design solutions to world-leading manufacturers of medical and in-vitro diagnostic devices, pharmaceutical companies, service organisations, and start-ups around the globe. 

CLIENTS

Our clients are as divers as the range of products and services we've been working on. While some of our clients have their own world-class human factors engineering and risk management teams, other clients do not have respective in-house expertise. The former typically request us to perform expert reviews and user studies, develop early-stage design concepts and instructional materials, and support specific initiatives such as compliance reviews and process updates. The latter typically ask us represent their human factors, use-risk management, or design role within their projects, and to support their organisation in training new team members and service providers.

SOLUTIONS

We have been supporting our clients in the design and development of auto-injectors, inhalers, insulin pumps, point-of-care devices, medical analysers, laboratory information systems, pre-filled syringes, vial-kits, wearable healthcare solutions, and novel drug delivery systems. I.e., we've been developing industrial design concepts, graphical user interfaces, training videos, packaging and labelling concepts including instructions for use. We furthermore have been delivering compliant human factors and use-risk management documentation, test samples and test equipment, human factors research and validation studies, and successfully provided support to pre-and post-market activities including regulatory approval processes.

USERS

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, impairments, comorbidities, as well as different cultural backgrounds into risk management and design solutions.

SCENARIOS

We are experts in analysing, specifying, designing, and testing user needs, user requirements, 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.

CONTEXTS

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 of these use environments include extreme weather conditions, varying noise levels, poor lighting conditions, presence of distractions, multiple stressors, competing tasks, as well as potentially life threatening hazards.

APPROACH

We ensure the seamless integration of human factors, risk management, and design activities including cross-functional alignment in our clients' projects. 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.