We have been supporting world-leading manufacturers of medical devices, drug-device combination products, and in-vitro diagnostic solutions around the globe in the development of innovative, safe, and approvable solutions.
Our clients are as divers as their design and development projects and include world-leading manufacturers of medical devices, drug-device combination products, and in-vitro diagnostic solution, as well as SMEs, start-ups, and service providers around the globe. Some clients have their own world-class human factors engineering and risk management teams while others don't. Depending on the project, we work as part of the client's team and assume the Human Factors Engineering, Risk Management, and/or User Interface Design role, and offer to support projects by delivering pre-packaged solutions and consulting services.
We have been working on 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, novel drug delivery systems, and many more. I.e., we've been developing industrial design concepts, graphical user interfaces, training videos, and packaging and labelling concepts including instructions for use. We have been delivering compliant human factors and use-risk management documentation, test samples and test equipment, formative human factors research and (summative) validation studies, and successfully provided expert support to pre-and post-market activities.
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.
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.
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.
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.