CLIENTS

We have been serving a wide range of clients including many of the world-leading MedTech and Pharma companies, specialised service organisations, as well as start-ups. While some of our clients have their own human factors engineering and risk management departments, others do not have any respective in-house expertise. The former often request us to perform expert reviews and user studies, develop design concepts and instructional materials, and support specific initiatives such as compliance reviews and process updates. The latter often request us to represent human factors, risk management, and/or design roles within their projects, and to support their organisation in selecting and training new team members and service providers.

SOLUTIONS

We have been developing, testing and optimizing design solutions for auto-injectors, inhalers, insulin pumps, 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 test samples. We furthermore have been performing user studies and successfully supporting pre- and post-marketing activities and 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 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.

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. 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.