CURRENT PROJECTS
A brief summary of some projects we are working on at the moment.
Human factors process optimisation to ensure its compliance and efficiency
Optimisation of the current human factors engineering process towards compliance, required resources, cross-functional touch-points, and timely delivery. Strengthening the analysis and systematic incorporation of user needs and design thinking methodologies. Updating the current work instructions and document templates.
Switzerland
Client: Multinational Pharma Company
Human factors project management for the development of an emergency use auto-injector
Managing all human factors related activities within the development of an auto-injector for a novel emergency use therapy. Activities include user needs analysis, task- and risk analysis, management of external suppliers and human factors studies, development of design concepts, labelling contents, and patient instructions. Documentation of all human factors related aspects and supporting health authority interactions.
Switzerland, USA, Japan
Client: Multinational Pharma Company
MDR remediation and documentation support for our client's portfolio of auto-injectors
Comparing the documentation and labelling contents of currently marketed auto-injectors with the requirements set forth in the EU Medical Device Regulation 2017/745. Performing expert reviews and impact assessment of MDR requirements on design validation requirements. Risk-based documentation updates including provision of residual risks to patients and users.
Switzerland
Client: Multinational Pharma Company
Human factors project management for a novel intravitreal injection device
Managing all human factors related activities within the development of an injection device for intravitreal injections. Activities include user needs analysis, task- and risk analysis, management of external suppliers, performing human factors expert reviews and user studies, development of design concepts, labelling contents, and patient instructions. Documentation of all human factors related aspects.
Switzerland, Germany
Client: Multinational MedTech Company
Human factors validation study on a breath-actuated inhaler
Performing a human factors study, aiming to demonstrate the use-related safety and effectiveness of an inhaler for its intended use by US-based patients in their home environment within the scope of a clinical phase III trial.
Italy, USA
Client: Multinational Pharma Company
OUR EXPERIENCE
Since the company was founded in 2017, we have been supporting numerous clients across the globe. Below a brief summary of our experiences.
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.