MedTech Product Design and Development

Cobalt apply a user-centred approach to all medical product development with the aim of improving outcomes for both the patient, and healthcare professional. Understanding typical product users and their behaviours offers a range of insights that are used to inform and guide the design process. These insights allow our designers and engineers to develop innovative, creative solutions that not only address the functional and performance requirements, but also ensure the product will effectively address the user needs; a critical element to any well designed, successful product.

Cobalt employ a range of techniques to develop these insights during each project. These range from observational or ethnographic research, workflow mapping, user/stakeholder workshops, consultation with subject matter experts (SMEs) and product/user testing and evaluation.

Regulatory compliance is a key part of any medical device development program. Cobalt has extensive experience with developing medical products for global regulated markets such as USA, Europe and China. Our medical device design projects are operated under our dedicated quality management system that is closely aligned with ISO 9001 and the medical device specific ISO 13485. Our system provides a flexible yet practical approach, tailored to fit the unique requirements of each project. We employ a customer focused, process-based approach, to enhance efficiency and effectiveness, reduce risk and successfully deliver every project.

Cobalt has a long history of innovation in design and engineering receiving numerous industry awards and accolades. Many of these were for advanced medical design projects, including the coveted Sir William Hudson award – Engineers Australia’s highest accolade – for our work on the Cylite Optics HP-OCT.

We firmly believe that high quality product development is the result of a highly collaborative environment where a variety of expertise and inputs are combined and distilled to best match the product and user requirements. Our designers and engineers work closely throughout the entire process to ensure form, usability and style preferences are balanced against the practical realities of function, performance, and manufacturability.