Services
Requirements Capture
Using our technical knowledge and medical device industry experience, we listen carefully to capture, comprehensively understand, and fulfil your medical device design requirements including user and design inputs. We seek to align design intent, user requirements, design specifications, patient functional, psychological and emotional needs, with suitable materials and manufacturing capability.
Concept Generation
We think differently, “outside the box”, and focus on the solution instead of the problem. We make use of design thinking methodologies, brainstorming, ideation and endeavour to find practical ideas and solutions with ingenious simplicity for your patient-centred medical device.
Prototyping
We use 3D printing rapid prototyping to accelerate development of proof-of-concept prototypes and delivery of feasible product solutions, with key attention to detail for design function, manufacture (DFM) and assembly (DFA). We collaborate to integrate electronic technology with mechanical designs.
Development
We project manage and collaborate with clinicians, users, patients, manufacturing suppliers to develop your next-generation medical device technology solutions. Problem solving, design modification and iteration for development of proof-of-concept prototypes, novel features added to improve existing product performance and usability.
Design Presentations
We create SolidWorks 3D CAD models, visual diagrams for intellectual property (IP) patent applications. We deliver professional visual presentations including 3D models, SolidWorks 3D animation videos of product concept designs, 3D-printed prototypes, feature details, 2D technical drawings, to aid communication for medical device development.
Design Control
We control design to comply with ISO 13485 regulatory standards & FDA 21 CFR Part 820.30 Design Controls, ISO13485 Medical devices — Quality management systems — Requirements.