We “get” medical device and digital health product development. We apply user-centered design thinking, starting with a deep understanding of the clinical needs and requirements for your device. We consider the patient, physician, providers, and other stakeholders in the equation and remain consistent with regulatory standards
Our design and development processes are consistent with regulatory standards governing medical device development. Some of these include standards regarding software (IEC 62304), risk management (ISO14971), and usability engineering (IEC62366). So whether you want our help in the proof-of-concept stage, or advancing seamlessly through more formal later stages of development, we can help along the way.
Our team combines extensive design and engineering experience with a rapidly growing background of medical device and surgical products. This hands on experience spans work on medication dispensing devices, gate measurement systems, blood coagulation readers, protein purification systems, cardiac ablation systems as well as various surgical instruments and digital health products. Our goal is to bridge the gap between medical industry needs and winning healthcare solutions with our desire to make a change where it counts the most and our proven expertise in human-centered design and product development.