design for success
From napkin sketch to commercially-viable product, we take a holistic approach to product development, addressing all the required aspects for your device to be successful:
Technical
Ensuring the device can perform as required to deliver the intended clinical results
Usability
Ensuring the device can be operated in the intended clinical setting
Standards
Ensuring the design and development process is documented in compliance with ISO 13485:2016 and that the design meets the requirements imposed by relevant regulatory standards
Manufacturability
Ensuring manufacturing is feasible within your business case assumptions and identifying qualified suppliers and manufacturing partners
Financial
Optimizing device cost of goods sold (COGS)
