For more than 20 years I have been fascinated by the product design and development process.
Merging creativity with an utilitarian approach, the design of a new product or service is at the core of every innovation.
In our regulated world, this creative process needs to be formalised, described, documented, audited, certified, approved…etc.
There are many amazing design and development studios. Some of them have an ISO13485 certification and can take care of your complete design and development work. If that’s what you are after, I can readily provide recommendations, regardless of geography. Nonetheless do not assume that choosing this pathway will magically liberate you from all engineering&design-related decision making duties. Establishing a successful partnership requires great communication based on well defined objectives and scopes, and a solid understanding of design controls best practices and the regulatory requirements behind them. Beyond the introductions, Diapason can be your eyes and voice in this process, managing the bi-directional communication in the best interest of your innovation.
You may choose otherwise to keep full control of your design, and to bet on building up your own design and development team. This is a fascinating adventure in its own right, which can produce great rewards. Give us a call; Diapason can help you implement an agile process from the ground up and provide a bespoke accompaniement and mentorship into engineering management. We can build a culture of quality and design controls excellence from the earliest stages of your team growth, ensuring easier regulatory compliance in the long run.
In-between these two options are countless combinations based on subsystems. Some companies may focus their technical interest and IP on algorithms development and happily outsource their hardware development, whilst other do the opposite. We can assist here in managing this duality. We can even act as a CTO-as-a-service to kickstart your development.