At RDM, we were privileged to be part of the foundational journey of NovApproach Spine, a company now renowned for its innovative spinal interbody fusion system. Our involvement was critical during the startup phase, where we played a key role in bringing their vision to life.

Engineering Design Principles Applied:

• Design Control: We ensured meticulous control over the design process, aligning all aspects with FDA standards. This was crucial for the eventual FDA approval of the interbody fusion device.

• Design History Maintenance: A comprehensive design history was maintained, documenting every step from concept to prototype, aiding in regulatory compliance and facilitating future iterations.

Our Role in NovApproach Spine's Success:

• Startup Phase Contribution: From the outset, we were hands-on, dedicating thousands of hours to CAD design, refining the interbody fusion system through multiple iterations to meet stringent medical device standards.

• Surgeon Collaboration: We traveled across the country, engaging in high-level design meetings with world-class surgeons, ensuring the device's design was both innovative and practical for surgical use.

• Wet Lab Observations: Our team spent hours in the wet lab, observing surgeries on cadavers to validate our designs, which significantly informed our engineering approach.

Relationship with Founder Raymond Cloutier: Our partnership with Raymond Cloutier, the founder of NovApproach Spine, was not only professional but also profoundly influential. His vision and leadership were instrumental in deepening our passion for engineering, providing us with invaluable exposure to cutting-edge medical technology development.

Beyond Design - Impact and Growth:

• FDA Approval: Our rigorous adherence to design principles and regulatory requirements paved the way for the device's FDA approval, a testament to our commitment to quality and safety.

• Company Growth: Post-approval, NovApproach Spine expanded, eventually establishing an in-house engineering team to handle ongoing regulatory and design needs. While we stepped back as the company scaled, our foundational work has been integral to its success.

The NovApproach Spine project stands as a highlight in RDM Engineering's portfolio, showcasing our ability to blend engineering excellence with medical innovation. We are proud of the lasting impact our work has had on spinal health outcomes and the development of a now-thriving medical device company. This project not only demonstrates our technical capabilities but also our dedication to advancing healthcare through engineering.