How a Fortune 500 orthopedic OEM leveraged the EXALTA Integrated Platform to take an anterior cervical system from Voice of Customer to product launch in 24 months.
EXALTA is the dedicated orthopedic implant and instrument business post spin-off from RTI Surgical, formerly known as Pioneer Surgical. The distinguished metals manufacturer has developed a reputation for challenging the status quo of the orthopedic CDMO space by successfully dedicating its business to a model it developed 20 years ago: Private Label Original Equipment Manufacturer (PLOEM).
The EXALTA PLOEM business model is unique to the orthopedic industry as it addresses the critical resource constraints that may otherwise hinder the advancement of an OEM's portfolio evolution. EXALTA commits all necessary departments to pushing innovative orthopedic system ideas from concept to market launch in a highly competitive timeframe, and then manages the maintenance of that system with dedicated partner-specific resources.
The EXALTA PLOEM model goes beyond standard CDMO offerings. The full value chain addresses unmet market needs like managing Design History Files (DHF), post-market activities, design transfer to manufacturing, and quality system integrations.
Customer A has a longstanding tradition of excellence within the orthopedic industry, in both market share and innovation. In 2021, they were challenged with the need to transform their cervical portfolio to both meet and exceed industry innovation standards.
However, Customer A was faced with limited internal resources for a wholistic development project. They were looking for a partner to provide an end-to-end solution offering the entire value chain in-house.
With the competitive landscape of orthopedics becoming more demanding, and internal projects consuming Customer A's resources, the need to launch an innovative product with speed was critical to the cervical portfolio transformation. Customer A required a dedicated team of experienced resources who could interpret the project's high demands and transfer them into a highly structured project plan.
“The need to launch an innovative product with speed was critical to the cervical portfolio.”
The EXALTA integrated model commits all departments to a unified operating model across four phases of device commercialization. Each phase is staffed with dedicated resources — not shared capacity borrowed from other engagements.
After proving themselves to be the ideal partner, EXALTA was awarded the cervical portfolio transformation project. Shortly after being awarded the project, the EXALTA Product Development Process (PDP) was implemented.
The PDP is an agile design methodology with iterative design cycles, allowing for a customized approach to each unique solution built from the ground up. This detailed process ensures Customer A's organizational needs are met early on and throughout the process.
This differentiates EXALTA from competitors who sell comprehensive solutions only to strip them down mid-project as constraints surface — adding more time and cost.
The EXALTA PDP granted Customer A the opportunity to mimic their own PhaseGate approach to product development. EXALTA adopted Customer A's terminology and specific vernacular to aid in effective communication between organizations — strengthening the partnership and acting as a true extension of Customer A's resource pool.
“EXALTA is committed to designing and testing on the same manufacturing equipment scheduled for production quantities. This increases the speed to market by abbreviating the design transfer process while optimizing scalability and predictability.”
The PDP ensures organizational needs are embedded early and re-validated throughout — eliminating downstream surprises.
As with any new system launched in orthopedics, a concise and accurate timeline is critical to success. With the intent of high-volume quantities, a unique advantage of the EXALTA PDP process is designing and testing on the same manufacturing equipment scheduled for production — increasing speed to market while optimizing scalability and predictability.
Once the project reached launch phase, the transition from a dedicated design team to a dedicated CAST (Customer Advocacy and Support Team) team occurred. The CAST team ensures the successful life-cycle management of both implants and instruments post-launch — specializing in scalability, continuous improvement, and post-market activities.
No matter your size, portfolio, or industry, EXALTA has the potential to unlock your “Speed to Revenue.” Every partner's needs will vary, which is why EXALTA offers flexibility in approach — specializing in the capability to launch fully designed systems inclusive of gaining and maintaining market access through holding the DHF.
“The EXALTA platform exists to solve one problem: the gap between what OEMs need and what traditional CDMOs deliver. We don't just manufacture — we co-develop, we hold the DHF, and we stay accountable from first design input through post-market. That's the difference.”