By Sean Fenske, Editor-in-Chief

The orthopedic market is changing at the clinical level. The increasing role of ASCs, influx of robotic-based solutions, and growing interest in single-use, sterile packaged instrumentation have created a need for product innovation. In response, orthopedic device OEMs are seeking assistance from their design and manufacturing partners to help develop and launch new systems.

To answer the call, supplier organizations are offering different solutions to help address their customers’ needs. This includes the expansion of capabilities and introduction of platform technologies, providing orthopedic device makers with an established starting point from which to produce a new product. This can result in valuable cost and time savings for the firm.

To further explain how the supply chain is enabling new innovation while ensuring patient safety, David Hannah, Chief Technology Officer at EXALTA Group, responded to several questions. In the following Q&A, he explains the advantages of the recently formed organization, how it’s helping OEM customers with their new product development, and the considerations those companies should keep in mind.

Sean Fenske: Can you please share what EXALTA Group is? What advantages are realized from the unification of the different companies?

David Hannah: EXALTA is born from the fusion of three orthopedic pioneers: Intech, Tyber Medical, and Resolve Surgical Technologies. The group has come together to form a next-generation medtech solutions provider that combines deep contract manufacturing expertise with integrated OEM system development.

The advantage for our customers is speed, agility, and scale: instead of working with a variety of suppliers, our customers now access design, manufacturing, regulatory expertise, and post-market surveillance within one integrated platform. With a global reach, we offer precision contract manufacturing as well as turnkey, 510(k)- and EU MDR-cleared systems that help OEMs accelerate time-to-market. As the manufacturer of record, we reduce risk, streamline complexity, and bring innovation to life faster.

Fenske: How is the role of the traditional CMO changing? Is innovation development becoming more of a part of the equation/total product offering?

Hannah: The role of a CMO has evolved significantly. Historically, CMOs were viewed primarily as manufacturing partners. Today, OEMs expect more. They expect help across the entire value chain from innovation to regulatory navigation, as well as scalability.

At EXALTA, we see ourselves as an extension of our customers’ R&D and operations teams. Through Integrated OEM Solutions, we give OEMs access to a digital library of patented and regulatory cleared “technology bricks,” design validation data, and documentation templates (for comprehensive platforms such as plating, cabling, and screw systems for multiple surgical indications). These can be combined with their own IP or infused with unique features to create differentiated products.

The advantage is speed to market: OEMs can leverage our established technical files and clearances to adopt and deploy solutions rapidly, without compromising quality or compliance.

Innovation is no longer optional. It’s central to what we deliver.

Fenske: When working with a supply chain partner on innovation development, what advantages are realized? How does the partner help with the regulatory pathway and commercial introduction?

Hannah: The right partner reduces friction across the development lifecycle. We bring proven platforms, engineering expertise, and validated processes that lower risk and compress timelines. We have an established track record of helping customers reach market in six to 12 months versus the 24 to 36 months it might take on their own.

Our teams have decades of experience with product design, clinical testing, FDA submissions, and EU MDR technical files, enabling customers to move through reviews more efficiently.

And from a commercial perspective, it’s not just speed-to-market, it’s speed-to-revenue. By refreshing product lines, filling portfolio gaps, or capturing “quick wins” with proven platforms, OEMs can unlock growth much faster than if they tried to pursue development in-house, where projects often stall due to limited resources or competing priorities.

Fenske: What role do supply partners need to play in developing innovation for a changing clinical orthopedic environment (e.g., the shift from hospitals to ASCs)?

Hannah: “Accelerating MedTech” is not just a tagline, it’s our promise. The role supply partners must play in today’s orthopedic environment is changing as clinical needs evolve: more procedures are moving to ASCs, robotics adoption is rising, and patient-specific solutions are becoming the norm. To keep pace, OEMs need partners who do more than manufacture. They need partners who anticipate change, simplify complexity, and provide flexible platforms that speed innovation.

At EXALTA, that means developing and validating comprehensive implant systems with modular trays and sterile-packed procedure kits that streamline sterilization and turnover. It also requires advancing mission-critical precision instrumentation designed for seamless integration with robotics, ensuring OEMs can align with the way procedures are increasingly performed. By pairing these solutions with regulatory-ready platforms, we help OEM partners bring differentiated products to market faster and position them for the future of orthopedic care.

Fenske: Can the right supply partner provide “shortcuts” for OEMs in getting a product to market faster? For example, can a customer leverage the pre-cleared system platforms of a CMO?

Hannah: “Shortcut” isn’t the right word. Compliance and patient safety can’t be rushed. But the right partner can dramatically reduce time and complexity by providing a proven foundation to build upon.

At EXALTA, OEMs can leverage pre-cleared platforms spanning the orthopedic spectrum (spine, extremities, trauma, recon, and cardiothoracic) from our Integrated OEM Solutions division, instead of developing or piecemealing sets from scratch. With more than 50 R&D engineers on staff, we have secured over 250 patents and supported more than 150 510(k) clearances, giving OEMs a validated base on which to build.

Fenske: What’s ahead for EXALTA Group? What’s to be expected from the company and for customers?

Hannah: With integration well underway, our two business units (Manufacturing Solutions & Integrated OEM Solutions) are now aligned under the new EXALTA banner. Together, they position us as a true tier-1 medtech partner, while serving different customer needs.

• Manufacturing Solutions ensures scale, quality, and nearshoring options through our global footprint.
• Integrated OEM Solutions provides pre-cleared platforms and co-development expertise to accelerate new product introductions.

For customers, this means the ability to fast-track product development and launches as a vertically integrated partner, with greater agility to respond to evolving clinical and market needs. Ultimately, our goal is to advance transformative technologies that improve patient outcomes.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Hannah: Yes. I’d like to clear up a common misconception we’ve heard from time to time:

Myth: “EXALTA is now a competitor. I see their name on 510(k)s and products like trauma plates or spinal interbodies on their website.”

Fact: EXALTA partners with OEMs and has no direct sales channels. The technology platforms we build are backed by clinical expertise, regulatory strength, and post-market data.

For OEM customers, these platforms are a head start: systems they can tailor and scale to fast-track their next launch. This is how we stay true to our purpose: accelerating medtech innovation and enabling better patient outcomes.

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