More Than Build-to-Print: How a Single-Source CDMO+ Helped Bring Pulmera’s CBeam™ to Market

Bringing Pulmera's CBeam™ to Market

"Bringing a new technology to market takes a great team, and Kapstone Manufacturing has been an important part of ours. Their practical solutions and critical infrastructure support have helped ensure CBeam's readiness for commercialization, and we're excited to keep building with them."

— Kevin McGann, CEO, Pulmera

Many med device startups and OEMs expect a contract manufacturer to support them from design freeze to when the parts ship. The problem is that most contract manufacturers are not set up to support when the specifications are not finalized, when there are regulatory questions, and when the need is limited to low volumes for prototyping and early production, making it very challenging to get to market. 

Kapstone Manufacturing is set up as a CDMO+ for exactly this reason. As a single-source partner, our team spans New Product Development, Human Factors Engineering and Usability, Quality Assurance, Regulatory Affairs, Manufacturing, and Commercialization Support. That's what we mean by CDMO+: we help streamline getting a new device to market and scale production as demand grows, starting at any point in the development process whether you're a one-person startup or a global OEM.

The clearest way to explain it is to share the story of one of our customers. Recently, the team at Pulmera reached a major milestone, and we were glad to help streamline their path to market.

Key Takeaways:

• Kapstone Manufacturing is a single-source CDMO+ partner: New Product Development, Human Factors Engineering & Usability, Quality Assurance, Regulatory Affairs, Manufacturing, and Commercialization Support.
• Customer Pulmera received FDA 510(k) clearance for its CBeam™ 3D Imaging Platform in June 2026.
• CBeam is an integration of hardware and software; Kapstone Manufacturing supported the hardware assembly, software installation and testing, and production infrastructure within our ISO13485-Certified Quality Management System.
• Kapstone Manufacturing helped deliver the first two CBeam units to Atrium Health Mercy Hospital in Charlotte, NC.
• Known for a long history with orthopedics and spine, Kapstone has developed experience across a wide range of medical device specialties.

A device built to expand access

Pulmera set out to solve a real access problem: advanced intraoperative 3D imaging has long been out of reach for many hospitals and ambulatory surgical centers because of high capital costs and complex setups. Their CBeam™ platform addresses that by transforming an existing 2D x-ray C-arm into a precision 3D imaging system, rather than requiring a hospital to purchase dedicated equipment.

CBeam is both hardware and software. The physical imaging system is paired with the software that constructs a 3D image from a conventional C-arm, two domains that have to work as one. Pulmera's engineering team leads the hardware and software design and validation, while Kapstone Manufacturing focused on execution of the final hardware builds, software integration, and the physical and quality infrastructure to produce them to a repeatable standard. Supporting a device that spans both hardware and software domains is where a manufacturing partner has to be more flexible than a typical contract manufacturer who builds to a print.

In June 2026, the FDA granted 510(k) clearance for the CBeam technology, opening the door for Pulmera to commercialize their technology. In July, Kapstone Manufacturing helped complete and deliver the first two CBeam units to Atrium Health Mercy Hospital, here in our home city of Charlotte, NC. After successful early cases at the hospital, members of the Pulmera team visited our Charlotte site to mark the milestone with the Kapstone team who supported the build.

Rooted in orthopedics. Built to launch any medical device.

Kapstone is best known for its work in orthopedics and especially spine, and the hospital’s first cases using CBeam for navigated spine fusion are certainly fitting. Kapstone Medical and Kapstone Manufacturing have developed and applied the same integrated development model to help launch products in a wide range of device specialties:

•    Cardiovascular
•    Orthopedic & Musculoskeletal
•    Neurology
•    Dental
•    Wound Care
•    Surgical Instruments & Equipment
•    Aesthetics
•    Monitoring & Wearables
•    Endoscopy & GI
•    Urology & Renal
•    Rehabilitation & Assistive
•    Diagnostics & IVD
•    Ophthalmology

An intraoperative imaging platform like CBeam is a good example of why that breadth matters: imaging crosses specialty lines, and a partner who has worked across device types can adapt to requirements that a single-specialty shop might not be able to handle.

Why single-source matters at this stage

For an early-stage device company, the handoffs between separate design, quality, regulatory, and manufacturing vendors are where timelines slip and risk accumulates. Consolidating those functions under one partner keeps decisions connected; design choices account for how a device will actually be built, quality and regulatory work move alongside development rather than after it, and manufacturing is ready to scale when clearance comes. The integration of disciplines is the difference between a build-to-print supplier and a CDMO+ partner. It's also why 510(k) success depends on the production floor as much as the submission, a point we cover in Regulatory Strategy for Contract Manufacturing.

Congratulations to the entire Pulmera team on this milestone. We're looking forward to what's next.

Frequently Asked Questions

Can I work with a medical device contract manufacturer if I only have a concept or an early prototype?

Yes, but this is a specialized type of contract manufacturer with a quality system built for design and development and regulatory support. A single-source partner like Kapstone Manufacturing can start at the concept or feasibility stage, before your design is locked. Kapstone Manufacturing supports individual inventors and early-stage teams from Phase 0 feasibility and prototyping through design iteration, so you don't need finished production drawings to begin.

What's the difference between a build-to-print contract manufacturer and a full-service CDMO?

A build-to-print manufacturer makes parts from a completed design specification you hand them and stops when the parts ship. A full-service CDMO, what Kapstone calls CDMO+, also has ability to support areas including New Product Development, Human Factors Engineering and Usability, Quality Assurance, Regulatory Affairs, and Commercialization Support under one roof, so development, compliance, and production stay connected instead of fragmented across vendors.

Should a medical device startup use one partner or separate vendors for design, regulatory, and manufacturing?

A single integrated partner reduces the handoffs between design, quality, regulatory, and manufacturing where timelines slip and risk accumulates. When these functions sit together, design choices account for how the device will actually be built and regulatory work moves alongside development, which shortens time to market and lowers the chance of costly rework later.

How do I scale medical device production from prototype to full volume without triggering re-validation?

Involve your manufacturing partner early so that verification and validation testing is done on production-equivalent units, not lab-scale samples. When submission-level processes match how the device is actually manufactured at volume, you avoid the re-validation and repeat testing that can set a program back months, a risk covered in Regulatory Strategy for Contract Manufacturing.

What additive manufacturing processes and materials does Kapstone Manufacturing offer for prototyping and production?

Kapstone Manufacturing offers prototyping and production through both polymer and metal additive manufacturing methods. Common metal 3D printed materials include 316L and 17-4PH for instruments and Ti-6Al-4V and CoCr for implants while polymer 3D printed materials typically include options like resin-printing of silicone or rigid materials with biocompatibility requirements, SLS printing of Nylons for flexibility or toughness. These materials may be developed for use ranging from single-use surgical instruments, to trauma fixation hardware, implants, and delivery-system components. 

What types of medical devices does Kapstone manufacture and develop?

Kapstone works across a broad range of device specialties. It is best known for orthopedic and spine work, and has experience with cardiovascular, neurology, dental, wound care, surgical instruments and equipment, aesthetics, monitoring and wearables, endoscopy and GI, urology and renal, rehabilitation and assistive, diagnostics and IVD, and ophthalmology devices. That breadth makes Kapstone a partner who can adapt to specialized requirements.

Is Kapstone a US-based medical device manufacturer, and is it quality-certified?

Yes. Kapstone Manufacturing is a US-based medical device contract manufacturer in Charlotte, NC, and holds an ISO 13485-certified quality management system. It operates as a single-source partner alongside Kapstone Medical, so your production runs in a certified quality environment from first build through scaled production.

Additional Resources

• Kapstone Manufacturing - ISO 13485-Certified Contract Manufacturing
• Regulatory Strategy for Contract Manufacturing: Why 510(k) Success Starts on the Production Floor 
• Navigating Medical Device Design Transfer Under the New QMSR
  
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