The majority of medical device startups never reach commercial scale. The reasons are familiar: regulatory missteps, fragmented vendor relationships, manufacturing surprises during design transfer, and IP portfolios that collapse under due diligence scrutiny. The transition from concept to commercialization is exactly where most companies falter, and where the right partnership makes all the difference.
At Kapstone, we believe the solution is a single source partnership rather than trying to manage fragmented consultants and contract manufactures. Our decade-long partnership with GetSet Surgical is one of many strong examples of how our vertically integrated model can support your company from its founding through high value acquisition.
The GetSet Surgical journey began in 2016. From day one, the focus was on building a commercial-ready product.
Kapstone Medical’s engineering team supported the design, prototyping, and testing for three core spinal systems. By 2021, as the industry shifted toward additive technologies, we expanded this portfolio into titanium 3D-printed programs. Since our engineers are in constant communication with our manufacturing team, each component was designed with the end manufacturing process in mind.
Each of these systems required close coordination between device engineering and manufacturing cost feasibility, a challenge that would have been nearly impossible across separate, disconnected organizations. Because Kapstone Medical and Kapstone Manufacturing operate as a unified team, GetSet’s product roadmap was shaped by real-world production constraints from day one, dramatically reducing the cost and time associated with late-stage design changes.
The Design Transfer stage is historically the most challenging phase of product development. Typically, a startup hands off a design to a contract manufacturer (CMO) who then discovers problems with manufacturing to specification, leading to higher-than-expected cost of goods sold, costly redesigns and significant delays.
At Kapstone, the team that designs the device is the same team that validates the manufacturing process. For GetSet, this meant that prototyping, material selection, supplier audits, and product cost were handled within a single ecosystem. This continuity ensured that manufacturing readiness was baked into the development cycle, allowing for scaling capabilities that ensure cost targets while meeting both EU and US market demands.
An innovative product is useless if it doesn’t achieve market clearance. Our partnership with GetSet was deeply rooted in regulatory expertise. Kapstone played a pivotal role in:
By providing ongoing post-market surveillance and quality leadership, Kapstone allowed GetSet to focus on their clinical mission while we handled the rigorous burden of global compliance.
A medical device company’s value is tied directly to its IP portfolio, especially during due diligence. Throughout the multi-year engagement, Kapstone supported GetSet’s IP strategy development in alignment with commercialization goals.
This meticulous stewardship ensured a clean, well-defended, and strategically managed portfolio. This level of oversight is a key differentiator in maturing a startup to be ready for major Medical Device OEMs to acquire.
In Feb 2025, Demetra Holding acquired a majority stake in GetSet Surgical and acquired the remaining stake in March 2026, a testament to the commercial maturity the company had achieved over nearly a decade of disciplined partnership with Kapstone. From its founding in 2016 through FDA clearances, CE Marks, and ISO 13485 recertification, GetSet arrived at the due diligence table with something rare in the MedTech startup world: a complete, defensible, and fully operational commercial infrastructure.
Strategic acquirers do not simply buy products, they buy quality. They need to see that a company’s design history files are complete, that quality systems are audit-ready, that manufacturing can scale without disruption at the best cost, and that regulatory submissions are clean. Because every one of those elements was managed under a single roof at Kapstone, GetSet was positioned as a de-risked, high-value asset. The acquisition was not the end of the story, it was the validation of a process executed correctly from the very beginning.
“When engineering and manufacturing operate as one team, you don’t just build a better product, you build a better company. That’s what we did with GetSet Surgical, and their acquisition by Demetra Holding is the proof.” — Mike Burgan, COO, Kapstone Manufacturing
When you partner with a single-source provider, you aren't just hiring a vendor; you are gaining an integrated project team. Our cross-functional support across engineering, regulatory, quality, and manufacturing provides the consistency needed to successfully execute the project.
For early-stage startups and established OEMs alike, this model eliminates the friction of managing fragmented consultants. It provides a single point of accountability and a streamlined bridge from Kapstone Medical’s design expertise to Kapstone Manufacturing’s execution.
The GetSet Surgical partnership demonstrates that when engineering and manufacturing are treated as a single continuous process, the result is better product which reaches the market and scales faster ensuring financial viability. The acquisition by Demetra Holding in 2025 is a direct reflection of the market readiness GetSet achieved through that process. As we look toward the future of MedTech, this vertically integrated approach remains the gold standard for bringing life-changing technologies to patients worldwide.
If you are building a medical device company and want a partner who will be as invested in your success as you are, from your first prototype to your final acquisition, we invite you to learn what the Kapstone model can do for you.
A single-source medical device partner is an integrated partner like Kapstone that handles the entire product lifecycle from initial concept and IP strategy to regulatory clearance and full-scale manufacturing.
Strategic buyers look for "de-risked" assets. By having design, manufacturing, and quality records all managed by a single professional team, the due diligence process becomes cleaner and more compelling for strategic buyers.
Yes. As seen with our partnership with GetSet Surgical, we manage international regulatory requirements such as U.S. FDA 510(k) clearances and European CE Marking (MDR) compliance, along with ISO 13485 audits.