Incubation & Ongoing Operational Support for Medical Device Companies

We provide services in all of the key functional back office areas that a company needs early on including Engineering, Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Logistics and Distribution, and Operations. Consider Kapstone your bridge from startup to building out your internal staff. You can take time with important hires to make sure that you have the right people and processes in place for effective scalability.

Manufacturing

Kapstone Manufacturing, a wholly owned subsidiary of Kapstone Medical, is a unique type of contract manufacturer that provides end-to-end capabilities for medical device production. We serve companies of all sizes, from startups to large multinationals. Through a global network of strategic partners, we can provide the best combination of quality, price, and lead time. Our model is set up such that virtually any manufacturing process is available, allowing for the optimal solution to a particular product, project, and customer.

Operations

Our operational support team manages all aspects of product and process flow, from ordering inventory through delivery to the end user and invoicing. We have the capability to inspect, inventory and ship anywhere from our Charlotte, NC location. And within our enterprise ERP system, inventory and financials are handled seamlessly on behalf of our clients.

Key Process Support

Often early-stage medical device companies don’t have the financial resources, access to talent, or training to perform all of the key processes required to be successful in the market and compliant to applicable regulatory requirements. We apply best practices with our expert staff to help run key processes in a capital-efficient manner. Through a fractional approach, we can be embedded with your current staff in order to execute your strategy in a timely manner, allowing your team to focus on market entrance, revenue generation and/or fundraising.

Exit Strategy

Many of our customers are not necessarily looking to build a long-term business based on their first product, but rather to prove clinical and economic efficacy and then try to sell to a larger strategic acquirer. One advantage to working with Kapstone is that you can leverage our expertise to launch and scale your commercialization plans without having to build an internal team. This allows much more flexibility down the road for a potential acquisition event.

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If Kapstone sounds like the right fit for your business or you have further questions, please reach out to our team.

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