Kapstone Medical was founded to make medical device development easier, more efficient, and even more enjoyable. We do that by providing a single-source solution for medical device devices, big to small, allowing them to check multiple competency boxes under the same roof. No need for multiple hires: your company can save money and time by bringing our team on board, whenever and wherever you need us.
We offer seasoned, multifaceted expertise in:
We take a fully integrated approach to new product development (NPD), weaving our expertise in design, IP strategy, engineering, regulatory affairs, quality assurance, and manufacturing into a comprehensive and effective development process based on decades of experience and dozens of projects. Our medical device experts partner with your team to advance your product at any stage of the process and help you to navigate a cost-effective and expedited route to market.
Our NPD teams are fully customizable and flexible to meet your needs for developing product. Whether looking to employ one resource or multiple, we can step in and step out at any stage of the NPD process. Whether you want to be completely hands off or involved in the project, our NPD teams are accustomed to working in our quality system or a customer’s. You have the flexibility to dial in our team as best suited.
Typically, we follow a phase based approach for NPD. Our development teams are flexible to work in your system or within your process.
I started a very complex project with Kapstone. What I found was a group that was incredibly responsive to my needs and receptive to my ideas.
Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.
See the benefits of working with an ISO 13485-certified QMS partner who can audit your existing system or help you install a new one.
Explore our end-to-end manufacturing capabilities, from experienced material selection through to efficient commercialization.
Build confidence in your regulatory strategy with help from Kapstone, an experienced regulatory partner who can help you identify the most compliant, efficient path to clearance.
Developing an innovative product will only go so far without a plan to get it to the field and in users’ hands. Let Kapstone assist with the go-to-market strategy.