Expert Consultation on All Aspects of Medical Device Product Launch

Knowing how and when to launch your product is often as critical as the product itself. We have helped launch dozens of new products - from single-use surgical kits to home-based therapeutic devices - by assisting our clients with product and process readiness activities including design transfer, inventory build, regulatory compliance and operational support. With our breadth and depth of experience, we are ideally suited to you with establishing your strategic launch plans.

And it doesn’t stop with a commercialization event; Kapstone continues to support limited and full launches with ongoing activities in all of our main service areas.

Design History File Remediation

Just because a product is ready for launch does not mean that the documentation to support the development of the device is ready. Kapstone has been engaged by a number of clients to help ‘clean up’ the product documentation, most important of which is the Design History File, or Technical Dossier. We are experts at remediation activities in order to bring the documentation of the design and development process up-to-date and ready for commercialization.

Design Transfer

Transferring a product from the design and development stage over to commercialization involves a number of steps, which are critical to success. Unfortunately, some of these steps are often overlooked, or minimized, in the rush to get to market. Kapstone takes a measured approach, recognizing the business need to get to market and begin generating revenue while understanding that a solid documentation package will not only prevent uncomfortable audit situations down the road, but also add to product and enterprise value through mitigation of risk in the short term.

Limited Market Release

Kapstone’s expertise in supporting product launches often begins with a limited market release. This is especially helpful for new technologies, new materials or entering new markets where gaining critical feedback from a small number of accounts helps to gain critical input for a larger release down the road.

Our services during this phase often involve supply chain oversight and optimization, manufacturing runs (including all required validation activities), assimilating clinical feedback for engineering modifications and quality documentation.

Product Manufacturing

Through our extensive supplier network, combined with in-house capabilities, Kapstone Manufacturing can handle the entire process from initial manufacturing through packaging, labeling and sterilization. We are technology agnostic, meaning that we will find the best technology platform to fit your unique needs - whether that is traditional machining, additive manufacturing, injection molding, or a host of other options.

Product Distribution

Kapstone can advise on distribution model selection, helping you identify a model that works for your capabilities, product, cost structure and target markets. Our decades of experience are leveraged for your benefit in order to help craft the best distribution strategy for your product.

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