What is a CDMO+, and how is it different from a contract manufacturer?
A contract manufacturer typically builds parts to a finished design you hand over and stops when the parts ship. Kapstone Manufacturing is a CDMO+, which means a contract development and manufacturing organization with added, in-house expertise across new product development, regulatory, quality, prototyping, manufacturing, and commercialization. That means Kapstone can join a program at the concept stage, not just at build-to-print, and carry it through to scaled production under one quality system.
What services does Kapstone Manufacturing offer beyond build-to-print?
Beyond producing parts, Kapstone Manufacturing supports concept feasibility studies, design and engineering (including Design for Additive Manufacturing), prototyping, human factors, regulatory strategy, quality-system support, metal and polymer manufacturing, in-house metal finishing (DLyte), and commercialization. We are a single partner that connects design, compliance, and production as a unified team, so you don’t have to manage multiple fragmented vendors.
Can Kapstone help if I only have a concept or an early prototype, not a finished design?
Yes. As a CDMO+, Kapstone can start at the concept or feasibility stage, before a design is locked, through a Phase 0 feasibility study and prototyping, then help turn the idea into a manufacturable, testable design, and into commercialization.
What does “single-source” mean, and why does it matter for regulated products?
Single-source means new product development, quality, regulatory, manufacturing, and finishing are available under one roof and one quality system. For regulated products, that reduces the vendor hand-offs where timelines slip and evidence gets lost, keeps design intent and documentation in one place, and shortens the path from prototype to production.
How does Kapstone Manufacturing work with Kapstone Medical?
Kapstone Manufacturing and Kapstone Medical work together form a single-source CDMO+. Kapstone Medical brings expertise and services in device design, regulatory, and quality, and Kapstone Manufacturing brings in-house metal and polymer production and finishing and a global network of approved suppliers for other manufacturing methods. This enables our customers to move from concept through commercialization with one partner.
What metals can Kapstone Manufacturing 3D print?
Kapstone prints 316L and 17-4PH stainless steel in-house using laser powder-bed fusion and can source additional alloys such as Ti-6Al-4V ELI and CoCr for implant applications. In-house 316L and 17-4PH cover a wide range of instruments, hardware, and components across regulated industries.
What are 316L stainless steel 3D printed parts used for?
316L is a corrosion-resistant austenitic stainless steel well suited to reusable surgical instruments, trauma and fixation hardware, fluid-path and housing components, and subsea, marine, and industrial parts that require corrosion resistance. Its ductility and corrosion resistance make it a versatile choice for both medical and non-medical regulated applications.
What are 17-4PH stainless steel 3D printed parts used for?
17-4PH is a precipitation-hardening stainless steel valued for high strength and hardness after heat treatment. It is commonly used for surgical instruments and cutting or gripping features, structural and mechanical hardware, and components for defense, oil & gas, and robotics where strength and wear resistance matter.
When does metal 3D printing make more sense than CNC machining?
Metal additive manufacturing is often the better choice for complex geometries, internal channels or lattices, consolidated assemblies, and low-to-moderate volumes where hard tooling isn’t justified. CNC machining remains ideal for simpler geometries, certain very tight tolerances, and higher volumes. Kapstone is process agnostic, which means we will recommend the best manufacturing method based on the customer’s specific requirements.
What is Design for Additive Manufacturing (DfAM), and why does it matter?
DfAM is designing a part knowing the specific strengths and limitations of the intended additive manufacturing process. Our design engineers and manufacturing specialists set the material, wall thickness, build orientation, supports, and post-processing as the design develops, so the part is producible, repeatable, and cost-effective. Applying DfAM early prevents redesigns later and is a core part of Kapstone’s engineering support.
What printing process does Kapstone use for metal parts?
We print 316L and 17-4 stainless steel in-house on our SLM 280, with additional alloys such as Ti6Al4V ELI (Grade 23), CP titanium (Grade 2), and cobalt chrome available on request through our approved supplier network.
What polymer additive manufacturing (3D printing) does Kapstone offer?
Kapstone offers in-house polymer 3D printing for prototyping and low-volume production, using a variety of processes depending on the application requirements. Our engineers will help identify the right material and process for each component.
What polymer materials are available, and what are they used for?
Options include rigid and elastomeric photopolymer resins (including biocompatible grades) for form, fit, and functional models, and nylons for tougher, more flexible functional parts. Typical uses include prototypes, fixtures, handles and housings, and delivery-system or instrument components.
When is polymer 3D printing the right choice for a medical or industrial part?
Polymer printing is ideal for early form, fit, ergonomic, and functional evaluation as well as for components where production volumes do not financially justify injection mold tooling. Kapstone helps match the material and process to the part’s functional and regulatory needs.
Can Kapstone 3D print biocompatible polymer components?
Yes, we have experience developing biocompatible photopolymer materials and other medical-grade materials to get new 3D printed applications to market. Rather than just building out of a certain material, we can provide integrated support for design, regulatory, quality, manufacturing and commercialization needs.
What is DLyte dry electropolishing?
DLyte is a dry electrolytic polishing technology that uses solid electrolytes rather than liquid acids to produce a smooth, uniform surface finish on metal parts while preserving geometry and edges. Kapstone Manufacturing was the first US-based medical device CDMO+ to bring DLyte in-house, adding precision finishing to its metal additive and machining under one roof.
Why does surface finish matter for metal additive and machined parts?
Surface finish affects cleanability, corrosion resistance, fatigue life, and for medical devices biocompatibility and sterilization. Additive parts in particular often require finishing to reach specification, which is why validated finishing is treated as part of the manufacturing process.
What post-processing does Kapstone provide for metal AM parts?
Kapstone supports the full post-processing chain for metal additive parts, heat treatment or HIP, support removal, machining of critical features, surface finishing (including in-house DLyte electropolishing), and cleaning, with documentation to back each step.
How does in-house DLyte finishing reduce lead time and supplier hand-offs?
Keeping finishing in-house removes a separate outside supplier and the qualification, shipping, and scheduling that come with it. That shortens lead times, tightens process control, and keeps the finishing evidence within Kapstone’s quality system.
What materials and part types is DLyte suited for?
DLyte is compatible with stainless steels, cobalt chrome, titanium, Nitinol, copper-, nickel-, and aluminum-alloys, and to parts where a consistent finish on complex geometries and preserved edges matters, including surgical instruments, additive parts, and precision components.
What industries does Kapstone Manufacturing serve?
Kapstone provides precision manufacturing for highly regulated industries. This can include medical devices, defense, oil & gas, subsea/marine, and robotics, where fast lead times, complex parts, demanding materials, and documented quality are essential. The same engineering and quality discipline applies across all of them.
What subsea and marine components are a good fit for metal AM?
Parts requiring corrosion-resistance, complex geometries that are difficult to machine such as sensor and electronics housings, connector bodies, pressure housings, ROV tooling, and flow components are strong candidates, often in 316L for corrosion resistance. Additive manufacturing is beneficial for low volumes, complex geometry, customization, and design iterations with no tooling requirements.
What oil & gas / downhole applications suit metal additive and precision machining?
Downhole tool components, flow and control hardware, and complex, low-volume parts that must withstand demanding environments are well suited to metal additive and precision machining. Material selection and finishing are matched to the pressure, temperature, and corrosion requirements of the application.
What types of medical devices does Kapstone manufacture and develop?
Kapstone works across a broad range of device types and is especially strong in orthopedics and spine, with additional experience spanning surgical instruments & equipment, cardiovascular, neurology, dental, wound care, aesthetics, monitoring & wearables, endoscopy & GI, Urology & Renal, Rehabilitation & Assistive, Diagnostics & IVD and Opthamology. As a CDMO+, Kapstone can develop and manufacture, not only build to print.
What metal additive materials are used for medical instruments vs. implants?
Reusable instruments and fixation hardware are commonly produced in 316L and 17-4PH stainless steel (printed in-house), while permanent implants typically use titanium (Ti-6Al-4V ELI) or cobalt-chrome, which Kapstone sources for those applications. Material selection follows the device’s intended use and regulatory pathway.
Can Kapstone support a device from prototype through scaled production?
Yes. Kapstone can take a new device concept from Phase 0 feasibility and prototyping through design, low-volume or bridge production, and scaled manufacturing & commercialization.
How does Kapstone handle supplier evidence and quality documentation for medical parts?
Kapstone builds and delivers the process and quality evidence behind each part, including machine qualification, material and reuse controls, post-processing and finishing validation, inspection, and traceability, within our ISO 13485 quality system, so the documentation supports your regulatory submission and inspection readiness.
What is a Phase 0 feasibility study, and when should I run one?
A Phase 0 feasibility study is an early, multidisciplinary assessment. It is customized for each project and may include market, regulatory, IP, design, and manufacturability assessments. The purpose of Phase 0 is to de-risk a concept before you commit to full development. Consider Phase 0 when you have a device concept but need to confirm it can be built, there is a viable regulatory path, and it can manufactured at a viable cost.
How does Kapstone support new product development and design engineering?
Kapstone’s engineers provide concept development, CAD, material selection, prototyping, design for manufacturability, and design transfer, so the design is production-informed from the start rather than reworked later.
What regulatory and quality support does Kapstone provide?
Through the combined Kapstone team, customers can access regulatory strategy and submission support and quality-system expertise, including design controls, risk management, supplier controls, and documentation, alongside manufacturing. This is a key benefit of the CDMO+ model over a build-to-print shop.
How does Kapstone manage the transition from prototype to production?
Kapstone plans production from the prototype stage, carrying design and process knowledge forward, validating on production-equivalent processes, and scaling volume methods (for example, from additive to machining or molding) when the economics justify it.
What quality documentation do you deliver with production parts?
Kapstone delivers documentation appropriate to the part and industry, process qualification and validation records, material certifications and traceability, inspection data, and finishing records, maintained within our ISO 13485 quality system. The specific package is defined in the quality agreement.
What information do you need to quote a metal 3D printed part?
The most helpful inputs are a 3D CAD model, the material, quantity, critical dimensions and tolerances, finish and post-processing requirements, and the intended application or industry. If you don’t have some of this information, then even a concept or drawing is enough to start the conversation.
Can you review parts I currently source elsewhere and tell me what’s missing?
Yes. Kapstone can review the design, process, and documentation behind components you source elsewhere, identify gaps, and scope how to address them.
Can you review parts I currently source elsewhere and tell me what’s missing?
Yes. Kapstone can review the design, process, and documentation behind components you source elsewhere, identify gaps, and scope how to address them.
