Kapstone Medical

What Kapstone Medical does

Kapstone Medical, LLC is a privately held, founder-owned medical device services company founded in 2007 and headquartered at 520 Elliot Street in Charlotte, North Carolina. The company operates as a single-source commercialization partner for medical device firms, offering six integrated service pillars: New Product Development, Human Factors Engineering & Usability, Quality Assurance, Regulatory Affairs, Manufacturing Solutions, and Commercialization Support. Its wholly-owned subsidiary, Kapstone Manufacturing, provides ISO 13485:2016 certified contract manufacturing including prototyping and production at the same Charlotte facility, enabling a 'design here, build here, sell here' domestic model.

Underlying technology is an integrated QMS-centered workflow rather than a software product: design controls (per 21 CFR 820.30), regulatory strategy (510(k), CE-mark, Health Canada), human factors evaluation, and manufacturing execution all run under one ISO 13485 quality management system. Proprietary elements include a Phase 0 Feasibility offering, an ISO 13485-ready and electronic-ready QMS template that clients can adopt, and (as of mid-2026) in-house DLyte dry electropolishing through the manufacturing arm.

Kapstone makes money through two revenue streams: fee-for-service consulting engagements covering NPD, regulatory, quality, human factors, and commercialization work; and hardware/contract manufacturing revenue from Kapstone Manufacturing. Pricing is quote-based and not publicly disclosed. Customers include medical device startups, physician/surgeon inventors, and established medical device OEMs across the US and EU, with named engagements spanning podiatry, dental implants, spine/orthopedics, and broader MedTech. The company reports 200+ customers served, 150+ products launched, and 100+ regulatory submissions completed, and is led by Founder & CEO John Kapitan.

Name

Kapstone Medical

Legal name

Kapstone Medical, LLC

Website

https://kapstonemedical.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Medical Device Consulting Services

NAICS

Surgical and Medical Instrument Manufacturing (339112), Professional, Scientific, and Technical Services (54), Management Consulting Services (54161)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

akta.pro secondary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Medical device consulting
• Regulatory affairs services
• Medical device manufacturing
• Quality management systems
• Human factors engineering

Headquarters

HQ city

Charlotte

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Consulting Services: Fee-for-service consulting engagements covering new product development, regulatory affairs, quality assurance, human factors engineering, and commercialization support. Projects billed based on scope and complexity.
2. Contract Manufacturing: ISO 13485 certified manufacturing services through Kapstone Manufacturing arm, providing prototyping and production services for medical devices.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Kapstone Medical provides integrated medical device commercialization services spanning new product development, human factors engineering, quality assurance, regulatory affairs, ISO 13485 contract manufacturing, and commercialization support. Delivered as a single-source engagement model, the firm combines regulatory strategy, design controls, and US-based manufacturing under one quality management system to take medical devices from concept through FDA/CE-mark submission and market launch.

Product overview

Kapstone Medical operates as a single-source medical device commercialization partner offering integrated consulting services. The portfolio consists of six core service pillars: New Product Development (NPD), Human Factors Engineering & Usability, Quality Assurance, Regulatory Affairs, Manufacturing Solutions, and Commercialization Support. Each core service contains multiple sub-services covering the full device lifecycle from concept through commercialization. The NPD Roadmap and Phase 0 Feasibility studies initiate projects; Design & Engineering, Prototyping, and Testing execute development; Quality Assurance and Regulatory Affairs ensure compliance; Manufacturing Solutions (through Kapstone Manufacturing subsidiary) enable production; and Commercialization Support drives market entry. The company reports 200+ customers served, 150+ products launched, and 100+ regulatory submissions, positioning itself as an integrated alternative to fragmented multi-vendor approaches.

Differentiator

Problem solved

Functional benefit

Products and services

• New Product Development (NPD) Comprehensive medical device development service for startups, inventors, and OEMs covering feasibility, design, prototyping, testing, and IP through a phase-gate process.
• Human Factors Engineering & Usability Service ensuring medical devices meet usability requirements through HFE & risk management integration, formative and summative evaluation, user research, and UI/UX and industrial design.
• Quality Assurance Quality management services including QMS implementation, eQMS, gap analysis, auditing, and quality training to ensure FDA and ISO compliance.
• Regulatory Affairs Regulatory strategy and submission services covering 510(k) pathways, CE-mark technical files, FDA submissions, compliance remediation, and regulatory training for US and EU markets.
• Manufacturing Solutions ISO 13485 contract manufacturing through the Kapstone Manufacturing facility in Charlotte, NC, including supply chain management and design-for-manufacturing services.
• Commercialization Support End-to-end commercialization services including business strategy, market entry planning, product launch execution, and ongoing operational support.
• Phase 0 Feasibility Early-stage feasibility studies that transform speculative clinical ideas into validated concepts, helping startups mitigate risk and control upfront costs.
• Design & Engineering Medical device design and engineering services including industrial design, mechanical and electrical engineering, and design controls per 21 CFR 820.30.
• Prototyping Medical device prototyping services from concept models to functional prototypes, bringing design concepts to physical form for testing and validation.
• Testing Comprehensive testing services including biocompatibility (ISO 10993), mechanical testing, cadaver testing, MRI testing, and sterilization validation.
• Intellectual Property IP services including patent research, landscape analysis, freedom-to-operate (FTO) studies, and patent filing assistance through a registered patent agent.
• Quality Management System (QMS) ISO 13485-compliant quality management system implementation and maintenance, available as a proprietary Kapstone ISO13485-ready and electronic-ready QMS.
• eQMS Electronic quality management system solutions for medical device companies, replacing paper-based systems with digital workflows.
• Regulatory Strategy Strategic regulatory planning services to determine optimal pathways (510(k), De Novo, PMA) and market entry strategies for US and international markets.
• Regulatory Submission Preparation and submission of regulatory documentation including 510(k) premarket notifications, technical files for CE-mark, and other international submissions.
• Supply Chain Management Management and qualification of suppliers and supply chain partners required to produce medical devices from raw material to clinical setting.
• Design for Manufacturing Engineering services optimizing product designs for manufacturability, cost efficiency, and scalability in production environments.
• Kapstone Manufacturing ISO 13485-certified contract manufacturing division in Charlotte, NC, offering in-house prototyping and production capabilities including DLyte dry electropolishing.

Quantifiable outcome

• 200+ customers served
• +2 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• DLytecoreTechnology or Integration · 4 June 2026Partnership with DLyte to become the first US-based Medical Device CDMO+ to integrate in-house DLyte Dry Electropolishing. This brings finishing capabilities in-house, removing a hand-off that had been costing AM medical device programs weeks of turnaround and an extra supplier qualification.

Scale indicators3 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• StarFish Medical: Medical device design, development, and contract manufacturing services firm serving startups through large OEMs. Comparable to Kapstone's full-lifecycle medtech commercialization model and ISO 13485 manufacturing.
• Velentium: Medical device-focused engineering, cybersecurity, and regulatory consulting firm serving OEMs and startups with embedded systems, 510(k), and quality services. Closely matches Kapstone's integrated NPD + regulatory + QA offering for the medical device industry.
• MED Institute: Medical device testing, regulatory, and clinical research services organization. Highly comparable in offering regulatory submissions, testing, and quality services to medical device manufacturers.
• Tegra Medical: Medical device contract manufacturer offering prototyping, production, finishing, and assembly. Comparable to Kapstone Manufacturing's ISO 13485 contract manufacturing and finishing capabilities.
• R&Q (Regulatory & Quality Solutions): Medical device regulatory and quality consulting firm providing 510(k)/CE-mark strategy, QMS, and compliance remediation. Overlaps with Kapstone's regulatory affairs and quality assurance service pillars.

Broad incumbents

• Integer Holdings: Large public medical device contract manufacturer and OEM serving cardio, vascular, and orthopedics end-markets. Overlaps with Kapstone Manufacturing but at significantly greater scale and broader geographic footprint.
• Jabil Healthcare: Global contract manufacturer with a dedicated healthcare division covering medical device design, manufacturing, and supply chain. Represents scaled competition for Kapstone's integrated commercialization offering.
• Flex (Flextronics): Global diversified contract manufacturer with medical device capabilities including design, manufacturing, and supply chain. Larger, broader-incumbent competitor for Kapstone's OEM and integrated offerings.

Emerging players

• Greenlight Guru: Medical device QMS and eQMS software provider with adjacent regulatory consulting. Overlaps with Kapstone's eQMS offering and quality management consulting, though delivered primarily via software rather than services.
• MindFlow Design: Smaller medical device design and engineering consultancy focused on human factors, usability, and NPD. Partial overlap with Kapstone's HFE and NPD service pillars, especially for early-stage clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/kapstonemedical
• LinkedInlinkedin.com/company/kapstone-medical
• Facebookfacebook.com/kapstonemedical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kapstone Medical