Velentium Medical

What Velentium Medical does

Velentium Medical, LLC is a privately held, Houston-area medical device engineering and manufacturing firm founded in 2012 by Dan Purvis and Tim Carroll. The company designs, develops, and manufactures complex, electromechanical active medical devices — spanning Class II wearables through Class III active implantables, including neurostimulators, leads, catheters, and cardiac rhythm devices — for medtech startups, mid-market companies, large enterprises, and academic research institutions globally. Its headquarters and FDA-registered, ISO 13485-certified, cGMP-compliant manufacturing facility in Richmond, TX is co-located with the R&D team, enabling integrated design-for-manufacturing and rapid iteration from prototype through commercial production with sterile packaging and order fulfillment.

The firm's core technology stack is an integrated medical device development platform that combines product design, cybersecurity, contract manufacturing, and automated test systems under one organizational structure. Notable proprietary components include the VEL-CAL cryptographic assurance framework (a tiered system aligned with FDA, EU MDR, and post-quantum readiness), the Secure Product Development Framework (SPDF) aligned with FDA, EU MDR/MDCG, and IEC 81001-5-1, and a STRIDE-based design-time security risk management methodology. The leadership team holds over 129 U.S. patents collectively and claims a 100% regulatory submission success rate for cybersecurity projects since 2017; CTO Randy Armstrong's firmware is embedded in devices residing in over 500,000 patients.

Velentium generates revenue through five streams: (1) USA-based contract manufacturing services for Class II and III devices; (2) medical device design and development engineering services across systems, electrical, firmware, mechanical, RF, usability/HFE, and SaMD disciplines; (3) cybersecurity services including premarket/postmarket support, vulnerability and penetration testing, and SBOM creation; (4) automated capital equipment test systems including characterization, design verification, and manufacturing test systems; and (5) a productized Cybersecurity Masterclass training at $2,995 per enrollment with $595/year continuing education. Pricing on services is quote-based and project-driven, while the firm operates an enterprise B2B field sales motion supported by thought leadership content, webinars, a podcast (The Leading Difference), and industry event participation. The company is PE-backed following a September 2021 growth recapitalization led by Great Point Partners and a $15M debt facility from Trinity Capital in July 2024.

Name

Velentium Medical

Legal name

Velentium Medical, LLC

Website

https://velentiummedical.com/

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

51–100 employees

Short description

Velentium Medical is a PE-backed engineering and contract manufacturing firm that designs, develops, and produces Class II and III active medical devices, including implantables and wearables, for medtech startups, enterprises, and research institutions, with co-located FDA-registered manufacturing in Richmond, TX.

Ownership category

akta.pro rank

Product category

Medical Device Engineering & Contract Manufacturing Services

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Energy-Based Surgical Devices (Electrosurgery, RF, Ultrasonic, Laser) (HLAHADAC)

akta.pro secondary industry

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

Keywords

• Medical device development
• Contract medical device manufacturing
• Medical device cybersecurity
• Automated test systems
• ISO 13485 manufacturing

Headquarters

HQ city

Katy

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Contract Manufacturing Services: USA-based FDA registered ISO 13485 certified manufacturing for Class II and Class III medical devices including active implantables, leads, wearables, catheters. Covers prototype through commercial production with sterile packaging and order fulfillment.
2. Engineering and Consulting Services: Medical device design and development services spanning systems engineering, cybersecurity, firmware, electrical, mechanical, RF, usability/HFE, and mobile/SaMD development. Supports full product lifecycle from concept through regulatory submission.
3. Cybersecurity Services: Comprehensive product security governance, premarket and postmarket cybersecurity support, vulnerability testing, penetration testing, SBOM creation, and security training. Services adapted to project scope, team size, and budget.
4. Training and Certification: Medical Device Cybersecurity Masterclass with certification exam - $2,995 per enrollment with optional $595/year continuing education for recertification. 12 months access to course content, virtual office hours, and Slack workspace.
5. Automated Test Systems: Capital equipment test systems including test requirements development, characterization test systems, design verification and validation test systems, and manufacturing test systems. Includes vision systems and robotics integration.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Velentium Medical designs, develops, and manufactures complex, electromechanical active medical devices as an integrated B2B partner. The company offers end-to-end medical device development services (systems, firmware, electrical, mechanical, RF, usability/HFE, SaMD), comprehensive medical device cybersecurity services, FDA-registered ISO 13485 contract manufacturing for Class II and Class III devices, and automated capital-equipment test systems, all delivered by co-located integrated teams. It also sells a Cybersecurity Training Masterclass as a standalone education product.

Product overview

Velentium Medical is an engineering-first medical device partner offering integrated services across four core areas: Medical Device Development (spanning systems, cybersecurity, usability/HFE, software/SaMD, electrical, firmware, mechanical, and RF engineering), Contract Manufacturing (USA-based FDA registered, ISO 13485 certified, cGMP compliant for Class II and III devices), Cybersecurity Services (covering premarket and postmarket activities including threat modeling, SBOMs, vulnerability testing, and FDA submission support), and Automated Test Systems (capital equipment test systems for design verification and manufacturing). The company also offers Cybersecurity Training Masterclass as a separate training product, hosts The Leading Difference Podcast, and publishes thought leadership content through whitepapers and the SEC-GUIDE series. All services are delivered by tightly integrated in-house teams working side-by-side to reduce handoffs and maintain accountability from early concept through commercial reality.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Development End-to-end medical device design and development services spanning systems engineering, cybersecurity, usability/HFE, mobile/SaMD, electrical, firmware, mechanical, and RF engineering disciplines. Sold to medical device companies developing Class II wearables through Class III active implantables.
• Contract Manufacturing USA-based FDA registered, ISO 13485 certified, cGMP compliant contract manufacturing services for Class II and Class III medical devices, including prototype, preclinical, clinical, and commercial unit production with sterile packaging and order fulfillment. Co-located with R&D team in Richmond, TX.
• Cybersecurity Services Comprehensive medical device cybersecurity services including product security governance, premarket and postmarket cybersecurity, vulnerability and penetration testing, threat modeling using STRIDE, SBOM creation, and FDA submission support aligned with October 2023 FDA cybersecurity guidance.
• Automated Test Systems Capital equipment test systems for medical devices including test requirements development, characterization test systems, design verification and validation test systems, and scalable manufacturing test systems with vision systems and robotics integration.
• Medical Device Cybersecurity Masterclass Virtual self-paced masterclass training for engineers on medical device cybersecurity covering pre-market activities, regulatory compliance, secure culture, and post-market activities, with certification exam. Priced at $2,995 per enrollment with optional $595/year continuing education for recertification; 12 months access to course content, virtual office hours, and Slack workspace.

Quantifiable outcome

• 100% regulatory submission success rate for cybersecurity projects since 2017
• +1 more outcomes

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

Five partnerships are on record, tiered minor and core.

• MedTech InnovatorminorOthers · 10 April 2026Velentium Medical sponsoring MedTech Innovator 2026 Accelerator Cohort webinar on successful CDMO partnerships. Webinar aimed at helping medtech companies build partnerships with Contract Design and Manufacturing Organizations during product commercialization.
• Ginkgo BioworkscoreStrategic or Co-development Partner · 22 December 2025Strategic partnership for ARPA-H funded cancer screening project with Carnegie Mellon University. Velentium serves as corporate partner alongside Clinical Research Strategies and Platypus Bio, contributing expertise to develop novel cancer screening diagnostic involving oral pill with tumor-targeting sensors and home-use detection device.
• Carnegie Mellon UniversitycoreStrategic or Co-development Partner · 22 December 2025Academic lead for ARPA-H POSEIDON program developing novel cancer screening approach. Partnership involves multidisciplinary team including researchers from University of Pittsburgh, University of Massachusetts Amherst, and KU Leuven. Project aims to create orally administered pill with engineered tumor-targeting sensors and companion at-home urine testing device.
• Clinical Research StrategiesminorStrategic or Co-development Partner · 22 December 2025Partner in ARPA-H cancer screening project providing clinical research expertise alongside Velentium Medical, Ginkgo Bioworks, and Platypus Bio.
• Platypus BiominorStrategic or Co-development Partner · 22 December 2025Partner in ARPA-H cancer screening project providing biotechnology expertise alongside Velentium Medical, Ginkgo Bioworks, and Clinical Research Strategies.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Planet Innovation: Australian-headquartered medtech design, development, and contract manufacturing company with growing U.S. footprint. Comparable in providing integrated product development and manufacturing services to medical device clients across Class II and III risk profiles.
• Tegra Medical: Medical device contract manufacturer and design partner for complex interventional, surgical, and implant components. Comparable in delivering integrated design-to-manufacturing services to medtech OEMs, particularly for Class II/III devices.
• Integer Holdings: Largest medical device outsource manufacturer focused on active implantables (cardiac, neuromodulation, orthopedic) and electrophysiology. Directly comparable in Class III implantable design and manufacturing capability, though at much greater scale and public-company capitalization.
• Resonetics: Medical device contract manufacturer specializing in laser micromachining, nitinol components, and interventional/structural heart device manufacturing. A relevant peer for high-precision component manufacturing and finished device assembly for Class III implants.
• Cirtec Medical: Privately held CDMO specializing in active implantables, neuromodulation, and minimally invasive interventional devices — covering design, manufacturing, and finished sterile packaging. A near-clone of Velentium's implantables focus and Class II/III capability profile.
• Donatelle: Medical device contract manufacturer offering design assistance, injection molding, and assembly for Class II/III devices. Comparable as a mid-sized integrated CDMO serving medtech OEMs across complex therapeutic device categories.
• Phillips-Medisize: Molex-owned integrated medical device design, development, and contract manufacturing organization serving drug delivery, diagnostic, and medtech OEMs. The closest direct comparison to Velentium's co-located design + manufacturing + cybersecurity platform, particularly in connected and combination products.
• StarFish Medical: Canadian medical device design, development, and contract manufacturing firm specializing in imaging, IVD, and therapeutic devices. Comparable integrated design + manufacturing model serving medtech startups and mid-market OEMs, with similar co-located engineering and production teams.

Broad incumbents

• Jabil Healthcare: Healthcare division of Jabil, one of the largest global contract manufacturers. Overlaps with Velentium on medtech design, manufacturing, and supply chain services, but with substantially larger scale, multi-site footprint, and broader product category reach.
• Flex (Health Solutions): Global EMS giant with a dedicated Health Solutions business covering medtech design, manufacturing, and connected device services. Competes for the same integrated programs as Velentium but as part of a far larger, diversified services portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/velentiummedical
• Xx.com/velentium
• Facebookfacebook.com/Velentium

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles19 records

Funding overview

Funding rounds3 records

Investors3 records

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

M&A1 record

Investments

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

Frequently asked questions about Velentium Medical