DoubleLock Healthcare

What DoubleLock Healthcare does

DoubleLock Healthcare, Inc. is an early-stage, privately held U.S. medical device company developing the DoubleLock Sterile Entry Intravenous Port and Syringe System™, a patented hardware solution targeting catheter-related bloodstream infections (CR-BSI) and Luer-lock misconnections. The system uses a protective cover and unique connector architecture designed to deliver 100% compliance with IV port and syringe tip asepsis without alcohol swabs or alcohol-impregnated caps, while preventing wrong-route infusion or injection drug errors. The product is covered by US Patent 9,352,141 and addresses a CDC-cited $13 billion annual U.S. cost burden from healthcare-associated infections (HAIs).

The company was co-founded by Danny M. Wong, PharmD (35 years as a hospital pharmacist) and Elizabeth Wong, CRNA, MSN (40 years as an RN/CRNA, currently practicing at Desert Regional Medical Center in Palm Springs, California). It is pre-revenue, headquartered in California, and operates with a stated headcount of two co-founders plus accelerator support. The firm is currently at Prototype #11/#12 and is pursuing FDA 510K clearance, with planned validation through VCU Operating Room Simulator Testing, repeat laboratory testing, and antimicrobial susceptibility testing.

The business model is planned hardware sales of FDA-cleared IV port and syringe devices to acute-care hospitals, surgical centers, and other healthcare facilities performing IV drug delivery, distributed via direct sales. Current non-dilutive funding comes from CASCADE Grants and the Mass Challenge Accelerator, with no disclosed venture capital or private equity. Co-founder Elizabeth Wong serves on six GEDSA committees and two ISO committees, positioning the firm to influence IV access device standards alongside its regulatory submission.

Name

DoubleLock Healthcare

Legal name

DoubleLock Healthcare, Inc.™

Website

https://doublelockhealthcare.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

DoubleLock Healthcare is a pre-revenue U.S. medical device company developing a patented IV port and syringe system designed to prevent catheter-related bloodstream infections and Luer-lock misconnections, pursuing FDA 510K clearance for sale to acute-care hospitals.

Ownership category

akta.pro rank

Product category

Medical Devices (IV Drug Delivery / Infection Prevention)

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges) (IMALAIAE)

akta.pro secondary industry

Reprocessing & Endoscope Infection Prevention (AERs, Drying/Storage, Leak Testing, Brushes) (HLAHANAJ)

Keywords

• IV port medical device
• Sterile syringe system
• Healthcare infection prevention
• Intravenous drug delivery
• Catheter bloodstream infection

Headquarters

HQ city

California

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales

Revenue model

1. Medical Device Sales: Pre-revenue company developing IV port and syringe medical devices. Revenue model will likely be hardware sales of medical devices to healthcare facilities once FDA approval is obtained through 510K pathway.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

DoubleLock Healthcare is developing a patented IV port and syringe system (the DoubleLock Sterile Entry Intravenous Port and Syringe System) intended to prevent bacterial contamination of IV ports and syringe tips, deliver 100% asepsis compliance without alcohol swabs or caps, and stop Luer-lock misconnections and wrong-route drug errors during IV drug delivery. The product is pre-FDA approval and currently in prototype development, with future revenue expected from hardware sales of the medical device to hospitals and acute care facilities.

Product overview

DoubleLock Healthcare is developing a single unified product: the DoubleLock Sterile Entry Intravenous Port and Syringe System™. This patented medical device system is designed to address healthcare-associated infections (HAIs) by preventing bacterial contamination during IV drug delivery. The system consists of specialized IV port and syringe components with built-in protective covers and unique connectors that ensure aseptic entry and prevent Luer-lock misconnections. The product is currently in the pre-production prototype phase (Prototype #11/12) and has not yet received FDA approval.

Differentiator

Problem solved

Functional benefit

Brands

• DoubleLock Sterile Entry Intravenous Port and Syringe System™: The company's patented product solution for IV drug delivery that aims to prevent bacterial infection and ensure 100% compliance with IV port and syringe tip asepsis.

Products and services

• DoubleLock Sterile Entry Intravenous Port and Syringe System A patented medical device system for IV drug delivery comprising a sterile IV port and syringe with a protective cover that prevents bacterial contamination of the IV port and syringe tip, and a unique connector design that prevents Luer-lock misconnections and wrong-route infusion or injection drug errors. It is targeted at acute care hospitals, surgical centers, and healthcare facilities performing IV drug delivery, and is intended to deliver 100% asepsis compliance without alcohol swabs or alcohol-impregnated caps. The product is not yet FDA approved.

Quantifiable outcome

• 100% compliance with IV port and syringe tip asepsis vs. current 10% compliance with disinfection
• +3 more outcomes

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Five partnerships are on record, tiered core and minor.

• GEDSA (Global Engineered Device Supplier Association)coreStrategic or Co-development PartnerDoubleLock Healthcare, Inc. has joined GEDSA as a member. Elizabeth Wong serves on six GEDSA committees, indicating deep engagement in standards development and industry collaboration for medical device safety.
• AAMI (Association for the Advancement of Medical Instrumentation)coreStrategic or Co-development PartnerDoubleLock Healthcare, Inc. has joined AAMI, the U.S. representative to the International Organization for Standardization (ISO). Active participation in standards-setting organizations helps position the company for regulatory compliance and industry influence.
• ISO (International Organization for Standardization)coreStrategic or Co-development PartnerThrough AAMI membership, Elizabeth Wong serves on two ISO committees, contributing to international standards development for medical devices and IV access systems.
• VCU (Virginia Commonwealth University)coreStrategic or Co-development PartnerPlanned partnership for Operating Room Simulator Testing as part of the product development and clinical validation pathway. This is listed as a key next step in the company's development roadmap.
• Desert Regional Medical CenterminorStrategic or Co-development PartnerClinical site where co-founder Elizabeth Wong practices as a CRNA. Her personal use and observation of current IV port limitations informed the product development. Potential clinical testing site.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Baxter International: Diversified IV therapy and infusion systems manufacturer with significant hospital channel presence. Baxter competes broadly in IV drug delivery infrastructure where DoubleLock's sterile port/syringe system would integrate.
• B. Braun Medical: Global IV therapy and infusion device manufacturer offering needlefree connectors and IV administration sets. B. Braun overlaps with DoubleLock on hospital IV safety and infection-prevention positioning.
• Smiths Medical (ICU Medical): Manufacturer of IV catheters and vascular access devices with established hospital relationships. Its needlefree connector portfolio competes in the same infection-prevention category DoubleLock is pursuing.
• Becton Dickinson (BD): Dominant incumbent in vascular access and IV therapy, offering the MaxPlus and MaxZero needlefree connectors and broad infusion portfolios. BD competes in the same hospital accounts and IV access category DoubleLock targets, but across a much wider product portfolio.
• Teleflex: Major vascular access player with IV catheters, needlefree connectors, and related consumables. Teleflex targets the same acute-care hospital customers and infection-prevention use cases, providing direct competitive context.
• 3M Health Care: Infection prevention leader whose sterilization, skin antisepsis, and vascular access products compete for the same hospital budgets and ECRI-cited safety priorities. 3M is an adjacent incumbent addressing the same downstream HAI outcomes.
• Merit Medical Systems: Vascular access and infusion device manufacturer serving interventional and acute-care hospitals. Merit competes in adjacent IV safety and access device categories where DoubleLock would need to position.

Direct peers

• ICU Medical: Direct competitor in needlefree IV connectors and closed-system catheter components. ICU Medical's NanoClave and ChemoClave product lines overlap directly with DoubleLock's positioning on contamination prevention and Luer-lock misconnection avoidance.
• Vygon: Specialized IV access and neonatal/infusion device maker with needlefree connector and IV admin set offerings. Vygon is a closer-fit peer to DoubleLock given its narrower focus on IV access safety consumables.

Emerging players

• Cyto360 (or comparable early-stage sterile connector startup): Small innovators in sterile/closed IV connector and barrier device design (e.g., Catheter Connections, Tego). These emerging players pursue the same infection-prevention angle and would compete for similar early-adopter hospital accounts.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutu.be/yLFxW3ZhjZQ
• LinkedInlinkedin.com/company/doublelock-healthcare-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds1 record

Investors1 record

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

M&A

Investments

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

Frequently asked questions about DoubleLock Healthcare