What EnPak does

EnPak LLC is a privately held, bootstrapped medical device operations support company founded in 2011 in Warsaw, Indiana — the "Orthopedic Capital of the World" — by Marlene Betances and Rick Rivera. It provides MedTech and life science companies with an integrated suite of back-office services spanning consulting and regulatory affairs, medical device cleaning, kit management, warehousing and logistics, packaging and labeling, operations support, and recall/rework management. The firm holds FDA establishment registration (number 3015119628), is FDA 21 CFR Part 820 compliant, and is ISO 13485:2016 certified following a 2024 third-party audit by Eagle Registrations Inc.

The company's core technology stack is intentionally lightweight: BarTender labeling software and Robar and other web-enabled labeling systems for UDI-compliant label creation, integrated with a customer sales portal and email-based order fulfillment. In 2024, EnPak formed a strategic partnership with Ecoclean Inc. to establish the Clean & Pack Technology Center in Warsaw, officially opened in March 2026 with a ribbon-cutting ceremony. The Center combines Ecoclean's precision cleaning equipment (EcoCcompact vacuum system, ultrasonic immersion UCMSmartLine and UCMCombiLine) with EnPak's downstream packaging, inspection, labeling, and inventory management under one roof — an integration that competes against multi-vendor outsourcing models.

EnPak operates a relationship-driven, direct-sales go-to-market with no disclosed pricing tiers and no minimum volume requirements, explicitly targeting startups through established OEMs. Approximately 70% of customers are small businesses, and EnPak provides full backend support for 70% of those accounts, embedding itself into customer operations. Named customers include WishBone Medical, Iconacy Orthopedic Implants (12+ year relationship), Nextremity Solutions, Novecu LLC, Clyra Medical Technologies, First Call Inc., and Navigate Maternity. The firm remains founder-owned with no institutional capital, employs 11–50 people, and has expanded its leadership with a senior Project Manager hire in February 2025.

Name

EnPak

Legal name

EnPak LLC

Website

https://enpakllc.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

EnPak LLC is a Warsaw, Indiana-based medical device operations support firm offering consulting, cleaning, kitting, logistics, labeling, and recall services to MedTech and life science companies, from startups to established OEMs.

Ownership category

akta.pro rank

Headquarters

HQ city

Warsaw

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, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Medical Device Operations Support Services: EnPak LLC generates revenue through providing a comprehensive suite of services to medical device manufacturers including consulting, kit management, logistics, medical device cleaning, operations support, and recall management. Services are delivered without minimum volume requirements, supporting startups through established manufacturers.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

EnPak LLC provides integrated logistics, cleaning, kitting, packaging, labeling, and recall management services to medical device manufacturers, OEMs, contract manufacturers, and life science companies. The company also offers consulting in regulatory affairs, quality management systems, project management, document legalization, and validation. Services are delivered from its Warsaw, Indiana facility, including the joint Clean & Pack Technology Center with Ecoclean Inc., with no minimum volume requirements, supporting both startups and established manufacturers.

Product overview

EnPak LLC provides an integrated suite of medical device operations support services for MedTech and life science companies. The core offerings include Consulting & Specialized Services (regulatory affairs, QMS, validation), Medical Device Cleaning (via Clean & Pack Technology Center partnership with Ecoclean), Kit Management (kit creation, replenishment, decontamination), Medical Device Logistics (warehousing, inventory, fulfillment, returns), Operations Support (packaging, inspection, labeling), and Recall Management (rework, relabeling, compliant disposal). The Clean & Pack Technology Center represents the company's latest integrated offering, combining cleaning and packaging under one roof. Services are delivered without minimum volume requirements, targeting startups through established OEMs.

Differentiator

Problem solved

Functional benefit

Brands

• Clean & Pack Technology Center: A joint facility with Ecoclean providing integrated precision cleaning and packaging for medical device components, supporting FDA- and MDR-compliant supply chains.

Products and services

• Consulting & Specialized Services Medical device operations consulting covering regulatory affairs, quality management systems, project management, document legalization, and validation services for MedTech and life science companies. Delivered by an experienced team led by professionals with decades of medical device industry experience.
• Medical Device Cleaning Parts cleaning processes, contract cleaning, passivation, and downstream services delivered through the Clean & Pack Technology Center partnership with Ecoclean Inc. Includes Ecoclean EcoCcompact vacuum cleaning, UCMSmartLine ultrasonic immersion cleaning, and UCMCombiLine systems.
• Kit Management Comprehensive kitting solutions including kit creation, replenishment, decontamination, inspection, component kitting, and loaner set management for MedTech and life science companies.
• Medical Device Logistics End-to-end logistics services including warehousing with real-time tracking, inventory management by lot number, order fulfillment, returns processing, and supply management for medical device product lifecycles.
• Operations Support Non-sterile packaging, kitting, visual and dimensional inspection, label design and creation using BarTender software, surgical loaner kit management, and medical device scrap disposal services.
• Recall Management Recall and rework management services including product retrieval, quarantine, documentation, over-labeling, relabeling, repackaging, re-boxing, inspection, and compliant scrap disposal with full traceability.
• Clean & Pack Technology Center Integrated precision cleaning and packaging facility combining Ecoclean's cleaning technologies (EcoCcompact, UCMSmartLine, UCMCombiLine) with EnPak's packaging, inspection, labeling, and inventory management services for FDA- and MDR-compliant medical device supply chains.

Quantifiable outcome

• 70% of EnPak's customers are small businesses, and they provide full backend support for 70% of them

Named customers7 records

Segments5 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Ecoclean Inc.coreStrategic or Co-development Partner · 12 March 2025Strategic partnership to establish the Clean & Pack Technology Center in Warsaw, Indiana. Combines Ecoclean's advanced cleaning technologies (EcoCcompact vacuum system, ultrasonic immersion cleaning UCMSmartLine, UCMCombiLine) with EnPak's packaging, inspection, and inventory management services. The facility provides process development, industrial trials, and scalable contract cleaning services for medical device OEMs, CMOs, and supply chain partners.

Scale indicators4 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Avalign Technologies: Avalign provides medical device contract manufacturing, precision machining, and finishing services for orthopedic and surgical OEMs - overlapping EnPak's orthopedic-focused customer base and contract finishing/operations services.
• Donatelle: Donatelle is a medical device contract manufacturer specializing in orthopedic implants and assemblies, serving many of the same Warsaw-area and orthopedic OEMs that EnPak supports.
• SteriPack Group: SteriPack offers medical device contract packaging, assembly, and kitting services with cleanroom manufacturing and global operations - closely aligned with EnPak's kitting, labeling, and packaging focus for medical device customers.
• Life Science Outsourcing (LSO): Life Science Outsourcing provides medical device contract packaging, kitting, labeling, and sterilization services - a direct counterpart to EnPak's operational support and packaging offerings targeting MedTech OEMs and startups.
• Marle Group: Marle Group provides medical device contract manufacturing and assembly, including orthopedic components - a direct peer competing for similar medical device OEM business with transatlantic operations.
• Tegra Medical: Tegra Medical provides medical device contract manufacturing, precision machining, and assembly for implants and instruments - directly comparable to EnPak's operations support and finishing services for MedTech OEMs.
• Nelipak Healthcare Packaging: Nelipak manufactures medical device packaging and offers kitting and sterilization services across multiple sites - directly comparable to EnPak's packaging, labeling, and kitting offerings for medical device OEMs and CMOs.

Broad incumbents

• Catalent: Catalent is a major global CDMO with medical device packaging, labeling, and contract services capabilities - a broad incumbent offering overlapping services but at much greater scale and scope than EnPak.
• Phillips-Medisize (Molex): Phillips-Medisize, a Molex company, is a large medical device contract design, manufacturing, and assembly services provider - a broad incumbent offering end-to-end outsourced operations similar to EnPak's but at far greater scale.
• NAMSA: NAMSA is a medical device-focused contract research, regulatory, and quality consulting organization - aligned with EnPak's consulting/regulatory practice and overlapping on MedTech compliance and quality system work.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/enpakllc
• LinkedInlinkedin.com/company/enpak-llc

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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 EnPak