What Medbio does

Medbio, LLC is a full-service medical device contract manufacturer founded in 2004 and headquartered in Grand Rapids, Michigan. The company provides precision injection molding, in-house tooling, assembly, and packaging services to medical device and biotechnology OEMs across more than ten clinical verticals including diagnostics, cardiovascular, drug delivery, orthopaedic, BioPharma, ophthalmological, and neurological surgery. Manufacturing is delivered through four ISO 13485:2016-certified facilities in Michigan and New York totaling over 115,000 square feet, equipped with 400+ molding presses (17-440 ton), ISO Class 7 and Class 8 cleanrooms, and proprietary processes including the Prototype-Plus™ bridge tooling system, scientific molding with cavity pressure sensing, O2-free molding, and all-electric silicone processing. Medbio is trusted by over 1,500 medical customers and the top 30 medical device manufacturers, supplying production parts and custom assemblies for named programs at HemoSonics, Natus, SBE Medical, and Convergence Medical, among others.

The company's business model is built on quote-based, multi-year contract manufacturing engagements that span design-for-manufacturability engineering, prototype and bridge tooling, validated production molding, cleanroom assembly (laser/ultrasonic welding, bonding, pad printing), and certified packaging. Go-to-market is enterprise field sales with regional account managers across US territories plus a dedicated international sales contact; demand generation is supplemented by presence at major medical device tradeshows (MD&M, INTERPHEX, DeviceTalks) and a resource library of case studies and white papers. The platform was assembled through three strategic acquisitions (Concept Molds in 2014, AIM Plastics in 2019, Polymer Conversions in 2020), all rebranded under the Medbio identity by April 2021 and supported by private equity sponsor Graham Partners from 2020 onward. Complementary offerings include ready-to-ship Medical Catalog Products for transactional revenue and a 5-step Tool Transfer service for domestic or offshore tool repatriation.

Name

Medbio

Legal name

Medbio, LLC

Website

https://medbiollc.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

101–250 employees

Short description

Medbio is a full-service medical device contract manufacturer offering precision injection molding, in-house tooling, cleanroom assembly, and packaging across four ISO 13485-certified facilities, serving over 1,500 medical customers including the top 30 medical device OEMs.

Ownership category

akta.pro rank

Headquarters

HQ city

Grand Rapids

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Medbio generates revenue through full-service medical device contract manufacturing, providing services from design through production and packaging. This includes injection molding, tooling, assembly, and packaging services for medical device companies.
2. Production Manufacturing: Recurring production manufacturing services for medical device components and assemblies under long-term contract manufacturing agreements with medical device OEMs.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Medbio is a medical device contract manufacturer that provides plastic injection molding, tooling, assembly, and packaging services for medical and life-sciences OEMs. The company operates ISO 13485:2016-certified, FDA-registered manufacturing facilities in Michigan and New York, supporting customers from prototype development through full-scale production. Its proprietary Prototype-Plus bridge tooling allows customers to begin production on production-grade tooling ahead of full tooling completion, accelerating time-to-market.

Product overview

Medbio is a full-service medical contract manufacturer offering comprehensive precision manufacturing solutions for medical and biotechnology devices. The company's portfolio centers on injection molding services (standard, micro, two-shot, implant, and silicone) complemented by in-house tooling and mold design, assembly services, and packaging. Key proprietary offerings include Prototype-Plus™ bridge tooling, a process that bridges prototype and production using the same tool. Services are delivered across four ISO-certified facilities (Grand Rapids, Clinton Township, Schoolcraft, and Orchard Park) totaling over 100,000+ square feet, with cleanroom capabilities ranging from ISO Class 7 to Class 8. The company also provides tool transfer services for rapid production return and engineering support including DFM, validation protocols, and program management. All facilities are ISO 13485:2016 certified and FDA registered.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Injection Molding Plastic injection molding of medical-grade components using 400+ presses under an ISO 13485:2016 quality system, intended for medical device OEMs requiring compliant, validated production.
• Medical Tooling & Bridge Tooling (Prototype-Plus) Design, fabrication, and modification of medical-grade tooling, including a proprietary Prototype-Plus bridge tooling system that enables production on production-grade tooling prior to completion of full hard tooling.
• Medical Assembly Cleanroom assembly of medical device sub-assemblies and finished devices, supporting downstream packaging and sterilization partner handoffs under the same ISO 13485 quality umbrella.
• Medical Packaging Validated packaging of finished medical devices within the same regulated quality system, supporting sterile barrier and labeling requirements prior to shipment to end customers.

Quantifiable outcome

• Trusted by over 1500 medical customers and the top 30 medical device manufacturers
• +2 more outcomes

Named customers4 records

Segments12 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Three partnerships are on record, tiered regional.

• The Right PlaceregionalStrategic or Co-development Partner · 1 January 2022Regional economic development organization for West Michigan that assists companies with investment and job creation. Supports the Greater Grand Rapids Region's health sciences industry including medical device companies.
• MiDeviceregionalStrategic or Co-development Partner · 1 January 2022Michigan-based consortium dedicated to medical device design, development, manufacturing and distribution. The only Michigan-based organization focused on medical device lifecycle from concept to distribution. Aims to build collaboration and grow the medical device industry into a nationally recognized cluster.
• Greater Rochester Chamber of CommerceregionalStrategic or Co-development Partner · 1 January 2022Trusted partner for businesses in Greater Rochester, New York area. Drives economic vitality of the Finger Lakes region through advocacy, resources, and support.

Scale indicators6 records

Recent moves14 records

Expansion highlights6 records

Direct peers

• Phillips-Medisize: Phillips-Medisize (owned by Molex/AptarGroup) is one of the largest medical device contract manufacturers globally, offering precision injection molding, assembly, and drug delivery device manufacturing. It directly competes with Medbio for enterprise medical OEM contracts across diagnostics, drug delivery, and surgical devices.
• SMC Ltd. SMC Ltd. is a US-based medical device contract manufacturer specializing in precision injection molding, cleanroom assembly, and finished device manufacturing. It directly overlaps with Medbio's capabilities across diagnostics, drug delivery, and minimally invasive surgical devices.
• Freudenberg Medical: Freudenberg Medical provides silicone and thermoplastic molding, extrusion, and assembly for medical devices globally. It is directly comparable to Medbio's silicone molding, LSR processing, and cleanroom assembly services targeting the same medical OEM customer base.
• Tessy Plastics (SWM International): Tessy Plastics, now part of Schweitzer-Mauduit International (SWM), is a precision injection molder serving medical device OEMs. It offers comparable capabilities to Medbio in molding, tooling, and high-volume medical component production.
• Mack Molding: Mack Molding is a US-based contract manufacturer offering injection molding, assembly, and full-service medical device manufacturing from concept to commercialization. It competes directly with Medbio for North American medical OEM programs in diagnostics and surgical devices.
• Resonetics: Resonetics is a medical device contract manufacturer specializing in laser micromachining, nitinol components, and precision metal/plastic processing. It is comparable to Medbio as a tier-one medical CMO serving similar cardiovascular, neurovascular, and surgical device OEMs.
• Donatelle Plastics: Donatelle Plastics is a Midwest US medical device contract manufacturer offering precision injection molding, assembly, and validation services. It is highly comparable to Medbio in size, geography, ISO 13485 certification, and customer mix across Class II and III medical devices.
• Confluent Medical Technologies: Confluent Medical specializes in nitinol components, polymer processing, and finished medical device contract manufacturing. It is comparable to Medbio in serving cardiovascular, neurovascular, and structural heart OEMs with precision-engineered components.
• Vesta (Lubrizol Life Science Health): Vesta, the medical device manufacturing arm of Lubrizol, provides precision silicone and thermoplastic molding, extrusion, and assembly for medical OEMs. It directly overlaps with Medbio's silicone molding, LSR processing, and cleanroom assembly capabilities.

Broad incumbents

• Teleflex Medical OEM: Teleflex Medical OEM is a division of Teleflex providing contract manufacturing of extrusions, catheters, and finished medical devices. As a larger, publicly-traded incumbent, it offers broader capabilities than Medbio but competes for similar interventional and surgical OEM programs.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/c/medbioinc
• LinkedInlinkedin.com/company/medbio-inc-

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries3 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 Medbio