What Donatelle does

Donatelle is a medical device contract manufacturer founded in 1967 and headquartered in New Brighton, Minnesota. The company operates as a Contract Development and Manufacturing Organization (CDMO) serving medical device original equipment manufacturers (OEMs), with core capabilities spanning medical device injection molding (including PEEK, micromolding, overmolding, and bioresorbables), liquid silicone rubber processing, precision machining, extruded medical tubing (microbore, multilumen, PEEK, high-pressure braided, silicone), catheter technologies (reinforced shafts, dilators/sheaths, steerable/deflectable shafts, complex catheters, medical balloon catheters), medical balloon manufacturing, ultra-fast and femtosecond laser processing, flexible sterile packaging (including DuPont Tyvek), finished device assembly, tool building, and additive manufacturing / 3D printing.

The business model is fee-for-service B2B contract manufacturing, with quote-based pricing and direct enterprise sales engagement targeting medical device OEMs across 16 therapeutic and industrial verticals, including cardiovascular, structural heart, electrophysiology, neurovascular, orthopedics, MIS/robotic surgery, fluid management, GI/enteral feeding, pharmaceutical/biopharma, ophthalmology, urology, trauma/wound care, diagnostics, neuromodulation, drug delivery, and industrial/defense. The company holds ISO 13485 certification and offers a component webstore (shop.spectrumplastics.com) as a complement to traditional project-based quoting.

In July 2024, DuPont de Nemours acquired Donatelle Plastics for $313 million and integrated it into Spectrum Plastics Group, A DuPont Business, where Donatelle's catheter, balloon, and injection molding capabilities now sit alongside Spectrum's broader CDMO platform. Donatelle's original website has been redirected to the Spectrum Plastics Group site, and the entity now operates as a wholly-owned subsidiary of DuPont (NYSE: DD) rather than as an independent company.

Name

Donatelle

Legal name

Donatelle Plastics, LLC

Website

https://donatellemedical.com

Company type

Private

Founded year

1967

Operating status

Acquired

Headcount range

251–500 employees

Short description

Donatelle Plastics is a medical device contract manufacturer offering injection molding, liquid silicone rubber processing, catheter technologies, medical balloons, and device assembly for medical device OEMs, now operating as part of Spectrum Plastics Group under DuPont de Nemours.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Medical Equipment and Supplies Manufacturing (3391), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Miscellaneous Plastics Products (3080), Fabricated Rubber Products, Nec (3060)

akta.pro primary industry

Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)

Keywords

• Medical device contract manufacturing
• Medical injection molding
• Extruded medical tubing
• Catheter technologies
• Liquid silicone rubber processing

Headquarters

HQ city

Brighton

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Contract Manufacturing Services: Fee-for-service contract development and manufacturing organization (CDMO) providing comprehensive medical device manufacturing services including design, prototyping, component production, and finished device assembly for OEM customers.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

Donatelle is a medical device contract development and manufacturing organization (CDMO) providing precision injection molding, liquid silicone rubber processing, precision machining, extruded medical tubing, catheter technologies, medical balloons, laser processing, and finished device assembly services. The company serves medical device OEMs with end-to-end capabilities spanning design and development, rapid prototyping, component production, manufacturing transfers, and full-scale commercial manufacturing of medical components and devices.

Product overview

Donatelle Plastics, now part of Spectrum Plastics Group, A DuPont Business, is a leading medical device contract manufacturer specializing in comprehensive CDMO (Contract Development and Manufacturing Organization) services. The offering is organized as a platform-plus-modules architecture centered on core manufacturing capabilities (medical device injection molding, liquid silicone rubber processing, precision machining, device assembly, tool building) combined with specialized technology units (extruded medical tubing, catheter technologies, medical balloons, laser processing, flexible packaging & film, additive manufacturing). These are supported by service modules covering design & development, quick-turn prototyping, manufacturing transfers, quality & regulatory support, and scalability. The company operates a component webstore for component sales and serves applications across cardiovascular, structural heart, electrophysiology, neurovascular, orthopedics, minimally invasive surgery/robotics, fluid management, GI/enteral feeding, pharmaceutical/biopharma, ophthalmology, urology, trauma/wound care, diagnostics, industrial/defense, and food packaging markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Injection Molding Precision injection molding services for medical devices, including PEEK injection molding, micromolding, overmolding, insert molding, multishot molding, implantables/bioresorbables molding, and micro metal injection molding (Micro MIM). Targeted at medical device OEMs requiring tight-tolerance plastic and metal medical components.
• Liquid Silicone Rubber Processing Liquid silicone rubber (LSR) molding for medical device components requiring flexibility, biocompatibility, and dimensional precision. Targeted at medical device OEMs needing silicone-based medical components.
• Precision Machining Precision machining services for medical components requiring tight tolerances and exact specifications. Targeted at medical device OEMs requiring high-precision machined parts.
• Finished Device & Assembly Complete device assembly and sub-assembly manufacturing services for finished medical devices, integrating manufactured components into final packaged products. Targeted at medical device OEMs needing turnkey assembly.
• Extruded Medical Tubing Medical-grade extruded tubing including microbore, multilumen, PEEK tubing, fluid management tubing, high pressure braided tubing, silicone extrusion, and core mandrel production. Targeted at medical device OEMs requiring precision medical tubing.
• Catheter Technologies Advanced catheter manufacturing including reinforced shafts, dilators/sheaths, steerable/deflectable shafts, silicone catheter assemblies, complex catheters, and medical balloon catheters. Targeted at medical device OEMs in cardiovascular, structural heart, electrophysiology, neurovascular, and other catheter-based therapy areas.
• Medical Balloons Medical balloon manufacturing including thermoplastic medical balloons, silicone medical balloons, balloon extrusions, and medical balloon laser processing. Targeted at medical device OEMs requiring balloons for catheter-based therapies.
• Laser Processing Ultra-fast and femtosecond laser processing capabilities for medical device manufacturing including ablation, cutting, drilling, tipping, wire stripping, and hypotube processing. Targeted at medical device OEMs requiring precision micromachining on medical components.
• Flexible Packaging & Film Sterile flexible packaging solutions for medical devices including performance films, converted bags and pouches, sterile packaging, and DuPont Tyvek pouches, header bags, and lids. Targeted at medical device OEMs and pharmaceutical companies requiring sterile barrier packaging.
• Additive Manufacturing / 3D Printing Additive manufacturing and 3D printing capabilities for medical device prototyping and production. Targeted at medical device OEMs requiring rapid prototyping or low-volume production of complex geometries.
• Design & Development Services Comprehensive design and development services for medical devices from concept through commercialization. Targeted at medical device OEMs seeking engineering and product development support.
• Quick-Turn Prototyping Rapid prototyping services to accelerate product development cycles for medical devices. Targeted at medical device OEMs needing fast iteration on prototypes.
• Manufacturing Transfer Services Manufacturing transfer services to move medical device products from development to full-scale production. Targeted at medical device OEMs transitioning products to commercial manufacturing.
• Quality & Regulatory Support Quality management and regulatory compliance support services for medical device manufacturing, supporting ISO 13485 and other regulatory frameworks. Targeted at medical device OEMs requiring regulatory and quality compliance.
• Tool Building Tool building services for medical device manufacturing, including injection mold prototyping and tooling development. Targeted at medical device OEMs needing tooling for production tooling.
• Component Webstore Online component webstore for ordering medical device components and materials. Targeted at medical device OEMs and developers seeking standard or catalog medical components.

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• DuPont de Nemours, Inc.coreStrategic or Co-development Partner · 1 July 2024DuPont acquired Donatelle Plastics in July 2024 for $313 million, integrating it into Spectrum Plastics Group. This acquisition strengthened DuPont's position in the medical device sector and expanded its CDMO capabilities.
• Spectrum Plastics GroupcoreStrategic or Co-development Partner · 1 July 2024Donatelle Plastics is now part of Spectrum Plastics Group, A DuPont Business. Together they offer comprehensive CDMO services across the healthcare value stream.

Scale indicators1 record

Recent moves5 records

Expansion highlights4 records

Direct peers

• Tegra Medical: Medical device contract manufacturer specializing in precision machining, injection molding, and finished device assembly for interventional and surgical OEMs; directly comparable in core services.
• Vesta (medical device contract manufacturing): Medical device contract manufacturer focused on silicone and thermoplastic components, catheters, and assembly for interventional and surgical OEMs; comparable in LSR and catheter capabilities.
• Biomerics: Medical device contract manufacturer with strengths in interventional, minimally invasive, and catheter-based devices, including extrusion, balloon forming, and assembly; directly comparable in catheter technologies.
• Integer Holdings: Pure-play medical device contract manufacturer with capabilities in components, sub-assemblies, and finished devices across cardiovascular, neurovascular, and orthopedic markets; closely comparable in scope and customer base.
• Putnam Plastics: Specialty medical tubing manufacturer (now part of Polyzen) focused on microbore, multilumen, and balloon tubing; comparable in medical extrusion capabilities.
• Freudenberg Medical: Medical device CDMO offering silicone and thermoplastic processing, extrusion, and molding for OEMs across multiple therapeutic areas; comparable in LSR and component manufacturing.

Broad incumbents

• Teleflex: Diversified medical technology company with significant OEM manufacturing and catheter-based product lines that compete with Donatelle's catheter and extrusion capabilities.
• West Pharmaceutical Services: Leading global medical device CDMO specializing in elastomeric components, containment and delivery systems for injectable drugs, and medical device components; directly comparable in regulated component manufacturing.
• Nordson Medical: Medical device component and contract manufacturing business of Nordson, offering precision components and assembly for OEMs; comparable in component manufacturing and OEM focus.

Others

• Spectrum Plastics Group: Now the parent platform of Donatelle under DuPont, Spectrum Plastics Group offers overlapping medical device CDMO capabilities in film/packaging, extrusion, and assembly, making it the closest structural peer after integration.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/donatelle

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 Donatelle