Roncadelle Operations

What Roncadelle Operations does

Roncadelle Operations s.r.l. (commercially branded as RoncaMed) is an Italian MedTech manufacturer founded in 2019 and headquartered in Castel Mella (Brescia), Italy, specializing in injectable drug delivery devices and pharmaceutical packaging solutions. The company's core technology is the proprietary SafeR® passive safety mechanism — a fully automatic needle retraction system designed to reduce needle-stick injuries for healthcare workers while preserving standard clinical technique. Its product portfolio includes SAFER® Passive Safety Syringes, SafeR® Shield Devices for pre-filled syringes, RTU (Ready-to-Use) pharmaceutical packaging solutions, and closures and accessories for injectable therapies. Manufacturing capabilities span precision injection molding, extrusion, thermoforming, over-molding, and balloon forming across medical-grade materials (polyolefins, polycarbonates, polyamides, bioplastics, metals), all conducted in a 14,000 SQM ISO 13485-certified, cGMP-compliant facility.

The business operates across four revenue streams: (1) direct sales of medical device hardware to healthcare providers and pharmaceutical companies, (2) CDMO services providing device development, process scaling, and GMP manufacturing for third-party injectable therapies, (3) technology licensing and royalties — most notably to Terumo Medical Corporation for the SurTract™ Safety Syringe launched in the US market in Q1 2026, and (4) pharmaceutical packaging solutions including RTU packaging and closure systems. Go-to-market combines enterprise OEM/licensing partnerships (Terumo), global distribution alliances (Sharps Technology Inc., March 2024), authorized distributor networks, and direct relationships with hospitals, clinics, and emergency-care settings. The company's addressable market is the retractable needle safety syringes segment, projected to reach $8.13 billion by 2030 at a 7.8% CAGR.

Roncadelle serves two primary customer verticals: healthcare providers requiring needle-stick injury prevention and infection control solutions, and pharmaceutical companies needing validated, scalable manufacturing for injectable drug delivery devices and packaging. The company holds ISO 13485, CE Mark, and 510(k) regulatory capabilities, with materials compliant to USP Class VI, ISO 10993, and FDA standards. Leadership is led by CEO Erik Ryckalts. The company is privately held (Italian s.r.l. structure) with 11-50 employees and no disclosed institutional investment or parent company.

Name

Roncadelle Operations

Legal name

Roncadelle Operations s.r.l.

Website

https://roncadelle-operations.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Roncadelle Operations (RoncaMed) is an Italian MedTech manufacturer specializing in injectable drug delivery devices and pharmaceutical packaging. It develops SafeR® passive safety syringes and provides CDMO services to pharmaceutical companies and healthcare providers globally.

Ownership category

akta.pro rank

Product category

Medical Devices — Injectable Drug Delivery Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Prefilled Syringes & Safety Syringes (HLAHAIAA)

akta.pro secondary industries

Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges) (IMALAIAE), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH)

Keywords

• Passive safety syringes
• Injectable drug delivery devices
• Medical device CDMO
• Pharmaceutical packaging solutions
• Retractable needle syringes

Headquarters

HQ city

Castel Mella

HQ country

Italy

HQ region

Europe

Offices1 record

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. Medical Device Manufacturing: Design, development and industrialization of injectable drug delivery devices including safety syringes and prefilled devices. Revenue from device sales to healthcare providers and pharmaceutical companies.
2. CDMO Services: Contract development and manufacturing organization services providing device development, process scaling, and GMP-compliant manufacturing for injectable therapies.
3. Technology Licensing: Licensing of SafeR® passive safety technology to partners like Terumo for integration into their branded products. Revenue from technology licensing and royalties.
4. Pharma Packaging Solutions: Ready-to-use (RTU) packaging solutions and closures for pharmaceutical applications including prefilled syringe components and vial accessories.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Roncadelle Operations designs, develops, and manufactures injectable drug delivery devices and pharmaceutical packaging solutions, with its flagship being the SAFER® Passive Safety Syringe featuring proprietary SafeR® fully passive automatic needle retraction technology. The company also produces SafeR® Shield Devices for pre-filled syringes, prefilled syringe components for flush applications, RTU packaging solutions, and closures and accessories, while providing integrated CDMO services spanning device development, precision injection molding, automation, and GMP-compliant high-volume manufacturing.

Product overview

Roncadelle Operations (trading as RoncaMed) is a specialized MedTech manufacturer offering a portfolio of injectable drug delivery devices and pharmaceutical packaging solutions. The core product line includes SAFER® Passive Safety Syringes with automatic needle retraction technology, SafeR® Shield Devices for pre-filled syringes, and prefilled syringe components for flush applications. These safety devices are complemented by RTU Packaging Solutions, pharmaceutical closures, and accessories. The company provides CDMO (Contract Development and Manufacturing Organization) services and OEM platforms that span device development, precision injection molding, automation, and GMP-compliant manufacturing, enabling partners to scale from validated device design to high-volume industrial production.

Differentiator

Problem solved

Functional benefit

Brands

• SafeR®: Passive safety technology for retractable needle safety syringes
• SAFER®
• SurTract™
• RoncaMed

Products and services

• SAFER® Passive Safety Syringes Passive safety syringes featuring proprietary SafeR® fully passive automatic needle retraction technology, designed to reduce needle-stick injuries for healthcare providers while preserving standard clinical technique. Targeted at hospitals, clinics, and emergency-care settings.
• SafeR® Shield Devices Safety shield devices designed for pre-filled syringes to protect healthcare professionals during injection procedures. Targeted at pharmaceutical companies and healthcare providers using pre-filled syringe systems.
• Prefillable Syringe Components for Flush Applications Prefillable syringe components specifically designed for flush applications in medical settings. Targeted at healthcare providers performing IV flush procedures.
• Pharma Packaging Solutions (RTU Packaging, Closures & Accessories) Comprehensive pharmaceutical packaging solutions including Ready-to-Use (RTU) packaging solutions that enhance process performance, plus pharmaceutical closures and accessories ensuring quality and compliance for injectable therapies. Targeted at pharmaceutical companies packaging injectable products.
• CDMO Services (Contract Development and Manufacturing Organization) Contract Development and Manufacturing Organization services spanning device development, precision injection molding, automation, and GMP-compliant manufacturing for injectable therapies. Targeted at pharmaceutical companies seeking to bridge validated device design to high-volume industrial production.

Quantifiable outcome

• Retractable needle safety syringes market projected to reach $8.13 billion by 2030 at 7.8% CAGR

Named customers2 records

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

Two partnerships are on record, tiered core.

• Terumo Medical CorporationcoreOEM/ Whitelabel/ Licensing Partner · 6 January 2026Terumo launches SurTract™ Safety Syringe powered by SafeR® passive safety technology developed by Roncadelle Operations. Distribution begins Q1 2026 across US hospitals, clinics, and emergency-care settings. Partnership combines Terumo's clinical expertise with Roncadelle's validated safety technology.
• Sharps Technology Inc.coreChannel Partner/ Reseller/ Distributor · 1 March 2024March 2024 global sales and distribution partnership combining distribution networks and product portfolios for advanced retractable safety syringes. Partnership leverages combined capabilities to expand market reach globally.

Scale indicators4 records

Recent moves5 records

Expansion highlights6 records

Broad incumbents

• SCHOTT Pharma: Specialist in pharmaceutical glass packaging including prefilled syringe glass barrels and sterile containment for injectables. Overlaps with Roncadelle's prefilled syringe component and packaging solutions products serving the same injectable therapy market.
• Gerresheimer AG: European pharmaceutical packaging and drug delivery devices manufacturer including glass syringes and plastic components. Adjacent competitor offering prefilled syringe components for the same pharma and biopharma customer base.
• B. Braun SE: Major medical device and pharmaceutical solutions company with safety hypodermic needles/syringes (e.g., Injekt®, Sterican®) plus IV therapy and injectable drug delivery. Competes across product category and shares Roncadelle's hospital safety syringe positioning.
• West Pharmaceutical Services: Global leader in pharmaceutical containment and delivery components, including syringe plungers, seals, and stoppers for prefilled syringes. Overlaps with Roncadelle's RTU packaging and closures portfolio for injectable therapies serving the same pharma customers.

Direct peers

• Smiths Medical (ICU Medical): Manufacturer of safety hypodermic needles and syringes (e.g., Needle-Pro, Safety-Shield) for hospitals and acute care. Direct competitor in retractable safety syringes targeting needle-stick injury prevention in similar healthcare settings.
• Becton, Dickinson and Company (BD): Global leader in injection and drug delivery devices, including the BD SafetyGlide and other retractable/passive safety syringes. Most direct large-scale competitor in the safety syringe category served by Roncadelle's SafeR® technology, competing for the same hospital and clinic procurement budgets.
• Stevanato Group: Italian-headquartered drug containment and delivery solutions provider including prefillable syringe platforms, device CDMO capabilities, and pharmaceutical glass packaging. Comparable integrated offering for injectable therapies with broader scale.
• Retractable Technologies, Inc. US-based specialist in retractable safety syringes (VanishPoint®, EasyPoint®). Closest pure-play comparable to Roncadelle in product category — small/mid-cap peer competing on passive needle retraction technology.
• Terumo Medical Corporation: Both a key Roncadelle partner (Terumo's SurTract™ is licensed SafeR®) and a major medical device competitor in syringes, needles, and drug delivery devices. Operates in the same hospital, clinic, and emergency-care customer segment.
• Sharps Technology, Inc. Both commercial partner and direct competitor — Roncadelle and Sharps Technology have a March 2024 global distribution partnership, while Sharps also markets its own retractable safety syringe portfolio (Syringe and Needle Guard devices) competing in the same category.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UC2XFtiHARyASa6rjf7_WWsA
• LinkedInlinkedin.com/company/roncadelle-operations

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 Roncadelle Operations