Roncadelle Operations
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.
- Company typePrivate
- Founded2019
- HeadquartersCastel Mella, Italy
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Roncadelle Operations firmographics
Firmographics- 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
Roncadelle Operations industry classification
Industry- 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
Where Roncadelle Operations is headquartered
LocationHeadquarters
- HQ city
- Castel Mella
- HQ country
- Italy
- HQ region
- Europe
Offices1 record
Markets served
Roncadelle Operations business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Supply Chain, Infrastructure, Technology or R&D, Marketing or Sales
Revenue model
- 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.
- CDMO Services: Contract development and manufacturing organization services providing device development, process scaling, and GMP-compliant manufacturing for injectable therapies.
- Technology Licensing: Licensing of SafeR® passive safety technology to partners like Terumo for integration into their branded products. Revenue from technology licensing and royalties.
- 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
Roncadelle Operations product offering
Product offeringCore 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
Companies that use Roncadelle Operations
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles3 records
Roncadelle Operations technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Roncadelle Operations partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Terumo Medical CorporationcoreTerumo 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.coreMarch 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
Roncadelle Operations competitors and assessment
Company assessmentBroad 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
Roncadelle Operations social profiles
Digital presenceRoncadelle Operations compliance and trust
Trust signalCompliance5 records
Roncadelle Operations financial estimates
Financial estimateRevenue estimate
Valuation estimate
Roncadelle Operations leadership team
Management profileNumber of profiles
Profiles1 record
Roncadelle Operations funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Roncadelle Operations M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Roncadelle Operations
What does Roncadelle Operations do?
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.
Is Roncadelle Operations a public or private company?
Roncadelle Operations is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Roncadelle Operations founded?
Roncadelle Operations was founded in 2019. It employs 11 to 50 people.
Where is Roncadelle Operations based?
Roncadelle Operations is headquartered in Castel Mella, Italy, in the Europe region.
How does Roncadelle Operations make money?
Four revenue lines are on record. Medical Device Manufacturing is the primary driver. The others are CDMO Services, technology Licensing and pharma Packaging Solutions.
Who are Roncadelle Operations's main competitors?
Broad incumbents on record are SCHOTT Pharma, Gerresheimer AG, B. Braun SE and West Pharmaceutical Services. Direct peers are Smiths Medical (ICU Medical), Becton, Dickinson and Company (BD), Stevanato Group, Retractable Technologies, Inc., Terumo Medical Corporation and Sharps Technology, Inc..
Does Roncadelle Operations have an API?
No public API is recorded for Roncadelle Operations.
What industry is Roncadelle Operations in?
Roncadelle Operations's product category is Medical Devices — Injectable Drug Delivery Devices. Its primary akta.pro industry code is HLAHAIAA, Prefilled Syringes & Safety Syringes, with a secondary code of IMALAIAE, Parenteral & Injectable Packaging Components (Stoppers, Seals, Syringes, Cartridges). Its NAICS code is 339112 and its SIC code is 3841.