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Manufacturing your Success


Orthopaedic manufacturing expertise Marle serves the worldwide orthopaedic industry with specialized manufacturing services to produce hip, knee, shoulder, spine, extremities implants and instruments of the highest quality, within the shortest timeframe.

FROM DESIGN TO DELIVERY: FULLY-FEATURED, CUSTOMER-FOCUSED MANUFACTURING SERVICES Marle manufacturing operations are designed to bring you a fully-featured service, from design to delivery.

Exclusively focused on orthopaedic manufacturing, Marle is a strategic and reliable long-term partner, that translates your clinical expertise into complete, efficient and quality-driven industrial production.

Feasibility, manufacturability and design studies

Simulations

Rapid Prototype Development

Manufacturing design and programming

Production

Supply-chain

Marle offers a wide combination of technologies, that enables you to manufacture the most diverse implant geometries, with strict tolerances and the highest quality and cost-efficiency achievable on the market

AN UNMATCHED ORTHOPAEDIC MANUFACTURING EXPERIENCE Marle has been devoting its entire manufacturing expertise to orthopaedic implants for more than 35 years. Marle teams belong to the most experienced professionals in this field and have kept abreast of all technological and regulatory evolutions of the orthopaedic market. HIGH ADDED-VALUE, EARLY-STAGE ENGINEERING EXPERTISE Marle’s experts efficiently intervene in early-stage engineering operations and assist your team, to fine-tune implant designs, greatly reduce lead time, shorten production timeframes, reduce costs, ensure quality and guarantee safety.

Forging

Investment casting – air and vacuum

Heat treatments

Milling

Grinding

Turning

Electroerosion

 olishing – P automatic and manual

Anodizing

Coating

Laser marking

Testing

Cleaning and passivation

Clean room packaging

QUICK TO REACT PRODUCTION CAPABILITIES Marle answers the growing need for speed and flexibility with flexible production plans that can quickly adapt to your market moves, with short, medium or long run productions.

KEY FIGURES ■ 35 years of experience ■ 1 million implants produced a year ■ 500 employees

TECHNOLOGY-DRIVEN MANUFACTURING EXCELLENCE Marle massively invests in innovative manufacturing processes to offer ever more quality, reliability and speed to implant OEMs.

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100 % ORTHOPAEDIC IMPLANTS With 35 years of experience, Marle has developed a wide array of manufacturing capabilities, that span all orthopaedic segments: ■

L arge and small joint reconstruction - Hips - Knees - Shoulders - Ankles - Elbows

 pinal implants S - Intervertebral discs - Peek cages

 Instruments - Rasps - Handles

GENUINE EXPERTISE IN BIOMEDICAL-SPECIFIC ALLOYS AND SPECIAL PROCESSES Marle engineers benefit from well-established expertise in alloys and superalloys used to address specific biocompatibility, elasticity, fatigue and wear resistance. Our two laboratories are equipped with the apparatus suitable for performing various metallographic inspections.

AN ORTHOPAEDICS-FOCUSED QUALITY AND VALIDATION MANAGEMENT SYSTEM The Marle Quality and Validation Management System has earned us the trust of the most respected players of the orthopaedic industry. All production sites are ISO 13485 certified. They benefit from a medical-specific management system that lays stress on traceability and validation for all special processes. Marle plants integrate a comprehensive set of testing tools: mechanical tests, 3D inspection and metrology, fibroscopy, endoscopy, X-Ray, metallographic inspections, spectrometry, FPI, … Marle’s commitment to quality also fosters the continuous progress of our industrial practices, on a daily basis: lean manufacturing, 5S, etc.

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The most complete set of manufacturing technologies dedicated ENGINEERING AND MANUFACTURABILITY

With complete dedication to orthopaedics, Marle has built highly specialized manufacturing capabilities, equipped with one of the most comprehensive sets of technologies available worldwide. Production includes widely automated operations that increase speed and reproducibility.

FORGING

EXPERIENCED AND SPECIALIZED ENGINEERING SKILLS, FOR FLAWLESS QUALITY AND SAFETY, MAXIMUM MANUFACTURABILITY AND FASTER TIME-TOMARKET Marle’s engineering fasttracks and streamlines your development process, to speed the manufacturing process and optimize your cash flow:

MASSIVE FORGING CAPABILITIES TO PRODUCE THE HIGHEST QUALITY IMPLANTS Marle’s forging enables us to produce implants with superior and highly predictable strength properties. ■

 obalt chrome, titanium C and stainless steel forgings

Near-net shape forging

 ontrolled grain size and C direction and simulated material flow to ensure maximum strength

CASTING

STATE-OF-THE-ART INVESTMENT CASTING TECHNOLOGY, FOR PRECISION, RELIABILITY AND COST-EFFICIENCY Marle has developed air and vacuum investment casting capabilities that benefit orthopaedic implant production in many ways: ■

L arge freedom of design, well suited to shoulder and knee implants

 ast choice of medicalV specific alloys and superalloys

 xperienced industrial E project management skills with orthopaedics expertise  lloy, selection and A validation

 igh ductility and H resistance properties

T ight dimensional tolerances

 omplete CAD / CAM and C simulation capabilities

 ptimal response to heat O treatment

 igh reproducibility and H consistency

 Specific Design For Manufacturability knowhow

 xceptional dimensional E stability

 onsistent metallurgical C properties

 pecific heat treatment S to enhance physical and chemical properties

Rapid Prototyping Facilities

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to orthopaedic implants MACHINING

POLISHING AND FINISHING

COMPREHENSIVE MACHINING CAPABILITIES, FOR VALUE-ADDED DESIGN

COMPLETE FINISHING TECHNOLOGIES TO MEET THE HIGHEST QUALITY STANDARDS

Marle’s comprehensive in-house up to 6 axis machining capabilities complement casting and forging technologies, offering unlimited design. Our expertise notably spans specific orthopaedic shapes: femoral stem distal grooves, impaction and extraction holes, tapers, modular and monobloc femoral rasps, femoral knee shapes, etc.

Marle has developed a complete set of finishing techniques dedicated to orthopaedic implants that yields extremely precise production, including high volume series:

Milling

Turning

Grinding

Electroerosion

Heat treatment

 anual, electrolytic and M automated polishing

Tribo-finishing

Laser marking

COATING

CLEANING AND PACKAGING

COATINGS FOR ADVANCED IMPLANTS

READY FOR STERILIZATION

Marle’s coating technologies enable to enhance implant biomechanical properties with active osseointegration,

Marle’s production lines are equipped with ultrasonic and chemical cleaning automated stations that guarantee implants’ microbiological maximum safety before sterilization.

 lasma spray technology P (atmospheric or vacuum)

 ydroxyapatite or metal H single layer or double layer with metal and hydroxyapatite

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Packaging is performed in clean, controlledatmosphere rooms. ■

 ouble pouches or double D blister packs

 Cardboard or polypropylene boxes

Custom packing


Quality-driven Marle’s deep-rooted quality and medical risk analysis culture guarantees total control of production and addresses the even more demanding international regulations on the worldwide markets.

ISO 13485

Medical Devices Quality Management MD 559928

FOCUSED QUALITY ASSURANCE SYSTEM AND CERTIFICATION

CONTINUOUS TRAINING AND SIGNIFICIANT INVESTMENT

Marle’s entire industrial production and management are certified under the EN ISO 13485 international medical quality assurance model.

Marle corporate strategy lays significant stress on employees’ empowerment and skills improvement. Members of our teams benefit from a continuous training path fitted to their needs. Our training programs address management, quality, technical and basic skills alike.

Marle’s unique focus on orthopaedics has led our teams to implement and continuously enhance a specific quality management system that puts the stress on traceability and reliability.

Our investment strategy matches our quality requirements and provides our teams with latest-generation control systems and laboratories:

Marle exclusively works with an approved and validated supplier list, has implemented a flawless raw material quality control scheme to increase reliability and neutralize variation. A SYSTEMATIC APPROACH TO MEDICAL RISK MANAGEMENT Marle’s highly specialized activity on orthopaedics implants has shaped several proprietary quality-assurance procedures and tools addressing the healthcare market: validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development and microbiological management, comprehensive process documentation, scientifically assessed risk analysis and statistically optimised manufacturing processes, etc.

 echanical tests (impact, hardness and micro hardness, M tensile, etc.)

Profile projectors

3D (CMM) inspection

Automatic air gages

NDT (penetrant testing, X-ray, fibroscopy, endoscopy)

 etallographic inspection (grain, corrosion, fracture, M surface, structures, cleanliness, porosity, contents, Alpha-Case and contaminated layers, flow lines…)

Spectrometry

ISO 14001 FOR SUSTAINABILITY Marle’s ISO 14001 certification demonstrates that our commitment to sustainability and environmental protection is met on a daily basis. These endeavors also translate in tighter process controls, comprehensive product life cycle analysis and management, reduced costs of waste management and energy savings.

Our quality system translates into total traceability, complete document management and thorough testing, and therefore end-user medical risk is perfectly controlled.

STANDARD BASED VALIDATION Marle’s validation approach is based on a strong standard watch in order to fit to best-in-class requirements (ISO and ASTM). Thus, packaging validation is made in accordance to ISO 11607 requirements. Hydroxyapatite coating is validated in accordance to ISO 13779 with masterfiles submited to the FDA. Cleaning validation is based on NFS 94-091.

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Customer-focused In an industry that demands even more flexibility, speed and accuracy, Marle teams are organized and trained to provide expert, efficient and proactive answers. GENUINE ORTHOPAEDICS EXPERTISE Marle expertise has been solely focusing on orthopaedics for more than 35 years.This strategy results in an unmatched skills base dedicated to the specific manufacturing needs of the implant industry. Our engineers and metallurgists are all key experts in their field and bring genuine value to your manufacturing outsourcing investments.

PROJECT SPECIFIC, MULTIDISCIPLINARY MANAGEMENT SYSTEM

EARLY-STAGE EXPERT ADVICE AND SUPPORT Marle’s expertise enables our teams to bring you expert advice to fine-tune implants designs and engineering choices to bring maximal value for orthopaedic OEM while optimizing manufacturing costs, quality and lead-time.

To bring your company maximum expertise, flexibility and responsiveness, each of your projects is managed by a multifaceted team that associates metallurgists, design engineers, industrial project managers, manufacturing professionals and quality assurance specialists. This multidisciplinary approach enables seamless transfer, from design to manufacturing, and brings you a complete and detailed follow-through on each project.

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Manufacturing your Success

Marle serves the medical industries with one of the most comprehensive in-house sets of technologies to produce orthopaedic implants, of the highest quality, within the shortest timeframe.

With more than 35 years of experience, Marle’s teams provide OEMs with expertise in orthopaedic manufacturing enabling us to guarantee quality and safety, reduce time-to-market and optimize costs.

BP 46 ZI rue Lavoisier F-52800 NOGENT Tel: +33 (0)325 318 579 Fax: +33 (0)325 316 265 www.marle.fr

Photos: J. Bedelet, E. Girardot, S. Ramillon, M. Stanic. Copyright Marle May 2017. All products, logos, trademarks or registered trademarks mentioned belong to their respective owners.

Marle is a leading contract manufacturer that exclusively serves the orthopaedic market and produces over a million implants a year.

Marle - brochure  

Overview of Marle, a leading contract manufacturer that exclusively serves the orthopaedic market.

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