Manufacturing your Success

Marle serves the worldwide orthopaedic indus-try with specialized manufacturing services to produce hip, knee, shoulder, spine, extremities implants and instruments of the highest quality, within the shortest timeframe.Exclusively focused on orthopaedic manufactu-ring, Marle is a strategic and reliable long-term partner, that translates your clinical expertise into complete, efficient and quality-driven industrial production.

AN UNMATCHED ORTHOPAEDIC MANUFACTURING EXPERIENCEMarle has been devoting its entire manufacturing expertise to orthopaedic implants for more than thirty years. Marle teams belong to the most experienced professionals in this field and have managed with all technological and regulatory evolutions of the orthopaedic market.

HIGH ADDED-VALUE, EARLY-STAGE ENGINEERING EXPERTISEMarle’s experts efficiently intervene in early-stage enginee-ring operations and assist your team, to fine-tune implant designs, greatly reduce lead time, shorten production time-frames, reduce costs, ensure quality and guarantee safety.

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

■ 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

■ Forge

■ Investment casting – air and vacuum

■ Heat treatments

■ Milling

■ Grinding

■ Turning

■ Electroerosion

■ Polishing – automatic and manual

■ 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.

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

Orthopaedic manufacturing expertise

KEY FIGURES■ 30 years of experience■ 800 000 implants

produced a year■ 450 employees

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100 % ORTHOPAEDIC IMPLANTS With 30 years of experience, Marle has developed a wide array of manufacturing capabilities, that span all ortho-paedic segments:

■ Large and small joint reconstruction - Hips - Knees - Shoulders - Ankles - Elbows

■ Spinal implants - Intervertebral discs - Peek cages

■ Instruments - Rasps - Handles

GENUINE EXPERTISE IN BIOMEDICAL-SPECIFIC ALLOYS AND SPECIAL PROCESSESMarle engineers benefit from well-established expertise in alloys and superalloys used to address specific biocompa-tibility, elasticity, fatigue and wear resistance.

Our two laboratories are equipped with the apparatus sui-table for performing various metallographic inspections.

AN ORTHOPAEDICS-FOCUSED QUALITY AND VALIDATION MANAGEMENT SYSTEMThe 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, fi-broscopy, 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.

Orthopaedic manufacturing expertise

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

■ Experienced industrial project management skills with orthopaedics expertise

■ Alloy, selection and validation

■ Complete CAD / CAM and simulation capabilities

■ Specific Design For Manufacturability know-how

■ Rapid Prototyping Facilities

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

■ Cobalt chrome, titanium and stainless steel forgings

■ Near-net shape forging

■ Controlled grain size and direction and simulated material flow to ensure maximum strength

■ High ductility and resistance properties

■ Optimal response to heat treatment

■ Exceptional dimensional stability

■ Consistent metallurgical properties

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

■ Large freedom of design, well suited to shoulder and knee implants

■ Vast choice of medical-specific alloys and superalloys

■ Tight dimensional tolerances

■ High reproducibility and consistency

■ Specific heat treatment to enhance physical and chemical properties

ENGINEERING AND MANUFACTURABILITY

CASTINGFORGING

The most complete set of manufacturing technologies dedicated to orthopaedic implants

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.

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COMPREHENSIVE MACHINING CAPABILITIES, FOR VALUE-ADDED DESIGNMarle’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.

■ Milling

■ Turning

■ Grinding

■ Electroerosion

COMPLETE FINISHING TECHNOLOGIES TO MEET THE HIGHEST QUALITY STANDARDSMarle has developed a complete set of finishing techniques dedicated to orthopaedic implants that yields extremely precise production, including high volume series:

■ Heat treatment

■ Manual, electrolytic and automated polishing

■ Tribo-finishing

■ Laser marking

COATINGS FOR ADVANCED IMPLANTSMarle’s coating technologies enable to enhance implant biomechanical properties with active osseointegration,

■ Plasma spray technology (atmospheric or vacuum)

■ Hydroxyapatite or metal single layer or double layer with metal and hydroxyapatite

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

Packaging is performed in clean, controlled-atmosphere rooms.

■ Double pouches or double blister packs

■ Cardboard or polypropylene boxes

■ Custom packing

MACHINING COATING CLEANING AND PACKAGINGPOLISHING AND FINISHING

The most complete set of manufacturing technologies dedicated to orthopaedic implants

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Marle’s deep-rooted quality and medical risk ana-lysis culture guarantees total control of production and addresses the even more demanding interna-tional regulations on the worldwide markets.

FOCUSED QUALITY ASSURANCE SYSTEM AND CERTIFICATIONMarle’s entire industrial production and management are certified under the EN ISO 13485 international medical quality assurance model.

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.

Marle exclusively works with an approved and validated supplier list, has implemented a flawless raw material qua-lity control scheme to increase reliability and neutralize variation.

A SYSTEMATIC APPROACH TO MEDICAL RISK MANAGEMENTMarle’s highly specialized activity on orthopaedics im-plants 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 pro-cess documentation, scientifically assessed risk analysis and statistically optimised manufacturing processes, etc.

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

CONTINUOUS TRAINING AND SIGNIFICIANT INVESTMENTMarle corporate strategy lays significant stress on em-ployees’ empowerment and skills improvement. Members of our teams benefit from a continuous training path fitted to their needs. Our training programs address manage-ment, quality, technical and basic skills alike.

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

■ Mechanical tests (impact, hardness and micro hardness, tensile, etc.)

■ Profile projectors

■ 3D (CMM) inspection (7 centres)

■ Automatic air gages

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

■ Metallographic inspection (grain, corrosion, fracture, surface, structures, cleanliness, porosity, contents, Al-pha-Case and contaminated layers, flow lines...)

■ Spectrometry

ISO 14001 FOR SUSTAINABILITYMarle’s ISO 14001 certification demonstrates that our commitment to sustainability and environmental protec-tion 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.

STANDARD BASED VALIDATIONMarle’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 vali-dated in accordance to ISO 13779. Cleaning validation is based on XPS 94-091.

Quality-obsessed

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In an industry that demands even more flexibility, speed and accuracy, Marle teams are organized and trained to provide expert, efficient and proac-tive answers.

GENUINE ORTHOPAEDICS EXPERTISEMarle expertise has been solely focusing on orthopaedics for more than 30 years.This strategy results in an unmat-ched skills base dedicated to the specific manufacturing needs of the implant industry. Our engineers and metal-lurgists are all key experts in their field and bring genuine value to your manufacturing outsourcing investments.

EARLY-STAGE EXPERT ADVICE AND SUPPORTMarle’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.

PROJECT SPECIFIC, MULTIDISCIPLINARY MANAGEMENT SYSTEMTo 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 mul-tidisciplinary approach enables seamless transfer, from design to manufacturing, and brings you a complete and detailed follow-through on each project.

Customer-focused

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Marle serves the medical industries with one of the most comprehensive in-house sets of tech-nologies to produce orthopaedic implants, of the highest quality, within the shortest timeframe.Marle is a leading contract manufacturer that exclusively serves the orthopaedic market and produces over 800 000 implants a year.With more than thirty years of experience, Marle’s teams provide OEMs, with thorough expertise of orthopaedic manufacturing that enables 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

Manufacturing your Success

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