Detailed Project Report (DPR) on ORTHOPAEDIC IMPLANTS AND INSTRUMENTS PLATES LIKE PLATES, SCREWS & NAILS (STAINLESS STEEL, TITANIUM & CARBON FIBER) (PROJECT INVESTMENT RS. 1000 CRORES)

Detailed Project Report (DPR) on ORTHOPAEDIC IMPLANTS AND INSTRUMENTS PLATES LIKE PLATES, SCREWS & NAILS (STAINLESS STEEL, TITANIUM & CARBON FIBER) (PROJECT INVESTMENT RS. 1000 CRORES)

ORTHOPAEDIC IMPLANTS AND INSTRUMENTS PLATES LIKE PLATES, SCREWS & NAILS (STAINLESS STEEL, TITANIUM & CARBON FIBER) (PROJECT INVESTMENT RS. 1000 CRORES)

[EIRI/EDPR/4804] J.C.: 3025XL

Orthopaedic implants are developed mostly using treated steel and titanium amalgams for quality, and the plastic covering applied to them serves as an artificial ligament.

Inner fixation is an activity in orthopaedics that includes the careful usage of inserts to fix a bone. During the medical procedure of broken bones through inner fixation the bone parts are first decreased into their typical arrangement then they are held together with the assistance of interior fixators, for example, plates, screws, nails, sticks and wires.

Orthopedic prosthetic use to replace missing joints or bones, or to provide support to a damaged bone.

Orthopedic implants can be defined as medical devices used to replace or provide fixation of bone, or to replace articulating surfaces of a joint. In simpler words, orthopedic implants are used to either assist or replace damaged or troubled bones and joints. Orthopedic implants are mainly made from stainless steel and titanium alloys for strength and lined with plastic to act as artificial cartilage in order to reduce the stress at the articulating surfaces. Some implants are cemented into place and others are pressed to fit, so that your bone can grow into the implant for strength. Some examples of orthopaedic implants are: orthopaedic plates, orthopaedic nails, and orthopaedic screws. The key factor that guides bone healing is the interfragmentary movement, which determines the tissue strain and consequently the cellular reaction in the fracture healing zone. Thus, the methods of fracture fixation will be evaluated by considering their ability to reduce the interfragmentary movement. To achieve good and acceptable healing results, biomechanical principles should be understood and carefully taken into consideration. 

Orthopedic implants are mainly made from stainless steel and titanium alloys for strength and lined with plastic to act as artificial cartilage. Few are cemented into place and others are pressed to fit so that your bone can grow into the implant for strength.

COST ESTIMATION

Plant Capacity                        680000 Nos/Day 

Land & Building (40000 sq.mt.)  Rs. 42.95 Cr    

Plant & Machinery                    Rs. 68.67 Cr 

Working Capital for 3 Month    Rs. 1019 Cr 

Total Capital Investment          Rs.1142  Cr 

Rate of Return                          291%

Break Even Point                      5%




































CONTENTS



INTRODUCTION

SCREWS:

PLATES:

PROSTHESES:

WHY DO NEED FOR ORTHOPEDIC IMPLANTS ARISE?

ADVANTAGES & DISADVANTAGES OF ORTHOPEDIC IMPLANTS

TYPES OF ORTHOPEDIC IMPLANTS

1. JOINT REPLACEMENTS:

2. SPINAL IMPLANTS:

3. TRAUMA IMPLANTS:

4. DENTAL IMPLANTS:

5. ORTHOPEDIC SCREWS:

6. ORTHOPEDIC PLATES:

7. PROSTHETIC JOINTS:

8. SOFT TISSUE IMPLANTS:

9. ORTHOPEDIC WIRES AND PINS:

10. CUSTOM IMPLANTS:

TODAY’S IMPLANTS

ANOTOMY OF BONE

MATERIALS FOR ORTHOPAEDIC IMPLANT

METALS

POLYMERS

CERAMICS

IMPLANT PROPERTIES AND TISSUE RESPONSE

USES & APPLICATIONS

CARBON FIBER IMPLANTS

CARBON FIBER REINFORCED PEEK BONE PLATE WITH TITANIUM 

    FIXATION SCREWS

A BONE PLATE (100; 200) AND A SCREW (600), COMPRISING:

CARBON FIBER REINFORCED COMPOSITE IMPLANT IN ORTHOPEDIC

    SURGERY

MEDICAL APPLICATION OF CARBON FIBER IMPLANTS

WOUND HEALING PRODUCTS

BIOCOMPATIBILITY

GROWTH AND PROSPECT OF ORTHOPAEDIC IMPLANT IN INDIA

SIGNIFICANT GROWTH EXPECTED TO CONTINUE AND MARKET 

    ANTICIPATED TO REACH USD 2.4 BN BY 2030

EVOLVING MARKET COMPOSITION WILL ALTER THE ORTHOPEDIC 

     DEVICES LANDSCAPE

FOSTERING INNOVATION IN INDIA

INCREASE IN M&A AND PE DEALS

THE INDIAN ORTHOPEDICS MARKET IS AT A TURNING POINT

MARKET COMPOSITION, STRUCTURE AND SIZING

FIGURE: MARKET SIZE PROGRESSION OF INDIAN ORTHOPEDIC MARKE

GROWTH IN THE JOINTS SEGMENT

GROWTH IN THE TRAUMA-SPINE SEGMENT

FIGURE: KEY INDUSTRY PLAYERS – INDIAN ORTHOPEDIC DEVCIES

INCREASING LOCAL PRESENCE AND STRATEGIC FOCUS OF LEADING 

    MNCS IN INDIA

EMERGENCE OF INDIAN PLAYERS WITH INTENT TO MOVE UP 

    THE VALUE CHAIN

GROWTH DRIVERS

INCREASING INCIDENCE OF OSTEOPOROSIS, OSTEOARTHRITIS, OBESITY

INCREASE IN AGING POPULATION

UNTAPPED POTENTIAL AND EXPANDING HEALTHCARE ACCESS

IMPROVEMENT IN QUALITY OF HEALTHCARE DELIVERY

PROMOTION OF MEDICAL TOURISM

INCREASED AVAILABILITY OF MINIMALLY INVASIVE PROCEDURES

THE ADVANTAGES OF MINIMALLY INVASIVE TECHNOLOGY DRIVING

    ADOPTION INCLUDE:

GLOBAL MARKET OVERVIEW OF ORTHOPEDIC IMPLANT

KEY TAKEAWAYS:

GROWTH FACTORS

PRODUCT INSIGHTS

BIOMATERIAL INSIGHTS

TYPE INSIGHTS

GEOGRAPHY INSIGHTS

RECENT DEVELOPMENTS

KEY MARKET PLAYERS

LIST OF THE TOP 10 ORTHOPEDIC IMPLANT MANUFACTUTERS/SUPPIERS 

    IN THE WORLD

DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON

ZIMMER BIOMET

STRYKER

MEDTRONIC

ARTHREX

SMITH & NEPHEW

NUVASIVE

GLOBUS MEDICAL

WRIGHT MEDICAL GROUP

CORIN GROUP

PRESENT MANUFACTURERS/SUPPLIERS OF ORTHOPEDIC IMPLANTS

DETAILS OF ORTHOPAEDIC SCREW, PLATES & NAILS

ORTHOPEDIC SCREWS:

ORTHOPEDIC PLATES:

INTERLOCKING NAILS (RODS):

STEPS INVOLVED IN ORTHOPEDIC IMPLANTS MANUFACTURE

METALS

BUFFING PROCESS:

ELECTROPOLISHING PROCESS:

LASER MARKING PROCESS:

ULTRASONIC CLEANING:

OPERON STRATEGIST

ORTHOPAEDIC IMPLANT FACTORY DESIGN

ORTHOPAEDIC IMPLANT CLEAN ROOM

ORTHOPEDIC IMPLANT PRODUCT FEASIBILITY

TECHNIQUES TO MANUFACTURE ORTHOPEDIC IMPLANT

RAPID PROTOTYPING

COMPUTER NUMERICAL CONTROL (CNC)

MANUFACTURING PROCESS OF CARBON FIBER IMPLANT

PEEK MACHINING GUIDE

CARBON FIBER REINFORCED PEEK

DETAILS OF ORTHOPAEDICS MACHINING

MACHINING ISSUES

WORK HOLDING

TOOLING

MATERIALS AND MACHINING

TRACEABILITY

FINE SELECTION

PRODUCTS

SPECIFICATION FOR QUALITY STANDARD

PROCESS CAPABILITIES IN ORTHOPEDIC IMPLANTS

7-AXIS HIGH CONTOUR MILLING:

SWISS MICROMACHINING

AUTOMATED DEBURRING & POLISHING

CLEAN ROOM PACKAGING

TESTING METHOD OF ORTHOPAEDIC IMPLANT & INSTRUMENTS

METALLURGICAL ANALYSIS OF THE MATERIALS

MICROSTRUCTURE OF THE MODIFIED SURFACE

PHYSICAL PROPERTIES OF THE UNTREATED SUBSTRATE SURFACE

MECHANICAL PROPERTIES - MODIFIED SURFACE

MECHANICAL PROPERTIES - SUBSTRATE

BIOCOMPATABILITY

CLINICAL DATA

MANUFACTURING

REPORTING

(A). MANUFACTURING PROCESS OF ORTHOPAEDIC IMPLANTS 

        & INSTRUMENTS

(B). MANUFACTURING OF IMPLANT VIZ DHS/DCS PLATE

THE FOLLOWING OPERATIONS ARE CONNECTED:-

(C) MANUFACATURE OF IMPLANT VIZ SCREW

THE FOLLOWING OPERATIONS ARE CARRIED ON:-

MANUFACTURING PROCESS OF ORTHOPAEDIC INSTRUMENTS 

     (PLATING & NAILING)

THE FOLLOWING OPERATIONS ARE CONDUCTED:-

DETAILS OF ORTHOPAEDIC IMPLANTS MACHINING

MACHINING ISSUES

WORK HOLDING

TOOLING

MATERIALS AND MACHINING

TRACEABILITY

METHOD TO ENHANCED FATIGUE PROPERTIES OF ORTHOPAEDIC IMPLANT

DESIGN AND PROTOTYPING

THE DESIGN PROCESS USUALLY INVOLVES A 3D CAD MOCKUP

MILLING

EVERY IMPLANT AND INSTRUMENT STARTS FROM A SOLID BLOCK 

    OF METAL OR PEEK PLASTIC

AN IMPLANT BEING MILLED AND SPRAYED WITH COOLANT

FINISHING, INSPECTION, AND PASSIVATION

A ROBOT CHECKS A PART FOR PRECISE MEASUREMENTS

A QUALITY TECHNICIAN ALSO GIVES THE PARTS A LOOK OVER

PACKING AND STERILIZATION

LIST OF ORTHOPAEDIC IMPLANTS (MADE AS PER ORDER)

(A) NAILS:-

(B) PLATES:-

(C) SCREWS:-

B. ORTHOPAEDIC INSTRUMENTS

ADVANCES IN TECHNOLOGY AND MATERIALS FOR ORTHOPAEDIC 

    IMPLANTS AND INSTRUMENTS

ADVANCES IN TECHNOLOGY AND MATERIALS

RISING PRODUCTION COSTS

STRATEGIES FOR KEEPING COSTS DOWN

DESIGN PROCESS FOR IMPLANTABLE ORTHOPAEDIC MEDICAL DEVICES

DESIGN INPUTS

COMMERCIAL ASPECTS

PLANNING

REGULATORY REQUIREMENTS

DESIGN REQUIREMENTS

DESIGN REVIEWS

DESIGN

CONCEPT DESIGN

CONCEPT DESIGN MAY INVOLVE

DETAIL DESIGN

DESIGN VERIFICATION

INTRODUCTION

FINITE ELEMENT ANALYSIS

RISK ANALYSIS

RAPID PROTOTYPING

SUPPLIERS OF RAW MATERIAL

SUPPLIERS OF CFR PEEK

SUPPLIERS OF PLANT AND MACHINERY

ADDRESSES OF PLANT & MACHINE SUPPLIERS

SUPPLIERS OF ELECTROPLATING PLANT

SUPPLIERS OF BUFFING MACHINE

PLANT LAYOUT


APPENDIX – A:


01. PLANT ECONOMICS

02. LAND & BUILDING

03. PLANT AND MACHINERY

04. OTHER FIXED ASSESTS

05. FIXED CAPITAL

06. RAW MATERIAL

07. SALARY AND WAGES

08. UTILITIES AND OVERHEADS

09. TOTAL WORKING CAPITAL

10. TOTAL CAPITAL INVESTMENT

11. COST OF PRODUCTION

12. TURN OVER/ANNUM

13. BREAK EVEN POINT

14. RESOURCES FOR FINANCE

15. INSTALMENT PAYABLE IN 5 YEARS

16. DEPRECIATION CHART FOR 5 YEARS

17. PROFIT ANALYSIS FOR 5 YEARS

18. PROJECTED BALANCE SHEET FOR (5 YEARS)








































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