Orthopaedic implants are medical devices commonly used to replace or support damaged or missing bones and joints. Different types of orthopedic implants are used in the healthcare sector. Each implant is designed for specific purposes and anatomical locations. Orthopaedic implants are in high demand in the healthcare sector. Hence, entities are planning to venture into orthopaedic implant manufacturing business. We have prepared this detailed guide to help you start manufacturing orthopaedic implants in India.
We are one of India’s premier medical device consultants. The Pharmadocx Consultants team has set up the maximum number of orthopaedic implant manufacturing facilities in north India. We will help you set up your orthopaedic implant manufacturing factory per CDSCO regulatory guidelines. With our support, you will not face any regulatory obstacles while securing the CDSCO medical device manufacturing license.
Types of orthopaedic implants
Having an idea of the types of orthopaedic implants commonly used in the healthcare sector will be helpful for starting an orthopaedic implant manufacturing business. We have listed some of the common types of implants used in orthopaedics sector.
- Trauma implants: Bone plates are used to fixate fractured bones. Intramedullary nails are inserted into long bones to stabilize fractures. Screws and pins are implants used to secure fractures and bone fragments.
- Joint replacements: Hip implants are used to replace damaged or arthritic hip joints. Knee replacement implants are common orthopaedic implants used for total knee replacement surgery.
- Spinal implants: Spinal fusion implants are used to stabilize and fuse spinal vertebrae together. Pedicle screws and rods are mainly used for spinal stabilization in conditions, such as scoliosis.
- Custom implants: In certain cases, custom-made orthopaedic implants have to be designed and manufactured to perfectly fit a patient’s unique anatomy.
- Orthopaedic screws: Various types of orthopedic screws, such as cannulated screws and lag screws, are used for fixation and stabilization.
- Orthopaedic plates: Compression plates and dynamic compression plates are implants used to support bone healing.
- Prosthetic joints: In addition to commonly used hip and knee joints, prosthetic joints are used for other areas, such as ankle and wrist.
- Soft tissue implants: Soft tissue implants are ligament and tendon-like implants often used for reconstructive surgeries.
- Orthopedic wires and pins: These implants are used for temporary or permanent fixation in orthopaedic procedures.
- Dental implants: Dental implants have a vital role in replacing missing teeth. The common dental implants are root and plate form implants. Root form implants are surgically placed into the jawbone to support a crown. On the other hand, plate form implants are used when the jawbone is narrow and not suitable for root-form implants.
Materials used for manufacturing orthopaedic implants
- Stainless steel
- Titanium
- Titanium alloy
Machinery required for starting an orthopaedic implant manufacturing business
We have highlighted some of the machines you will require for starting an orthopaedic implant manufacturing business.
- EDM Machines
- EDM Drilling Machines
- Horizontal Machining Centers
- Lathes – Horizontal
- Gun Drilling Machines
- Mill/Turn Centers
- Screw Machines
- Swiss Lathes
- Vertical Machining Centers
- Vertical Machining Centers
- Computer Numerical Control (CNC)/Vertical Machining Center (VMC) machine system
Avail our machinery selection service. We will help you select equipment and machinery that will maximize output while ensuring quality and offering long-term reliability.
What are the basic processes involved in manufacturing orthopaedic implants?
- Buffing process: This process is used to increase the shine of metals or composites. The buffing process is also known as “polishing”. Cutting buff is the initial rough stage of buffing. This first step is used to remove imperfections, such as polishing lines, pits, or scratches. Then, the final stage is finishing buff. This process is used to refine the surface for a smooth and polished finish.
- Electropolishing process: Electropolishing is used to remove material from a metallic workpiece to improve its surface finish. By levelling micro-peaks and filling hollows on the surface of the metal piece, electropolishing is used to reduce surface roughness.
- Laser marking process: A focused laser beam with a precise spot diameter is used to create permanent marks on various materials. Laser marking process can be used to write brand names or identification codes on material’s surface.
- Ultrasonic cleaning: In this process, ultrasonic waves are used to remove contaminants from surfaces of various materials. It is an effective, efficient, and reliable process. This advanced cleaning technology is used for its superior results.
We have listed some of the common processes that are usually used for manufacturing orthopaedic implants.
9 basic steps involved in production of orthopaedic implants
- Design and development of the orthopaedic implants.
- Material selection is a vital step in manufacturing orthopaedic implants. Biocompatible materials, such as titanium, are usually used to manufacture orthopaedic implants.
- The orthopaedic implants are manufactured per standard protocol developed by bioengineers.
- Ensuring quality control is a vital part of medical device manufacturing. Compliance with quality standards has to be stringently maintained.
- Implants always have to be sterilized for safety.
- The implants have to be packaged properly. Sterile packaging conditions have to be strictly maintained.
- Regulatory compliance is a mandatory requirement for medical device manufacturers, given the impact of these devices on patient outcome.
- Clinical trials are conducted for ensuring the safety and effectiveness of these implants.
- Post-market surveillance is usually carried out to monitor the quality of the products.
Starting an orthopaedic implant manufacturing business
For manufacturing orthopaedic implants, you need to establish a manufacturing facility. Additionally, you need to comply with all the regulatory guidelines for securing the CDSCO manufacturing license. The CDSCO guidelines are in place to ensure all medical devices entering the Indian market are safe, effective, and of highest quality. Hence, compliance with CDSCO medical device regulatory guidelines is mandatory while manufacturing orthopaedic implants in India. We have highlighted some key points you must keep in mind when starting an orthopaedic implant manufacturing business.
1. Product feasibility
The first step for starting a business is determining the product feasibility. The technological, financial, and regulatory viability of a new orthopaedic implant have to be evaluated. While analysing the product feasibility, the design, materials, manufacturing process, market demand, and regulatory requirements are assessed. Our medical device detailed project report will provide detailed insights into the product feasibility as well as scope and potential outcomes of the business. Additionally, it focusses on market research, market analysis, target market size, projection of expenses, sales, and turnover.
2. Orthopaedic implant factory layout design
Like any other medical device factory, the orthopaedic implant manufacturing facility has to be carefully designed. The facility layout, workflow, and equipment placement have to be prioritised for efficient production of implants. Additionally, seamless material and personnel flow is required to ensure overall operational efficiency. By availing our factory layout service, you can rest assured to have an efficient, regulatory compliant, sustainable, scalable, and future-ready orthopaedic implant manufacturing facility.
3. Orthopaedic implant clean room
In a medical device manufacturing facility, clean room is a highly controlled environment designed to minimize the presence of particles, microbes, and other contaminants. The orthopaedic implant manufacturing facility should include a clean room. The clean room should have specialized ventilation and air filtration systems for maintaining the sterile environment necessary for manufacturing these orthopaedic implants.
4. Documents required for securing CDSCO license for manufacturing orthopaedic implants in India
We have provided an overview of the documents required for securing CDSCO license for manufacturing orthopaedic implants in India.
- Details and address proof of the applicant
- Cover letter
- Application form
- Power of attorney
- Undertaking demonstrating only authentic details have been provided
- ISO 13485 certificate
- CE design certificate
- Plant master file
- Device master file
- Free sale certificate
- TR6 challan
- Quality assurance certificate
For a detailed list of necessary documents, feel free to reach out to us. Additionally, we will help you prepare and compile the documents as per CDSCO requirements.
5. CDSCO license for manufacturing orthopaedic implants in India
To manufacture orthopaedic implants in India, you need to mandatorily secure the CDSCO medical device manufacturing license. The CDSCO medical device manufacturing license required will depend on the CDSCO class to which your orthopaedic implant belongs to. To check your medical device’s CDSCO class, use our free tool. The CDSCO medical device manufacturing license application form and process will depend on your product’s CDSCO class.
We have helped set up the maximum number of orthopaedic implant manufacturing facilities in north India. Our team has extensive knowledge and expertise in CDSCO regulatory guidelines for medical devices. With our support, you can start manufacturing orthopaedic implants in India in a hassle-free manner. Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you.
