We are a global medical technology company with a focus on repairing and healing the human body in two high-growth sectors: Arthroscopy and Extremities.
BIOTEK is one of the industry leaders in Arthroscopy and Extremities. These businesses jointly offer over 500 exclusive product ranges.
Our infrastructure continues to expand each year. We currently operate in more than 30 countries around the world. Substantial investment in our products and intensive research and development means that we are always ahead. Figures from last two years show that we stand at number one as the leading Indian company in Arthroscopy.Ageing populations worldwide
On average, people are living longer. To retain a high quality of life well into their later years, they are more likely to need treatment for Extremities, Arthroscopy and other conditions.
The key to satisfying the needs of patients and the medical profession is to develop technically advanced devices that offer new treatment possibilities, thereby expanding the market - as BIOTEK is committed to doing.Close to customers and patients
To help patients regain their lives more quickly and fully, we work with healthcare professionals on emerging new technologies and techniques. Our world-class, specialised sales force provides frontline support to our customers and enables us to gain greater understanding of their needs. Strong relationships with healthcare professionals are fundamental to our business. To earn their trust and confidence we know we must always behave with absolute integrity.Research and development
Our business strategy is based on researching, developing, manufacturing and marketing technically innovative and advanced medical devices. Our direct contacts with healthcare providers are a vital link in the chain. Clinicians' views of their present and future needs provide essential impetus for our own research work.
As one of our core values, we take an aggressive, proactive approach to quality through a company-wide initiative that touches all aspects of our operation. Our quality program challenges us to never compromise the high quality of our products, services and systems, while continually striving for improvement in these areas. At BIOTEK, we believe in bringing improvements in every aspect of our business on an everyday basis. We wish to offer the best possible products to our customers.
An important component of BIOTEK's mission is the support of the physician's role as patient advocate. BIOTEK is dedicated to offering surgeons numerous options that allow them to provide the best available care for their patients. This is done through our ongoing commitment to offering comprehensive surgical options designed to meet surgeon needs.
Awards & Certifications
BIOTEK maintains a quality management system which is regularly certified in accordance with the following international standards.
- MD 09 certificate issued by CDSCO
- ISO 13485:2016 Medical devices - Quality Management Systems
- CE certificate
- TGA approval from Australia
- Country Registrations, etc.
These standards make the development, manufacturing and supply of products and services at BIOTEK more efficient, safer and cleaner and provide us with a technical base for health, safety and environmental regulations, helps us in technological advances and maintaining good management practices, disseminates innovation, safeguards consumers, and users in general, of our products and services and last but not the least makes life simpler by providing solutions to common problems.
What We Do
Biotek means the responsiveness and innovation of a small company, with the resources and market presence of a large company. BIOTEK offers a highly specialized and exclusive product range which extends through sports medicine products; shoulder, elbow and radial head joint replacement prosthesis; all kinds of instrumentation for arthroscopic and orthopaedic procedures.
BIOTEK implants are made of stainless steel, pure titanium, titanium alloys and PEEK. The materials are tested for biocompatibility and safety according to EN ISO 10993 and EN ISO 14971. The Chromium-Nickel-Molybdenum alloyed austenitic stainless steel used for BIOTEK implants complies with the international standards ISO 5832-1 and ASTM F138. The chemical composition, mechanical properties, and the purity of the microstructure meet the requirements specified by these standards.
Titanium is used in different variations according to the product:
- As softer and more malleable pure titanium TiCP (ISO 5832-2);
- As harder titanium alloy Ti-6Al-4V ELI (ISO 5832-3/ASTM F136)
All PEEK (polyetheretherketone) polymer material used to manufacture our products meets ASTM F2026 specifications and is produced and extensively tested to meet ISO-10993 requirements. PEEK is an extraordinary high-performance polymer that brings together properties like extreme durability, temperature resistance, absence of corrosion, and light weight making it ideally suited for some arthroscopy implants. Additionally, PEEK stands out for good abrasion resistance and a low friction coefficient.
BIOTEK buys the implant raw material from reputed international certified suppliers. Appropriate laboratory material acceptance tests are carried out according to statistical criteria. The material is released for implant production only if its chemical composition, microstructure, purity, mechanical strength and surface quality comply with international standards. The 'material grade' quality stands out for highest purity, complete lot traceability and constancy in manufacturing and processing.
The quality of the implants is constantly proved and ensured by various in vitro and in vivo studies. Precision production techniques; surface treatment; exact individual manufacturing and final inspection ensure the consistency in high quality standards of BIOTEK implants. The producer meets the strict regulations of EU directive (Medical Device Directive 93/42/EEC). BIOTEK maintains a quality management system which is certified in accordance with international standards ISO 13485:2016.Unique Orthopedic Savoir-faire:
BIOTEK owes its rapid growth and international reach to its thorough expertise of the orthopaedics market and technologies. It employs highly experienced, innovation-driven professionals and engineers and manufactures more than 100,000 orthopaedic instruments and implants a year.Versatile Facilities:
BIOTEK operates state-of-the-art production facilities located in India. Our facilities currently produce several thousand different types of instruments and implants for the most demanding customers in the global orthopaedic sports medicine and extremities markets.Cutting-edge Technologies:
With over a decade of successful medical device product experience behind us, BIOTEK has learned to identify, adopt and master the technologies that can make a difference to our customers in terms of performance, quality, reproducibility, deadlines and production costs. We are now one of the uncontested leaders in India in the production of complex instruments and advanced implants.
Since our establishment, we have built a solid reputation as a manufacturer with the highest quality standards and integrity. We are committed to supply the highest quality products at an economic cost. Our goal is to set the standards for the industry.
BIOTEK serves the exacting and highly specialized requirements of the medical implant industry. Our design and manufacturing standards for precision implant manufacturing are among the highest in India.State-of-the-art-manufacturing & Design
We continuously invest in high precision, high-technology equipment including high - performance Japanese Make CNC machines, German make machines for Surface Passivation, laser part identification, and state of the art inspection lab.Engineering and Product Design
We have a solid background of designs, materials, tolerances and the quality demands of the orthopaedic industry. Our engineering staff works with our design engineers to provide value-added products and product enhancements. Throughout the implant design, development, testing stages, we work in concert with our technicians to develop optimal implant design and to engineer cost-effecting, statistically capable manufacturing processes and inspection processes.
ZW CAD operators using ESPRIT software transform concepts into final designs and manufacturing drawings. We do in-house Tensile testing and Torque measurement on German make equipment.Operations
Our skilled machinists work in house with the best equipment available. When required, we work with local testing labs to insure specification, safety and efficacy of products.Advanced Machining Capabilities
- CNC Multi-axis Machining
- CNC Turning
- CNC Milling
- Wire EDM
- Automated Buffing Process
- Laser Marking
- Sand Blasting
- Titanium Anodizing
- Ultrasonic Cleaning
- ISO 7 Clean Room Packaging
- ISO 8 Air-Shower
- ISO 5 Dynamic Pass Boxes
- Automatic self-validatable ETO Sterilization
- Laminar Air Flow
- Stability Chamber for In-House Stability Study