Sushrut’s organizational learning of nearly two decades was encapsulated in the formation of Adler Mediequip Pvt. Ltd. Set up in 1992 as part of the Sushrut-Adler Group of Companies, Adler was as a manufacturing company designed and benchmarked to meet the highest standards of infrastructure, critical to high quality medical device manufacturing. A key goal for Adler was the consistent design and manufacturing of devices that would meet stringent international norms and certifications.
Adler manufacturing facilities were set up to include capabilities for high precision machining, CAD/CAM enabled operations, esoteric and not easily available high end technologies like forging of stainless steel implants, high end finishing lines, well organized quality control sections and final packaging operations.
Considering the current product range being manufactured by Adler, capabilities were developed to handle different materials that include various grades of implant and instrument grade stainless steels, Titanium and its alloys, Chrome-Cobalt alloys and polymeric materials as defined in the ISO 5832 series of standards and various other international standards for orthopaedic medical devices. Further, in consideration of the various special needs of medical device manufacturing, Adler has over the years developed a strong organizational orientation to the special in process handling needs and packaging requirements specific to medical devices as well as the stringent discipline and documentation that is critical to safety in medical device manufacturing. Continuous internal training reinforces the entire manufacturing organisations’ understanding of risk management concepts and their implementation in the design and manufacturing activity.
Adler has invested heavily in the resource that it considers the most valuable and critical to the achievement and maintenance of high standards in medical device design and manufacturing; its people. Adler Engineers, over the years, have regularly traveled to advanced facilities in Europe and the U.S for training and exposure to the latest developments and advancements in the field. This process has enabled Adler to benchmark its activities with the world’s best in the crucial areas of product design, product validation and high quality manufacturing.
All Adler activities are carried out under an ISO 9001:2000 and ISO 13485 certified quality management system. The QMS is in place since 1999 and is a mature system with rigorous, well defined internal audits, regular management reviews and a finely honed and monitored system for implementation of Corrective and Preventive Actions. Metrics for regular improvement on critical parameters like rejection rates are set and monitored and annual improvements on these metrics are a well established feature of the manufacturing operations.
The various milestones related to manufacturing operations and quality standards, achieved by Adler, clearly established the company as a pioneer in the field in India. Adler was the first Indian manufacturing organization in the field of orthopaedics, in each instance, to achieve the ISO 9000 certification in 1999 followed by the ISO 9001:2000 certification, the CE certification in 2003, the ISO 13485 certification in 2006 and a manufacturing licence from the Indian Government Regulatory Authority (Office of the Drug Controller General of India) in 2008.