MEDICAL DEVICE MANUFACTURING FOR MATURE MARKETS

The Indian medical device and pharma manufacturers are striving hard to grow their product portfolios for the lucrative but difficult to penetrate mature markets like U.S., Europe and Japan. One of the key challenges is difficulty in complying with regulations and expectations of regulators of these markets.

To overcome this challenge, a few medical device and pharma manufacturers have partnered with medical, diagnostic and drug delivery device contract manufacturers that have the systems, resources, execution capability and proven track record of meeting both quality and regulatory requirements of mature markets. The key requirements of such contract manufacturers are as follows:

• Robust quality management system, certifications and registrations that will comply with regulations of mature markets

• Highly skilled and well-trained resource base

• Program management, speed to market and strength in execution during development, validation and manufacturing phases

• Supply chain management experience including capability to source and procure exotic materials and components from across the globe in small quantities, if required

SMC is uniquely positioned in this space as a medical, diagnostic and drug delivery device contract manufacturer headquartered in US and having a world class manufacturing facility (EOU) in Bangalore.

SMC has design and manufacturing facilities in U.S.A., U.K., Costa Rica and India. With 1 million square feet dedicated to medical manufacturing, SMC provides full services from initial concept through final packaged device including program management, design and development, validation, product manufacturing, clinical manufacturing, electronics integration, kitting and packing, sterilization management as well as global sourcing and supply chain management. In 2016, SMC acquired Oval Medical Technologies, a cutting-edge parenteral technology company based in Cambridge U.K.

SMC’s manufacturing facility in Bangalore makes complex medical device components, assemblies and finished devices for domestic, emerging and mature markets. SMC’s capabilities include device design rationalization, component design, tooling, process development and validation, injection molding, finished device manufacturing, manual / automated assembly, parts adhesion, ultrasonic welding, printing, coating, labelling, kitting, packaging, custom / inline device testing, sterilization management and global distribution. SMC also designs and manufactures custom inline manufacturing, inspection and testing equipment.

SMCs value proposition is as follows: