Manufacturing

Medical Device Manufacturing For Mature Markets

The Indian medical device and pharma manufacturers are striving hard to grow their complex and high-risk medical device product portfolios in particular for the lucrative but hard 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 comply with regulations of mature markets
• Best-in-class manufacturing practices
• State-of-the-art facility with sophisticated equipment for manufacturing and testing
• 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, even in small quantities

SMC is uniquely positioned in this space as a medical, diagnostic and drug delivery device contract manufacturer headquartered in U.S. and having a world class manufacturing facility (E.O.U.) 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.

SMC’s value proposition is as follows:

• SMC owned and operated 35,000 sq. ft. manufacturing facility at Bangalore
• ISO 13485 certification, US FDA registration, MedAccred certification, ISO 14001 certification and Japan health ministry accreditation
• Mature global quality management system
• Best in class new product development, engineering, validation, automation and sterilization services
• Tool design and build, injection molding and device assembly, kitting and packaging
• Manufacturing environment: ISO Class 7 and Class 8 clean rooms, air-conditioned and white rooms
• Global sourcing and supply chain management capability
• Exports to mature markets from over a decade

For more information, please visit www.smcltd.com or email manoj.bhardwaj@smcltd.com.