|
Mr.
Manoj Bhardwaj
Managing
Director
SMC Ltd., Bangalore |
Manoj Bhardwaj
is a Polymer Engineer having four decades experience in
manufacturing and service industries.
Manoj has worked in thermoset and
thermoplastic polymer compounding, polymer processing and
equipment manufacturing industries in various technical
and commercial roles including leading companies like
Windsor, Bright Brothers and Multibase, a Dow Corning
company.
Manoj has also worked in business
leadership positions in Consulting and IT Services
including like Satyam Computer Services and Tata
Consultancy Services.
Since 2012, Manoj is the Managing Director
of SMC Medical Manufacturing, a subsidiary of SMC Ltd.
headquartered in US. Manoj is responsible for SMC’s India
business and operations and has spearheaded the rapid
growth of SMC India. |
Abstract
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:
-
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