MEDICAL DEVICE INDUSTRY
UPDATE
June / July 2019
McIlvaine Company
Table of Contents
National Healthcare Photonics Centre Opens in UK
Cogmedix Expands to New, World-Class Headquarters
Pulse Systems Opens New East Coast Development Center
Teleflex Medical OEM Opens Two EPIC Medtec™ Centers
American Durafilm Announces New Cleanroom Expansion
American Durafilm Expands Cleanroom in Massachusetts
National Healthcare Photonics Centre Opens in UK
The Centre for Process Innovation (CPI) in the U.K. has officially opened its
state-of-the-art facility that will help develop next-generation light-based
health care treatments.
Based at NETPark in Sedgefield, England, the National Healthcare Photonics
Centre will support the advancement and commercialization of MedTech products
and provide a hub for businesses and academic partners to work on imaging
systems, innovative methods of diagnosing disease, and light-based treatment.
The two-story building encompasses more than 6500 sq. ft. and includes a suite
of specialist laboratories for optical system development and testing. The
facility also includes space for laser system applications development,
biomaterials handling and testing, ionizing radiation imaging and testing, 3D
printing, and electronics development and pilot manufacturing work.
In addition, the center features client office space to enable companies to
locate onsite and work on projects alongside CPI staff. The infrastructure was
created to enable businesses to drive forward innovative products and services
at reduced risk and with increased capital efficiencies, and to encourage large
companies to undertake more disruptive innovation in the health care market.
According to CPI, the National Healthcare Photonics Centre will provide
facilities and expertise to help companies of all sizes develop their
photonics-based technologies for health care, with an infrastructure to deliver
prototyping, scale-up, and validation of medical devices at the required quality
and consistency to feed into clinical validation studies.
The project officially broke ground on Nov. 10, 2017. The new center received
initial funding from the North East Local Enterprise Partnership as part of the
North East Growth Deal from the government.
Cogmedix Expands to New, World-Class Headquarters
Cogmedix, the wholly-owned medical device product development and manufacturing
subsidiary of Coghlin Companies, is pleased to announce their expansion into an
80,000 square foot, world-class facility located in West Boylston, MA.
The new single-story headquarters will be occupied by nearly 200 Caring
Associates and has been custom designed to support the unique and flexible
requirements of rapidly growing medical device innovators seeking a partnered
sourcing strategy deeply focused on compliance and rapid time to market. The
facility features multiple engineering and laser labs, vast certified cleanroom
space, multiple training areas, and a dedicated customer convenience center
fostering transparency and collaboration.
“We are so fortunate to be geographically located in the heart of one of the
world’s most treasured medical device innovation areas,” stated Chris Coghlin,
President and CEO of Coghlin Companies. “Our new facility allows for significant
growth and opportunity and will undoubtedly drive deeper collaboration and
efficiency in all areas of our business as we remain passionately focused on a
positive, compliant and efficient workplace culture.”
Cogmedix will continue to occupy manufacturing space at 17 Briden Street in
Worcester and welcomes Massachusetts Biomedical Initiatives (MBI) as a new
tenant who will develop up to 25,000 square feet of world-class incubator and
lab space for life science startup companies.
Pulse Systems Opens New East Coast Development Center
California-based medical industry supplier adds Marlborough, Mass. prototyping
facility to service the Eastern U.S. market
Pulse Systems has recently announced the opening of a new East Coast Development
Center facility in Marlborough, Mass. Pulse Systems currently provides prototype
and production support to customers worldwide from its facilities in Northern
California. This new facility in the Boston suburbs will provide medical device
designers in the Eastern U.S., particularly those in the Northeast, the
opportunity to explore manufacturability options at a local facility, and to
quickly produce prototype and low-volume laser-cut parts to facilitate their
development projects.
"Our medical device contract manufacturing business is strong, and we have
decided to increase our commitment to the expanding East Coast customer base by
adding this new Development Center in the Boston area," said Herb Bellucci,
president and CEO of Pulse Systems. "Our West Coast operations, located in the
San Francisco Bay Area, have been very successful in reaching the medical device
manufacturers and developers in that region and beyond. With this new location,
we're expecting to replicate that model in the Eastern half of the country as
well."
The new East Coast Development Center facility is managed by medical device
industry veteran, Bob Lamson, who joined Pulse Systems as Director of Sales for
the Eastern U.S. in 2015. Prior to joining Pulse, for the previous 20 years
Lamson had held senior-level management positions with industry suppliers
TechDevice and MicroGroup, and is well known in the East Coast medical device
manufacturing community.
Commenting on the Company's new Massachusetts operation, Lamson noted, "We
recognized the opportunity to provide local service to our East Coast customers.
The Marlborough Development Center will be starting out as a regional sales and
customer support office, and by the end of this year, we will be fully equipped
and staffed to operate as a low-volume, quick-turn prototype facility for laser
cutting of tubular components on behalf of medical device customers in the
Eastern U.S."
The Marlborough facility is strategically located for easy accessibility near
the junction of the Massachusetts Turnpike and Interstate 495, within a one-hour
drive of medical device developers and researchers from four states, and 40
miles west of Logan Airport in Boston.
Teleflex Medical OEM Opens Two EPIC Medtec™ Centers
Teleflex Medical OEM, a leading provider of medical device development and
manufacturing services, announces two state-of-the-art EPIC Medtec™ Centers
located in Mansfield, Massachusetts and Maple Grove, Minnesota. These facilities
bring together expert engineering talent and extensive, integrated capabilities
to enable clients to develop market-ready devices, reduce technical risk, and
get the devices to market faster. Most device development can be accomplished in
a few days instead of the weeks, months, or years required by traditional
methods.
The EPIC Medtec™ Center (Engineering, Prototyping, Innovation, Collaboration) in
Mansfield focuses on the development of sutures and performance fibers, while
the Maple Grove center is dedicated to catheter and access device innovation.
Teleflex Medical OEM already operates a third EPIC Medtec™ Center, focused on
catheter and access devices, in Limerick, Ireland.
The facilities utilize the multi-stage IDEA Medtec™ Process (Innovation,
Development, Engineering, Accelerator) that incorporates a client’s requirements
into a device. New product ideas can be explored, prototyped, and tested
on-site. Design for manufacturability is emphasized at each step of the process.
Guess work is virtually eliminated since decision-making is data-driven via
Teleflex Medical OEM’s proprietary analytic tools.
The smartly configured floorplans of the EPIC Medtec™ Centers were carefully
planned to promote innovation in a collaborative environment. Everything is in
place to move a device from concept to production-ready device. There are
immersion labs for concept development, design engineering, and demonstrative
prototyping and testing. Amenities such as a video conferencing center and 3D
printing studio are also available.
American Durafilm Announces New Cleanroom Expansion
America’s Most Experienced Solutions Provider for High-Performance Films,
Coatings, and Tubing Doubles Cleanroom Capacity
American Durafilm Company, Inc. is excited to announce the completion of another
expansion project that took place at its Holliston, MA facility earlier this
year. Adding to their original 1,000-square-foot cleanroom, American Durafilm
has finished construction on an entirely new cleanroom, which now claims its own
750 square feet of space. Both rooms are certified to class 10,000/ISO 7 in
accordance with cleanroom standards. The main purpose of both cleanrooms is to
serve as premier heat sealing areas for making bags and assemblies for the most
demanding applications primarily in the biopharmaceutical and semiconductor
industries. The new room marks a huge increase in capacity for American
Durafilm's existing technology and will enhance its ability to take on the
continued growth that the industry demands.
Mack Hendrick, President of American Durafilm, said, "As American Durafilm takes
on rapid growth, it becomes an absolute necessity for us to innovate and expand
our facility to keep up with the incessant demand we've been experiencing. Our
latest expansion just about doubles our cleanroom capacity and the ability to
produce intubated and straight-line sealed bags for our valued customers in the
biopharmaceutical and semiconductor space. As always, we continue to place our
customers at the center of our focus; increasing our capacity is a testament of
our commitment to continuous improvement. "
About American Durafilm:
American Durafilm® Co., Inc., an ISO 9001:2015 certified company, has
more than 70 years of experience in providing solutions for a wide range of
applications requiring high-performance films, coating, and tubing. Founded in
1949 as one of the three original Licensed Industrial Applicators of Teflon®
brand coatings, over half a century later, the company remains a leading
solutions provider of ultra-high-performance materials, coatings, and films,
including Kapton®, Teflon®, and Tedlar®, as
well as FEP rollcovers. Its Duralok™ technology offers the first and only
resealable FEP and Kapton® bag.
American Durafilm® can fabricate high-performance films to customer
specifications, including processes for thermoforming, heat sealing, and die
cutting. The company is well known for its responsive service and high-quality
products, having received numerous awards from commercial and government
customers for on-time performance and overall quality. Major functions of
fabrication, including heat sealing and assembly work, can be performed onsite
in its updated ISO 7/Class 10000 clean room facilities. In addition, American
Durafilm® manufactures seamless polyimide tubing in ID sizes ranging
from 0.005 inches up to 2.50 inches. The Tubing Division provides laser
machining, cut to length, necking, flaring, tipping, thermoplastic jackets,
re-flow, and sub-assembly services.
American Durafilm Expands Cleanroom in
Massachusetts
The addition of 750 sq.ft. of ISO Class 7 cleanroom will increase the company’s
heat sealing areas for bags and assemblies in the biopharma and semiconductor
industries
American Durafilm has completed another expansion project that took place at its
Holliston, MA facility earlier this year. Adding to their original 1,000 sq.ft.
cleanroom, American Durafilm has finished construction on an entirely new
cleanroom, which now claims its own 750 sq.ft. of space.
Both rooms are certified to ISO Class 7 in accordance with cleanroom standards.
The main purpose of both cleanrooms is to serve as premier heat sealing areas
for making bags and assemblies for the most demanding applications primarily in
the biopharmaceutical and semiconductor industries.
The new room marks a huge increase in capacity for American Durafilm's existing
technology and will enhance its ability to take on the continued growth that the
industry demands.
Mack Hendrick, President of American Durafilm, said, "As American Durafilm takes
on rapid growth, it becomes an absolute necessity for us to innovate and expand
our facility to keep up with the incessant demand we've been experiencing.”
Hendrick explained that the expansion just about doubled cleanroom capacity and
the company’s ability to produce intubated and straight-line sealed bags for the
biopharmaceutical and semiconductor space.
McIlvaine Company
Northfield, IL 60093-2743
Tel:
847-784-0012; Fax:
847-784-0061
E-mail:
editor@mcilvainecompany.com
Web site:
www.mcilvainecompany.com