MEDICAL DEVICE INDUSTRY
UPDATE
November 2015
McIlvaine Company
TABLE OF
CONTENTS
Medical Murray Completes of Expansion
BIT Group Establishes Manufacturing Location in China
Millstone Medical Outsourcing Announces Olive Branch
Expansion
Teva Pharmaceuticals, Philips to Invest in Israeli
Medical Device Firms
Raumedic Opens New Plant in Germany
Facility features an additional full service laboratory space
for designing, prototyping, and testing of medical devices.
Medical Murray, a leading medical device development and
contract manufacturing company, proudly announces the completion of their new
and expanded 6,000 square foot facility located in Charlotte, NC.
The new development
and manufacturing facility, located only miles from its previous location,
features an additional full service laboratory space for designing, prototyping,
and testing of medical devices. In addition, expanded manufacturing capabilities
including assembly and inspection of complex medical devices and components,
packaging, and logistics are now offered. Fueled by increased market demands,
the move comes after only two years of Medical Murray opening their first
regional facility.
“We are excited about our facility grand opening and meeting
future market demands by offering additional services to our customers, said
Tanner Hargens, regional vice president. “Using additional local engineering
expertise will also enable us to better serve our customers regionally and get
their innovative technologies to market faster and more cost efficiently.”
To celebrate the building completion, Medical Murray hosted an
open house on October 29 highlighting the new building located at 4508
Westinghouse Blvd., Charlotte, NC.
The open house provided guests the opportunity to tour the
facility and included a presentation on Medical Murray’s new and existing
services. Key team members including personnel from Medical Murray’s corporate
headquarters and manufacturing facility located in suburban Chicago also
attended giving attendees the ability to discuss their latest new and existing
device projects.
“The open house was a great success and provided an ideal
networking venue for both new and existing customers,” said Hargens. “We look
forward to continuing to foster relationships with medical device companies in
supporting our mission of developing complex disposable medical devices to
advance the betterment of patient care.”
Medical Murray is also collaborating with North Carolina
Biotechnology Center to foster growth of the life sciences community in North
Carolina including biotechnology research, business, education, and strategic
policy.
Irvine, Calif.-based BIT Group has established a comprehensive
medical instrument outsourcing manufacturing operation in Shenzhen, China as a
joint venture with Edan Instruments Inc. also based in Shenzhen. While BIT has
operated an ISO9001 certified parts and modules manufacturing facility in China
for several years, this new venture delivers increased capabilities, capacity
and a focus in in vitro diagnostic (IVD) instrument contract manufacturing.
“The Chinese medical technology market is expected to grow at
double digit rates in the coming years,” said Marius Balger, BIT CEO. “Our
newest China facility will allow us to provide our clients with an outsourced
CMS alternative to those which are not focused on the IVD business and lack
experience with system development and system contract manufacturing.”
BIT specializes in contract product development, manufacturing
and after-sales services for life science, medical and IVD instrumentation
original equipment manufacturers (OEMs); Edan is an established company in the
medical monitoring business. By joining forces, both partners remain focused on
core competencies, while providing a dedicated IVD contract manufacturing
solution for OEM’s seeking entry to the China market or for local OEM’s
requiring a transnational company to bridge local domestic needs.
BIT’s global clients
will benefit from the new ISO1385-certified facility through competitive product
pricing as well as Chinese domestic supply of product, lower transport and
import costs, and an expedited regulatory approvals process within the Chinese
market. BIT will offer contract manufacturing IVD solutions from this new
facility to its clients globally.
Millstone Medical Outsourcing announced that the company has
secured an additional 120,000 square feet in Olive Branch, MS. Now totaling over
270,000 square feet, Millstone's Olive Branch facility has added the capacity
required to meet the high demand of controlled environment warehousing space.
"This expansion gives us the opportunity to grow in parallel
with our customers," says Karl Neuberger, President of Millstone MS. "Two and a
half years ago we were operating only 46,000 square feet of space. The growth of
Millstone the past few years has been tremendous and we are excited to continue
on this upward trend for years to come."
This marks the second expansion for the company in 2015. In Q1
of this year, Millstone completed a 40,000 square foot expansion of their
headquarter facility in Fall River, MA, bringing an additional 10,000 square
feet of Class 10,000/ISO7-rated cleanroom capacity to the location. The company
is currently completing validations and the cleanroom will be ready for
production in Q4.
Teva Pharmaceutical Industries Ltd. and Philips are together
investing up to 100 million shekels ($26.5 million) over eight years in medical
device and health technology start-ups in Israel.
The joint venture, called Sanara Ventures, said it had already
invested in two companies: Kaleidoscope Medical, which has developed a system
for X-ray radiation shielding during catheterization procedures; and MGD, which
is creating a portable device for measuring lung function in patients with
Chronic Obstructive Pulmonary Disease.
Sanara Chief Executive Assaf Barnea said it had made another
two investments that could not yet be disclosed, and that two or three more were
expected by the end of the year.
Frans Van Houten, CEO of Dutch firm Philips, said: "We see
Sanara Ventures as a strategic way for Philips to tap into new developments in
the health technology industry."
Erez Vigodman, Van Houten's counterpart at Israel's Teva, the
world's largest generic drugmaker, said the healthcare industry is being
transformed as consumers devote more time and money to remaining healthy, rather
than merely waiting to treat an illness.
"That is driving the space. It means we can't confine our
business model to finding a new chemical entity," he said. "We need branded and
generic drugs, medical devices and diagnostic capabilities."
Philips is contributing to a new preventative care business
model with its first HealthSuite Labs co-creation center in the Netherlands.
Opened earlier this fall, the facility is designed to spur digital healthcare
innovation and supports healthcare organizations in the transformation towards
connected and more value-based, patient-centered care models. Healthcare
directors and general practitioners can work together in multidisciplinary teams
with patients as well as clinical, design, digital and business experts on the
co-creation and implementation of integrated care solutions to enhance
self-management and continuity of care for patients.
The company also is collaborating with the regional care
network Zorgnetwerk Midden-Brabant, which represents the Elisabeth-TweeSteden
Hospital (Netherlands) as well as general practitioners, home care nurses,
dietitians and patients in the region. Through the HealthSuite Labs co-creation
center, the organizations are developing a new regional connected health model
for people living with type-2 diabetes –-- the first such model in the
Netherlands.
Under this model, people will be given access to and control
over their own actionable health data. They also will be encouraged to set
realistic personal goals to support them in making decisions that are important
to their health and care management, Philips executives noted in a news release.
In this way, the project aims to enhance self-management for patients with
diabetes and improve their quality of life. Other important goals are to
decrease visits to caregivers, increase treatment and medication loyalty.
“Most of today’s healthcare budget goes to the fast-growing
population of people living with chronic illness,” said Jeroen Tas, CEO of
Healthcare Informatics Solutions and Services at Philips. “The pressure on
global healthcare systems is increasing, requiring them to find alternative ways
of care delivery. At the same time, people want to be more involved in managing
their own health. Together, these factors are shifting healthcare’s focus from
traditional hospital-based, treat-when-sick (acute) models towards prevention
and continuity of care in or near one’s home. Our HealthSuite Labs co-creation
center will help care providers speed up the development and implementation of
new integrated, connected and patient-centric healthcare delivery solutions that
enable these new models.”
Drawing on the effective collection, analysis and sharing of
health data, the solutions developed in the HealthSuite Lab co-creation center
will be enabled by the HealthSuite Digital Platform, Philips’ secure cloud-based
IT infrastructure.
“We want patients to be more empowered to manage their
condition and their health,” said Veronique Holtmaat, director of Zorgnetwerk
Midden-Brabant. “For this we need to improve the collection and exchange of data
that various professionals and patients collect and make that data relevant and
actionable. By working with Philips in the HealthSuite Labs co-creation center,
we gain access to a wealth of know-how plus insight from other stakeholders
across the care continuum and can set the next steps in creating truly
collaborative and patient-centric care delivery.”
Raumedic, a German developer and supplier of polymer-based
components to the medical device and pharmaceutical industries, has officially
opened its €26m technology center at its headquarters in Helmbrechts, Bavaria.
The firm said it was necessary to expand the plant, which has
been its headquarters for 10 years, to make room for research and development,
quality management, laboratory, production and logistics.
More than 21,520 sq. ft. (2,000m2) of cleanroom space,
certified according to ISO 14644 Class 7, now provides the polymer specialist
with the space necessary to continue to grow. Raumedic's new building in
Helmbrechts, Germany, is called Terbium Raumedic can implement new customized
projects at the technology center with a focus on precision injection molding
and fully automated assembly. High-tech system parts are manufactured using
highly automated and economical processes.
Martin Bayer, Chief
Executive of Raumedic, said the €26m was 'an investment in the future' and was
only possible 'thanks to our skilled and loyal employees, who are the heart of
Raumedic'. The firm said the new building would allow it to create another 190
jobs in the coming years.
At the same time, Raumedic is expanding its international
presence with the creation of a new US$27.1m production and technology center in
Mills River, North Carolina, US. It is expected that it will be opened by the
end of this year.
Raumedic was spun off from Rehau in 2004. At that time, the
company employed around 200 people. The firm now has 630 employees worldwide,
exclusively in the medical and pharmaceutical industry. Around 470 people work
at its headquarters in Upper Franconia, Helmbrechts.
Plastikos, a custom injection molder headquartered in Erie,
Pa, recently completed its medical expansion with over 17,000 square feet of
additional space. The new manufacturing cell and
ISO Class 7 cleanroom officially began supporting production
in August.
Plastikos and its sister company, Micro Mold, invested $2
million in brand new medical injection molding machines, robotics, and other
supporting auxiliary equipment and purchases. The Class 10,000/ISO 7 injection
molding cleanroom has been designed to accommodate eight brand medical molding
machines. The expansion also includes a separate ISO 7 assembly and packaging
lab, as well as corresponding medical production support departments
(maintenance, toolroom, quality, and general office and meeting room space).
The ISO 7 expansion consists of five injection molding
machines integrated with End of Arm Tooling capabilities vision systems, and
cavity pressure monitoring software. Press tonnages range from 88T to 220T. The
auxiliary room is reserved for downstream assembly and secondary operations
(i.e. pad printing, ultra-sonic welding, etc.).
The separate gowning area is approximately 100 square feet.
Here, workers don the appropriate required cleanroom specific garments
(full-length ankle-to-neck cleanroom gowns, hair nets, beard nets, boot covers,
etc.) before and after they enter the cleanroom.
The Plastikos housekeeping team continually cleans the
cleanroom space every day, and the company states that its actual particle
counts throughout the cleanroom register significantly below the ISO 7
requirements. They meet or exceed
medical device manufacturing best practices and general good manufacturing
practices with respect to specific, proprietary cleanroom protocols.
McIlvaine Company
Northfield, IL 60093-2743
Tel:
847-784-0012; Fax:
847-784-0061
E-mail:
editor@mcilvainecompany.com
Web site:
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