Greatbatch, Inc. manufactures and develops high-quality medical devices and
components primarily for large original equipment manufacturers (“OEMs”),
which depend on us to design, develop and produce reliable, long-lasting, intellectual
property protected medical device technologies. Greatbatch, Inc. acquired all
of the outstanding common stock of Lake Region Medical Holdings, Inc. (“Lake
Region Medical”) creating one of the largest medical device outsource
(“MDO”) manufacturers in the world serving the cardiac, neuromodulation,
orthopaedics, cardio and vascular, advanced surgical, portable medical, energy,
environmental and military markets. Simultaneous with the close of the Lake
Region Medical acquisition, Greatbatch, Inc. also announced its intention to
rename the combined entity Integer Holdings Corporation. Integer is defined
as complete, whole, and comprehensive, and represents the joining of Greatbatch,
Inc. and Lake Region Medical as well as the combined companys product and service
offerings provided to customers.
The Greatbatch Medical segment designs and manufactures products where Greatbatch
either owns or licenses the intellectual property or has unique manufacturing
and assembly expertise, primarily for the cardiac, neuromodulation, orthopaedic,
portable medical, vascular, energy, environmental and military markets. The
Greatbatch Medical segment also offers value-added assembly and design engineering
services for medical devices using, in many cases, our proprietary technologies.
The QiG segment focuses on the design and development of medical device systems
and components through a network of research and development professionals who
drive a diverse portfolio of new and innovative medical product opportunities.
QiG seeks to assist customers in accelerating the velocity of innovation while
delivering an optimized supply chain and critical cost efficiencies. QiG’s
neurostimulation technology platform, which will be owned by Nuvectra after
the completion of the Spin-off, has the capability to provide treatment to patients
in several established neurostimulation markets such as spinal cord stimulation
(“SCS”), sacral nerve stimulation (“SNS”), deep brain
stimulation (“DBS”), and other emerging neurostimulation markets.
The QiG segment is comprised of QiG Group, NeuroNexus Technologies, Inc. (“NeuroNexus”),
and Centro de Construcción de Cardioestimuladores del Uruguay (“CCC”).
The entities included in the pending Spin-off consist of QiG Group and its subsidiaries
Algostim LLC (“Algostim”) and PelviStim, LLC (“PelviStim”)
and NeuroNexus. As an independent publicly traded company after the completion
of the Spin-off, Nuvectra will be focused on the development and commercialization
of its neurostimulation technology platform and, in particular, its Algovita®
SCS system for the treatment of chronic pain of the trunk and limbs (“Algovita”).
The operations of CCC and certain other existing QiG research and development
capabilities will be retained by Greatbatch and are not included as part of
the Spin-off.
We operate our Company in three reportable segments: Greatbatch Medical, QiG,
and Lake Region Medical. As a result of the Lake Region Medical acquisition
and the pending Spin-off, we are reevaluating our operating and reporting segments,
which is expected to be finalized in 2016 once our corporate and management
reporting structure realignment is completed.
We leverage our strength as an innovative designer and manufacturer of finished
devices and components to the medical device industry. Our manufacturing and
engineering services include: design, testing, component production, and device
assembly. We have integrated our proprietary technologies in our own products
and those of our customers throughout the medical device industry. Our flexible,
high productivity manufacturing capabilities span sites across the United States,
Mexico, Uruguay, Europe, and Asia.
Due to the highly regulated nature of the products we produce, we have implemented
strong quality systems across all sites. The quality systems at our sites are
compliant with and certified to various recognized international standards,
requirements, and directives. Each site’s quality system is certified
under an applicable International Organization for Standardization (“ISO”)
quality system standard, such as ISO 13485 or ISO 9001. This certification requires,
among other things, an implemented quality system that applies (where applicable)
to the design and manufacture of components, assemblies and finished medical
devices, including component quality and supplier control. Maintenance of these
certifications for each facility requires periodic re-examination from an independent
notified body.
Along with ISO 13485, the facilities producing finished medical devices are
subject to extensive and rigorous regulation by numerous government bodies,
including the FDA and comparable international regulatory agencies in order
to ship product worldwide. For these facilities, we maintain FDA registration
and compliance to all applicable domestic and international regulations. Compliance
with applicable regulatory requirements is subject to continual review and is
monitored through periodic inspections by the FDA and other international regulatory
bodies.
