Medical DeviceQualified Supplier Directory

BIT Group

6 Thomas
CA  92618  us
Tel: (949) 238 1200
Fax: (949) 231 5028

BIT Group is the leading global resource (US, China, Japan, Germany, France) for development, manufacturing and service of IVD, medical and life science instrumentation. Our range of white-label instruments as well as the modular BITSMARTSOLUTIONS™ proprietary platform architecture enable rapid path to market solutions for our global clients. BIT Group is FDA registered as well as ISO-9001 and ISO-13485 certified.

Contract Manufacturer of In Vitro Diagnostic (IvD) Instrumentation

BIT Companies are the leading contract manufacturers of complex and In Vitro Diagnostic Instrumentation for the OEM medical, clinical, diagnostic, and bio-technology markets.

With 35+ years of experience and design engineering specialties in the areas of Clinical Chemistry, Immunology, Molecular Diagnostics and Hematology, BIT Companies design and develop IvD instruments and systems from concept through manufacturing and after-sales support. Whether it is a point-of-care instrument or a complex, large-scale clinical laboratory analyzer, BIT Companies excel in design, efficiency, precision and speed to market.

Customers benefit from the synchronized collaboration of the globally integrated BIT Companies located in USA (MA&CA), Germany, France, China & Japan. In addition, BITSMARTSOLUTIONS technology, which utilizes a vast library of pre-existing, proven engineered hardware and software, further enhances efficiency of cost and manufacturing and reduces production time.

BIT Companies adhere to the highest quality standards according to ISO 13485 / 9001, QSR compliance, and are FDA registered.

About BIT Companies

BIT is a full-service contract manufacturer providing product development, contract manufacturing, and after-sale service for medical devices and complex in vitro diagnostic instrumentation. BIT Companies include:

> BIT Analytical Instruments GmbH (Schwalbach / Germany)
> BIT Group USA, Inc. (Ludlow, MA / USA)
> BIT Group USA, Inc. (Irvine, CA / USA)
> BIT Group USA, Inc. (San Diego, CA / USA)
> BIT C2 Diagnostics (Montpellier / France)
> BIT Technologies (Kunshan / China)
> BIT Japan (Tokyo / Japan)

In addition to our multi-national facilities in USA, Germany, France, China, and Japan, BIT is part of the financially-strong, globally-situated Messer Industries which has helped to propel BIT in becoming a world-wide force in the development of IvD Instrumentation.

BIT employs nearly 250 engineers, managers, technicians and assembly staff and we assemble thousands of instruments annually for a full range of applications.

We can deliver full systems, manufactured within our global production facilities, or supply quality sub-modules for final assembly. This approach is optimized not only by today's technology, but also by BIT's efficient KAIZEN quality and process management, and international savvy. As a fully-synchronized company, we provide:

  • Single source solution services; product development, manufacturing, after-sale service
  • Contract manufacturing of medical instrumentation and medical devices
  • Quality standards;ISO13485, ISO 9001, QSR compliant, and FDA registered
  • Global operations and supply chain management
  • Value engineering with integrated cost management
  • Messer World ownership, providing the financial stability of broad-based global corporation
  • Worldwide production facilities in US, Europe, and China
  • International logistics experience and capabilities to manage your production needs
  • Flexible global manufacturing leveraging your markets and margins
  • Proven expertise in global quality and regulatory standards

Platform Technology and BITSMARTSOLUTIONS

With the development process time measured in years, and the average cost in the millions of dollars, customers are eager to "fast-forward" their projects by repurposing fundamental, proven technology in the shape of existing, validated platform modules.

Platform modules are previously-designed, developed components that have been tested, proven, certified and used in other IvD systems over time. They are composed of selections from a portfolio of existing hardware, electronics and software systems that can be scaled upward or downward to suit the purpose. All of the components comprising the platform module were specifically designed for operation within a complex medical diagnostic instrument and all systems were developed on the lowest level possible to allow for the highest vertical and horizontal integration.

Some platform modules are common and often used either in different types of analyzers (such as rotor drives, robotic units, temperature controls, etc.) or within one type of analyzer (such as detection units or user software modules). Thus, a set of platform modules providing standard and off-the-shelf solutions is preferable. However, there are different requirements even within one type of analyzer. For example, rotor sizes vary due to different assay packaging dimensions (different bottles, reagent packs) or variable throughput or "walk away time" requirements. Therefore, just employing a single module for different customer projects may not always be an option. Typically, a high level of modularization usually leads to some over-engineering, with features being included (to maintain modularity) that are not always required. In such cases, it is possible for unnecessary cost to be incurred.

To overcome this challenge, and keep the costs to a minimum, we take "one step back," developing autonomous sub-modules (ASMs) – also known as BITSMARTSOLUTIONS – that are independent of such varying requirements. Examples of BITSMARTSOLUTIONS are:

  • Linear drives
  • Multiple axis drives
  • Rotor drives
  • Dilutors
  • Needle plus liquid level detection
  • Mix and wash stations
  • Agitation units
  • Photometer module
  • Microcomputer basic control shell

Taking advantage of these ASMs can typically save our customers up to 25 percent in both time and development costs. More importantly, there is an immeasurable savings during the lifetime of the product due to the fact that the basic foundation of the system is validated and proven robust.