DESIGN & DEVELOPMENT
More than 45 years of outstanding work for medical, in-vitro diagnostic, and life science clients globally
We design and develop products in three R&D centers located in Europe and USA, serving clients in IVD, medical, and life science markets. Our processes are FDA QSR and ISO 13485 compliant to make global distribution for you as comfortable as possible. Our proven development and project processes always guarantee you transparency to evolve your product successfully to the current and future market needs. Such a guarantee is especially important since every project is agile and requires consistent, particular attention in our VUCA environment. Having production also under the same roof allows for immediate collaboration with operations right from the start to ensure “ready for manufacturing” and seamless transfer to internal production.
OUR SERVICE OFFERING
Feasibility Studies
We rapidly evaluate your prototype or early-stage IP to ensure clinical safety, technology functionality, and the identification of potential regulatory hurdles. This will provide confidence to your existing shareholders and encouragement for potential new investors.
Proof of Concept
We offer rapid prototyping services utilizing e.g., in-house 3D printing technologies to fabricate scale models of components, systems, and devices to proof technical concepts as quick as possible.
Pre-Developed Solutions
We can utilize robotics, optics, fluidics, electronics, and software pre-developed and pre-tested subassembly packages to reduce your development costs and accelerate time to market.
Design for Manufacturing (DFM)
We provide tailored Design For Manufacturing (DFM) services for our clients. Designing parts, components, or products for ease of manufacturing and service leads to a cost-efficient product and reduced field service intervention.
Full Systems Development
We turn your ideas or prototypes into reliable, competitive, and compliant medical devices. Our project team consists of interdisciplinary experts in systems engineering, robotics, electronics, fluidics, software, chemistry, and biology.
Project Management
We collaborate closely and transparently with our partners right from the start of the project. Our experienced project managers provide weekly reports to early identify and mitigate risks, ensuring the project gets delivered on time and budget.
Integration and Verification Testing
We procure, build, and test the engineering and verification prototypes all under one roof to ensure the product meets the specific requirements of the defined instructions.
Regulatory Consultancy
Our in-house regulatory team provides guidance throughout the whole project. By supporting our clients in preparing all necessary documentation, we ensure a streamlined submission process and reduction of reworks.
Product Market Assessment
We evaluate the technical fit and existing cost structures for our clients to be commercially successful.
OUR TECHNICAL CAPABILITIES
System Architecture Design   •   Industrial Design   •   Mechanical Systems Design (Robotics & Dynamics)   •   Software and Firmware Design   •   Electrical Hardware and Controls Design   •   Optics and Imaging Systems   •   Fluidics and Microfluidics   •   Temperature Control and Thermal Management   •   IoMT (Internet of Medical Things) and Cloud Connectivity   •   Interface Design and Software (Tablet, Smartphone, Computer)
OUR FACILITIES

Germany

  • Contract development and manufacturing of medium-large IVD instruments
  • 86,000 ft2 and ISO 13485 certified

United States

  • Contract development and manufacturing of small-medium IVD instruments
  • 29,000 ft2 and ISO 13485 certified
Examples of Our Work
Multi Array Xplorer 45k

• Bench Top ELISA Allergy Analyzer
• Client: Macro Array Diagnostics
• Design, Development, Manufacturing, After Sales Service by BIT

Molecular Diagnostics System

• Modular Molecular Diagnostic PCR System
• Client: Large European Food and Beverage Company
• Feasibility, Design by BIT

Miro Canvas

• NGS Library Prep Genomic Platform
• Client: Miroculus
• DFM, Manufacturing, After Sales Service by BIT

Alethia®

• POC Molecular Diagnostics Platform
• Client: Meridian Bioscience
• Design, Development, Manufacturing, After-Sales Services by BIT

Hybrid-XL®

• Automated Bench Top Immuno-assays Analyzer
• Client: DRG Instruments
• Design, Development, Manufacturing, After-Sales Services by BIT

LISTEN TO OUR CUSTOMERS
CH
Christian Harwanegg
Macro Array Diagnostics
CEO

We have been working with BIT since early 2016 and have just started our third IVD instrument development project. Having the guidance of an experienced team with very little turnover, the uncertainties of automation development become manageable for an application-driven startup company. BIT has also maintained our aggressive time-to-market schedules and design-to-cost constraints. This is of equal importance of BIT having all functions from instrument design to field service under the same roof and management.

EB
Eric Van Bladel
DRG International
COO

Our strategic partnership with BIT began when our company decided to expand from selling strictly consumables to include a fully automated diagnostic instrument. Not only did BIT take point in the design and development of our instrument, but the team successfully transitioned it into a full production project and later made incremental hard and software improvements based on feedback from the market. The senior management team at BIT was and continues to be very flexible, supportive, and pragmatic in their decision-making process as we collaborate with them. Although they are part of a multibillion-dollar conglomerate, they have the flexible thinking of a medium-sized company. Their senior management team, therefore, remains actively involved in key decisions which is critical for us.

JK
Jeffrey A. Klein
HK Surgical
CEO and President

One of the biggest advantages for us is BIT’s global presence because we have access to the expertise of their global talent. BIT’s access to its global supply chain has provided HK Surgical with a new, “best-in-the-market” product while meeting our demanding budget requirements. BIT’s client-centric approach and focus on our individual needs also provide us with flexibility and confidence that we will continue to grow internationally. The successful association between HK and BIT continues to support our position as a market leader.

GG
Dr. Claus Prümper
Siemens Healthineers
Franchise Lead Plasma Proteins

BIT and Siemens Healthineers are looking back on a more than 40 Years successful partnership. I experience this cooperation as a true team approach with a forward-leaning attitude and absolute commitment to ‘deliver’ – be it physical or on project goals. Thanks to our joined focus on quality, we have been able to serve our customers extremely well and through this could establish a solid and respected market position in many diagnostic segments.

WORKING ON A NEW MEDICAL DEVICE?
Mona Elkebir
Mona Elkebir
Vice President
Commercial Operations
irvine, USA