R_D Article BIT

BIT: Leaders in Product Development

Innovation is MORE than just inventing new technologies

BIT’s mission is to research, develop and manufacture innovative medical diagnostic devices for our partners to improve and save lives. To do so, we work closely with our clients to fill gaps in the small, mid-size and large sized automation instrument markets. We support instruments that are important for global health, and we know that the market for these instruments are different, compared to consumer electronics or automobiles.

This is why BIT’s sole focus is on the Diagnostics and Medical Device markets

BIT’s Research & Development department consists of three global facilities: Schwalbach, Germany; Montpellier, France; and Irvine, California. Each have a focus on the early phases of the product life cycle, starting with the idea for an automated IVD product and resulting in the successful transfer of the completely verified design to manufacturing. Everything in-between is processed by our global team of more than 150 engineers and scientists on staff, a group of passionate experts with a vast knowledge in a broad variety of technologies.

BIT’s Lifecycle Management Process

At our very first contact we evaluate the best approach to be successful together in building innovative technology that makes sense to our clients and their customers in a manner that accelerates the time to market. BIT’s R&D capabilities allow for us to take on any project at any development stage, whether still in the early concept stages all the way to industrialization and manufacturing transfer. To do that, we balance the best mix of the latest technologies, ready to use modules and the needs for additional features with the added value for you and your clients.

In one such example, recently a client utilized BIT’s in-house expertise to evolve their innovative ELISA based multiparameter allergen testing technology. By capitalizing on BIT’s lifecycle management process and development capabilities, we were able to transition their technology from a prototype to a standalone unit and now additionally offer a fully automated large testing platform. BIT worked with the client to understand their long-term direction and ensure they grew at the appropriate rate with a range of product offerings.

Another opportunity BIT offers clients comes in the form of solutions offerings during the development cycle. BIT can develop bespoke design solutions specific to client unique requirements or utilize robotics, optics, fluidics, electronics and software pre-developed and pre-tested subassembly packages to reduce development costs and accelerate your time to market. With 43 years of experience, BIT turns client ideas and processes into reliable, competitive and compliant medical devices that meet development budgets and timelines.

At BIT, lifecycle doesn’t end with a mechanical and software design transfer, we design for reliability. Our close knowledge of the manufacturing and service process guides our product design thinking. We also speak regulatory. With our inhouse regulatory team we prepare all documentation making sure your product is approved with the FDA and other local regulatory bodies. BIT acts as a consultant as well as a partner to provide guidance for your project through the constantly rising regulatory requirements in the medical industry. We understand most challenges can be managed quickly and efficiently through diligent risk management. BIT makes sure that all processes of the product development lifecycle are well documented; transparent and traceable. It is BIT’s approach to let you know what we know to help you to launch a safe and reliable product to the market as soon as possible.

Experienced and Results Oriented

BIT has a history of 40+ years of success and continues to deliver today. In 2019 alone, BIT plans to transfer 12 product development projects to manufacturing. Ranging from groundbreaking technologies in hematology, allergy, and molecular applications, these instruments will be shaping the future of the markets.

In conclusion, BIT continues to be a driving force of ingenuity and innovation of In Vitro Diagnostics and Medical Devices across the globe. By leveraging a deep history of knowledge, robust processes like our lifecycle management program and utilizing internal resources like pre-developed subassembly design and software packages BIT’s Research and Development team offers a wide range of options for our partners. These opportunities ensure BIT delivers the right design to meet our clients’ needs in an efficient and economical solution.

Are you a company in the field of in-vitro-diagnostic or life sciences looking for a partner with experience in developing automated solutions?

Click here to contact our global experts and discuss your instrumentation needs. Regardless of what stage your product lifecycle is in, BIT is your turnkey solutions provider.

Let’s Build Innovation Together.