BIT: 43 Years of Reliability and Manufacturing Excellence
Proven Dependability Through Lasting Partnerships
Contract manufacturing is in BIT’s DNA. Founded in 1976, BIT began the journey as a medical device contract manufacturer in Frankfurt, Germany. Notably, Behringwerke Marburg, now known as Siemens Healthineers, was BIT’s first client. Together Siemens Healthineers and BIT manufactured a pistol-grip vaccination gun, a device used to vaccinate large numbers of people in a short amount of time compared to traditional methods. Since the time of that inaugural partnership, BIT has manufactured over 190,000 instruments for a wide range of clients in the IVD industry and has over 35,000 laboratories utilizing BIT technologies.
BIT’s global footprint spans 3 continents, providing 130,000ft2 of manufacturing space in Germany, USA, and China. This international presence creates an avenue for BIT to serve clients locally and globally with the best-centralized production strategy based on their individual needs. To this day, all manufacturing facilities continue to focus exclusively on medical equipment; varying from hematology, through staining to molecular products. At each location, our focused experience and distinct capabilities allow for any manufacturing mix, ranging anywhere from low to high complex instruments with the ability to produce in low to high volumes.
BIT’s Manufacturing Philosophy Increases Efficiencies and Reduces Your Time to Market.
Throughout our 43-year tenure in the medical device and IVD industries, BIT has gained an acute understanding that a “manufacturing mindset” is imperative to a project throughout the entire lifecycle. BIT’s process flexibility allows for clients to come to us regardless of what stage their project is in. Whether you have utilized our R&D services to create an innovative and cost-effective design or are coming to us with an established design ready for transfer; our team of engineers, scientists, and manufacturing experts create the best action plan to bring your product to life effectively and efficiently.
From the time your project begins at BIT, our supply chain specialists begin working with our team of engineers to determine the best plan of action to take in order to start assembling as soon as possible. Our global supply chain correlates with all BIT facilities and surrounding areas in Europe, USA, and China assuring the highest quality parts at the lowest competitive market prices.
BIT’s global production system is based on our “Quality First” approach in which we incorporate lean production methods that utilize continuous improvement processes such as Kaizen and Value Stream Analysis. Kaizen and VSA play a major role in lean activities to remove waste and create additional value for our clients. Our Kanban-supermarket style scheduling system assures the production line has the proper amount of inventory at all times, reducing production downtime and overflow of excess parts. It is through these types of processes that BIT has been able to achieve 98% on-time delivery to our clients year after year.
Today, all manufacturing facilities continue to be 100% focused on the production of laboratory and clinical automation devices. With an in-house regulatory team and all manufacturing facilities operating under ISO 13485, FDA, and Japanese MHLW certifications, BIT can assure our clients that they are planning for and achieving all relevant regulatory requirements. In unison with the regulatory team, our quality assurance team provides confidence that your instrument is fulfilling all quality requirements every step of the way.
Do you have a plan in place for after-sale services and obsolescence issues that may arise?
Globally, BIT’s certified technicians service over 1000 units a year, covering depot repair service as well as field service for complex IVD instruments made available in Europe and the US. BIT also supplies spare part fulfillment and preventative maintenance plans, along with the refurbishment of instruments and subassemblies. Additional offerings include the creation of service manuals and service training to designated client technicians. To further continuous improvement in the service sector, BIT launched an innovative Augmented Reality (AR) Service Application to create a platform for improved training techniques and optimizing in-field servicing.
When your company chooses BIT’s service for your products you gain access to our entire team of design engineers, manufacturing engineers, and global supply chain. We provide continuous support; helping to quickly address many issues such as obsolescence and design improvements to maintain longevity and extend the life of your product in the market, as well as realizing cost-optimizations.
Are you a company in the field of in-vitro diagnostics looking for a certified, reliable manufacturing partner with experience with high complex instruments?
At BIT we continue to research, develop and manufacture innovative medical diagnostic devices for our partners to improve and save lives. Every year we manufacture and deliver over 6,000 complex automated testing instruments to our clients. In 2019 alone, 10 projects will be transferred to manufacturing, expanding our existing list of clients globally. With broad experience in manufacturing product complexity and volume ranges, our dedicated team can tailor the best production strategy for any medical device in the field of IVD and life sciences.
Click here to contact our global experts and discuss your instrumentation manufacturing, service or development needs. Regardless of what stage your product lifecycle is in, BIT is your turnkey solutions provider.