Startups - Medical Device Design

WE DEVELOP
AND MANUFACTURE
IVD AND
MEDICAL DEVICES
FOR START-UPS

When time matters and results count,

we are your partner of choice.

DISCUSS YOUR PRODUCT WITH US

what are your challenges?

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You have a prototype or early-stage IP?

Do you have limited internal resources to transition your technology to an automated device?

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You need to Meet Regulatory Requirements?

Are you being challenged by an increasingly complex regulatory environment and you are missing in-house regulatory processes?

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You need to provide confidence to investors? 

Do you need proof of concept to secure further development funding and to maintain positive cash flow?

THIS IS HOW WE CAN help YOU

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Leveraging Pre-Developed Solutions

We leverage our IP to reduce development costs and to achieve a short time to market cycle.

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Providing Regulatory Intelligence

Our in-house regulatory team provides guidance to assist you in achieving all local relevant regulatory requirements and can also support a future shift into the global market.

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Challenging the Business Plan

We evaluate the product-market fit and existing cost structures for our partners to be commercially successful.

CLICK HERE TO MAKE IT HAPPEN

BUT DON’T TAKE OUR WORD

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.

Christian Harwanegg

Macro Array Diagnostics

CEO

We have been working with BIT since early 2016 and 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.

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.

TALK TO OUR EXPERTS

OUR COMPETENCE WILL BOOST YOUR CONFIDENCE

Turnkey Solution

We design and develop your products with a manufacturing mindset to get you to market faster with the highest quality in mind.

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ISO 13485 certified

All our documentation and processes are FDA QSR and ISO 13485 compliant and built to help you through FDA (e.g., 510K or PMA), CE-marking, CSA, and JPAL approval.

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45 years of experience

We experience long-lasting relationships with large global partners, well-established small-medium enterprises, and innovative startups.

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Expertise in Different Markets

We are specialized in IVD, Medical Devices, and Life Sciences instrumentation innovation.

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Global Supply Chain

Our efficient, flexible, and regulatory compliant supply chain with selected vendors is developed based on our global footprint to ensure the lowest material costs and shortest lead time.

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Financial Strength and Stability

We are a Messer Family Company - a German family-owned business with annual revenue of $4 billion.

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LET'S DISCUSS TODAY

BIT Analytical Instruments GmbH

Am Kronberger Hang 3

65824 Schwalbach

Germany

Phone: +49 6196 806 100

connect with us

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BIT is your design, development, manufacturing, and service outsourcing partner for high-performance analytical IVD, medical, and life science devices.

From a revolutionary product idea to your products in hospitals and laboratories, we have all the right ingredients to be at your side for the lifecycle of your diagnostic devices. We work with promising innovative startups as well as world-leading corporations in Europe and Asia. Our mission is the same as that of our valued clientele—to improve the quality and delivery of health care.

We optimize time-to-market, total cost ownership, and provide complete lifecycle support for analytical IVD, medical, and life science devices. Collaborating as “ONE BIT” with state-of-the-art R&D and manufacturing excellence centers in Schwalbach (Germany), Montpellier (France), and Kunshan (China) allows us to serve our clients where they need us.