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Research and Development

Research and Development

Ideas need more than just courage. They need BIT.

A think tank that you can
trust to deliver

We help you turn your idea into a market-ready medical device: Fast. Reliable. Scalable.

Regulatory requirements, technical complexity, and time constraints make development a real challenge, especially when it comes to scaling up quickly without running into regulatory roadblocks. That’s exactly where we come in. BIT supports you from the initial concept. We bring over 50 years of experience in medical technology and laboratory automation to the table. And the drive to turn your vision into reality.

Partner, not supplier

We work alongside you, challenge when it matters, and bring the ideas that move your product forward.

Long-term vision shortens TTM

We’re in it from day one. That means more realistic timelines, and less regulatory roadblocks that cost you.

Scalable design

We develop your product ready for manufacturing from the start. So it scales with your success, from unit one to full series.

Regulatory compliance included

Approval is built into the plan from day one, so you never invest in a development that runs into a regulatory wall later.

Research and Development Services

  • Scope Definition: Project scope tailored to your specific requirements to mitigate risk from the outset
  • Feasibility & Proof of Concept: Evaluation of prototypes and early-stage IP for technical feasibility, clinical safety, and regulatory risks
  • Design for Manufacturing (DFM): Development focused on cost-effective mass production and low maintenance requirements
  • Full Systems Development: Interdisciplinary teams spanning systems engineering, robotics, electronics, fluidics, software, chemistry, and biology
  • Project Management: Weekly reporting, early risk identification, delivery on time and within budget
  • Regulatory Consultancy: IVDR, FDA, and ISO 13485 support across the entire project lifecycle
  • Integration & Verification Testing: Engineering and verification prototypes developed entirely in-house
Leistungen

 

Have an idea for a new diagnostic or laboratory device?

Let’s turn it together into reality.

“As a diagnostics start-up, PhAST had little room for error during the development of our first product. I am extremely pleased BIT as our partner on this endeavour; their strong team executed our project under budget and without delay. I look forward to our future work together.” 

– John (JT) Sauls, CEO PhAST

Your Questions

Depending on complexity, between 12 and 36 months from concept to market-ready product. We work in agile, transparent project phases, and provide weekly status updates throughout.

We not only understand the regulatory requirements during development, but also adhere to them in our daily work without unnecessarily complicating projects.

The most complex devices are built where multiple disciplines come together. Our teams combine mechanics, fluidics, electronics, optics, embedded software, automation, data analysis, and regulatory expertise. All under one roof.

Any questions? We’re here to help.

Konstantin Christou
CTO

Get in touch now
Ansprechpartner Konstantin Christou