The BioTex Difference

BioTex is both FDA registered and ISO 13485:2003 certified. By employing modern collaborative tools, our skilled team of program managers, engineers, and scientists can serve as a versatile extension of our partner’s own project team. Using our in-house knowledge, extensive network of global suppliers, and vertically integrated processes, we help reduce risk and cut development costs while still meeting commercial timelines.

We bring intuitive solutions to complex systems & environments

Our device programs vary in scale and scope. We stand out at solving design and development challenges from lasers and optical fibers, to robotics and fluid management systems, delivering sophisticated technologies that are safe and easy to use despite their complexity.

What sets us apart?

Leadership

Experienced entrepreneurs in design, development and manufacture of FDA-regulated medical products.

Biomedical Knowledge Base

Engineers and scientist with deep skill sets and long-term experience

Design Philosophy

Simplified and intuitive controls to enhance the experience for medical professionals and patients.

Clinical and Regulatory Guidance

Improved strategies with development teams that speak clinical and regulatory language

Viable Path to Market

Guidance from concept to market introduction with deep knowledge and expertise along the way.

Intellectual Property

Generation of value-creating IP which vests with our partner’s business.

Flexible Manufacturing Services

Support from low volume (clinical trial builds) to full-scale commercialization.

Global Component & Assembly Sourcing

The right components at the right price delivered reliably.

Supply Chain Optimization

Reducing suppliers, costs, and logistics, by encouraging value added work at qualified vendors.