Process Management

Product Development

At LBT Innovations, we have proven experience managing the end-to-end product development process from initial innovation, through to proof-of-concept, commercialisation and sales. Our history is founded on identifying the unmet need and bringing new technologies to market.

With MicroStreak, LBT’s first invention, and the APAS® Independence (our second), we managed the process of taking a product to market and delivering sales. Understanding the key steps in product development and navigating the end-to-end process in a regulated environment are key differentiators that set us apart. Throughout this process we have developed internal capability in systems and resources to continue to bring new technologies to market.

End-to-End Process Management

End to End Process management

Innovation to Final Product

Our dedicated engineering team have proven capability taking new idea’s, through proof-of-concept, to final product development. We understand the process of transforming early stage research into a product that meet’s the user’s unmet need.

Medical Device Software

We understand what is required to develop medical device software (IEC 62304). Our people are experienced in software engineering and we have mature quality management systems to support medical device software development.

Clinical Trials

We are experienced in managing clinical trials and In-Vitro Diagnostic studies as part of the product development process.
For our APAS technology, we completed a 10,000-patient, global clinical trial demonstrating the performance of the instrument.

Regulatory Know-How

A key part of bringing a medical device to market is understanding the regulatory requirements for your product and having a strategy to navigate these. At LBT, we have extensive experience commercialising new technologies across a range of geographies (e.g. FDA, CE, TGA).

Patented Technology

We understand the importance in maintaining a strong patent position for new technologies.
Our APAS technology is underpinned by a suite of patents that covers both the image capture device and the AI algorithm for analysing microbial growth.

Commercialisation

Commercialising new medical technologies and understanding the path to market is key to successful innovations. We have a committed global sales team dedicated to bringing our technologies to market and managing our distributors.

Dedicated Lab Facilities

LBT operates a state-of-the-art laboratory dedicated to the development of APAS®  products. The laboratory consists of a fully functioning microbiology capability, as well as hosting engineering activities. The laboratory is designed to PC2 standards, and boasts a large collection of wild and reference strains used for development activities.

Level 1
28 Dalgleish Street
Thebarton, South Australia, 5031
Australia