Product Development

STRATEC’s product development is an innovation driver both for our partners and for technologies in the industry. The core team for a development project consists of a program manager, system integration specialists, and experienced employees from the core disciplines of:

  • Instrument development
  • Mechanical construction
  • Electronics
  • Embedded software
  • Software
  • Verification
  • Documentation
Given the highly regulated environment in which STRATEC and its partners operate, an employee from the quality management department is also included on the team throughout the entire project.

Working in close cooperation with a partner’s project team and with employees from the partner’s marketing and assay development departments, the project is supervised throughout all of its development stages through to its successful market launch.

The first phase of a typical project involves a specification stage lasting approximately six months. After another nine months, STRATEC produces the first prototypes to test assay integration. Based on the insights gained along the way, after a further twelve months STRATEC produces serial-related evaluation systems that account for all of the learning and measures to date under full change control. These systems then serve for the purposes of generating approval data, performing beta trials, and undertaking initial marketing activities.

In the final production validation phase, STRATEC concludes the overall instrument development stage by helping facilitate the regulatory approval process. The length of time required to gain approval depends on regulatory requirements in the relevant markets. In the EU, for example, an instrument ready for serial production may be launched onto the market after approximately six to nine months.