Our Instrumentation Expertise

The experience and support that partners engaging with STRATEC require varies widely depending upon their experience with and knowledge of instrument development. STRATEC begins each partnership working with the partner to diagnose the services and solutions it can deploy to assure the partner’s success.

Working together with its partners, STRATEC analyzes the specific requirements of the target market, the application at hand and the work processes of laboratories and end users. On this basis, it draws up a system architecture concept and, where necessary, the associated reagent concept.

By undertaking technical risk assessments of preferred proposals, STRATEC then performs suitable feasibility studies to ensure that implementation of the subsequent development project involves minimum risks.

These advisory services mean that both STRATEC and its partners are effectively able to manage risk. Working together, both parties define and develop agreements that minimize financial exposure and address resourcing requirements at a very early project stage.

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.

While system development work is primarily focused within the company headquarters in Birkenfeld, Germany,  system production takes place in both Birkenfeld and Beringen, Switzerland, dependent upon the manufacturing challenges in terms of scale and complexity. Our Beringen and Birkenfeld facilities provide additional services across the group and to our partners such as spare part supply and repair service. Both locations are certified under ISO9001 and ISO13485, are FDA-registered and are regularly audited.

STRATEC’s proven production strategy involves outsourcing a major share of actual production work, including relevant test processes, to suppliers of modules that are supervised, certified and regularly audited. STRATEC then assembles the specific components and completes final system assembly and subsequent acceptance tests, including wet tests in the laboratory.
Production processes at STRATEC’s module suppliers are validated in detail, thus guaranteeing consistently high quality levels that satisfy partner standards and the regulatory requirements imposed by the respective authorities.
This manufacturing strategy allows STRATEC to manage manufacturing risks and produce the highest quality systems at the most competitive prices.

STRATEC also supplies its partners with the necessary consumables, maintenance and spare parts, and offers a repair service for high-value components.

STRATEC offers its partners all of the support needed for the entire lifecycle management of the products it supplies. This involves third-level support for instruments already operating in the field, including complaint management, technical support for field service, and error analyses for complex problems. STRATEC also works together with its partners to account for changes in market and regulatory requirements which may affect product features.

Lifecycle management also includes continuous production improvements and modifications resulting from discontinuation of modules and components. STRATEC cooperates with its partners to utilize progress in production processes and implements value engineering projects to make this progress available for existing product lines.