Spanning the entire instrumentation value chain, STRATEC consults, designs, develops and produces fully automated solutions for its partners in the fields of diagnostics including Blood banking. We develop and combine new and proven technology to maximize the performance of our partners’ reagents and create market-leading diagnostic systems. For that purpose, we explore new options, enhance existing systems and ensure that their technology is always at the leading edge of current developments and industry best practice.
To meet the global norms and requirements of the IVD industry and regulatory authorities, we support our partners in obtaining approval for the relevant markets.
Our commitment continues while the system is in series production, with us assuming responsibility for much of the costs associated with ongoing concurrent engineering and support.
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
- Embedded software
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.
Over the last 40 years, STRATEC has built market-leading expertise and a technology pool that is unique to its industry. This enables its partners to benefit from large numbers of existing components and thus substantially shorter development cycles. This invaluable expertise is supplemented by a broad intellectual property (IP) portfolio that is continually extended by innovative new developments.
The large number of existing patented components and technologies forms the basis of the modular construction of most of STRATEC’s systems. This enables rapid system development at a low technical risk for partners, while guaranteeing “freedom to operate” in many areas. Protecting and safeguarding the exclusivity of its partners’ existing intellectual property rights represents a fundamental principle of STRATEC’s collaborations.
STRATEC’s outstanding technological competence covers the fields of hardware (including liquid handling systems), automation and user interfaces, as well as electronics development (including process monitoring systems and distributed architectures). This not only significantly reduces development times, but also improves the servicing process and costs for systems in the field.
By focusing its software development on usability and workflow, STRATEC aims to make highly complex applications easy and transparent for its users, whether they are end users or service engineers.
The wealth of experience acquired over the years in developing complex systems has enabled STRATEC to devise high-performance tools to ensure that development work is consistent with regulatory requirements. These range from documentation and workflow systems, to testing tools and reliability growth models. This established infrastructure is subject to ongoing optimization and allows STRATEC’s developers and the company’s partners to channel all of their energy during development into the needs of the specific project – and thus collectively succeed in achieving their respective targets.