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Product development

New skills for better, faster market success

More varieties. Growing software shares. Shorter product life cycles. The development of complex devices and products presents considerable challenges to experienced industries such as medical technology, engineering and plant engineering, as well as the automotive industry. Three factors decide which companies remain competitive: Usability, rapid engineering and minimisation of development risks.

Accelerating product development

The regulatory requirements of developers and manufacturers of medical products are high; they require a lot of time and money. The Zühlke Medical Device Development Process (MDDP) accelerates development and authorisation with proven methods and allows for appropriate tailoring to project requirements.

The authorisation of medical products is bound by comprehensive regulatory requirements of the developer and manufacturer. The legal basis for this within the EU is the Medical Device Directive, in the US the FDA regulates using its guidances. The expense required to satisfy compliance specifications is increasingly a decisive competitive cost factor.

The verification of compliance with these legal requirements is easier if a manufacturer takes the relevant harmonised standards for development processes, risk management and technical procedures into account. Developers or manufacturers of medical products have the option of designing the development processes within the framework of their quality management system. The appropriate harmonised standards provide landmarks for this arrangement. Zühlke has an ISO 13485 certified quality management system.

 

Getting the right idea on the road – systematically

Zühlke teams have been developing medical products for over 40 years. The foundation for many successful product developments is our regularly updated Medical Device Development Process (MDDP), as well as a ISO 62304-compliant software development process, which describes our implementation of legal and normative development requirements. Our MDDP creates the framework for systematic work on the project and provides the necessary flexibility. We employ well-trained employees and experienced project leaders in the development teams.

Using our experience, we develop cost-effective and approval-assured medical products for you, including approval-compliant documentation. We develop and document as required, according to our proprietary MDDP or your company-specific development process.
 

Zühlke accompanies you right through the development process

Focus point 1: Lean compliance

In 40 years of medical developments, we've seen a lot: Companies that overshoot the mark with their processes and documentation for approval and tie up unnecessary resources, as well as companies who don't aim high enough and have to massively reassess their budgets in order to achieve approval. We have a process framework based on this experience, to help you create the appropriate documentation from the very beginning.
The central issue is tailoring processes and a risk-based procedure.

In medical projects, we rely on broad tool support of development activities, e.g. for document management, configuration management and automated regression tests. We have preferred solutions for these different tasks and these are preconfigured according to our development process. Time-consuming activities can be tackled more efficiently with these resources.

Focus point 2: Development process for medical products and medical software
Zühlke employs the Medical Device Development Process (MDDP) for the development of medical products.

MDDP is split into four development phases which reflect the development's increasing level of maturity, as well as the increasing regulatory requirements of the development procedure. Central guidelines in the MDDP allow for project-specific tailoring of individual activities and the scope of documentation in these process phases. Consideration of project risk is always the basis for this tailoring process. This gives us the flexibility to realise projects at appropriate expense.

Concrete instructions (standard operating procedures) are embedded within the Medical Device Development Process and describe the process, for example, for software development, electronics FMEA or risk management in greater detail.
Software makes up a significant portion of the development of modern medical products. For the procedure involved in the development of medical grade software, there is the IEC 62304 standard for Software Lifecycle Processes. It creates a series of tasks for the software life cycle for medical products.



We realise these tasks in concrete activities with a standard operating procedure (SOP). It transfers the standard requirements to an active development procedure. The Zühlke development process provides the framework by means of a proven process description and the concrete support by means of numerous templates. We have successfully been employing active development methods in the development of medical products for many years. Our SOP defines the necessary level of maturity of documents according to the MDDP phase model. With this, we are able to implement the recommendations of AAMI TIR45 (recognised as guidance in FDA 2012). At specialist events, our experts often provide insights into their experiences with these methods and also support customers with QM issues in the project.

Focus point 3: Risk management
Risk management, according to ISO 14971, is a fixed component of overall development. Zühlke supports risk management during system feasibility. We carry out a risk analysis (PHA) on the basis of intended purpose and the fundamental, technical product features. Over the course of development, we employ, among other things, the FTA and FMEA risk management methods.

We include risk control measures arising from risk analysis according to the specifications of traceability in the system requirements and transfer these to the design. We employ requirements management tools in order to demonstrate the traceability of risk control measures from design through to testing.

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Photo: Mr Thorsten Knauf

Thorsten Knauf

Director Business Development

Photo: Mr Jens von der Brelie

Jens von der Brelie

Director Solution Center