Our services in process development
Our tool design is the key to efficient and economical series production of medtech components. We have the great advantage that we use our tools in-house in production and can incorporate our production experience into new tool concepts. With decades of know-how and state-of-the-art CAD/CAM technology, we develop high-precision tools in both the plastics and stamping sectors that are optimally tailored to the requirements of our customers. We take aspects such as material behavior, cycle times and ease of maintenance into account right from the design phase - always with the aim of ensuring the highest quality and process reliability.
Customized fixtures are essential for stable and reproducible production. NICOLAY develops individual clamping, assembly and testing fixtures that are precisely tailored to the respective product and manufacturing process. Our fixtures make a decisive contribution to process reliability, ergonomics and efficiency - and enable consistently high product quality.
Quality begins with inspection. Our test equipment is specially developed to meet the requirements of our customers' products - whether for dimensional inspection, electrical and mechanical function control or for monitoring critical tolerances, e.g. by means of camera inspection during series production. We place particular emphasis on traceability, repeat accuracy and simple handling. In this way, we create the basis for seamless quality assurance throughout the entire production process.
Even in the early development phase, we use filling simulations to precisely analyze the flow behaviour of plastics in the mould. This allows potential sources of error such as air inclusions, weld lines or uneven filling to be identified and avoided at an early stage. The result: optimized component geometries, shorter development times and a stable series production process.
Precision through simulation and understanding of materials:
The precise prediction and targeted compensation of shrinkage and warping are crucial for the dimensional accuracy and functionality of plastic components - especially with complex geometries and tight tolerances. During the cooling phase after the injection molding process, the thermally induced shrinkage of the material causes dimensional changes that can lead to fit inaccuracies, stresses or even deformations if suitable countermeasures are not taken.
Our many years of experience in plastics processing enable us to specifically address material and process-related influencing factors.
These include, among other things:
- Plastic type and filler content (e.g. glass fiber reinforcement)
- Mold temperature control and cooling channel design
- Injection parameters such as pressure, speed and holding pressure profile
- Component geometry and wall thickness profile
By iteratively optimizing tool and component design, we ensure that your products meet the exact specifications even after cooling. If necessary, we also carry out real measurements, e.g. with 3D coordinate measuring technology or CT scans, in order to compare simulation and reality and continuously improve.
In this way, we guarantee maximum dimensional accuracy, minimize rejects and shorten development times - for economically and technically optimal plastic solutions.
The basis for stable series production and reproducible product quality is the targeted determination, definition and control of process parameters. At NICOLAY, we rely on a methodically sound approach in which modern statistical procedures play a central role.
Statistical Design of Experiments (DoE) is a particularly effective tool. It makes it possible to systematically identify the relevant factors influencing product quality and process reliability at an early stage of development. In combination with other methods such as Cp/Cpk analyses or the Statistical Overlap Coefficient (SOC), we develop reliable process models with a high degree of validity - based on targeted test series and minimal effort.
In practical use - for example in injection molding - we analyze parameters such as injection speed, pressure curves, temperature profiles or holding pressure behavior and their interactions. The target parameters and process limits derived from this form the basis for robust production processes with a low reject rate and high reproducibility.
This data-based process development is an integral part of our qualification and validation strategy and makes a significant contribution to reliably meeting regulatory requirements (e.g. ISO 13485, MDR). It not only provides the basis for well-founded decisions in product development, but also for stable, reliable and economical series production.
The qualification of production equipment, tools and processes is a central component of our quality management. In accordance with ISO 13485, FDA regulations and the EU MDR, we carry out structured qualification measures - from Design Qualification (DQ) to Installation (IQ) and Operation Qualification (OQ) through to Performance Qualification (PQ). In this way, we create the regulatory basis for safe and standard-compliant production.
As part of the qualification process, we ensure that machines, systems and equipment are fully installed and can be operated in accordance with standards - in compliance with all applicable requirements and manufacturer specifications. We also check whether systems and processes are capable of achieving the defined results in a reproducible and reliable manner, even taking into account all relevant influencing factors and limiting conditions - for example in worst-case scenarios. We determine the required process windows and parameters as part of targeted studies, including with the help of DoE methods. In this way, we create the basis for sound process approvals and stable series production.
The validation of manufacturing processes is mandatory for medical technology products - and for us, it is standard practice. NICOLAY validates all critical processes in accordance with the applicable standards and guidelines. In doing so, we fully document, e.g. with process capability analyses, that the processes reproducibly deliver products that meet the specifications under defined conditions. Our validation strategy is risk-based, efficient and designed for long-term process stability.
We validate critical processes of product realization that produce or influence the final specification and acceptance criteria of the products and critical software that serves as process software or ensures regulatory/ normative requirements and whose process result cannot be subsequently verified or is not verified. The standardization of process and software validations is carried out in accordance with the regulations 21 CFR Part 820 and ISO 13485.
Reliable measurement results are the basis of every quality decision. With measurement system analysis (MSA), we ensure that our measuring equipment can be used for your application without hesitation. We systematically analyze repeatability, reproducibility and measurement uncertainty - and thus create the basis for reliable test decisions. This gives our customers the certainty that quality at NICOLAY is not just measured, but understood.
