Particularly for medical devices, in-vitro diagnostics and pharma products, EU and FDA regulations enforce a unique device identification (UDI) for quality control (MDR). The plastic material segment accounted for 76% of the overall revenue share in 2019 of the medical industry.

Injection molding is a cost-efficient process ideal for high volume production of medical device components in plastics. Safety and functionality of medical devices are key and marking supports quality control and traceability trough all further production steps and along the value chain from producer to end-user. Our solution also helps meeting the requirements for industry 4.0 implementation. Log all production data (material, operator, customer) with the process data (in-cavity, mold tool side, from the machine and its periphery) and associate it to the very single part produced. Use this identity as the base for all further assembly and packaging steps. We provide a secure cloud solution to aggregate and handle these part-specific information, also as a handshake to your customer bringing the product to the market.

We support medical device manufacturer by providing a cost-effective solution enabling unique device identification, data warehousing and manufacturing process optimization. Since DynamicMold is not creating any dust or debris, nor relying on particular additives, nor consuming space on the fabrication floor, it is highly beneficial for clean room production facilities.

Labware: Similarly, our traceability solution is suitable for labware, such a well plates, vials, tubes and containers, which need to be tracked throughout an experiment (e.g. using LIMS), for instance to properly compare experimental and control groups between each other, or for storage of samples in (deep-) freezers, no loosing its label.

POC diagnostics: For microfluidic applications, standard marking solutions have limitations with respect to the materials used for such purpose. Lasers may not work well on certain olefinic polymers, which play a predominant role in the microfluidics market and inkjet-printed labels are difficult to apply on highly hydrophobic substrates, which are also very common in microfluidics.

The major advantage over competing solutions for microfluidic devices lies in the expected compatibility with practically all used polymeric materials used in microfluidics.