Mr. Funk, what types of implant components does your company make?
Markus Funk: We produce components for implantable ventricular assist devices (implantable blood pumps to support heart function), port-a-caths (implantable vascular access port systems), pedicle screws for spine fusion, and vascular implants, just to name a few. We manufacture both implant components for subassemblies (requiring further assembly at our client’s facility) and finished products ready for immediate patient use.
Do you typically use a collaborative process to design the components or do you produce them based on specific customer requirements?
Funk: We handle both scenarios. Some customers already have a specific design and plan and ask us for a precision implementation. Other customers prefer to sit down with us and we co-design the product. The benefit here is that we can share our manufacturing expertise to perfect the product design. Our customers often look at this process from a medical perspective, which means we have to find a common denominator and middle ground to manufacture the products with all the required features and achieve cost-effectiveness and process reliability at the same time.
What regulations and applicable standards do you have to meet when it comes to component manufacturing?
Funk: There are two important criteria for implants: implant surface quality and the purity of the components. The required surface quality depends on the implant application. Implantable heart pumps come in contact with blood, so it’s crucial to make sure they don’t trigger damage to the blood plasma. That’s why the implant surfaces have to be extremely smooth and must not pose a threat to the platelets. The setting is different when it comes to pedicle screws and rods. They actually require a moderately rough surface to allow the implant to have better bone-to-implant contact and promote osseointegration. The purity of all components is also critical. There must be no residual inorganic or biological impurities because they could trigger complications in the patient's body at a later point. This must be reflected in the entire series of production sequences. Some components receive their final purification and packaging in our clean room. This applies primarily to full packaged final products for our customers.
