Rudi Gall is the vice president marketing & sales at Raumedic, which serves medical device OEMs. Gall outlines market trends and challenges and shares his insight into the tubing sector both now and into the future.
What trends are you seeing in tubing?
There is a trend to unite metals – such as stainless steel – and plastics. Medical devices are incorporating more challenging designs and need to be able to deliver an increasing level of performance. There is a trend towards minimally invasive procedures, requiring smaller devices, made from micro-components, parts and tubing. We have a growing trend for medical device connectivity, where data is transferred from the medical device / patient to an analytical or diagnostic system. This ‘real time data’ allows for prognostic and strategic medical care of patients with the benefit for immediate treatment and prevention of critical health issues.
New neurological and neurovascular devices are a perfect example – thermoplastic polymers, metals and electronics morph into one product. One such device is Raumedic’s intracranial brain pressure catheter (ICP) which consists of a single lumen implant-grade polyurethane catheter protecting the wiring leading to a microchip embedded in a stainless steel tip at the distal end of the catheter.
What do OEMs want most from tubing?
They want high, persistent quality of products that ideally exceed their expectations. The medical device market does not like changes and acts nervously when quality is at stake. This is due to the invasive nature of some medical products and the regulatory framework of the medical device market.
Any recent technologic advancements and how have they made things better or more efficient?
One specific technologic advancement I would like to single out is the market launch of medical-grade Raumedic PTFE Moldflon tubing which is a symbiosis between PTFE properties and thermoplastic processing capabilities. It has similar physical properties as standard PTFE – high temperature and chemical resistance, very low coefficient of friction and tensile strength. The big difference however is that PTFE Moldflon is pelletised and can run continuously on a standard extrusion line, whereas traditional PTFE is a batch process and therefore non-continuous using RAM extrusion lines.
What are the challenges with new or advanced materials when it comes to tubing?
In recent months we have seen an interest to substitute PVC tubing with alternative. Alternative materials to PVC could be thermoplastic elastomers (TPE) or polypropylene blends (PP). TPEs however are not easy to bond to other substrates, such as polycarbonate (PC) or ABS connectors, which are widely used in standard IV tubing sets. Good bonding characteristics can be achieved with PP tubing using tetrahydrofuran (THF). However both TPE and PP both come with a high price and are not even close to the production costs of PVC. PVC will therefore stick around for the time being, until there is a political mandate to move away from it in the healthcare industry.
What examples do you have of innovative tubing solutions that met challenging OEM requests
One challenge was to heat-bond a tight tolerance microbore PVC tubing into a tubing coil as a space saver. To heat bond PVC is not a challenge but keeping tight tolerances on the tubing ID and OD, as well as on the tubing coil diameter is, as PVC has a low melting point. PVC tubing reacts and changes its characteristics in elevated temperatures resulting in out-of-spec dimensions. When heat-bonding PVC tubing in a secondary process the change of the material therefore needs to be carefully dialed-in to the production / extrusion of the tube so that an end product can be produced on basis of a statistically reliable process.
What might OEMs think is impossible but is actually possible when it comes to tubing?
How about integrating a miniature camera into a bi-lumen micro tube? Raumedic’s intelligent catheter capabilities include a chip-on-tip integration of a tiny camera probe and polymeric optical fibre within the distal tip of a nylon bi-lumen micro tube.
Any breakthrough advances on the horizon that will make tubing a lot better?
One topic which will somewhat change the current medical tubing landscape will be the introduction of bioabsorbable polymers such as PLLA / PLGA. Such materials are however expensive so tubing suppliers need to understand the extrusion process and the negative impact of a prolonged residence time on the physical properties of the tubing and the end device. Also concentricity (uniform wall thickness) of such tubes is very critical. Raumedic’s micro extrusion lines are capable of running very low volumes of such expensive formulations with minimal residence time.
