Daniel Prause, marketing communication & PR manager, RAUMEDIC, discusses the next generation of soft cannulas.
RAUMEDIC
The soft cannula market could experience a major disruption due to a manufacturing approach that could make production safer and more cost-effective: manufacturing soft cannulas as a single-piece injection moulded part.
In the evolving landscape of drug delivery, wearable injectors stand at the forefront, combining medication administration with a high degree of precision and patient comfort. Among these advancements, patch pumps and belt pumps for subcutaneous injections have emerged as game changers.
These devices simplify the management of diseases such as diabetes, a growing ailment affecting more than half a billion people worldwide – a number that is expected to grow by 46% by 2045. In the case of diabetes, novel devices are delivering insulin directly beneath the skin, offering an efficient and less invasive alternative to traditional injections.
The role of soft cannulas in modern drug delivery devices
Central to this revolution of drug delivery systems is the soft cannula, a critical component designed for subcutaneous (“beneath the skin”) injections. It serves as the critical final piece that connects the patient to the device. From an engineering standpoint, soft cannulas offer the upside of being versatile, catering to a wide range of drug delivery systems as an integral component of both patch pumps and belt pumps, enhancing patient comfort – and minimising the risk of complications.
Classic soft cannulas vs. novel soft cannulas from a single cast
RAUMEDIC
RAUMEDIC, a German company specialising in customised polymeric solutions for medical and pharmaceutical applications, can produce soft cannulas the “classic” way - as an extruded tube that is finished when forming the tip and flaring the tube end. Additionally, the connection to the insertion system and the pump mechanism is done via overmoulding with appropriate thermoplastic materials.
But there’s a challenge to this approach; the assembly technique for connecting a soft cannula to a distributor system is currently costly.
To address these challenges, RAUMEDIC has filed a patent for a soft cannula manufactured in one piece. This development is designed to not only streamline the manufacturing process by reducing the complexity and number of parts, but also to minimise the risk of leakage.
As RAUMEDIC is one of the few partners worldwide working to offer multiple manufacturing approaches for a fundamental cannula component, it is time to ask the most important question: will novel injection moulded soft cannulas, moulded in one piece, soon replace assembled and more complex “classic” soft cannulas? Answering this question requires a detailed look at the components, the manufacturing process, and the pros and cons of different soft cannulas.
The components
Classic soft cannulas typically consist of multiple components. In the case of RAUMEDIC’s needle insertion system: short pieces of an extruded tube, being formed to the soft cannula, thermoplastic overmoulded housing, an integrated septum, and a closing clip, bringing it to a total of four components.
With RAUMEDIC’s development, a soft cannula manufactured in a single mould, the number of parts can be lowered to three components: the cannula from a single mould, a septum, and a clip. Thus, this approach allows the combination of two components and saves several steps in the process.
The manufacturing process
The manufacturing process of classic a soft cannula involves cutting the tubing into short sections, forming a tip according customer requirements, and then tailoring the back end into various geometries for further processing. The method requires high precision to ensure a form fitting connection between the cannula head and the housing during the overmoulding process.
The single-mould soft cannula on the other hand reduces the necessary process steps. All process steps prior to the overmoulding such as tube extrusion, length cutting and the head forming of the tube can be eliminated.
Lower costs per unit and minimised risk of leakage
Besides eliminating costly and time-intensive production steps, there’s another striking benefit to the single-mould technique; due to its monolithic character, there’s no critical interface between the soft cannula and the housing. This is a major advantage as it further minimises the risk of adverse effects such as leakage.
In addition, the aspect of enhanced safety, which is always the paramount criterion for medical and pharmaceutical applications, the economic aspect of cost minimisation is an advantage not to be neglected. In a world of shifting demographics and economic uncertainty, public healthcare spending is under constant scrutiny, and the pressure on budgets is only set to grow. That’s one of the reasons why RAUMEDIC decided to develop a single-mould soft cannula - the unit price could be lowered in a meaningful and measurable way, compared to the classic approach.
Is the classic soft cannula past its peak?
Considering all the benefits of the approach of producing soft cannulas, this begs the question: will “classic” soft cannulas slowly but certainly disappear from the market, and become a museum piece to be examined with bewilderment by future MedTech professionals in the near future? The answer is a clear NO.
Certain designs, e.g. long versions of a soft cannula, cannot be realised through an injection moulding process but require the usage of the existing process and extruded tubes. In addition, certain dimensions and materials are not suitable for a moulding process, although the limitations are constantly changing.
With an assembled solution, the highest quality standards for materials, geometry and dimensions can be realised in the extrusion process. This approach offers far greater possibilities when post-processing extruded tubing to expand the assembly into customised soft cannulas. Thus, for many modern drug delivery systems, there is no viable alternative to a customised assembled version of a soft cannula.