The future of drug delivery: from detailed extrusion to a solution

Daniel Mielert, head of product development for Injection & Dosing Devices at Raumedic, discusses the future of drug delivery from detailed coextrusion to a comprehensive solution.

Complex requirements, user-friendly solutions 

Process engineering know-how and materials expertise are crucial to any project from the beginning. For the past two years, Daniel Mielert has led a team of eight in customer drug-delivery projects, an important market for the medical and pharmaceutical industry, in part because more than 537 million people worldwide now suffer from diabetes. 

As human life expectancy increases, so does the incidence of many chronic diseases. In hospitals, nursing care or home care, subcutaneous administration of medications is increasingly used where people need long-term or permanent drug therapies such as insulins, heparins, cytokines, interferons and immunomodulators, EPO or allergen extracts for hyposensitization. Subcutaneous drug administration is considered to have few complications and to be gentle on patients.  

A versatile prodigy for modern drug-delivery systems 

 Coextruded tubing has a minimum internal diameter of up to only 0.1 millimetre and is indispensable in many drug delivery systems. Depending on the application, it may have layers introduced during manufacturing — a process known as composite tubing extrusion — to improve the functionality and safety of the injection system. 

Here, the outer layer connects the coextruded tubing to other components of the fluid outlet such as the needle insertion system, reservoir or pump unit. The tubing and all connecting joints must withstand pressure of up to six bar. The inner layer is inert, thereby ensuring marginal interaction with the drug throughout the product’s life cycle.  

Properties like these make coextruded tubing an important component of the fluid outlet, the heart of any drug delivery system. Raumedic not only designs and adapts the tubing for individual systems, it also intelligently combines various manufacturing processes. 

Smart combination of processes and technologies 

“The complex requirements of modern medical technology, in particular in drug delivery, call for intelligent process combinations,” Mielert says. “Long-term applications, safety and reliability for home-care use, miniaturisation and greater user-friendliness all mean challenges in developing and manufacturing drug delivery systems. All the components have to dovetail reliably.”  

There is customised know-how in every phase of a development project along with the constant pursuit of the optimal complete system — from the first sketch and initial 3D models for rapid prototyping all the way to final specifications.   

“We observe the market and see the difficulties that can arise when components come from different suppliers and must be assembled into an overall system,” Mielert explains. Often, the components or materials are incompatible. The result can be additional corrections, a need for optimisation or even costly design or concept changes. That costs time and money unnecessarily – a powerful argument given rising costs and deadline pressures in healthcare, especially in light of the acute energy debate.  

“We consider the whole system right from the start: We find individual solutions for every requirement, no matter how complex,” Mielert says. This not only saves time and money, it minimises risk: Individual components are developed, manufactured and validated by an experienced expert.  

Individually designed soft cannulas 

Raumedic has demonstrated its expertise in combining technology and materials. This includes integrating soft cannulas into the fluid outlet of patch pumps.  

The cannula replaces the classic steel injection cannula and remains inside the patient for the duration of the application, enhancing comfort and drug delivery.  

With an assembled solution, the highest quality standards for materials, geometry and dimensions can be realised in the extrusion process, offering possibilities when post-processing extruded tubing to expand the assembly into customised soft cannulas. Alternatively, injection moulding reduces the number of steps because both the cannula shaft and the housing are produced from a single mould.