Working with vertically integrated manufacturers can help engineers optimize designs, improve manufacturability, and accelerate new product development.

Medtech design engineers are faced with extraordinary opportunities and challenges brought about by the rapidly evolving clinical market. In order to quickly bring innovative new products to the market, medical tubing manufacturers must understand the downstream processes of thermoplastics, thermosets, film casting, extrusion, and value-added that are critical to the production sequence.

Electrophysiological catheters, structural cardiac delivery systems, microcatheters, and other tubular medical devices use a range of polymer tube structures and materials, including polyimide, polyurethane, nylon, PTFE, and PEBAX.

Combining different materials and constructions is critical to achieving an ideal balance of strength, flexibility, torque response, kink resistance, and other performance characteristics in the finished component. Vertically integrated manufacturers can work with all of these to improve supply chain coordination and control of inputs.

The following are six important value-added features that can enhance the development process of medical catheters:

The assembly of finished tubular equipment requires various services. Contract manufacturers with a full set of secondary operations, assembly, packaging, and sterilization capabilities provide medical device OEMs and start-ups with additional value and supply chain influence.

The application of DFM as an engineering discipline optimizes the design of complex catheter shafts and other medical tube components to reduce manufacturing costs. DFM can correct potential problems in the design phase, which is the lowest point in the development process to solve problems.

Catheters and other tube-based medical devices that require high torque response, burst pressure, pushability, maneuverability, and kink resistance often use braided or coil-reinforced shaft designs. There are multiple variables at play when designing a reinforced shaft. Generally, the reinforced shaft has an inner lining, a braided or coiled reinforcement layer, and an outer sheath. These elements must be combined to achieve the desired size, taking into account inherent physical limitations such as the thickness of the inner lining, the thickness of the outer sheath, and the linear density (defined as the pic per inch or the pitch of the coil).

There are trade-offs when designing an enhanced shaft. For example, optimizing the device shaft for torque response may result in a weave pattern that is not optimal for bending stiffness. Modeling these complex reinforced shafts in a virtual space can reduce development time by weeks or months.

Reflow soldering is a manufacturing process that produces a multilayer shaft by reflowing (or melting) the inner and outer sheath materials to construct a composite shaft. Various wall thicknesses, hardness and support structures can be incorporated into the composite shaft to optimize the strength, kink resistance, maneuverability and torsion control of the shaft design. The reflow process enables the integration of all layers of complex engineering shafts and adapts to a wide range of configurations from 2 Fr to 36 Fr.

Two operations can create different pipe features and contours. These can include hub molding, overmolding, heat treatment/annealing, flaring, drilling, scraping, pad printing, thermoplastic flattening/molding, pouring, sealing, etching, welding, bonding, and swaging. As the predecessor of final equipment assembly, the cost of working with contract manufacturers that provide such secondary operations may be lower than the cost of sending components through multiple manufacturers, simplifying the supply chain.

Traditional medical device prototyping relies on manual and time-consuming trial and error processes, involving multiple rounds of material procurement, prototype assembly, and bench testing. The use of virtual pipe model analysis significantly reduces the time and resources required for physical prototyping of medical pipes-enabling engineers to model complex multi-layer braided pipes in minutes instead of hours and predict performance quickly and easily .

Design engineers face a lot of pressure and need to deliver on an aggressive development schedule. The right polymer pipe manufacturing partners can strengthen innovation and project execution.

Michael Holt is the chief application engineer for Integer (Plano, Texas). Holt has more than 20 years of experience in the design and development of complex catheter-based devices and holds a Bachelor of Science in Mechanical Engineering from the University of Tennessee.

The views expressed in this blog post are only those of the author and do not necessarily reflect the views of Medical Design and Outsourcing or its employees.

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