An Introduction to the Issues and Challenges with Fluid Handling in Medical Device Design

As diagnostic and medical technology continues to improve and grow, researchers and healthcare professionals require increasingly more sophisticated  systems, which are smaller, quicker, and more reliable. Simultaneously, system end users and manufacturers are facing increased pressure to be economical.

Device manufacturers should be more creative and identify innovative ways of enhancing efficiency to respond to these growing requirements.

Fluids have an important role to play in the operation of the majority of medical devices, with fluid handling being a significant component. Any application involving the control, monitoring, or measurement of a gas or liquid involves fluid handling, and this covers applications such as boiler control on sterilizers, the dispensing of reagents for in-vitro diagnostic equipment, or gas delivery to hospitals. Other applications include the cooling of medical lasers using fluids and accurate gas delivery for ventilators.

Fluid handling systems have different requirements, each with their own exclusive set of functional properties. These should be met before various processes such as mixing and dispensing, waste management, system washing, and liquid monitoring can be undertaken.

Fluidic applications can be divided into either macro-applications or micro-applications. Macro-applications involve medium-to-large volumes of fluid moving through an instrument (for instance, when a tank is filled, or when waste is disposed), while micro-applications require the exact delivery of small fluid volumes.

Fluidics in general, and microfluidics, in particular, are likely to be regarded as a ‘non-core’ technology for medical device manufacturers, which means it usually sits outside many professionals’ fields of expertise. While device manufacturers will know how to engineer the core technology behind their devices, they may not know how to develop the required auxiliary fluid systems. Therefore, many manufacturers make use of external fluid engineers to help them.

In this article, the challenges and development presently faced by specialists in the field of fluidics design are investigated.

Challenge 1: Consolidate and Simplify

There is an ongoing trend for manufacturers of medical devices to make their devices smaller in response to market requirements.

Smaller equipment offers a competitive benefit, as it will fit more easily into present laboratories. Many commercial laboratories are evaluated depending on their profit-per-square-foot, which means more compact instruments are generally selected. Producing more compact systems also paves the way for new applications, as these smaller systems can be transported for use in mobile labs or in the field. An excellent example of this is how mobile labs can be set up in disaster zones and for field emergencies.

Smaller systems can also gain from a greater user base. An excellent example of this would be a tabletop piece of diagnostic equipment that might be used in a GPs office, which would be unable to fit in large floor-size models.

Gems Medical Sciences redesigned the manifold of a transport ventilator, reducing space requirements by 40%.

Gems Medical Sciences redesigned the manifold of a transport ventilator, reducing space requirements by 40%.

When compacting and simplifying current systems, manufacturers face many different challenges specifically in fields like fluid flow management and tolerance variances. Additionally, smaller devices should also be energy-efficient — this is particularly true for devices that need to be portable.

Using different techniques, it is possible to reduce the size and weight of a device. Various system components can be assembled into one unit to achieve consolidation. Gems Medical Sciences used this technique to help a respiratory-products manufacturer develop innovative transport ventilators.

In order to make the system more compact, various components of the ventilator, such as the nebulizer and temperature probe, were incorporated into the system’s manifold block.

For certain applications, this might not be possible without negatively influencing the system’s operations. Here, automation may provide the solution to this issue. For instance, in the case of the ventilators, the original design had flow valves that required manual adjustment, and the need to access these valves restricted the design.

To solve this issue, Gems Medical Sciences substituted the valves with precision orifices, which were set into the manifold. This enabled the system to be reduced in size by 40% and eliminated the need for access.

Gems Medical Sciences also worked with a medical laser manufacturer, who wanted to make its large fixed-location system as compact as possible so that it can be used in a GPs office. To accomplish this, the laser’s cooling system had to be compacted.

Fluidics engineers at Gems Medical Sciences achieved this by combining the level sensor and temperature probe into a single system, which occupied less space in the fluid reservoir. This meant a smaller reservoir can possibly be used and, along with the use of smaller pumps and sensors, the system size was reduced by 50%.

Challenge 2: Cost Control

Manufacturers all across the medical sector recognize that there are increasing pressures to decrease production costs, and the medical device industry is no exception.

In the face of these pressures, OEMs should also be careful about reducing costs when they could result in poorer device performance. This is not as relevant when considering components like fluid handling systems, which perform an auxiliary function. Focusing on these systems can reduce the costs while retaining performance.

Cost control is specifically important for manufacturers working with consumables, for instance, IVD manufacturers (see the razorblade/razor model). To ensure the success of such an economic model, the base of the installed instruments must be increased and upfront costs, which could prevent installation, need to be reduced. Due to this reason, the majority of manufacturers offer the core system at an economical price (or, in many examples, for free), which means that costs related to equipment production are usually subject to severe industry pressures.

Conclusion

The highly competitive nature of current medical device marketplace means manufacturers should be innovative and flexible when designing novel systems. The demand for more reliable, economical, and miniaturized systems needs increasingly smart designs.

Regardless of the size of the system, many companies would gain from working alongside renowned fluid contractors to achieve their designs. This frees up employees’ time to work on building the technology, lowers the cost of manufacturing, and leads to faster development. Fluidics professionals can work with manufacturers on-site and carry out the extensive processes of testing and validation.

Manufacturers of medical devices can benefit from working with external fluidics contractors for enhancing the value of current systems as well as the development of innovative systems.

This information has been sourced, reviewed and adapted from materials provided by Gems Sensors and Controls.

For more information on this source, please visit Gems Sensors and Controls.

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