Medical Device Design - Issues & Challenges with Fluid Handling

As medical and diagnostic technology continues to develop and grow, healthcare professionals and researchers need increasingly more advanced systems, which are faster, smaller, and more reliable. At the same time, pressure on manufacturers and system end users to be economical is also increasing.

To respond to these growing needs, device manufacturers must be more innovative and find new ways of improving efficiency.

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

Fluid handling systems have diverse requirements, each with their own unique set of functional properties, that must be met before processes such as liquid monitoring, mixing and dispensing, system washing, and waste management can be undertaken.

Fluidic applications can be split into either micro-applications or macro-applications. Micro-applications require the precise delivery of small fluid volumes, whereas macro-applications involve medium to large volumes of fluid moving through an instrument (e.g. when waste is disposed, or a tank is filled).

Fluidics in general, and microfluidics, specifically, tend to be considered a ‘non-core’ technology for medical device manufacturers, which means it often sits outside many professionals’ areas of expertise. Whilst device manufacturers will know how to engineer the core technology behind their devices, they may not know how to build the required ancillary fluid systems. For this reason, many manufacturers use external fluid engineers to assist them.

This article will explore the trends and challenges that specialists currently face in the field of fluidics design.

Challenge 1: Consolidate and Simplify

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

Smaller equipment provides a competitive advantage, as it will fit easier into existing labs. Many commercial labs are assessed in terms of their profit-per-square-foot, meaning that more compact instruments are usually selected. Producing more compact systems also opens up opportunities for new applications, as these smaller systems can be transported for use in the field or in mobile labs. A good example of this is how mobile labs can be set up for field emergencies and in disaster zones.

Smaller systems can also benefit from a larger user base. A good example of this would be a tabletop piece of diagnostic equipment that could be used in a GPs office, which would not be able 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%.

Manufacturers face a range of different challenges when compacting and simplifying existing systems, especially in areas such as fluid flow management and tolerance variances. In addition, smaller devices must also be energy efficient – this is especially true for devices that should be portable.

Reducing the weight and size of a device is possible using several different methods. Consolidation can be achieved by assembling several system components into one unit. Gems Medical Sciences used this method to help a respiratory-products manufacturer develop new transport ventilators. Different components of the ventilator, such as the temperature probe and nebulizer, were integrated into the system’s manifold block in order to make the system more compact.

For some applications this might not be possible without negatively impacting the system’s operations – automation may be the solution to this problem. For example, in the case of the ventilators, the original design possessed flow valves that required manual adjustment, and the need to access these valves limited the design. To solve this problem, Gems Medical Sciences replaced the valves with precision orifices, which were set into the manifold. This removed the need for access and allowed the system to be reduced in size by 40%.

Gems Medical Sciences also worked with a manufacturer of medical lasers, who wanted to make their large fixed-location system compact enough so that it could be used in a GPs office. To achieve this, the cooling system of the laser had to be compacted.

Gems Medical Sciences fluidics engineers achieved this by integrating the temperature probe and level sensor into one system, which occupied less space in the fluid reservoir. This meant a smaller reservoir could be used and, alongside the use of smaller sensors and pumps, the system size was reduced by 50%.

Challenge 2: Cost Control

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

In the face of these pressures, OEMs must also be cautious about cutting costs when they could result in poorer device performance. This is not as relevant when considering components such as fluid handling systems, which perform an ancillary function. Focusing on systems such as these can drive costs down while retaining performance.

For manufacturers working with consumables (e.g. IVD manufacturers), cost control is especially important (see: the razor/razorblade model). For such an economic model to be a success, the base of installed instruments must be maximized and upfront costs, which could prevent installation, need to be minimized. For this reason, many manufacturers provide the core system at a low cost (or, in many instances, for free), which means that equipment production costs are often subject to intense industry pressures.

Conclusion

The highly competitive nature of today’s medical device marketplace means manufacturers must be flexible and innovative when designing new systems. The demand for miniaturized, more reliable and cheaper systems requires increasingly clever designs.

Irrespective of the system size, many companies would benefit from working alongside established fluid contractors to realize their designs. This frees the time of employees to work on building the technology, reduces the cost of manufacturing and results in faster development. Fluidics specialists can work with manufacturers on-site and undertake the lengthy processes of validation and testing.

Medical device manufacturers can benefit from working with external fluidics contractors, for both the development of novel systems or improving the value of existing 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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