Custom Manufacturing Is the Way to Go for Microfluidics Production

In this article we compare and contrast custom versus mass manufacturing for microfluidics production. We list advantages and disadvantages of custom microfluidics manufacturing, and explain why custom manufacturing has become the current industry practice for producing microfluidic device and chips.

What is custom manufacturing of microfluidics?

Custom manufacturing of microfluidics is an approach to fabricate new microfluidic devices, made-to-order, in relatively short time and without investing too much on tooling.

What is the main difference between mass production and custom manufacturing of microfluidic devices?

Although there are many differences, the obvious distinguisher is the quantity. Microfluidic devices are usually custom manufactured if the quantity is between hundreds to tens of thousands. Mass manufacturing is preferred for larger volumes.

Is the custom manufacturing of microfluidics the same as prototyping?

No, they are different. Microfluidic prototypes are usually needed during product development or for internal validation purposes, while custom manufactured microfluidic chips are sold or given to users. Custom manufactured chips may also be used for collecting data to submit to regulatory bodies for licensing a new microfluidic product.

Are custom manufactured microfluidic devices more expensive than mass produced ones?

Total cost of microfluidics manufacturing can be broken down to direct costs such as material (glass, thermoplastics, or PDMS) labor, capital (tooling), and also to indirect costs. Direct labor costs relate to paying assemblers, workers, technicians, machine operators, packers, and project managers. Direct capital costs relate to those equipment and tooling that are purchased or produced exclusively for the project such as microfluidic molds, custom automation equipment and robots. On the other hand, examples of indirect costs are administrative, quality control, supervision, insurances, energy, and facility depreciation. The table below very roughly compares different types of costs for custom versus mass fabrication of microfluidic devices.

In the microfluidics domain, cost of custom manufacturing per device is about one order of magnitude greater than a mass fabricated product. In other industries this relationship could be much larger, up to 2 orders of magnitude or more. The reason for this difference (between microfluidics and other industries) is that a mass manufactured microfluidic device such as a point of care PCR test cartridge (less its reagents) is still more expensive compared to a similar complexity component for consumer products.

Why does microfluidics industry prefer custom manufacturing?

Risk Mitigation

Although cost per device is higher in custom manufacturing compared to mass production, custom manufacturing is the preferred method for microfluidics production. This is because custom manufacturing allows more robust risk mitigation. Mass manufacturing is suitable for a tested and trusted product with an established market and a sizable user base. On the other hand, microfluidics designs and intellectual property have only emerged since early 2000s, with serious products entering the market from the year 2015 or so. Current products are experiencing rapid and frequent design changes due to advancements in microfluidics technology. In this environment it is a wrong business choice to invest millions on the manufacturing capital, and then withdraw the design for modifications. Another risk-related factor is quality or reliability. Traditionally, mass manufactured products are more reliable and are less costly for  quality control. Microfluidics, on the other hand, is different because the tolerances and defects requirements are very close to the manufacturing resolutions and limits. As an example, a 50 um defect in a car part is acceptable, while inside a microfluidic channel it can easily cause a reject. Thus for the mass manufactured microfluidic chip there is a risk that thousands be pulled due to a slight off-calibrated equipment or lightly damaged mold. A faulty product due to a very small manufacturing flaw may cause huge liability issues and lawsuits for a microfluidic chip used in health related applications.

None or Low Minimum Order Quantity

Another reason for businesses choosing custom instead of mass production in microfluidics is the market size. Most microfluidic products are just entering the market. Often, the businesses must create a market for their novel microfluidic product. This means it is unwise to invest in a mass produced product, manufacture several thousands, and then find out there aren’t enough users. Custom manufacturing is therefore a solution to fulfill genuine demand. The minimum order quantity for custom manufacturing of microfluidic chips could be very low or non-existent contractually.

Agility

And finally, another super important reason to prefer custom microfluidics manufacturing over mass production is the time spent from order to the first shipment. In microfluidics, it can take up to two years to establish a mass production facility. This includes sourcing and assembling equipment, building and equipping a few thousand square feet cleanroom, designing, sourcing, installing and testing the automation lines, recruiting and training personal. And finally applying and receiving the necessary license and authorizations. An agile custom microfluidics manufacturing partner, on the other hand, can deliver few hundred devices in four weeks post ordering, and a few thousands in four months or less, while ramping up the volume further if needed. Design change options are available while custom manufacturing microfluidcs by the right partner.

What are disadvantages of custom microfluidics manufacturing?

Favoritism by the custom manufacturer

Because of the small size of projects it is possible that manufacturers cherry pick between clients, or have unwritten strategic reasons for favoring certain segments or companies. This could be due to: territorial attachments, having an eye on potential acquisitions, government relations, selecting more straightforward projects, and many other reasons. Discrimination makes it much harder for new or smaller entities to pick a reliable custom manufacturer, or simply find anyone who manufactures their microfluidic device. A small company could be like a race car that has to start the race behind all others, in an already fast paced competition. 

Unreliability of the custom manufacturer

A quick investigation into list of custom microfluidics manufacturer during the past decade shows that many of them have been acquired by larger/multinational companies or by joint ventures backed by VCs. While choosing a custom manufacturer, it is close to impossible to predict whether the custom manufacturer would change its priorities and interests, or worst case scenario become as a component of a large competitor to your business.

Reliance on the custom manufacturer’s expertise

Each custom manufacturer has developed or acquired proprietary know-how to be able to process complex microfluidics projects more efficiently. The client therefore heavily relies on the knowledge and skills of the manufacturer’s technicians and engineers. A custom microfluidics manufacturer who is new to the domain (although might have long history in other fields such as electronics, aerospace or medical device) may compromise the client’s microfluidic design by forcing too restrictive rules.

Cost

Unlike the belief that smaller means cheaper, in the microfluidics domain the necessary small size features mean a relatively expensive product. Due to lower levels of automation, and the need for human interaction at multiple checkpoints during production and during the final quality control, cost for custom manufacturing of microfluidic devices could be high compared to similar size devices from other industries.