Additive Manufacturing in The In Vitro Diagnostics Field

Additive Manufacturing (AM), more commonly known as 3D printing, has had the potential to change the face of manufacturing for over 30 years. However, while consumer adoption of this technology is an all-time high buoyed by a flood of entry-level 3D printers on the market, the manufacturing industry appears to be lagging.

Each week there seems to be a new demonstration of the potential for the technology, whether it is printing concrete, carbon fiber, glass or even food. There seems to be no shortage of applications where this technology can be applied, yet the AM share of the manufacturing market pie still remains small.

It can be speculated that AM’s lethargy in revolutionizing the industry has not come from a lack of vision of what the technology can offer us, but through a lack of confidence in the quality of the parts able to be produced. But this attitude seems to be changing. What we are seeing, certainly in the past two years, is a palpable shift in attitude within the industry with more and more businesses acknowledging the advantages that AM delivers. This growth can be witnessed in the increasing share of production parts, rather than prototypes, being produced by third-party printing services.

Given this shift and the benefits this technology has for the low to mid-scale manufacturing, it just might be time to reconsider your design and manufacturing options and leverage the significant advantages this technology is starting to offer.

Why it is interesting

As a company designing, engineering and manufacturing relatively low production volume diagnostic instruments for our clients, we are often faced with a dilemma over the choice of manufacturing methods. With a market that requires relatively low-volume production levels of tens to thousands of units annually, the two most common manufacturing methods of injection molding or machining are often unpalatable due to cost implications.

The high upfront cost of injection-molding and typical low part-volumes leaves the amortization of the tool adversely affecting the finished part cost. Similarly, the labor-intensive nature of machining parts creates a higher part cost relative to the raw material.

The advent of high quality molding and machining out of China over the past decade has lessened the cost impact for smaller volume manufacturing, but with China’s growing standard of living, it is worth recognizing that this won’t remain a low-cost option forever.

However, with the democratization of additive manufacturing technologies (in-particular machine cost, material choice and ease of use) means we now have a more viable third option; and one uniquely suited to low-volume production numbers.

What we are doing about it

While certainly not a panacea for all engineering challenges, the technology does offer a level of flexibility and speed that is perfect for diagnostic instrument design, engineering and manufacturing. Within Invetech, we are starting to realize opportunities where we leverage the technology to provide better utilization of internal resources as well as reduce time to market, the following being current examples:

Implementation of 3D printed production parts on our instrument platforms with some compelling reductions in risk and cost (refer to Orlando’s story below).

Achieving better utilization of in-house CNC machinery and staff through the use of 3D printed jigs and fixtures required for manufacturing. The technology enables production personnel to participate in the design process through immediate trials and feedback, resulting in increasingly optimized designs in rapid succession.

One key learning for those of us used to designing for “traditional” production processes of machining, molding, folding, it requires a dramatic shift in design thinking for designers and engineers to design for AM production components. Traditional design rules no longer apply – you have the freedom to design parts that cannot be made through any other method: This can be quite a challenge for experienced designers. One way to encourage free thinking when embracing AM production is to challenge your design team with questions such as: “If you could only use 3D printing to solve this problem, how would you design your parts?”

Conclusion

Given the rapid pace of change in this field, it is not hard to see a future three to five years from now where the proliferation of this technology has reached parity with the existing manufacturing base; one in which our expectation for short lead times and parts complexity are profoundly changed. This is a future in which the design iterations can be measured in hours instead of months, a future where production printers sit on every manufacturing line.

In the expectation that manufacturing will eventually adopt AM technology more wholeheartedly, it is worth asking yourself not only just how you will adapt to this new future, but what can you start today to best leverage this opportunity?

Orlando’s Story

Leica Biosystems Explores AM for Advanced Staining Platforms

Orlando SkeeteWorking in sustaining engineering within Leica Biosystems, Melbourne, Value Engineering Program Manager Orlando Skeete had always had frustrations with a sub-assembly used on a staining platform. As part of a larger wash robot, the sub-assembly was a complex assembly of machined and sheet metal components, electronics and looms, with time-consuming alignment and assembly challenges.

Identifying that this complex assembly would benefit from simplification, Orlando initially considered injection molding but given the complex geometry, tooling would have been excessive.

Recognizing that AM might be a more suitable alternative, Orlando worked with production assembly personnel rapidly developing multiple design iterations. Each was trialed in production with immediate feedback feeding into the next iteration until a final design was established.

To establish confidence in the assembly, Orlando subjected it to a series of chemical and fatigue tests to prove that it met the functional requirements for its intended use. In fact, in some cases it out-performed the original with the only failure during testing coming from the assembly it was set out to replace.

In creating the AM component, many advantages were realized as per the table below:

Original DesignAM Design
MaterialAluminum, Sheet Metal, AcetalNylon
Part count51
Quantity per year~1000~1000
Fixtures required for production20 items of 5 sizes10 items of 2 sizes
Assembly build time100 percent65 percent
Part cost100 percent9 percent
Lead Time4 weeksdays
Performance0.05 mm stopping accuracy0.01 mm stopping accuracy
Inventory managementFour weeks of productionZero inventory - on demand

Outcome

This part is now in production and performing as expected. Of course, the true savings are not just in the part cost, but in the reduced business overhead with fewer parts to manage and less parts to stock.

Having proved the value of AM in instrument manufacturing Orlando is now leading an improvement activity to identify more opportunities for AM integration.