When going to market with lateral flow immunoassay (LFI) devices, medical device original equipment manufacturers (OEM) have opportunities to gain from automation in more ways than one. Understandably, cost is a high priority on every device developer’s radar, and it’s true that increasing automation lowers the price per unit sold over the long term. However, there are other immediate benefits of automation for LFI OEMs to reap.
Most lateral flow devices are made of a cassette housing and a test strip. (See diagram below for an example.) A test strip typically consists of multiple flexible materials that are striped, or coated, with conjugate and reagent chemistries so that the strip will respond appropriately to a test specimen ( urine, blood, etc.). The treated flexible materials are then laminated together and slit into individual test strips. Strips are often placed into a cassette then pouched, or multiple strips may be placed into a desiccant vial. Some LFI producers use reel-to-reel automated machinery to laminate, stripe, cut, and assemble their devices. However, some still use manual methods or semi-automatic equipment. Primary advantages of fully automated LFI device manufacturing include improved quality, flexibility and consistency.
Here are the top three reasons to consider automation.
Reason #1: Quality
Automation significantly reduces risks for quality problems that can impact an LFI device OEM’s profits and brand reputation. LFI device manufacturers and developers need to be confident that their devices will deliver high sensitivity and specificity and, in the end, the right results. There is very little room for error. Just one malfunctioning LFI device on the market could seriously impact a patient care plan, the outcome of a workplace drug test, or an important family-planning decision. Whether it’s a striping, laminating, cutting, assembly, or pouching process, every manufacturing step must be consistently performed with precision, or else device quality will suffer.
With a fully automated, reel-to-reel LFI manufacturing line, there are no worries that workers might accidentally choose the wrong settings or use a poor manual alignment technique in a crucial production step. When relying on a contract manufacturing organization (CMO) with highly automated systems, an OEM can rest assured that every process, from LFI reagent deposition to packaging, is performed exactly to specifications.
The latest reel-to-reel automated LFI manufacturing lines feature finely tuned sensors to monitor manufacturing on the fly and make inline adjustments as needed. For example, sensitive cameras and quality control systems measure a product’s adherence to tolerances as materials are processed at high speeds. There is no need to stop, measure, and record quality findings manually during the production run.
Using automated equipment also significantly improves yield. For example, with a manual or batch process, a manufacturer might make LFI test strips from 300-mm-long backing cards. Over the course of slitting the cards into 5-mm test trips, the manufacturer typically loses at least 10 mm of material (3.3 percent) on each end of the card as scrap. When cutting those same strips from a 100-meter roll of finished material with a reel-to-reel automated machine, the scrap rate would be less than 1 percent. 1
Reason #2: Consistency
Automated LFI manufacturing also provides much-desired product consistency. In particular, when a developer partners with a CMO with LFI expertise, it can leverage that CMO’s repeatable, reliable processes for rapid yet tightly controlled production volume scale-up.
If they collaborate early in the product development cycle, supply chain partners can identify opportunities to choose production processes and product parameters that reduce product variability risks. Also, with automated, computer-controlled LFI production lines, each product’s profile is stored in the system’s memory. Therefore, manufacturers are not as reliant on human memory and manual set-up procedures when changing over from one LFI device to another. In this way, automated assembly methods de-risk a lot of the production process. This is especially critical with highly sensitive quantitative LFI tests. This also supports high-growth periods when OEMs need to quickly ramp up their product volume while consistently adhering to specifications and producing devices that meet all performance criteria.
In the past five to 10 years, the entry point at which OEMs can economically justify automation—and all of the product consistency benefits that come with it—has become much more attainable for firms of different sizes. Whereas in the past an LFI device maker might need an order of 1 million to 2 million units to consider fully automated production, today that tipping point is in the hundreds of thousands, thanks to CMOs’ use of automated equipment.
Reason #3: Flexibility
Finally, automation allows for greater manufacturing agility, freeing device developers and OEMs from many constraints of manual production methods. Perhaps the greatest form of flexibility is the ability to quickly and profitably scale up production. If an OEM needs to ramp up from manufacturing several hundred thousand LFI devices to several million devices, the company need not be backed into hiring, training, and paying many more workers or acquiring multiple batch processing systems. If production is outsourced to a CMO with highly automated LFI lines, the OEM can simply leverage the CMO’s capacity and infrastructure. It is not necessary for the OEM to invest in designing or buying new equipment and staffing additional lines. Some medical device companies experience eight-fold productivity increases when they begin working with a highly automated CMO partner.
Also, once an automated process has been validated as the manufacturing method of record, the OEM can return to that process again and again, whether making an order for 500,000 or 5 million LFI devices. This scalability of the original manufacturing method eliminates the prospect of time spent validating new processes or machinery to support surging demand.
Using automated machinery does not mean that equipment cannot be quickly and easily adjusted. In a typical LFI manufacturing operation, very few steps require fixed, rigid tooling. For instance, with minimal time or added cost, materials can be repositioned, a strip size can be changed, or a test line can be relocated. That said, it’s ideal to design the product from the beginning with automated processes in mind. Then there will be less need for major changes as the product heads into mass production. The right CMO partner can help an OEM or device developer to design processes for high-volume manufacturability.
In conclusion, automation plays an essential role in enabling LFI device OEMs to achieve not only their product goals around quality, consistency, and performance, but also their overarching business goals for growth, market share, and responsiveness. By partnering early with a CMO with highly automated operations already in place, OEMs and device developers can focus on activities that add the greatest value to their evolving LFI product portfolios and their customers’ current and future requirements.
1. Source: Kinematic Automation.