“Cost” is an awfully big word for being only four letters.
And as developers of point-of-care diagnostic reagent blisters know well, the costs to bring reagent blister products to market have many different sources.
Some are easier to spot than others. Some stay hidden until it’s too late, putting years of work (and lots of money) in jeopardy.
Here, we offer our take on manufacturing cost drivers and share ways a manufacturing partnership can keep your program on track for successful commercialization.
The characteristics of the reagent held within a blister will impact material and manufacturing decisions that influence overall cost in two main ways.
First, some reagents are corrosive to the plastic lining of material layers that are welded together to form blisters. The corrosive effect can degrade the seal over time, increasing the risk of a leak that could damage costly analyzing equipment. To combat this, materials with different barrier properties or a different heat sealing process might need to be specified.
Second, some reagents are temperature-sensitive and must be kept refrigerated. That introduces the following cost drivers:
- It’s much more costly to ship bulk reagent in refrigerated containers
- It’s more costly to keep reagent in refrigerated storage
- The heat sealing process of blister manufacturing becomes much more complicated for reagents that degrade when exposed to heat
The earlier a product developer is aware of these potential issues, the more proactive they (and their manufacturing partner) can be in identifying material or manufacturing process alternatives that keep programs on track for timely, cost-effective commercialization.
Blister material set
As the applications of point-of-care testing have evolved, so have the materials available to manufacture reagent blisters.
As this variety widens, it’s critical that developers understand that cheaper is usually never better. Granted, some programs in which the cheapest materials are specified can be successful. But in our experience, that’s rare and often only coincidental.
It’s better to rely on thorough investigation and sound engineering to land on the right materials that will result in the most reliable, least risky large-scale manufacturing.
Depending on industry or statutory requirements, some blister products must undergo more intensive testing for validation prior to commercialization.
Manufacturing partners add value to this stage of product development because they understand how to appropriately manage product development and manufacturing timelines that account for more time-intensive validation stages.
They also understand the additional raw material requirements that must be satisfied for successful product testing (for example, the difference in cost between non-destructive and destructive testing that results in reagent loss can be significant).
Finally, they know how to develop validation processes and are familiar with the equipment required to execute them.
Seal strength and pierce force specifications
Seal strength refers to the strength of the bond formed when blister materials are welded together via heat sealing. Pierce force is the force required to cause the blister to break to access the reagent for testing.
It’s critical that a blister’s seal strength be greater than its pierce force. If a seal is weaker than the force required to puncture a blister, reagent will leak out of the blister from the failure site and potentially damage the sensitive electronics inside an analyzer.
However, material capabilities and reagent chemical properties make for a tricky tradeoff.
For one example, some materials are incapable of achieving extremely high seal strengths regardless of how the manufacturing process is tweaked. For another, even if chosen materials and an adjusted manufacturing process do achieve a given seal strength and pierce force combination, it’s all for nothing if the reagent cannot tolerate those parameters.
Developers and manufacturing partners must learn in advance whether it’s more cost effective to iterate on material specs or manufacturing processes to accommodate actuating equipment characteristics, or whether revising the actuation process will allow for the use of more established and cost-effective materials.
Manufacturing expertise from J-Pac
Any successful reagent blister product development program hinges on the combination of the right materials and the right manufacturing process to produce blisters by the million without fail.
As such, J-Pac Medical’s diagnostic reagent blister service emphasizes design for manufacturability. This solution-seeking approach guides customers toward simplified product designs that reduce complexity and variability in manufacturing. It results in a more robust and reliable production program that saves time and money.
What reagent blister product development challenges do you face? Our engineers are ready to lend their eyes and ears to help identify the right solution. Talk to one here.