Top Five Considerations in Microfluidics Disposable Product Design
One thing that we are frequently asked is, “What are the most important things to consider in microfluidic IVD disposable product design”? Although each product is different, the process remains the same: define the system requirements, define the instrument/ disposable interactions, and then define the instrument and disposable requirements. At Phase Three, we do all of this within the framework of ISO 9001 and 13485 Design Controls so that the design process is understood, controlled, and well documented.
Once the disposable requirements are defined we then keep these considerations in mind during the design process:
1. On-board reagents
Simplicity of use by the end user is often assisted by clever integration of on-board reagents. At Phase Three Product Development we have extensive experience with lyophilized reagents, fluid release blisters, fluid mixing strategies, liquid and material compatibilities, particle suspensions, bulk fluid additions, and many other areas related to effectively utilizing on-board reagents.
2. User-instrument interaction
A product’s overall success often relies in part on the end user having a positive interaction with the instrument and disposables. Instruments that have high technical ability, but are difficult or tedious to use are not desired. This is why Phase Three Product Development constantly is considering how to design disposables that are pleasant for the user to interact with from the very start of the project. Simplicity of use for the final product requires smart engineering throughout the design process.
3. Manufacturing strategies
It is important to keep large volume production in mind when designing microfluidic disposables. Designing a part with a strong manufacturing strategy helps lower long-term production costs. At Phase Three we consider traditional manufacturing processes, such as injection molding, as well as emerging manufacturing methods to streamline the process and minimize long-term cost for the customer.
4. Fluid movement options
The field of microfluidics offers multiple ways to direct fluid through channels. Capillary action is a passive technique to direct fluid movement, and can be controlled by precise engineering of the fluidic channels. Active fluid movement methods using a pump to create positive or negative pressures are often effective, versatile fluid movement solutions. Pumping can be directly integrated into the instrument or generated by an interaction between the instrument and microfluidic disposable. Digital droplet technologies can be very attractive using both air and oil for droplet separation due to the small fluid volumes possible. Material properties including hydrophobicity and surface roughness can also help control fluid. Phase Three has a well-developed toolbox of fluid movement strategies to reliably and consistently move small volumes of fluid through microfluidic architectures.
5. Cost
At Phase Three, we strive to optimize the design, materials, and manufacturing methods to reduce the cost of microfluidic disposable production. It is important to consider cost saving strategies throughout the design process to ensure the microfluidic consumables are developed on budget and on schedule.
As you can see it is a very complex process, but we bring many tools and years of experience to make the design tradeoffs needed to help our customers arrive at the goal. If you would like to discuss your project in detail, please contact Kris Buchanan at Phase Three Product Development at kbuchanan@phasethreedev.com.