16 Jun Benefits of IVD Cartridge and Instrument Development by One Partner
We know assay is king when it comes to IVD product development. We also know that parallel cartridge and instrument development is required to hit milestones during fast-paced development programs. As diagnostic devices become more complex, the development requires more involved and interdisciplinary decisions about the cartridge and instrument interface. The ideal development team will architect, design and prototype BOTH your cartridge and instrument with a holistic view of the IVD system.
Key Benefits of IVD Parallel Development:
There’s no doubt that parallel cartridge and instrument development with one partner provides benefits to the client.
Those advantages can be boiled down to three simple things:
- Saving time – Streamlined processes done in parallel eliminate the need for one vendor having to wait on the other, wasting precious time. Additionally, for those occasions when challenges arise, they can be addressed quickly in both the consumable and instrument providing a shorter timeline to architecture freeze.
- Saving money – Parallel development also minimizes the chances of one system component being changed significantly without the other system being adjusted accordingly. This issue can cause months of delays and significant cost overruns.
- Preventing go-to- and post-market challenges – The holistic development of the product allows for intelligent decisions to be made from beginning to end; ultimately creating a better product for market. One vendor also allows for efficient solutions for those bumps in the road that happen.
1. Early De-Risking
Once the critical aspects of the assay have been defined, the team can determine what functionality may be needed in either the instrument or the cartridge. Developing these in parallel, under one roof, provides another layer of de-risking to the process; allowing teams to identify areas of risk, like thermal interface or volumetric accuracy, early.
Thermal risk typically needs to be addressed early because the temperature of the fluid in the cartridge needs to be controlled very precisely. However, typically the temperature cannot be directly measured. In order to optimize thermal control and performance, the IVD instrument and cartridge must be designed in concert.
Accuracy is essential when moving or aliquoting fluids on the cartridge. There are several variables that can affect volumetric accuracy including: the pumping method, material selection, fluidic channel/chamber geometry, fluids properties, etc. These factors make it even more important that the IVD cartridge development is done in parallel with the instrument.
With so many variables at hand, single partner, multidisciplinary de-risking prevents delays and ensures integrity as development progresses. For each step of the system, the cartridge and instrument should be broken down into their component parts and feasibility tested together.
2. Holistic Architecture Decisions
During the parallel development process, designers and engineers responsible for both the cartridge and instrument are always thinking ahead and asking questions that relate them both, like:
- What is the overall system going to look like?
- How is the user going to interface with the device?
- How does the cartridge get loaded?
- Where are the touchpoints?
- How big is the instrument and where does it live?
Not all questions are so broad. Many relate to specific interfaces such as:
- Fluidic handling
- How much fluid will be handed? Single microliter? 10 ml?
- How will fluid be moved? Blister and piston? Electronics?
- How will the instrument be kept from touching fluid and being contaminated?
- Fluid/reagent storage
- How are fluids stored?
- Will the fluids crystallize?
- How will evaporation be prevented?
- Is rehydration needed?
- Is a motor required to pop blisters containing fluids?
- Mechanical interfaces
- How will the cartridges be held? Clamps? Internal pressure?
- How is the cartridge inserted?
- Thermal interfaces
- How many temperature zones does the cartridge need?
- How can the multiple temperature zones be best managed?
- What thermocycling should be considered? What temperatures? How many cycles? How quickly?
- How will condensation be prevented?
- Optical interfaces
- Does the assay need an optical sensor?
- Where does the light need to shine?
- Where does the fluid stop?
- Magnetic interfaces
- Are magnets required? Where?
- Electrical interfaces
- Will the consumable require onboard electronics?
- How can success be ensured?
- Motor interfaces
- Is DNA extraction required? How should the motor be used to do this?
- Cameras
- Does this assay require cameras for fluid control?
The importance of these questions cannot be overstated because the answers affect everything that comes after. By developing the cartridge and instrument in parallel, these interdisciplinary conversations take place early and often.
3. Better Test Design for IVD development
When using one vendor for IVD device development, consumables are often more mature by the time the alpha build rolls around than they would be with two vendors, simply because they’ve had the opportunity to be de-bugged and de-risked earlier and more frequently in the process.
The one-vendor model enables rapid iteration on both cartridge design features and instrument features, allowing a systematic approach to enable the correct workflow and ultimately save months of schedule. With two vendors involved, the test bed may vary slightly in ways that are subtle but important and they don’t get caught until the cartridge and instrument are tested together.
Once the alpha phase has started, there are now prototype cartridges and prototype instruments that allow the vendor and the client to begin running tests on the chemistry.
4. Better IVD Product Software/Firmware Decisions
Developing in parallel can also ease the headache of determining where specific software and firmware are installed. While typically the software and firmware are almost entirely found on the instrument, sometimes a cartridge can have the assay workflow loaded onto it. When this happens, it is a lot simpler to work with one team that can make holistic, educated decisions about what code needs to be developed and where it needs to be loaded.
How Key Tech Can Help
“Our claim of integration is truly the case,” said Ben Lane, Key Tech’s Director of Engineering. “We have cartridge designers and instrument designers who are literally sitting next to each other and talking to each other all day long.”
The architecture phase is essential to getting a project started on the right foot, and our experience as a team is invaluable.
“Part of what enables that experience,” Lane says, “is that it is rare that someone leaves Key Tech. We have great retention and a collection of experience and knowledge under this roof that it makes that architecture phase go really well, so we can confidently dive into the design phase and not be worried about turning around and changing our direction.”
“The decisions that you make [with IVD parallel development] happen more efficiently, more quickly, and are in the best interest of the program and not the organization,” Lane said.
Let our expertise and parallel approach lead to your commercial success. We want to work with you on your next IVD product. Every challenge is different, tell us about yours.
