3 Game-Changing Advancements in IVD Product Development

You know that medical technology advancements to IVD product development reduce cost, increase efficiency and speed time to market.

Keep an eye on these three advancements to improve your IVD product development project:

  1. Diverse Disposables
  2. Off-the-Shelf Lab Automation
  3. Virtual Prototyping

IVD Disposables Getting ‘Smarter’

CD4 IVD lab on a chip

KMC developed an IVD POC instrument that uses this biochip technology.

High patient costs have driven a demand for more complex disposables that reduce costs otherwise incurred from lab work, additional parts and labor.

According to a recent MDT article, “In the past five years (2009-2013), molecular diagnostic near patient or POC companies have raised over $650 million in investments, financings, and (to some extent) public offerings. This total does not include grants and other sources of support that are available, especially from the programs that are trying to promote development of tests for use in resource-limited countries.”

This intelligent technology moves IVD testing from the lab to the point of care.

Smart disposables now incorporate the use of biosensor technology, shifting some electronics from the large instrument platform to a small chip.

KMC developed a customer's Point-of-Care Cell Analysis System, which contained a biochip disposable cartridge (pictured above).

Although this particular example doesn't integrate biosensor technology, there is an intimate relationship between the biochip and the instrument. The biochip has both liquid blister packs and powdered reagents on board. As the blister packs burst, plungers with tuned motor-control software manage the flow of reagents for automated micro-channel mixing.

Just this April, the National Institute of Standards and Technology (NIST) announced its discovery of how to implement valves in lab-on-a-chip microfluidics devices.

Large OEMs are developing new platforms to capitalize on the benefits on these technologies.

OTS Lab Automation Creation

KMC's IVD product lab automated pipettor

KMC's robot automates pipetting for IVD products.

Just picture it.

Robots lifting sample trays, sample processing slides flipping, pipettors stopping at just the right moment to aspirate … and it just keeps running smoothly … like magic.

Lab automation: essential in IVD platform development

Add scalable and flexible off-the-shelf solutions - and savings compound!

A recent MDDI article states:

Laboratories worldwide are facing similar challenges, fueled by greater demand for diagnostic testing, shortages of trained technologists, new quality mandates for health providers, and changing reimbursement policies. The key challenge for medical testing laboratories of all sizes and their suppliers is to find innovative and cost-effective ways to improve testing efficiency, eliminate errors, conserve labor, and relieve workload pressures.

Lab automation coupled with scalable, flexible off-the-shelf solutions improves test efficiency, and reduces errors, labor and workload pressures.

For example, KMC has developed lab automation XYZ robots with hardware and software that can be customized to fit specific customer needs.

Imagine the IVD-product-automation possibilities … then talk to your team or a contract medical product developer to realize those automation concepts!

Virtually Cost-Free

KMC uses virtual prototyping software in IVD product development.

KMC uses virtual prototyping software in IVD product development.

Cost-free? OK, not really. But, the cost-saving benefits of virtual prototyping are significant.

Virtual prototyping allows you to simulate and evaluate instrument architecture and concepts in a virtual environment, avoiding the cost and time associated with fabrication and building hardware to test. Not to mention the risk of manufacturing a mistake.

In 3 Strategies for Assessing IVD Medical Product Development, Stacy Tuccolo states:

By enhancing a simulation model to accurately reflect the processes of an instrument, potential bottleneck issues and interaction conflicts are uncovered before the design process even begins. KMC performs simulation via a computer-based model in a manner that mimics the proposed system architecture to:

    • Describe the interaction between samples, reagents and disposables
    • Define required resources such as sample and reagent racks, ovens, pipettors, transports, detectors
    • Determine required activities such as washing, heating, detecting and mixing

Optimize your IVD product development project through advanced disposables, lab automation and virtual prototyping to keep up with the latest medical device advancements – and give your customers cost-saving products that will keep them coming back for more.

What other advancements impact IVD product development? Let us know in the comments below!

Next, check out our Three Strategies for Assessing IVD Instrument Feasibility Early in the Design Process white paper.

KMC IVD Development White Paper

Topics: medical device development, ivd product development, ivd medical instrumentation, medical instrumentation development, ivd instrument development, In Vitro Diagnostics