
Over the last two decades there have been numerous technology breakthroughs including thermodynamics, optics, microfluidics, fluorescence detection and high precision motion control to serve the challenges of automation within many biological applications such as hematology, PCR, immunology and microbiology.
In the past, the significant challenges for designing in vitro diagnostic (IVD) products were to replicate labor-intensive activities through automation, maintaining the precision and quality of human skills while dramatically increasing throughput, thus justifying the development investment. Later, new diagnostics challenges required technology breakthroughs to enable instrument systems to carry out tests and assays that lab technicians could not achieve manually. Sample volumes have reduced, temperature controls have become more precise, micro-particles and cell counting require the best engineering solutions to allow biologists access to a new range of data. But with these technological advances, instrument complexity has risen while at the same time there has been significant pressure to maintain instrument prices.
In parallel with the increasing technology challenges, the industry has also witnessed further changes such as more scrutiny on risk management by regulatory bodies, the gradual rise of the Point of Care industry and the associated rise in instrument production volumes, and gradual expiry of key patents such as many associated with PCR. While this shifting landscape may be perceived by some as further constraints on business, other instrument developers and contract manufacturers see it as a great opportunity to add lean design principles to their repertoire.