The blood industry is under intense regulatory scrutiny. Since it was discovered in the mid-1980s that HIV could be transmitted through blood, the public has demanded that regulatory bodies ensure a safe blood supply. Regulatory agencies have become extremely rigorous in product reviews. The U.S. FDA's Center for Biologics Evaluation and Research (CBER), which reviews Haemonetics' products, is very thorough in its review process.

Perhaps even more importantly, unlike medical devices used immediately by physicians after FDA clearance, blood technologies require further licensure. U.S. licensed blood collectors wishing to use the FDA-cleared technology are also mandated to have an amended license that ensures they themselves are capable of using the technology safely. Under scrutiny by the FDA, they are thus highly cautious about adopting new technology.

Haemonetics' Response: Automation

Automation has been cited by FDA as one way to improve quality by automating processes, including quality control procedures, which used to be done by hand. Automated collections exhibit better quality control over the end product – the blood component.