},
{
"type": "list",
"title": "",
"items": [
{ "text": "Shortage of critical-care nephrology nursesโa 14% vacancy rate in North Americaโlimits the effective utilization of devices and forces hospitals to rent extra units without full utilization, depressing ROI on upgrades.", "level": 1 },
{ "text": "Single-use filter sets remain priced at $270โ$310 per treatment, accounting for 42% of running costs; hospitals' inability to negotiate volume discounts suppresses year-round usage even when hardware is available.", "level": 1 }
]
},
{
"type": contrast",
"content": "Opportunities
The 2024 EU MDR grandfather clause allows mid-size CE-marked devices to be marketed after only a notification until 2028, giving US and Asian OEMs a fast-track entry with minimal clinical burden. The rise of home-based acute care, supported by CMS Acute Hospital Care at Home waivers, is forcing vendors to design small-footprint devices, opening a new $1.8B service-based revenue stream that will reshape the Continuous Blood Pur