eNews February 19, 2020

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Does your product fit into existing workflows?

You may think your innovative medical technology will be adopted because of its potential for improved patient outcomes or lowering overall costs, but if it adds steps or if it changes a procedure, you’re interrupting people — and they don’t like that. In an opinion piece in STAT, two executives from MedTech Innovator (a nonprofit competition and accelerator for medical device, digital health, and diagnostic companies) cite 10 reasons why startups fail, including this one about workflow. “New technology should fit as seamlessly as possible into existing workflows, not delay or interrupt them,” they write. “That’s why it is essential to learn every step and every aspect of a customer’s workflow and every person who will be affected by it. A surgeon might love your technology, but if it adds too much work for nurses or technicians, an adoption hurdle looms. Conduct discovery, focus groups, and user testing with everyone in the workflow and in as many environments as possible.”

AI and ultrasonography

A recent FDA decision brings artificial intelligence into the ultrasonography suite and into the hands of medical professionals who may not be experts in ultrasonography, such as RNs. Earlier this month, the agency authorized Caption Guidance to market its software to assist medical professionals in acquiring cardiac ultrasound, or echocardiography, images of acceptable diagnostic quality. The software is an accessory to compatible diagnostic ultrasound systems.

Sepsis in hospital rising

U.S. hospitals saw a 40 percent increase in the rate of Medicare beneficiaries hospitalized with sepsis over the past seven years, with an estimated cost to Medicare of more than $41.5 billion in 2018 alone, according to a study by the U.S. Department of Health and Human Services. Researchers determined that the increase was not due to the growing number of American seniors enrolling in Medicare. (From 2012 through 2018, the U.S. saw a 22 percent increase in Medicare enrollment rates but a 40 percent increase in the rate of sepsis-related hospital admissions among beneficiaries.) Most patients with sepsis arrived at the hospital with the condition, rather than developing it in the hospital, a possible indicator of success for CMS efforts to reduce hospital-based cases of sepsis. However, two-thirds of sepsis patients had a medical encounter in the week prior to hospitalization. This finding represents an opportunity for improved education and awareness among patients and healthcare providers, as well as the need for diagnostics to detect sepsis early.

Supply chain and Novel Coronavirus (COVID-19)

The FDA reports it is on the lookout for potential disruptions or shortages of medical products due to COVID-19. In a Feb. 14 statement, Commission Stephen Hahn said, “We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our … approach to identifying potential disruptions or shortages. The FDA has dedicated additional resources to review and coordinate data to better identify any potential vulnerabilities to the U.S. medical product sector, specifically from this outbreak.”