The FDA has released final guidance for a new, voluntary review process that would streamline its review of devices and device-led products designed to treat non-life-threatening diseases and make available medical treatments safer.
Modeled on the agency’s breakthrough devices program, the Safer Technologies Program (STeP) would cover devices that could improve the safety of treatments or diagnostics for underlying diseases or conditions that are less serious than those eligible for its breakthrough devices program The breakthrough program is for devices designed to treat life-threatening or irreversibly debilitating diseases or conditions. By Nancy Crotti
I talk with orthopedic folks in different companies every day. It astonishes me how many people in our industry get caught up in the inertia of the successes of the 20th century. When business is healthy and growing, people fall back into historic business behaviors.
While these default orthopedic folks are sleeping, new disruptive orthopedics companies are challenging the status quo with a new thinking in orthopedics.
It is estimated that today, roughly one third of all healthcare spending is wasteful, providing no benefit to patients — and that wasted money amounts to a humbling $1 Trillion. Further, studies show that hospitals waste $12 Billion per year on poor communication.
With increasing numbers of big name hospitals reporting decreases in operating margins, this is an alarming trend. But where is all of this money going? According to a recent Forbes article, a few of the biggest culprits of the dismal state of hospital financial health are: “purchasing redundant, expensive medical equipment … and … tolerating massive inefficiencies in care delivery (see ‘the weekend effect’).”
Get onboard with digital patient health or get run over
A new report exhorts the medtech industry to invest in customer-centric capabilities and digital collaborations to build personalized health solutions or die by being outgunned by tech companies with deep expertise and data-driven consumer solutions.
A report released this week at the annual conference of the trade association for medical device and diagnostics companies had a stark message to deliver: invest in customer-centric capabilities and digital collaborations to build personalized health solutions or die.
Die by being outgunned by large tech companies with deep expertise data-driven consumer solutions and unlimited deal making capability.