Medical Device General Discussion

crumbling due to a foundation built on sand. The Bible warned against thus. Ask Elmore

Ethicon weekly reports are a legendary waste of time.

Hello!

The 510(k) process is the focus of his argument --

In order to avoid stifling innovation, the FDA created a system called the 501(k) pathway, which allowed companies to avoid thorough testing for devices that are “substantially similar to one that had come before.” But this also created a dangerous loophole: As of 2017, Oliver reported, over 80 percent of medical devices are cleared through that system, including around 400 implanted devices per year. In this diluted process, products can be …

A number of them have of never had a discussion with a physician about what's important to them in a customer driven sales consultant, much less ever even seen the inside of an ASC or an OR. Yet, they have all the capabilities and intuitiveness to determine what successful reps, Directors, VP's and CEO's do to become successful??? Crazy! And no, I am not against GOOD, CREDIBLE recruiters. I do believe there are good ones and have used them routinely. But, dig deep and look at previous place…

My kind of guys for sure!

Has anyone seen CoreLink's Lateral Access System in a case?

Medical device company CoreLink Surgical launched its Lateral Access System and two implant systems — the F3D and CL5 Lateral interbody fusion devices — designed for lateral fusions, reports Business Wire.

Four things to know:

1. The F3D Lateral implant uses CoreLink uses 3D printing and finishing methods to develop the Mimetic Metal technology, which has a trabecula structure with interconnected 500-micron pores.

2. The implant is fus…

bye bye sales reps

Very cool tech -

It is accurate now, maybe not when it came out though.

Considering how many surgeries are moving towards robotic techniques, it's scary to think about how little experience some residents will have if robotic surgery becomes the standard of care in most specialties.

Anyone hear or have any familiarity with an upcoming robotic surgery company called Virtual Incision? They are developing a two-pound robotic device that operates entirely inside the body through a single abdominal incision and is expected to be less expensive and more portable than existing laparoscopic surgery robots. The company is gearing up to seek a 510(k) clearance for its device. I can't find much else except the story from MDDI.

Braun is still better.

I never realized how much money is at stake for surgeons who invent devices and then license them to medical device companies. As a sales rep, we are never exposed to the payment and contracting details but it can get ugly according to some of the cases I've been reading about. Not only can it cost the device company a pretty penny, the surgeon needs to ensure they aren't getting taking advantage of.

In a case I read about in the Indianapolis Business Journal, Indiana Spine Group President Rick …

Right but how many of the narcissistic managers in the medical device industry listen to this advice?