Filling a medical devices void

Q: If big device companies like Medtronic don’t seem to think the pediatrics market is worth their time and effort, why do you think you can build a profitable pediatrics device business. Moran spoke with MedCity News about how PediaCath came together, his plans for PediaWorks’ next spinoff, and why it’s so tough to find cash to develop pediatric medial devices. This new device will vastly diminish surgical time and minimize the brain trauma caused by the procedure. So I did a Google search and used Google Translate to translate a number of websites from Japanese into English. But through this joint venture, it also is getting access to some of the top minds in interventional cardiology and gaining experience with the Food and Drug Administration approval process in the United States. If that’s the case, Moran appears the right man for the job, since he has plenty of fundraising experience, including helping two Cleveland Clinic spinoffs secure cash. I found that Medikit was selling small adult cardiac catheters that were approved for sale only in Japan, so I cold-called the company. During that process, a cardiologist I contacted mentioned that he’d heard of a company or companies in Japan making smaller catheters than available elsewhere. Q: What’s the biggest obstacle you’re facing or have faced as you’ve gotten PediaWorks started. My focus then was to find catheters from another source that could be re-purposed for pediatric cardiac applications. So far, PediaWorks has received some funding from nonprofits, but Moran admits that fundraising is likely to remain its largest challenge. We also hope to form more corporate joint ventures like PediaCath. He also worked in the administration of former Cleveland Mayor Jane Campbell, serving as the “ tech czar ” with the aim of helping develop technology companies in the region. Like many healthcare startups, PediaWorks was born from the entrepreneur’s personal experience. A: We are working on a new tool for brain surgery that will take a completely different approach to a standard procedure that hasn’t changed in 40 years. Another option is Small Business Innovation Research funding for individual spin-off companies. A father of four, Moran remembers hearing his prematurely born daughter scream in pain when the only available, excessively large airway mask was strapped to her head. Plus, most are regionally focused and shy away from medical-related projects. These benefits are especially important for children because they’re very sensitive to anesthesia, and brain trauma can have serious, lasting effects. A: Getting sufficient funding is the major challenge. Medikit’s interest in PediaCath is primarily humanitarian. How did you connect with Medikit and convince it to put $500,000 into the venture....

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FDA's Medical Device Innovation Initiative

To ensure continued access to innovative medical devices, which often fulfill unmet public health needs, CDRH is launching the Medical Device ...





US House Panel Questions FDA Device Regulation

WASHINGTON -( Dow Jones )- U.S. House Republicans said the Food and Drug Administration is overregulating medical-device approvals, and suggested the agency could be driving jobs and innovation away from the U.S.

"The United States' leadership position in the global medical-device industry is in jeopardy," Rep. Fred Upton (R., Mich.) said in his opening statement. "The overly burdensome regulations that are stifling American innovation and job creation must end."

Rep. Joe Barton (R., Texas) echoed the remarks saying the "FDA is unpredictable and discourages innovation, and that hurts patients."

Jeffrey Shuren, FDA director of the Center for Devices and Radiological Health, said in written testimony that the center needs better training for reviewers, improved oversight and better staff guidance on benefits and risks of devices. "We need to find the means to handle the ever-increasing workload and reduce staff and manager turnover, which is almost double that of the FDA's drugs and biologics centers," he said.

What type of paint is safe for use in medical devices?

I need to find a non-toxic paint (any color) that is approved for use in medical devices. I'm not sure of the actual application, but let's just assume it will be implanted into someone's body, so we can make sure it's VERY safe.
okay, how about


never heard of such a paint. most all medical devices that are implanted are made of different kinds of metals and maybe some kinds of plastic.

What are the US taxes and Tarriff for importing consumer medical devices to the USA?

The medical devices include some electronics and are aproved by the FDA as OTC.
(Class 1)


The Tariffs from US Customs & Border Patrol are here:



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