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How to get your medical device accepted for use in hospitals

Ryan Amin on October 29, 2013 Source: MedCityNews.com

In healthcare innovation, fixing a problem is not enough for a product to become a standard in the industry.

Jill Drew and Kelly Reif co-founded NoNo Sleeve, but faced many difficulties for their simple solution to a common problem.

The NoNo Sleeve acts as a large stop sign to warn nurses not to do IV hookups or blood tests on a type 2 diabetes patient's arm that has an arteriovenous fistula. Using arms with AV fistulas (a surgically created access point for dialysis) for IV hookups or blood tests can cause complications with blood clots, drainage and the lymph system. Drew and Reif are both registered nurses who have seen this problem occur many times.

The sleeve is a cost-effective solution, according to Drew and Reif, but they said hospitals are still hesitant to commit even if they are the least bit unsure. "A lot of hospitals are trying to save money because reimbursement is down and the future of healthcare is unsure," said Reif.

The co-founders understand that their product is simple and useful, so they were not expecting such resistance from hospitals for a low-cost product.

"It has never been an issue that people don't like the product," said Drew. "It is always about cost. All hospitals now ask us is if we are part of a GPO because they want the lowest possible price, but we are not part of a GPO because GPOs won't go with us unless hospitals are buying from us, so it is a catch-22 in the present time."

The most important thing the co-founders agreed on was to never give up during the process of getting a medical device in the hospital. "You can't take anything personal and let it make you rethink your product," said Reif. "You have to keep hammering for communication, and understand your email or message is not the only one in their inbox."

Other tips from Reif and Drew:

Mentorship - "Have an adviser in the industry who understands the business side as well." Mentorship played a huge part for Drew and Reif because their nursing background did not prepare them for the business of healthcare. "Advisors will inform you exactly who to talk to and what points to talk about, and that can be a huge time saver."

Stay current online - "I didn't even know what twitter was," said Drew. "But now it is a common part of how people run businesses now and communicate with a larger customer base." The website is updated with patient and doctor comments to help people feel more comfortable with using new medical devices.

[Photo by - PHOTOS GOVA]

Category:  Creation  Execution  Tags:  Entrepreneur, Startup, Medical Device, Business Plan, Communication

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