York Community Leaders Congratulate Madris Tomes & Device Events.

York, PA – October 11, 2017 – York County leaders congratulate Madris Tomes, Founder & CEO of Device Events, on winning the $100,000 investment from Steve Case’s Rise of the Rest competition on Tuesday, October 10th.  The win shines a light on York County as a place where innovation and the entrepreneurial spirit is alive and growing.

View Video…

Device Events Wins!  Steve Case selects Device Events as Rise of the Rest winner of a $100,000 Investment.

Central Penn Business Journal – October 10, 2017 – A York County businesswoman who created a software tool that identifies problems with medical devices rose above all of the others in “Rise of the Rest.”

Madris Tomes, founder and CEO of Device Events LLC, was chosen Tuesday from among nine entrepreneurs vying for a $100,000 investment from investor Steve Case, a co-founder of AOL.

Case has described “Rise of the Rest” as an effort to help budding entrepreneurs in middle America, those distant from the traditional tech investment hubs of New York, Silicon Valley and Seattle.

Read More…

Kevin Schreiber of the York County Economic Alliance interviews Madris Tomes of Device Events on Rise of the Rest competition.

York, PA – October 9, 2017 – Kevin Schreiber, President & CEO of the York County Economic Alliance interview Madris Tomes, Founder & CEO of Device Events, on being selected to compete in Steve Case’s Rise of the Rest pitch competition on Tuesday, October 10th.  Nine businesses were selected from eighty Central PA startup candidates to pitch their business vision, plan and objectives with the hope of winning a $100,000 investment from Mr. Case.

View the Video…

Entrepreneur shoots for $100,000 investment from AOL founder in Rise of the Rest pitch competition.

YDR.COM – October 2, 2017 – A mind-boggling amount of data exists about medical device failures. In some ways, it’s too much to make sense of.  Enter Madris Tomes of York County, who believes she has the answer.  Her company, Device Events, helps the healthcare community identify signals that medical devices could potentially be a problem to the health and safety of patients.  She applied, along with 80 other Central PA startup businesses, and was selected as one of the nine finalists to present to Steve Case in his Rise of the Rest pitch competition on October 10.  The Rise of the Rest is a three-year old nationwide initiative designed to support and promote entrepreneurs in emerging startup regions.

View the Video…

Device Events selected to present to Steve Case in the ‘Rise of the Rest’ pitch competition for a $100,000 Investment.

York, PA USA – 14 September 2017 – Device Events announced today that it has been selected as one of the nine finalists to pitch their company vision and business plan to Steve Case in their Rise of the Rest pitch competition on October 10.  The nine finalists were selected from over 80 Central PA startup businesses. The Rise of the Rest is a three-year old nationwide initiative designed to support and promote entrepreneurs in emerging startup regions.

Read More…

F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems

July 11, 2017 – WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.

Device makers will still have to quickly report any injuries or deaths related to their products. They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury.

The deal is part of a pact between the F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday.

“There are approximately 65,000 new adverse events every month, and you don’t have enough analysts to review those reports,” said Madris Tomes, who worked on such reports at the agency from 2010 to 2014. “They read them typically in order of importance, starting with deaths and injuries and malfunctions. When they come in the next day, they once again start with new deaths and injuries and malfunctions.”

Read More…

Women harmed by sterilization coils push FDA to act

June 6, 2017 – Philadelphia Inquirer – The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Read More…

Madris Tomes to Lead “Scope and Strategy AUDI Working Group”

February 8, 2017 – Medical Device Epidemiology Network – Madris Tomes has been selected to Lead the Scope & Strategy Team of the Augmented Unique Device Identifier (AUDI) working group.  There are a total of four working groups whose mission is to provide the framework for best practices in expanding the UDI-associated device system to manage clinically significant attributes not currently found in the GUDID.

Read More…

Tracking trouble – Entrepreneur develops software to keep tabs on medical devices.

January 20, 2017 – Central Penn Business Journal – The federal government fields some 70,000 reports a month on problems with medical devices, with implications ranging from minor to deadly. Patients, lawyers, doctors and others trying get a picture of possible problems with artificial knees, syringes and other devices don’t have the time to sift through all those reports. Madris Tomes of York County is trying to make sure they won’t have to.

Read More…