Blog

17Jun 2017

It takes a certain level of passion and perseverance to break new ground. For the innovator introducing a disruptive technology to improve patient outcomes and lives, the creativity fueling the process of getting a Class III device to market is rivaled only by the determination and dedication to prove that device’s safety and effectiveness. Read […]

20May 2017

For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA that the device—for which there’s no comparable predecessor—is safe and effective enough to be used on patients. Read more […]

06Apr 2017

It was a lot to take in running on about five hours of sleep following an international flight complete with a lost luggage cliché. Representatives from multiple agencies—governmental, regulatory, medical device companies, hospital purchasers, materials experts, testing laboratories, and more—were coming together in Lima, Peru, for a workshop on medical device regulation and standards. Read […]

12Jan 2017

When Cartiva Inc. successfully sped through their Class III device premarket panel in less than half the average time—71 days instead of 159—that caught my attention. For more than 18 years, the Empirical family of companies has partnered with medical device developers to bring new products to market. Read more in MPO Magazine…

26Sep 2016

As I prepped my two young sons for the new school year, it wasn’t just about the hunt for supplies and stocking the pantry with healthy lunch options. Maybe the tone of the presidential election coverage has thinned my skin, but as the first day of school drew nearer, I found myself spouting frequent reminders […]

14Apr 2016

In Dawn’s most recent column for ODT Magazine, Dawn interviews Dr. Michael J. Bauer about how tissue-based products are affecting the development of new treatments and what that means for the medical device industry. Read more here: Blood Will Tell.

04Apr 2016

R&D Update

April 4, 2016

With economic uncertainties, mergers and acquisitions, legislative issues and other factors, research and development for orthopedics hasn’t been as robust as it was a few years ago. But we’re really encouraged by this piece in ODT that turns to thought leaders for their take on the state of R&D and how this affects our industry. Kudos […]

23Mar 2016

Jenni Buckley has done it again. Our good friend, brilliant engineer, inspiring professor at University of Delaware and co-founder of The Perry Initiative has won the Trabant Award for her contributions to women’s equity. Jenni is a frequent speaker for Empirical and the reason our own Dawn Lissy supports the Perry Initiative. Jenni has dedicated her […]

17Mar 2016

For St. Paddy’s Day, we’re wearing green, stealing pinches, thinking about stout and sharing this cool feat of Irish engineering. The Boyne Viaduct was built more than 160 years ago to connect Belfast and Dublin. It was a huge undertaking that entailed all kinds of problems and issues, but once it was done, it was […]

03Mar 2016

Odds are most of the Empirical team is walking the floor of AAOS 2016 this week, but someone’s always holding down the fort. It’s our own version of Florida Mission Control. Stop by and say hi and learn how the Empirical team can help you bring your medical device to market.

17Feb 2016

For her February column in MPO, Dawn gazes into her crystal ball to predict common roadblocks on clients’ path to market. Because she works both with medical device innovators and regulatory agencies, Dawn sees both sides of the industry. Learn more from her experience here. Watch movie online The Transporter Refueled (2015)

02Feb 2016

Dawn Lissy, CEO and co-founder of Empirical, is always surprised and humbled when people want to hear her story. She was particularly flattered to be featured in Spark, a KICVentures Health-Tech news site. We really appreciate Spark taking the time to chat with Dawn about her professional and personal journey.

28Jan 2016

Empirical President Dawn Lissy and her trusty sidekick, Meredith May, VP of Empirical Consulting, are in Dubai for Arab Health. It’s a huge tradeshow that draws people from all over the world to come together to find out what’s going on in a range of health-related industries, including medical devices and orthopedics.Watch Full Movie Online […]

20Nov 2015

Like everyone else in the medical device industry, we’re working for the best possible outcomes for patients. So we thought the news in this article from Becker’s Spine Review was interesting. Check out the five key findings of a study comparing ProDisc-C and spinal fusion.

05Nov 2015

Thanks so much to everyone who’s come out for our North Florida Medical Device Workshop in St. Augustine, Fla., today. We’re off to a great start with this stellar list of speakers, and we really appreciate everyone who’s joined us today for an in-depth look at how to get your medical device to market as quickly […]

03Nov 2015

Dawn had a great time at the recent MPO Summit in Utah September 29. She was invited to speak on a panel about women in medtech, which was also the topic of her most recent byline in MPO Magazine. After the panel, MPO conducted a brief video interview with her. You can watch it here. […]

28Oct 2015

From the Desk of Dawn Lissy:Watch movie online The Transporter Refueled (2015) We hope where ever you are, the turn of the seasons finds you well. For us here at Empirical, with burst of color in our Colorado fauna came a trip to NASS in Chicago. It was a great event — we really enjoyed catching up with old friends […]