Lab Notes
2015 Edition no. 1
Features
From the Desk of Dawn Lissy
Evolution or Revolution?
From the Desk of Dawn Lissy
Medical Devices: The Auto
Industry 2.0?
Speaker Series Online
A few years ago we began building on the platform of
testing and evaluation services Empirical is known
for. Testing isn't performed in a vacuum, rather in a
context we'd grown to understand extremely well.
Our position as leader in the field provides unique
insight into the practices that make development and regulatory
projects successful. From this, our consulting business was
launched and has grown to be an integral part of the ways we
partner with our clients. Together we've seen...
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Completion of 54 510(k) clearances, including 17 in 2015.
Partnering with SpineFrontier for their regulatory clearance
of the first Invibio HA-enhanced PEEK implant in only 107
days.
Our Meredith May authoring a chapter in the Fundamentals
of US Regulatory Affairs.
Planning of our upcoming inaugural Quality and Regulatory
Workshop in St. Augustine, FL on November 5th, featuring
guest speakers on a variety of topics, including usability
studies and steam sterilization validation.
Being engaged in aspects of the development and regulatory
elements has raised the level of the device testing services we
offer. Whether it's ensuring a new and innovative design will have
the highest chance of regulatory success or delivering only the
necessary testing services on a budget, we'll optimize the testing to
fit your project's specific needs.
This expertise was the basis of my recent article for the good folks
at MPO and ODT magazines. The path to regulatory clearance is
tried and true, and with the right partner leads to quick
approval. I'm also excited to be part of the Women in Medtech
panel at MPO's upcoming Summit Meeting, September 29-30, in
Park City, Utah. If you make the Summit, please come say hi.
Upcoming Events
By the Numbers
Upcoming events
MPO Summit
(Dawn Lissy Presenting)
Park City, UT USA
September 29-30, 2015
North American Spine Society
(NASS) Annual Meeting
Booth #1203
Chicago, IL, USA
October 14-17, 2015
AAOS Annual Meeting
Orlando, FL, USA
March 1-5, 2016
By the Numbers
107 - Days for
FDA clearance of the
first HA infused PEEK
implant, submitted by
Empirical Consulting for
SpineFrontier
I hope you can take some time to visit our relaunched website at
www.empiricaltech.com. You'll find more info and contacts for all
three of the companies that make up Empirical - Empirical Testing
Corp., Empirical Consulting and Empirical Machine, our small-batch
manufacturing and prototype machine shop. We'd also love to hear
from you on our Facebook page.
Returning to the title question: We know your product
innovations are often revolutionary, so we adapt our business and
the services we offer to the changing regulatory and
industry environment. But we remain true to the testing platform
and the sound business principles and expertise on which you
depend as we evolve to meet your needs.
We appreciate your business, and wish you continued success!
33 - Days until MPO
summit meeting in Park
City
10 - New presentations on
Empirical's youtube
channel from the 2015
Speaker Series
Quick Links...
Our Website
Services
Dawn Lissy
About Empirical
Contact Us
Join Our Mailing List!
Medical Devices: The Auto Industry 2.0?
Empirical's Dawn Lissy outlines how the elements of device
approval evolve, but adherence to the fundamentals is the
recipe for success.
"So what does it take to earn that internationally
sought clearance or approval? It's rarely a smooth,
straight road to market, particularly for first timers
or innovators who don't have the backing of a major
international corporation."
With a perspective gained from years of partnering with device
companies throughout the development process, Lissy shares the
fundamentals of successful device approval, including
understanding the regulatory pathway at the outset, firmly
establishing and validating the role a product will play, and
navigating the regulatory highways with a broad view.
For further insights, see the entire article here.
Empirical Speaker Series Presentations Online
Innovators sharing the latest in the industry now available online
The Empirical Speaker series was again a highlight in
the Exhibit Hall of the 2015 AAOS Annual Meeting in
Las Vegas.
If you missed it, not to worry. The presentations are
at the Empirical Channel on YouTube, along with
those from our 2014 event as well.
In our 2015 event, presenters included Dr. Alfons Kelnberger of
CeramTec (pictured), Dr. John DeVine of Invibio, and Dr. Stephen
Spiegelberg of Cambridge Polymers, each sharing the latest in
research and applications for their materials. The current state of
regulatory and clinical trials development was shared by Jodi Scott
and Dawn Lissy, while Merle Richman provided best practices in IP
protection. Finally, Robert Havey presented functional assessment
of implants, Dr. Nadim Hallab explained particle analysis, Dr.
Michael Bauer provided the latest in tissue banking, and Dr. Jenni
Buckley shared the status of her program encouraging diversity in
orthopedics.
Be sure to check out these valuable presentations online, and we
look forward to seeing you at a future Empirical Speaker Series
Event.
Empirical holds A2LA accreditation for the largest number of medical device testing methods in
the United States. We have been partnering with you since 1998 as the global leader in
orthopedic device testing.