COMMERCIALIZATION SOLUTIONS FOR THE ORTHOPEDIC INDUSTRY
OCTOBER 2019 | VOLUME 1

We spoke to leadership at Camber Spine, NuVasive, SeaSpine and Spinal Elements and saw debuts from Brainlab, Globus Medical, Medtronic and Zimmer Biomet. Here's what we learned this year.


Brainlab, Corin, DePuy Synthes, Exactech, Smith & Nephew and Stryker are enhancing their joint replacement and spine hardware offerings. We review what these technologies bring to the table.


Nine shoulder replacement implants, including stemless offerings, and one positioning guide have received FDA 510(k) clearance thus far in 2019. We recap each product's specifications.


Myriad complexities await those who wish to succeed in China. Dale Tempco has worked intensively there, and shares observations on culture, communication and the orthopedic market. 

Another way of asking this question using typical quality system language is to ask how to determine the scope of the validation, suggests guest author Carolyn Guthrie of Kapstone Medical.

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117 companies have confirmed their exhibit space to date. We plan for ~170 exhibitors. Check it out !

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Electric discharge machining (EDM), laser cutters and plasma cutters offer alternative ways to cut metal parts at different speeds. Here's what you need to know about these machine tools.

Conformis will supply patient specific instrumentation to Stryker. Innovasis signed a deal to access porous HA PEEK, and SeaSpine is entering the 3D-printed interbody space. 

Featured White Paper:

Use of intelligent software increases the accuracy of force measurement and material testing, and can free engineers to be more innovative with their designs. This paper addresses the role of software and automation in your testing plans.

Brainlab is back with more robotic technology. Epica announced a mobile CT imaging system now cleared for human use applications, and Onkos has enhanced joint sparing tumor procedures.

The October Issue of BONEZONE is available! Click to read the ePub .

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In keeping an eye on lesser-known companies, we noticed two up-and-comers to share. These small startups are increasingly appearing in the news, including recent announcements in September.
From the Archives:

Well-executed regulatory strategy can lead to a more predictable product development and clearance process. Know the regulatory requirements and applicable guidance documents, as well as their underlying intents. This popular article from FDA expert Mark Kramer remains relevant - have a look.


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