Focus: The Need for Innovation in Orthopaedics is Real
Challenges in orthopaedics have created new opportunities to innovate. Here, we look at two: delivery of care and manufacturing techniques....
Sep 08 2016,
Competitive Landscape
Reimbursement in Spine: A NASS Priority
In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making...
Sep 07 2016,
Resubmitting a 510(k) is More Than a Regulatory Decision
Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis...
Sep 07 2016,
Making the Most of UDI
UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own...
Aug 04 2016,
Medtronic, Zimmer Biomet Enter 2-level Cervical Disc and Robotic Markets
In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have...
Aug 04 2016,
Cartiva Receives FDA PMA for Synthetic Cartilage Implant
Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported...
Jul 27 2016,
FDA Guidance Outlines How to Create a Unique Device Identifier
FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier....
Jul 26 2016,
New Trauma Technologies Emerge to Treat Infections
Infection control has been on the radar of various orthopaedic device companies, from startup to top five. In the trauma...
Jul 26 2016,
How to Register Your Device in Australia
This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking...
Jul 13 2016,
3 Points to Consider from the Long-Awaited EU Medical Device Regulations
The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe. ...
Jul 11 2016,
What the Future of Orthopaedics Means for You
To thrive in the healthcare environment of tomorrow, device companies will need to operate within a greater portion of the...
Jun 23 2016,
Third Party Reviews – Is This the Real Deal?
Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and...
Jun 23 2016,
Trade Secrets Go Federal
Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA...
Jun 23 2016,
Invibio Settles FTC Antitrust Allegations Concerning PEEK Market
Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it...
May 25 2016,
FDA Issues Draft Guidance on Additive Manufactured Devices
FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among...
May 24 2016,