Trauma and Spine Gain New Players with First 510(k)s in 1H17
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine...
Aug 07 2017,
Competitive Landscape
ConMed Acquires MedShape’s ACL System to Boost Arthroscopy Portfolio
Revamped marketing and R&D priorities, product launches, recent licensing agreements and now, an acquisition and portfolio expansion with the ExoShape...
Jul 27 2017,
Hip and Spine: New Players Receive FDA 510(k)s
Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one...
Jul 24 2017,
Zimmer Biomet CEO Resigns
Zimmer Biomet announced preliminary 2Q17 overall results alongside news of the departure of David Dvorak, its CEO of ten years....
Jul 12 2017,
Reimbursement Tips: Four Things Payors Want
The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in...
Jul 11 2017,
Arthroscopy/Soft Tissue Technologies to Watch: 1H17 Funding Recap
Funding announcements that we tracked from orthopaedic companies in 1H17 included eight arthroscopy/soft tissue-related technologies we’d like to highlight because...
Jul 11 2017,
Want to Talk About Your Invention? Follow These Five Rules
Before you show your invention or share your idea, get familiar with these five rules to protect yourself and your...
Jul 10 2017,
Infection Prevention Spurs New R&D Ideas
Post-surgical infection control remains a topic of importance in orthopaedic product development, as surgeons, researchers and device companies continually seek...
Jun 22 2017,
May 510(k) Review: New Players in SI Joint Fusion, Hip Recon
Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen...
Jun 21 2017,
R&D Recap: Leading Orthopaedic Device Company Product Initiatives
Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players,...
Jun 06 2017,
Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage
While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing...
Jun 06 2017,
Proving Your New Design is Production Equivalent
Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh...
Jun 05 2017,
Don’t Treat Your FDA Inspection Like an ISO Audit
Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems....
May 16 2017,
Pareto Analysis: Tools for New Product Testing
Testing is, of course, a critical component to product development. To better understand how it can be proactively employed to...
May 10 2017,
Elos Medtech’s Advantage Lies in Nimble Approach to Serve Orthopaedic Customers
As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S....
May 10 2017,