Making a Device Design Change? Document These Critical Steps
No matter where you are in the design process and no matter your internal procedures, control and documentation of design...
Jun 28 2018,
Competitive Landscape
Zimmer Biomet Responds to FDA Form 483
The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf...
Jun 28 2018,
Hospital, Surgeons Provide Insight Into Purchasing Priorities
The OMTEC® 2018 opening Keynote Panel offered perspective on hospital actions and priorities while addressing critical industry topics including pressure...
Jun 21 2018,
Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies
The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint...
Jun 20 2018,
FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances
To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first...
Jun 20 2018,
Generic Device OEM Defines Value in Orthopaedic Care
We are witnessing the transformation of healthcare - the push to capture cost and outcomes data to support moving from...
Jun 19 2018,
FDA Clears Artificial Intelligence Software for Wrist Fractures
Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze...
Jun 06 2018,
Prototyping: OEM Survey Highlights Challenges
We surveyed engineers and senior-level employees from orthopaedic device companies of all sizes, asking about prototyping, 3D printing, in-house vs....
May 31 2018,
Laser Marking: Suppliers, OEMs Both Reaping Benefits of Versatile Technology
"The laser is one of the most versatile tools an engineer has," one supplier says. "Lasers can not only be...
May 30 2018,
Executive Interview: Elos Medtech Commits New Investments to Orthopaedic Market
Jodie Gilmore, Managing Director of Elos Medtech Onyx, explains how the company is developing cross-site relationships and building out capabilities...
May 29 2018,
Why the Inadvertent Release of Non-Conforming Products is Reportable, Recordable
It is recommended to err on the side of caution in these situations and report the product release, as well...
May 29 2018,
Mid-Journey on the Road to the Forgotten Knee
Much was achieved in total knee replacement during the last 45 years in materials, design and computer technology. Robert A....
May 23 2018,
Optimizing Your Supply Chain with Science, Data and People
It is recommended to implement your optimal management of inventory, capacity and response time buffers to get the best possible...
May 21 2018,
coflex Gains Disposable Instrument PMA, NASS Coverage Policy Recommendation
These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles....
May 04 2018,
Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%
Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market....
May 04 2018,