Additive
How the EU’s MDR Will Impact Your Supply Chain
The forthcoming EU Medical Device Regulation will impact your supply chain, both in manufacturing and distribution. You must talk with your partners now to ensure that you possess the information you need from themand they from youto meet regulatory requirements, your timeline for CE Market Approval and critical considerations for audits. Mike Wolf, Director of Solutions Delivery at Maetrics, outlines some talking points for you and your suppliers.
Contract Manufacturer M&A: 2017-3Q18
Merger and acquisition activity is shaping the broader orthopedic supply chain base, with contract manufacturers of all sizes transforming in the last decade to keep pace with their scaling device company customers. We've identified three M&A trends in this portion of the market.
Contract Manufacturing Market Primed for Growth
The orthopaedic contract manufacturer market comprises hundreds of companies that serve orthopaedic device manufacturers and, in many cases, other contract manufacturers. We estimate that revenue for this market reached $5 billion in 2017, +7.6% or $360 million from 2016, as published in THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.
Medacta Gains FDA Clearance, Announces First U.S. Procedure for Hip Implants
Medacta received FDA 510(k) clearance to market its Mpact 3D Metal and Augments 3D Metal implants for use in total and revision hip arthroplasty.
Renovis Surgical Receives FDA Clearance for Tesera X Lateral Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusion system.
Nexxt Spine Clinical Trial Evaluating 3D Printed Ti vs. PEEK
Nexxt Spine commenced a clinical trial evaluating Nexxt Matrixx® 3D-printed lumbar interbody fusion devices vs. PEEK cages.
Spine Company M&A Picks Up in 3Q18
We've tracked 31 mergers and acquisitions in the spine space from 2017 through mid-September 2018...with eight of them happening in just the last four weeks. The global spine market comprises nearly 300 companies; players need broad portfolios or novel technologies to vie for market share today.
Joint Reconstruction Expected to Continue with Steady Growth
The 1H18 performance of companies that make up ~80% of the joint reconstruction market achieved 4.1% growth vs. 1H17. These companies posted 2.4% growth in 1H17 vs. 1H16. Here is a look at past activity and future predictions for hip, knee and extremities.
NASS Conversations Reaffirm Spine’s Focus on Additive, Computer-Assisted, Materials
The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.