July 2018 | Volume 2


EU MDR and third-party audits--time-sensitive topics--were discussed between device companies and suppliers during an OMTEC panel. We recap the conversation.

M&A activity among top contract manufacturers continues with Tecomet's purchase of instrument supplier HD Surgical. 

Market Update: Patent, Funding Recaps

Technological innovations are occurring amongst smaller and growing orthopaedic companies, as evidenced by these strategic announcements:
  • Spine leads our review of 1H18 patent activity, followed by arthroscopy/soft tissue repair; all segments are represented, as are multiple countries.
  • The year-to-date funding announcements we've tracked include products that seek clinical trial data and that utilize technologies such as robotics and imaging systems. 

The recently-retired CEO of MTF Biologics  shares practical advice for industry newcomers and veterans alike, as well as predictions for the orthobiologics market. 

Current instrument options, according to orthopaedic surgeons on the OMTEC Closing Panel, lead to changes in surgical planning, downtime between surgeries, significant cost assumed by the hospital or ASC and inventory management issues.
While Lean and Six Sigma remain popular approaches to manufacturing, alternatives exist for performance improvement. Operations Science is a method in which success is built by making  decisions using practical, scientific principles.
Manufacturers need not rely on go/no-go gaging methods. With non-contact video and multi-sensor systems, not only can 100% inspection be realized, but speed and throughput can increase due to automated measurement routines.
Success in outsourcing  is complex and impacts your entire organization. Before you send a request for quotation, make sure you know why you're outsourcing, know what you're outsourcing, complete your due diligence and make sure your internal team is prepared.