Suppliers Speak to Economic and Regulatory Challenges in Global Expansion
New market entry presents logistical hurdles for every company. Suppliers provide insight based on their own experience of opening overseas operations. Jul 09 2014,
Materialise Certifies HP Printers for 3D Printed Anatomic Models
The certification ensures that medical professionals can use HP 580 series printers with Mimics software to print patient-specific anatomical models for diagnostic and surgical planning purposes. Jun 03 2019,
The Unknowns of Surgical Drilling
A study by The Oregon Manufacturing Innovation Center, Research & Development team finds change to design and materials can extend the lifespan of orthopedic drills. Mar 22 2021,
EU Proposes Significant Changes for Importers and Distributors
The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, which differs from the current fragmented national regulation. Dec 10 2014,
Pssst…It’s a Secret…Don’t tell anyone!!!
Remember back to your youth when keeping secrets was an everyday occurrence? Sometimes it was between classmates or siblings, and... Jun 30 2010,
How Far is “Possible” for Risk Management?
A controversial interpretation of the medical device CE Marking requires risk reduction without room for economic consideration. This approach conflicts directly with the Essential Requirements of the European Medical Device Directives. In order to comply, manufacturers need to carefully review procedures and risk management files. Apr 09 2014,
Regulatory, Reimbursement & Clinical Challenges in the Orthopaedic Marketplace
The medical device industry faces a number of significant challenges. Federal health care reform, unpredictable U.S. regulatory pathways and an... Jun 30 2011,
Catalyst Granted 510(k) for Convertible Stemmed Total Shoulder
Catalyst OrthoScience is reportedly the first to market with a fully convertible system that features an ellipsoid anatomic head. Feb 15 2023,
Is Depreciation Expense a Misleading Illusion?
“Sunk costs are irrelevant" is a principle stated in Shlomo Maital’s book "Executive Economics" and in almost every book on decision making ever written. Despite this well-accepted principle of decision science, most companies continue to include their biggest sunk cost as a major factor in determining product and process costs as well as in other decision making situations. Oct 04 2012,
Ricoh Gains FDA Clearance for Orthopedic Anatomic Modeling
RICOH 3D for Healthcare received 510(k) clearance for its craniomaxillofacial and orthopedic patient-specific anatomic modeling. Jun 16 2022,