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Source: Today’s Medical Developments
“The global medical device market offers opportunities for U.S. manufacturers, with large and small players showing adaptability and tenacity.”
Read More: Size and Shape of the US Medical Device Industry by 2016 ITA Medical Devices Top Markets Report
Size and Shape of the US Medical Device Industry Read More »
Source: mdtmag.com
Heat treatment standards are stricter in the aerospace industry than in the medical industry where lives are on the line. This doesn’t make sense and something is being done about it.
Click here to read more about how Bob Hill, President of Solar Atmospheres of Western Pennsylvania believes the medical industry could benefit from adopting quality standards from the aerospace industry.
Author: Bob Hill, President, Solar Atmospheres of Western Pennsylvania
What the Medical Industry Can Learn from the Aerospace Industry Read More »
Source: Stratasys Direct Manufacturing
Heat Treat Enhances Density of DMLS 3D Tools Read More »
Source: Today’s Medical Developments
The most commonly used medical device materials are stainless steel 304 and 17-4. These materials have a natural passive corrosion-resistant layer, consisting of chromium oxide, which resists repeated sterilization and has an inert surface that will not react inside the body.
During the manufacturing process, multiple machining steps can remove or degrade this passive surface by embedding iron chips and particles into the surface. The material must then be put through passivation to rebuild the passive layer – removing iron from the part’s surface, which also removes potential corrosion sites.
The style of mark required by the medical device industry is called a dark or annealed mark. This mark does not remove any material from the part, avoiding any potential for any contamination to collect. When handling the part, the dark or annealed mark must not be able to be felt on the surface of the material. The heat input needed to build up this oxide layer tends to degrade the passive layer on the marked surface and can cause local migration of alloying elements.
Read More: Laser Marking for Passivation and Corrosion Resistance by Geoff Shannon and Gary Firment
Laser Marking for Passivation and Corrosion Resistance Read More »
Source: Today’s Medical Developments
“According to the U.S. Energy Information Administration, manufacturing accounts for one-fifth of the annual energy consumption in the United States – approximately 21 quintillion joules (20 quadrillion BTU) or equivalent to 3.6 billion barrels of crude oil. To reduce this staggering amount and improve sustainability, manufacturers need to accurately measure and evaluate consumption of energy and materials, as well as environmental impacts, at each step in the life cycles of their products.”
Read More: NIST, Partners Create Standard to Improve Sustainable Manufacturing
NIST, Partners Create Standard to Improve Sustainable Manufacturing Read More »
Source: Today’s Medical Developments
“Our Austofix product design engineers, working with IPAS, were able to innovate within a flexible design and manufacturing process. This environment was key to our ability to take the prototype to market within such a short timeframe,” he said. “There are key components of the plate manufactured using 3D printing, this enabled us to create a complex design without the costs associated with traditional manufacturing. It also enabled us to bring the device to market quickly.”
Austofix has a number of products including a range of stainless steel and titanium surgical nails, which it exports to the Middle East and China.”
Read More: 3D Printing, Ultrasonic Milling Medical Orthopedic Devices
3D Printing, Ultrasonic Milling Medical Orthopedic Devices Read More »
Source: MPMN Medtec Pulse
The FDA has released “leapfrog” draft guidance for the rapidly evolving world of 3-D printed medical devices.
The agency based the guidance on input from device manufacturers, 3-D printing companies, and academics who testified at a 2014 hearing. The document covers device design, manufacturing, and design testing. For the purposes of the draft, FDA identified four main types of 3-D printing—powder fusion, stereolithography, fused filament fabrication, and liquid-based extrusion.
Manufacturers would have to clearly identify every step in the 3-D printing process, and might need to submit a “high-level summary of each critical manufacturing process step,” the guidance says. They would also have to document each step’s risk, and describe how they would mitigate those risks.
Read More: FDA has Important New Views on 3-D Printed Devices
FDA Has Important New Views on 3-D Printed Devices Read More »
Source: QMED – Qualified Suppliers to the Medical Device Industry
“The FDA last month designated a Medline Industries guidewires recall as Class I.
The Medline guidewire is identified as the ACME Monaco Guidewire .035×150 3MMJ TCFC item number 88241, with affected products distributed between March 2013 and August 2013.
The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries. It is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
The guidewires in question, however, have the potential for the coating to flake off of the wire, according to the FDA.”
Read More: 7 Recent Medical Device Failures Catching FDA’s Eye
7 Recent Medical Device Failures Catching FDA’s Eye Read More »
Source: 3D Print.com
“Stryker’s proprietary Tritanium technology has now been applied to spinal implants designed to encourage healthy regrowth of the bone tissue, and to reduce any strain or damage caused by being implanted. The Tritanium Posterior Lumbar (PL) Cage is a 3D printed intervertebral body fusion device that was developed to help patients dealing with lumbar spinal fixation due to ongoing back problems brought on by degenerative disc disease.”
Read More: Stryker’s Spine Division to Debut 3D Printed Tritanium Posterior Lumbar Cage Spinal Implant
Solar Atmospheres, Inc. has announced that it has become the first company to receive MedAccred critical process reaccreditation. Furthermore, Solar Atmospheres, Inc. successfully expanded its scope of accreditation to include Hardness Testing and Metallography & Microindentation Hardness. MedAccred is an industry-managed critical process supply chain oversight program which was developed by leading medical device companies to improve device quality and most importantly enhance patient safety.
The effort to establish MedAccred began in 2010 when the Performance Review Institute (PRI) was asked to consider the development of a Nadcap-style special process supplier accreditation program for the medical device industry. An industry roundtable was organized and convened in 2012 among interested medical device companies and PRI. Following this roundtable meeting, briefings were held with the FDA Center for Devices and Radiological Health’s (CDRH) Office of Compliance and the FDA’s Office of Global Operations within the Office of the Commissioner. The program purpose and scope was discussed, along with the results of proof of concept audits which were conducted to demonstrate the program’s viability. The FDA provided positive feedback and strong encouragement to pursue the development of the program.
By 2014, several critical process Task Groups were operating on a formal basis, program documents were drafted, circulated and approved by the executives of the participating companies and audit criteria had been published in several critical process areas. Solar Atmospheres, Inc. committed to hosting the first MedAccred audit.
In early 2015 the first MedAccred critical process accreditation was issued to Solar Atmospheres Inc. for Heat Treating.
Today’s functioning critical process Task Groups include Cable & Wire Harnesses, Heat Treating, Plastics Injection Molding, Printed Circuit Board Assemblies, Sterilization and Welding. The industry managed task groups develop audit criteria, conduct audits, and award MedAccred Critical Process Accreditations to leading suppliers at all tiers in the Medical Device Supply Chain. Many companies are seeking MedAccred Accreditation to demonstrate their commitment to quality and patient safety. Future MedAccred Task Groups under consideration for development include Material Testing Laboratories, Assemblies, PCBs, Batteries, Chemical Processing, NDT, Cleaning, Coating, Optics, Packaging, etc. Active OEM and Contract Manufacturer participants include: Johnson & Johnson, Philips, Stryker, GE Healthcare, Medtronic, NYPRO Jabil, Steris, etc. The list of participating suppliers is growing steadily.
Joe Pinto, Executive Vice President and Chief Operating Officer of PRI explained the significance of Solar Atmospheres’ accomplishment: “Gaining a critical process accreditation from MedAccred is recognition of a company’s commitment to quality and the high standards of critical process manufacturing which they maintain. The successful completion of a reaccreditation audit is a clear indication that a company is able to consistently uphold those extremely high standards over an extended period of time. I would like to congratulate the whole team at Solar Atmospheres on this important achievement.”
Solar Atmospheres Receives First Reaccreditation from MedAccred Read More »