Eric Olson is the chief executive officer and president of Amedica, the only company that produces medical grade Silicon Nitride. He took a moment to participate in the following Q&A about the unique material and its impact in medical devices, specifically in the orthopedic implant area.
Ordinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...
Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.
While the advent of electronic health data offers impressive potential when it comes to treatment and diagnosis, it brings with it a host of security issues. The issue is cumbersome and often slow-moving regulatory bodies are scrambling to keep up with the quickly changing landscape of the medical world and they’re leaving a path of semi-regulation in their wake.
Nowhere is the concept of developing a system with ‘point-products’ more hazardous than in medical devices. It is here that the performance of every aspect of the system is critical to the long-term behavior of the end product. Interoperability between components takes on a whole new meaning in the context of critical care. Like Shelley’s monster, multiple devices from multiple suppliers will perform differently under identical conditions.
On average, implantable devices account for 30 percent of total hospital supply spend, and make up 50 to 80 percent of the total cost for some procedures. Despite these large numbers, processes around managing and tracking these devices are rife with inefficiencies and revenue leakage.
Training is extremely important to the future of manufacturing in the United States, yet in many states, it has fallen by the wayside. Training for skilled manufacturing positions has been hit by a perfect storm of budget cuts and the mistaken idea that all young workers should go to college. What training exists has a near-exclusive focus on non-manufacturing skills.
It’s no secret that getting a medical device to market can be a lengthy, frustrating process. Facing the new medical device excise tax and lack of clarity from the FDA around regulatory policies, medtech startups are now starting to rethink launching in the U.S.
For companies involved in designing and developing medical devices and diagnostic instruments, adhering to design control principles at every stage is critical. This begins with the identification of user requirements (voice of the customer) and continues through verification and validation testing.
Design engineers are charged with creating reliable, high quality, safe medical devices that easily (and quickly) pass U.S. FDA and other geographies’ regulatory requirements. Because of the unique challenges that a medical device OEM must overcome to stay competitive, more and more OEMs are choosing to outsource manufacturing.
Wireless healthcare is upon us. Each day, it seems more devices and technology are becoming untethered or new capabilities are being added to wireless devices. No longer are the applications of wireless devices limited to patient monitoring, but rather an array of therapies are now available for treating patients at home or even on the go.
Critics of the new 2.3% medical device excise tax are hitting new heights with their claims of dire consequences. Conservative blogger and attorney Johnathan Emord blogged that the tax will "wipe out an entire industry," and further asserts that the tax is "one of the most draconian tax burdens in history." What are the facts? Is the industry overreacting?
Unique energy-based surgical devices afford broad clinical use in the cutting, coagulation, and ablation of tissues using a high velocity jet of thermal plasma, and the PlasmaJet surgical system is one example of this medical device evolution. Plasma is formed when sufficient energy is added to remove outer electrons from a gas to form ions.
In an era of intense media pressure, growing patient power, and escalating litigation, it is extraordinary that so many medical device recalls are due to labeling errors. After years of robust, highly compliant medical research and product design, ensuring the correct information is included with each device should be a given.
Miniaturization of medical devices is dependent upon the reliability of their assembled components, which is crucial for proper functioning devices. Miniaturization creates material challenges—especially in electronic medical device applications such as implantable cardiac devices.