These days, savvy medical device engineers, designers, and manufacturers are partnering with suppliers to accelerate new products to market. Whether it’s by providing advanced materials, upgraded solutions, cleaning and regulatory training, or assisting with process validation, a well-chosen supplier assists their customer every step of the way.
There is growing need in a wide variety of medical markets to solve difficult system challenges where power, performance, efficiency, security, and reliability are critically important. Microsemi’s recent acquisition of Zarlink brings key capabilities to a portfolio that already include some of the industry’s broadest ranges of products and technologies for implantable devices, diagnostic equipment, portable health monitoring systems, and other medical systems.
As a medical device manufacturer, it is no secret that complex regulations continue to be increasingly challenging to meet. But beyond regulations, product quality is paramount for patient safety and brand protection. The other side of the equation is minimizing costs in R&D, manufacturing, the supply chain, and compliance.
Was just reading an article about a lab at Hershey Medical Center that has identified a virus that has killed cancer cells in laboratory tests and human breast cancer tumors in infected mice.
Healthcare reform is needed due to rising costs for stakeholders across the board. After that statement, the water gets murky.
I saw in this article that online gamers collaborated to solve a challenge posed to them in the form of a game. The challenge was to create an accurate model of a retrovirus protein that will allow researchers to design
A new electronic patch that applies to the skin like a temporary tattoo offers medical monitoring applications such as heart rate, brain waves, or muscle tissue activity.
Finite Element Analysis (FEA), or computer simulation, is a powerful tool in the medical product development industry, but it is often misunderstood or misused. If you decide not to read much further, understand this one thing: FEA is a prototype reducing tool, not eliminating. Any one of the myriad of simulation programs can output very colorful and technical looking plots, but detailed experience and physical testing are critical to back them up. The only way to know for certain if you are right is to test it.
The concept of generating ideas within a group environment is nothing new to product development. Alex Osborn popularized the process and contributed a set of highly influential rules in 1953. Since then, a wide range of techniques have been developed to help product development teams develop novel ideas effectively and efficiently. Unfortunately, few design professionals are aware of these methods, and even fewer understand the elements of creativity to help make ideation sessions more productive.
A few months back, MIT Sloan, in collaboration with Boston Consulting Group (BCG), recently published the verbosely titled Sustainability & Innovation Global Executive Study and Research Project. It's a well-researched study—which is to say that it's a long read—and definitely worth reading.
Back in October 2010, I reported on attending the joint AAMI-FDA Infusion Device Summit, which took place at the FDA’s Rockville, MD campus. The summit brought together 330 diverse stakeholders: doctors and nurses, clinical/biomedical engineers, hospitals and other healthcare organizations, FDA officials, device manufacturers, product development firms (like Farm), academicians, safety organizations, and others.
In March 2010, IEC 62366:2007, “Medical Devices–Application of Usability Engineering to Medical Devices,” went into effect, and compliance to this standard is now required by the European regulatory bodies. Compliance to the standard’s predecessor, ANSI/AAMI HE74:2001, “Human Factors Design Process for Medical Devices,” has been required by the FDA for more than ten years. Both documents state that medical device manufacturers must demonstrate that all potential use-related hazards in their devices have been identified, tested, and mitigated.
Little attention has been given to the way in which usability results— the actual categorization and measurement of the problems discovered through an array of usability evaluations— are communicated. Common practice indicates that most usability practitioners organize the usability results they identify by (1) category or attribute of a problem and (2) severity. Unfortunately, there is little agreement among practitioners on which list of categories is the most comprehensive and which severity scale is the most appropriate. The most common response, of course, remains “it depends.”
Over the last five years, the U.S. FDA has received more than 56,000 reports of adverse events attributed to the use of infusion devices. Critical to patient care, these medical devices are embedded in our healthcare system, which has prompted the FDA to launch a major initiative on exploring their safety, including a website dedicated to the topic.
As designers envision more complex, functional products, and manufacturers increase production speeds, the engineers in charge of the next step—assembly—need to step up their game, as well. Part of any continuous improvement initiative involving assembly should take a look at continuous motion technology.