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.
The medical device industry is bracing for the impact of the Obama Healthcare Plan’s new medical device excise tax. The tax, along with rapidly changing regulations and rising production costs, are expected to affect every health industry firm’s bottom line, regardless of company size or profitability.
A common question posed to adhesive companies supplying into the medical device industry revolves around the need to qualify a process to ensure a hermetical seal or bond line in the device itself. It all boils down to “How do I design and qualify a process to ensure that I have 100% yield of good parts, with 0% failures?” When working with light-curable medical device adhesives, a solid process can go a long way to achieve this goal, as long as proper care is taken to understand the variables which could affect the process.
As medical devices become smaller and more finite, to be suitable for minimally invasive surgeries done in the doctor’s office or surgical center, the challenge for design engineers is to reduce the size of the overall device going into the body. One common technique is to reduce the size of the catheter wall.
Polyurethane tubing is often softened by using a plasticizer. This plasticizer can either be a short-chain or long-chain polymer, where the short chain is highly mobile and comes to the surface easily at both room temperature or higher temperatures, and where the long-chain polymer is not as mobile, and gets tangled in the polyurethane backbone of the tubing.
Was reading this article about a security researcher, Jay Radcliffe, who has determined how easy it is for someone with the right tools to hack into a wireless medical device and wreak havoc on it.
There is an interesting debate going on in Washington right now over a report by the Institute of Medicine released last Friday – July 29th, 2011. The Institute of Medicine, a group consisting of physicians, academics and lawyers, is making an argument for a tougher approval process through the Food and Drug Administration (FDA) for a wide variety of medical devices including defibrillators and hospital pumps.