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.
Being a Human Factors/Usability professional, I’m often asked how to select cities for user research. With market research, studies are often large and encompass a number of geographic regions in order to get a statistically significant sample. The focus is on what features a product should have and what will motivate people to buy the product.
The future perfect By the time you arrive, I will have gone to the hospital. This sentence is an example of the verb tense the future perfect. The unnerving reality of the future perfect is that it describes two or more independent variable actions that may occur in the future - always with a level of uncertainty. Naturally, we respond to the future perfect with mixed emotions: anxiety, skepticism, fear, perhaps a little excitement. It’s no surprise, then, that we respond to the idea of ethnofuturism (or, if you prefer, Futures Thinking) in much the same way. Ethnofuturism, like the future perfect, is research for the future, and understanding the future is never a perfect science.
Product Development Technologies Outlines Strategy for Successfully Designing for Developing CountriesSeptember 1, 2010 12:11 pm | by Bob Coon. | Comments
Global design firm offers three guidelines for those looking to break into new markets.
We [Kaiser Permanente] evaluated the four major players and found that clinical performance and pricing were comparable, but there were big differences in terms of sustainability performance," explained Robert Gotto, the executive director in Kaiser Permanente's Procurement & Supply group. "One supplier had the foresight to develop a camera that doesn't need to be sterilized with chemicals. It uses steam instead, and can cut down chemicals in operating room by half." So the steam-sterilized endoscope provider ended up getting the five-year, $100 million contract.
Question: Our tube set application uses a nylon tube bonded to a clear urethane tube, with a bond gap overlap of 0.010 inch x 0.004 inch thick bond gap. We have been looking at a DYMAX medical grade light-curable adhesive to bond the tube sets and get good adhesion, but we found that during our manufacturing run, some of the adhesive gets pushed inside the opaque nylon tube, and does not cure. Will this material cure by itself over time?