The greatest obstacle to success in the design of a device is that, often times, the design engineer overlooks the need to keep electromagnetic interference in mind when he designs his device. When a product is not in compliance, it can be interfered with by radio waves emitting from other electronic devices in the home, causing the product to malfunction.
“Take two and call me in the morning.” That’s the phrase that came to mind while preparing a particular article recently. While “Coating for Consumption” doesn’t deal with taking two pills and calling the doctor in the morning, I couldn’t help but think about how far we’ve come since the days when that phrase reflected what most people thought was “modern healthcare.”
For all of us in Quality Assurance departments, on-site inspections are a regular occurrence. Our Quality Management System may be subject not only to the scrutiny of FDA Investigators, Health Canada Inspectors, and ISO Auditors, but also to the audits and inspections conducted by our clients.
Here at Uson, we are obsessed with leak testing methods. One problem that we see often, particularly in the medical device industry, is the widespread belief that one type of leak test method is inherently better for nearly all applications. This is simply not true and the misinformation seems to have taken on a life of its own.
In today’s medical facilities, healthcare providers face heavy workloads and care for more patients with decreased clinical staff. They need products and technologies that help them provide effective care as efficiently as possible. At Covidien, our goal is to provide monitoring solutions that enhance patient care in a range of clinical environments.
As a project manager leading teams of highly educated, experienced, and intelligent engineers and industrial designers, I spend a lot of time creating a positive upbeat project culture where everyone feels included, free to speak up, and reassured that their contributions matter. I welcome all news and road blocks, and I listen when team members worry about any aspect of the project.
In this blog, we’ll explore challenges associated with conducting reliable usability evaluations and offer insights as to how to overcome these challenges. We’ll also discuss how to improve usability testing practices to ensure we are identifying the most important issues.
Scott Fallon, formerly the general manager of Global Specialty Products for SABIC’S Innovative Plastics business, was a part of the staff written article, “Materials Impact Medical Device Design Trends.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Aaron Updegrove, Marketing Manager for Saint-Gobain Performance Plastics, Healthcare Markets, responded to questions regarding the use of materials in medical device design and manufacturing. He was included in the staff written article, “Materials Impact Medical Device Design Trends.” Following are all of the responses he provided.
Eastman’s Gopal Saraiya, global segment leader of medical devices at Eastman Chemical Company, took time to address a number of questions related to the use of materials in medical device development. He was included in the staff written article, “Materials Impact Medical Device Design Trends.” Following are all of the responses he provided.
Human factors engineering, as applied to the design of medical devices, has never been as important as it is today, especially since the release of the U.S. FDA’s draft guidance document Applying Human Factors and Usability Engineering to Optimize Medical Device Design. With the rise of mobile health apps, human factors engineering principles will become even more vital to the success of this industry and to the safety of the patients.
The medical device ecosystem is changing dramatically from stand-alone “device + patient + physician” in the clinical environment to include access and mobility outside the four walls of the hospital. Every medical device manufacturer should consider developing a strategy around how mobile connected health will affect their business models and how they will play in the evolution of the market.
The growth in sales of medical technologies is set to outperform prescription medicines over the coming five years. Data from Evaluate Medtech indicates that over the period 2011 to 2018, the overall global compound annual growth rate for the sector will be 4.4%, in contrast to just 2.5% for drug products.
One of the most interesting things about my position is seeing the changes in one of the most dynamic industries around—the medical device industry (and, in a broader sense, the healthcare industry). In my 13+ years of reporting on this industry, I’ve seen many changes and technological advances. It truly is remarkable to think about how far certain sectors of the industry have come in what is really a very short period of time.
Home healthcare and the use of medical devices outside of the professional healthcare environment are on the rise. Modern medicine allows us to live longer and provides those with chronic diseases the ability to receive medical care at home. Examples of home-use devices are oxygen concentrators, hospital beds, sleep apnea monitors, body-worn nerve and muscle stimulators, and dialysis machines, just to name a few.