I regularly run into manufacturing engineers and other support staff throughout Europe who do not clearly understand the basic principles of leak detection for the medical device industry. As a result, they continue to run compromised assembly lines.
Designers should look for a company that not only provides the right silicon, but also development tools, software, and support that are tailored for two main phases of a typical smartphone/tablet-based medical design. The first phase consists of the smartphone interface, and the second phase is the design of the medical device itself.
To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.
As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
The greatest challenge [in designing for the consumer] is recognizing the limited knowledge and abilities of a home user. There needs to be an understanding that the home patient is not a medical professional and is not exposed or practiced with the multitude of technologies the designer may have previous experience with.
The single greatest objective of every business, no matter its size, industry, or history, is to achieve and maintain a positive cash flow, a condition where cash coming in equals or exceeds cash going out. According to Chad Carson, president of the Avicenna Division of Ametek Engineered Medical Components, the primary key to [business] success is cash flow, an opinion shared by most successful business professionals.
There have been reports of issues and lawsuits from procedures gone wrong when a robotic surgical system was used. Yes, there have been issues and they do need to be addressed, however, abandoning robotic surgical systems is not the answer. In fact, it would be a complete mistake.
When designing a medical device that is meant to be used directly by patients in their home, the designer has to keep in mind that the environment of a patient’s home is likely going to be dramatically different compared to a medical facility.
I have one family member in nursing school and one in medical school, which means I sometimes find myself on the cold end of a stethoscope while they check my radial pulse, blood pressure, respiratory rate, and whatever else they need to practice. As a result, I’ve developed a somewhat obsessive, but healthy habit of tracking my blood pressure.
The business proposition was for a new application of an existing technology and had never been applied before to that particular patient group, so there were significant development unknowns. However, as technical director/CTO for the company, I realized the same issues kept popping up with our professional investors—expectations management and development timescales.
Around 15 years ago, I was fortunate enough to study for a Ph.D. with an Entrepreneurial Professor. Five years later, after working on a few healthcare-related projects, we were then fortunate enough to snag an ambitious MBA graduate with an executive retail background, looking for a new challenge, and gained support of doctors.
“Smart” eyewear has just collided with smart vision correction — and no, I’m not talking about the prescription-based versions of Google Glass that are in development. Researchers have taken the concept of Google Glass and applied it to soft contact lenses.
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.