CleveMed Blogs

"You get what you pay for" – an idiom that has been around just about forever. It suggests that the quality of a product improves or increases with the amount of money one pays for that product. But for medical devices, quality products need to equate to more than a just a price tag.

Quality medical devices need to equate to a commitment – a commitment from top executive management that the products a company produces, not only meet “customer” requirements, but are safe and effective for their intended use. This commitment is to be communicated to all individuals at all levels of the organization who need to "buy–in" to it - and since this commitment is driven from the top down, employee resistance or "push back" should be reduced into the "slim to none" category!

Because they know their job functions best, employees need to become actively involved in the development of processes and procedures specific to their area of responsibility. These processes and procedures will evolve into the company’s "bible" or Quality System that guides and directs the operation.

"Customers" can be "internal" (engineering may be a customer of marketing, manufacturing may be a customer of sales) as well as external (regulatory agencies are customers of the Quality & Regulatory department, the end user or patient is a customer of sales or product support). A quality medical device is produced when customer requirements and specifications are translated into attainable and realistic design inputs. These inputs will develop into a finished medical device which, prior to being released to market, must go through extensive verification/validation testing to ensure the medical device functions according to specifications and is indeed safe and effective.

Consistency is paramount. Adhering to those employee developed processes and procedures such as purchasing items used in manufacturing only from pre-determined, experienced and competent suppliers are instrumental in maintaining the quality of a medical device.

Lastly, the commitment to quality cannot ever become stagnant. Customer requirements, customer feedback, processes and procedures used in product design and manufacturing as well as the infrastructure of the business itself must be continuously monitored, assessed, measured and improved upon if the medical device organization is to remain competitive, profitable and compliant with regulatory agencies.

Notice that throughout this blog cost was never mentioned? Sometimes you get a lot more than what you pay for!

You’re driving a car that’s barreling toward a ramp at 90 miles an hour. You take off and are flying through the air for just over a second, landing on the other side at a force of 6 G’s (that’s more than the g-forces experienced by Blue Angel’s pilots!). What kind of physiological reaction do you think your body would experience?

CleveMed had the opportunity to work with ESPN and find out the answer to that very question. We were invited to measure the physiological changes in a rally car driver completing a record breaking 250 foot jump. To measure this, we used the BioRadio 150, a wireless programmable physiological monitor. The BioRadio is compact, subject worn and can record up to 14 channels of data including ECG, EMG, EEG, respiration, acceleration and more.

At a site in California, we used the BioRadio to measure ECG, heart rate and respiration from the driver while he completed a series of jumps. The device was mounted inside the car to also measure the g-forces. Data was wirelessly transmitted to a PC in the car where the data was stored.

Interested in seeing the jump and the physiological changes that occurred along with it? Click HERE to view the video!

It all began when it was time for the needed photoshoot for SleepView, (our new baby among CleveMed’s family of sleep diagnostic devices). I went to Sarah (my boss) and said, “Who should be the model?” She paused a moment, then rattled off 2 names from the engineering department. “Maybe they would like to help?” she smiled sweetly.

I emailed them both; a pleading, cajoling couple of sentences, and waited. Surprisingly, they seemed quite happy to switch gears for a bit, and the first affirmative came 48 minutes sooner than the other. So the choice was easy: Dominic.

The day before the photo/video-shoot was quite a buzz of activity.

Dominic was kind enough to not back out of the whole thing while he had the chance.

Tony (our photographer) was just amazing. Just being in Tony’s studio, seemed to make the creative juices flow. We were spouting all kinds of ideas for future ad campaigns: one part of me marveled, yet another part of me cringed. But we needed this rambling I think… Dominic needed to take his mind off the discomfort he must have surely endured, from holding his hands out over a white board, and obeying 5-syllable instructions from Tony: “An-inch-to-the-left.” “Turn-device-clock-wise. No, your clock-wise.” “Curve your index finger a little toward you?” (No kidding, Dominic left for vacation the next day).

Finally, Tony dropped off our DVD and I must say that Dominic’s hands look good holding the SleepView and the SleepView looks just great: small, compact, and oh-so-easy to handle! But Tony was not the only one who took pictures that day. I just had to sneak a couple of cell phone pics that I have posted on our Facebook page. Hope you enjoy them as much as I did.

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I remember the story of a biomedical engineer I know. As an undergrad, he planned to graduate, leave school and enter the industry. In the last weeks of class, a professor brought in a patient with a high level spinal cord injury. He demonstrated how FES (functional electrical stimulation) could be used to control weak or paralyzed muscles. When he saw this paralyzed patient move his arms, he was hooked. He went on to graduate with a PhD in biomedical engineering with a focus on rehab engineering.

Biomedical Instrumentation 101: students learn circuit design, how to build an amplifier, data acquisition, signal processing, etc. The concepts are taught; but is there enough emphasis on how this information can be used in applications outside of the classroom? Education in these areas of engineering and physiology is important, but how it can be used in real world applications is just as critical.

CleveLabs is a lab course system that uses wireless data acquisition hardware and interactive software to teach engineering, data acquisition, digital signal processing and basic and advanced physiology. In addition to these customary topics, we also include a section of clinical applications: labs that demonstrate to students where they can apply all that they’ve learned. How about using electro-oculography (movement of the eye) to control the position of a dot on the screen, and control the color of the dot just by blinking? This shows how EOG can be used for computer cursor control, where blinking represents a click, for persons with high level spinal cord injuries. Or what about using electromyography (electrical muscle activity) from the biceps and wrist extensor muscles to control the elbow angle and hand grasp of a virtual robotic arm? This explains how the use of existing muscles can control a prosthetic limb. In addition, heart rate detectors are created, gait and stride time are measured, EEG is used to detect different states of alertness. CleveLabs goes beyond the traditional topics using clinical examples of biomedical engineering applications.

Where can real world examples, such as the story of my friend, take your students?