Media & Content

Manufacturing Medical Devices: Where Manufacturing Meets Healthcare

  Edge Factor Team   |     September 27, 2022 |   9 minute read
Edge Factor releases a new film, Pulse: Where Manufacturing Meets Healthcare

We go through our day-to-day lives with little thought about the devices and objects we use. We expect things to work how they are supposed to, but we don’t think about how or why it was made or who made it. 

 

According to the CDC, an average of 130 million people visit their local hospital’s emergency department every day. Of those who visit, 16.2 million people are admitted. Think about the medical equipment, technology, and devices needed to triage, register, treat, and monitor each patient’s condition. 

 

When we face a medical emergency, we expect the devices our healthcare professionals use to perform.  We rely on them to provide us with an accurate diagnosis and treatment plan. 

 

Someone was inspired to think about how to manufacture these medical devices, someone works to improve them, and someone designs builds, and maintains them. 


At Edge Factor, we have the amazing opportunity to go behind closed doors to create career media and learning tools that inspire people to explore, prepare and connect on their career journey. We have filmed thousands of Virtual Workplace Experience Career Profile videos and more. Every once in a while, we come across a story worthy of being told in its own cinematic film. When we heard how Reece Hughey, Quality Manager at Qualitel, and Cardiac Electrophysiologist Dr. Gust Bardy’s paths crossed professionally and personally, the idea for a new film was born. 

 

Where Manufacturing Meets Healthcare

 

Dr. Gust Bardy is the Founder and Chief Medical Officer of Bardy Dx. He is a researcher and inventor in many fields of heart-related study including cardiac defibrillator technology, cardiac arrest, ablation, heart failure, and atrial fibrillation. 

 

Qualitel is a mission-critical electronics manufacturer focused on high reliability and quality of the products they ship to companies in various industries from aerospace, military, defense, and medical. 

 

“I got the name Qualitel from quality electronics,” said Tuanhai Hoang, President, Qualitel. “Our focus has always been on the highest reliability and quality that we can produce in any products that we shipped from our company. Many mission-critical companies are attracted to the ability we have to produce something they don't have to worry about. They can focus on designing their product and we can focus on building the best product for them.”

 

Qualitel is in the market of making the best possible quality electronics. BardyDx is in the market of saving lives above all else. The two companies have a symbiotic professional relationship. But it was about to get personal.

 

It All Begins with A Great Story

 

Dr. Gust Bardy spent years studying the human heart. His own wife, Lorene, met an untimely death due to irregular heart rhythm complications. This inspired Dr. Bardy to do something about the fact that the heart monitoring devices weren’t providing sufficient, precise information doctors could use. 

 

Dr. Bardy set out to honor his wife by designing a medical device that would prove essential to making an accurate diagnosis for future patients like Lorene. He created the idea for the Carnation Ambulatory Monitor or CAM patch.

 

“Building a new invention is not an easy task. Eventually, the ideas in your head have to merge into a real-life product.” - Matt Pennings, Senior Production Manager, Edge Factor.

 

At first, Qualitel hesitated to take on the manufacturing of the CAM patch, but when Dr. Bardy mentioned that the device could save lives, Mr. Hoang was inspired to take on the project seeing that Dr. Bardy’s expectation for a precise, high-quality product was a good fit with Qualitel’s mission to provide a reliable product.

 

When lives are at stake there can be no room for error and product quality is crucial.

 

“Heart rhythms are complex and it’s a particular subdomain of cardiology. I have spent my years caring for patients with heart rhythm disorders and researching new approaches to care for patients with heart rhythm disorders.” - Dr. Bardy

 

Mayo Clinic explains that heart rhythm problems or heart arrhythmias occur when the electrical impulses that coordinate heartbeats don't work properly, causing the heart to beat too fast, too slow, or irregularly. Heart arrhythmias may feel like a fluttering or racing heart and may be harmless. However, If the heart is not properly pumping blood throughout the body, this can lead to a host of life-threatening problems such as organ failure or a stroke.

 

Manufacturing quality electronic equipment is a daily commitment for Reece Hughey. As the Quality Manager for Qualitel, Reece thinks about how devices are built and ensure the best quality performance of the products manufactured at Qualitel. He was assigned to the Bardy DX CAM patch from the start. 

 

“Any medical product is going to impact people, so we have a high interest in making sure that it's a good, reliable product and consistent,” said Reese Hughey. “We take that product, we run it through our systems, we review it. We have very extensive analysis and systems in place to really hone in and focus on any minor improvements that could be made to those processes.”

 

Sometime after being involved in ensuring the quality and reliability of the Bardy DX CAM patch, Reece faced a personal health scare related to heart arrhythmia. He went from visiting an urgent care clinic to visiting the emergency room to undergo an echocardiogram and an MRI, relying on the care of a cardiologist. Reece was eventually diagnosed with myocarditis, an inflammation around the heart. But his doctor wanted to monitor his heart to be sure he’d been given an accurate diagnosis. 

 

Reece’s doctor told him he was going to mail him a device to monitor his heart while he went about his daily routine. Reece didn’t put it together until he held the CAM patch in his hands.

 

“Quality is my business, so I had every bit of confidence the device was going to work.” - Reece Hughey 

 

The CAM patch collected precise and accurate information so the experts could properly diagnose and treat Reece’s heart arrhythmia. 

 

 

From the design to packaging, every job is crucial.

 

From the engineers involved in the creation of the CAM patch, we learn about the amount of effort, technology, systems, and the different expertise that goes into creating a device like this. Everyone from design to electrical engineers, even just normal operators on the line who handle packaging, is involved in making a device available to a wide variety of people. What initially appears to be ‘all in a day’s work’ is actually a complicated and impressive feat of human achievement. Every single person involved in turning the idea of the CAM patch into a reliable, usable product played a crucial role in saving lives. 

 

Edge Factor tools are categorized into four phases of the Career Journey: Inspiration, Exploration, Preparation, and Connection. It’s what we call the IEPC Journey. No matter what age or stage you’re at in your career journey, Edge Factor’s multimedia tools help inspire you to explore careers, prepare for the next step in your lifelong journey of learning and connect you with training and career opportunities in your community.

 

We travel the globe filming real people working in diverse industry sectors to create high-impact career exploration media. Our e-learning resources provide educators and students with the tools they need to dig deeper and make meaningful connections.

 

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