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It Takes a Village to Create an Innovative Medical Device
The Peerbridge Cor, a wearable, wireless electrocardiogram (ECG) device that attaches to a patient’s chest, works in tandem with a cell phone that transmits heart rhythm data to a physician’s portal. Patients simply push a button on the device when they feel symptoms. Photo courtesy of Peerbridge Health, Inc.
Extensive collaboration, engineering support, and custom molding were key to the development of an award-winning remote heart monitor.
Award-winning medical devices, like the Peerbridge CorTM Wireless Electrocardiogram (ECG) Monitor, are typically celebrated for their innovative, aesthetically pleasing designs. What often goes unnoticed is the engineering support that brings those designs to life, transforming them from concepts to actual manufactured products.
George Doumani, vice president of sales and engineering at Acromatic Plastics, is a mechanical engineer who made a career in helping designers’ concepts become reality. He joined Acromatic in 1991, when the company’s co-owner and president, Peter Crisci, asked him to come and work in the sales and engineering end of the business.
“I was one of Acromatic’s customers, and had worked with Digital Equipment for years,” Doumani said in an interview at Acromatic’s facility in Leominster, Massachusetts, in June. “I said to Pete, ‘I’ve never worked in manufacturing, and I’m certainly not a salesman.’ He said, ‘That’s not what I need. I need someone who can work with the customers and help them apply the technology.’”
Doumani said it was his and Crisci’s ability to work with customers on product development projects, helping them to understand what is and isn’t possible with injection molds, that led Peerbridge Health’s design team to choose Acromatic Plastics as their injection molding partner for the Peerbridge Cor project.
“I’d say it was strictly our engineering support that led to our being chosen for this project,” Doumani said. “They needed that type of support to solve some of the problems, as far as how they relate to molding.”
Less Noise and Cleaner Data
The Peerbridge Cor, developed by New York City-based Peerbridge Health, Inc., is an ergonomically designed, wireless ECG device that patients can wear for up to seven days to enable a physician to monitor their heart rhythms remotely. It’s a lightweight, multi-channel device with multiple leads that gives physicians a more expansive view of a patient’s heart function than a single lead would provide.
The Peerbridge Cor is a multi-channel device with multiple leads that gives physicians a more expansive view of a patient’s heart function than a single lead would provide. Photo courtesy of Peerbridge Health, Inc., New York, N.Y.
Patients receive a cell phone along with the sensor device, which snaps onto an adhesive patch attached to the chest. The device, which includes a button that patients can press when they feel symptoms, works in tandem with the cell phone to wirelessly transmit heart monitoring data in near real time to the physician.
“As soon as the patient puts it on, if they’re symptomatic, they can press the button and the doctor will see the arrhythmia within minutes on their portal,” said David Hartmann, director of business development for Peerbridge Health, in a phone interview. “Our physicians are finding that they’re able to treat their patients much more quickly, and have a higher level of efficacy, because of those near real-time events.”
The FDA-approved device won a Medical Design Excellence Award (MDEA) in June, earning a Silver Award in the Digital Health Products and Mobile Medical Apps category at the Medical Design and Manufacturing (MD&M) East event in New York. Acromatic Plastics was recognized as a supplier for the project. Acromatic provides custom injection molding, insert molding, and overmolding of parts, as well as engineering support, for the ECG monitor.
Hartmann said the Peerbridge Cor reflects the vision of the company’s founder, Dr. Angelo Acquista, M.D., to remove the wires from ECG monitoring devices while also providing more complete and accurate information by using multiple channels and leads.
“If you have a single channel, you’re only looking at the heart beating from the front, or the side, depending on how you place that recorder,” Hartmann told Design-2-Part Magazine. “But because the Peerbridge Cor has multiple channels, we can see the heart from different angles, and so we’re able to show the physician how the heart is beating from the side, the front, and then another side. That allows them to have a better, more accurate understanding of how the heart is beating.”
Hartmann added that in ECG reporting, there’s often noise from muscle movement or external interference that stymies the transmission of accurate information. Another benefit of having multiple channels is that it helps reduce the noise and gives physicians cleaner information, he said.
“The problem with single channel devices is, if you have noise, you just have to throw that information away. In our clinical trial, when we did a side-by-side comparison with the Holter monitor, there was significantly less noise with our product,” Hartmann said.
Fertile Ground for Innovation
Acromatic Plastics is located in the heart of what Doumani called a “plastics intensive” area of New England. “This is where it really started with plastics, in this part of the country,” he told a reporter while leading a tour of the firm’s manufacturing facility. About a half hour from Acromatic’s plant is the University of Massachusetts Lowell, a prolific developer of plastics engineering talent for the region and beyond.
Acromatic Plastics Vice President of Sales and Engineering George Doumani shows a sample of the Peerbridge Cor. Acromatic’s engineering support and custom molding capabilities were essential to the development of the wearable ECG device. Photo by Design-2-Part.
“Just about all of our process engineers have graduated from UMass Lowell,” Doumani said.
But there’s a difference between process engineering and product design and development, and that’s why Doumani and Crisci are Acromatic’s only engineers who work extensively with customers upfront on a part.
“My background is all product development, and Peter grew up in the plastics industry,” Doumani said. “He probably knows, better than anybody, about the limits of what you can do with molds, and what you can’t.”
A Super Clean Facility
The first thing you notice when you step into Acromatic’s molding facility is how clean it is: no oil or dirt on the floor, no hanging wires, no visible dust or foul odors in the air. The facility is about 15 years old and is fully air conditioned, Doumani said. It has two clean rooms for medical manufacturing: A Class 100,000 hard wall clean room for molding, and a Class 100,000 soft wall clean room where trained personnel perform specialty packaging, assembly, and sonic welding.
“We built this building specifically with medical in mind,” Doumani said. “Most molders have fans in the ceiling to get the heat out, and all they’re doing is stirring up dust. By having an air-conditioned facility, we eliminate that problem.”
The cleanliness of Acromatic’s molding facility evidently impressed the registrar who came to certify the clean rooms. After taking an impromptu test to measure the air quality outside of the clean rooms, he told Doumani that the overall space measured “close to a class 100,000” environment. “I think it’s primarily because we’re not stirring up a lot of dust,” Doumani said.
Unlike many other molding facilities, Acromatic uses an underground tunnel system for its utilities, keeping them out of view and enabling more efficient use of the resources used to clean its machines.
A Class 100,000 clean room at Acromatic Plastics. Photo courtesy of Acromatic Plastics, Leominster, Mass.
“Watch your head!” Doumani warns as he weaves through a maze of pipes in the underground tunnel. “I don’t think you’ll find too many molders who have something like this. Down here, you can see the rows of machines, and we could just drill up through the floor. Over here, we’re bringing our utilities right up to the machine to keep things clean.”
Doumani said that the company’s previous facility was just as clean, but the utilities weren’t kept below ground.
“When we moved in here, we were really targeting more the medical business, and this was part of the thinking. The whole idea was, ‘Let’s make this a super clean facility.’ The customers who come here are looking for this type of an environment: You get a feeling of confidence that we’re going to give you a product that’s going to meet your expectations.”
For the medical industry, Acromatic has molded surgical instruments, filter housings, heat exchangers, and fluid motion measuring devices, among other products. The company is ISO 9001:2015 and ISO:13485 certified and is well-equipped to meet the stringent quality standards that the medical industry requires. But it also serves clients in various other market segments. Although Acromatic doesn’t seek out automotive work anymore, it has retained a job with one automotive customer that requires back-lit buttons that are very difficult to mold, Doumani said.
“We do a lot in what we call the industrial space,” Doumani said. “We make some housings for air moving devices–really high-quality fans. We also make some enclosures for portable welding equipment for another company.”
Doumani said that when OEMs evaluate Acromatic as a potential supplier, they see the company as a low risk because of its financial health. Acromatic is owned by two brothers, Jim and Pete Crisci, who have no business debt, he said.
A fluid motion measuring device that was insert molded by Acromatic for the medical industry. Photo courtesy of Acromatic Plastics, Leominster, Massachusetts.
“Everything you see, they own–it’s paid for. And they’re not afraid to spend money. You’ll notice all of our equipment is fairly new, like these state-of-the-art dryers. They’re $40,000 each.”
Engineering Support Is Key to Medical Device Project
Most of the customers that come to Acromatic require early engineering involvement and support, Doumani said. One reason is that their projects require custom parts that are often complex.
“There’s a lot of interaction that goes on through the whole development stage because most of the work we do is very fussy,” he said. “We don’t do commodity products that someone would find at a department store. It’s all kind of specialized.”
Another reason is that many engineers, even if they’re excellent in their field, lack experience in injection molding and therefore don’t understand the capabilities and limitations of the tooling.
“It’s very difficult to find an engineer out there who understands enough about injection molds, and that’s the whole key to it,” Doumani said, “because you want to build as much functionality into the part as possible. We try to explain that there are ways to build actions in the tools, and hydraulics, and other means to have undercuts. So, we’re able to sometimes really improve on their design dramatically.”
The Peerbridge wireless ECG monitor is designed so that parts get snapped onto mating parts on the body. One of the keys to the work, Doumani said, was crafting the design so that the snaps could be held in position while molding around them.
“It also had to be designed in a way where we could build a mold so that we could get a seal-off in this area, because this is how they recharge the battery and do their electrical test: They have to be able to contact that circuit board,” he explained. “So, this is a very difficult part; there’s a lot of complexity in that.”
A selection of complex, tight-tolerance parts molded by Acromatic Plastics for medical applications. Photo courtesy of Acromatic Plastics, Leominster, Massachusetts.
The collaboration between Acromatic and Peerbridge’s engineers was extensive, Doumani said, and well worth the effort.
“It took a lot of meetings and give-and-take, telling them what you can do and can’t do, and adjustments to the mold after we built it. In this case, there’s probably more complexity and some very fine detail for snapping these parts together. With microelectronics, there’s a lot going on in a very small space.”
Peerbridge’s Hartmann said that the product development process required a balance between software and hardware to make a wearable device that’s both functional and aesthetically pleasing. “You need to have the competencies in both to create something at this scale, so it’s a balancing act,” he said.
Hartmann credited the contributions of experts from a variety of disciplines.
“For anything in the medical space, it takes a village to really produce anything of value, and you’re constantly bringing in thought leaders from different areas to provide innovation. There was definitely a heavy influence from electrical engineers, to product manufacturers, to design firms.”
When people look at the Peerbridge Cor, they see something very different from traditional medical products, he said.
“We really do stand out amongst other medical devices. It’s a design that is both aesthetic and functional, and that’s what we really wanted to focus in on,” Hartmann said. “It was important to create something that’s not intimidating, and almost attractive, so that the patient is more compliant with the technology, because the compliance drives better outcomes.
“The Peerbridge Cor really speaks to the core values of what the Medical Design Excellence Awards (MDEA) was looking for or stands for. It really blends into the patient’s lifestyle. It’s functional and helps doctors do their jobs and care for their patients better. But at the same time, it has a respect and appreciation for design and aesthetics.”
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