Packaging Quality, Service, and Creativity Since 1949 Comar Resolves Market Growth Needs for the myPatch®sl Holter Recorder Unlike most scale-up efforts where the simple maintenance of quality is paramount, dms-service challenged Comar to make significant process improvements in an effort to increase their already high-level of quality without disrupting supply. The principal focus of this effort was the recorder’s hermetic seal achieved via ultrasonic welding during assembly of the molded recorder components. Ambulatory Electrocardiogram (ECG) Monitor Lynda Cole knew that she would need additional manufac- turing capacity to support the successful 2017 launch of dms- service’s innovative myPatch®sl Holter recorder. Lynda, owner/manager of dms-service, first started in the Holter recorder industry in 1977 with her father’s business Scole Engineering Co., Inc. Since this time, Lynda has witnessed first-hand the technological advances in Holter monitoring that are represented in the revolutionary myPatch®sl design. These technical advances have resulted in a recorder design that requires advanced molding and assembly capabilities. As an ambulatory electrocardiogram (ECG) monitor, the my- Patch®sl recorder is regulated by the United States Food and Drug Administration (FDA) as a Class II medical device under 21 CFR Part 820 and supported by a 510(k) regulatory clear- ance by FDA’s Center for Devices and Radiological Health (CDRH). Waterproof Design dms-service released a true game changer with the my- Patch®sl recorder. The myPatch®sl features an IP rating of 68, waterproof up to 2 meters of water for 1 hour and 2 channels of continuous ECG recording for 14 days. It offers multiple electrode sizes for patient comfort and convenience and is available in adult, pediatric, ladies, sports, and neonate elec- trodes. What does this IP rating mean? It means that the patient does not need to worry about taking a shower while wearing the device or a quick swim with the sports electrode. To achieve this IP rating and prevent recorder failure, the my- Patch®sl design relies on a hermetic, ultrasonic seal between the injection molded recorder components to protect the recorder’s internal PC circuit board and battery. Challenges in Medical Device Manufacturing Electrode sizes for myPatch®-sl recorder
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Packaging Quality, Service, and Creativity Since 1949
Comar Resolves Market Growth Needs for themyPatch®sl Holter RecorderUnlike most scale-up efforts where the simple maintenance of quality is paramount, dms-service challenged Comar to make significant process improvements in an effort to increase their already high-level of quality without disrupting supply. The principal focus of this effort was the recorder’s hermetic seal achieved via ultrasonic welding during assembly of the molded recorder components.
Ambulatory Electrocardiogram (ECG) MonitorLynda Cole knew that she would need additional manufac-turing capacity to support the successful 2017 launch of dms- service’s innovative myPatch®sl Holter recorder.
Lynda, owner/manager of dms-service, first started in the Holter recorder industry in 1977 with her father’s business Scole Engineering Co., Inc. Since this time, Lynda has witnessed first-hand the technological advances in Holter monitoring that are represented in the revolutionary myPatch®sl design.
These technical advances have resulted in a recorder design that requires advanced molding and assembly capabilities.
As an ambulatory electrocardiogram (ECG) monitor, the my-Patch®sl recorder is regulated by the United States Food and Drug Administration (FDA) as a Class II medical device under 21 CFR Part 820 and supported by a 510(k) regulatory clear-ance by FDA’s Center for Devices and Radiological Health (CDRH).
Waterproof Designdms-service released a true game changer with the my-Patch®sl recorder. The myPatch®sl features an IP rating of 68,
waterproof up to 2 meters of water for 1 hour and 2 channels of continuous ECG recording for 14 days. It offers multiple electrode sizes for patient comfort and convenience and is available in adult, pediatric, ladies, sports, and neonate elec-trodes.
What does this IP rating mean? It means that the patient does not need to worry about taking a shower while wearing the device or a quick swim with the sports electrode.
To achieve this IP rating and prevent recorder failure, the my-Patch®sl design relies on a hermetic, ultrasonic seal between the injection molded recorder components to protect the recorder’s internal PC circuit board and battery.
Challenges in Medical Device Manufacturing
Electrode sizes for myPatch®-sl recorder
Choosing a Supplier“The advanced design of the myPatch®sl recorder coupled with the quality systems and regulatory compliance require-ments to support an FDA cleared medical device also limited dms-service's choices for an alternative molder/assembler”, cited Lynda Cole. “We quickly identified Comar as a supplier that offered the full suite of services we needed, as well as, the agility required to support the molding and assembly of our device", added Cole.
Comar is a trusted medical device contract manufacturer with a reputation for industry-leading design-for-manufacturing services, in-house mold making and prototyping, diverse molding technologies, and printing (e.g. logos, decorations). Their production facilities are registered to ISO 13485:2016 and ISO 9001:2015 quality standards and home to Class 8 cleanrooms. Comar also possesses an establishment registra-tion for medical devices with the FDA.
These competencies are components of Comar’s IDWORKS® Concept to Commercialization program which includes de-sign, prototyping, molding, and assembly, all under a strict QA/RA umbrella. The components are offered individually or as a complete program for small to medium-sized companies in an effort to provide Comar customers the benefit of agili-ty offered by larger molders exclusively to large, established medical device manufacturers.
“We recognize the benefit that agility plays in delivering a quality product to market quickly”, states Scott Conklin,
Comar’s Executive Vice President of Sales & Marketing. “Comar has provided medical device and diagnostic manufacturers this benefit for a number of years now. The market rewards the first to arrive and it is incumbent on Comar to serve as a partner in our customers’ successes – no matter the size of their company or the opportunity”, added Conklin.
Improving Quality During Scale-UpUnlike most scale-up efforts where the simple maintenance of quality is paramount, dms-service challenged Comar to make significant process improvements in an effort to increase their already high-level of quality without disrupting supply. The principal focus of this effort was the recorder’s hermetic seal
Cleanroom assembly
For more information, contact your Comar Account Manager
achieved via ultrasonic welding during assembly of the mold-ed recorder components.
Comar’s design capabilities coupled with their extensive molding, assembly, and ultrasonic welding experience al-lowed for improvements to the recorder’s hermetic seal to be easily introduced during ongoing manufacturing operations without affecting supply chain.
“Improving on an already high IP score against water ingress
Capabilities plus Commitment Builds TrustComar has been serving the pharmaceutical, medical device, and dietary supplement industries since 1949. Their eight manufacturing facilities in the USA and Puerto Rico encom-pass more than 800,000 square feet and house some of the most advanced technology and equipment available.
In the FDA/CDRH-regulated medical device space, Comar manufactures molded components and devices for drug
“Our market growth plans could not tolerate any delay. I was very impressed with Comar’s capabilities as all of the design and manufacturing improvements made not only kept our commercial plans on track, they were successful-ly and concurrently implemented. Comar has helped us considerably.”
Lynda Cole, Managerdms-service
was a challenge during scale-up operations”, ex-plains Scott Taylor, Medical Device Market Manager for Comar who managed the relationship with dms-ser-vice. “However, we have very strong resources and capabilities in design, manufacturing, and final testing whereby we were able to easily modify the recorder seal design and introduce an improved ultrasonic welding horn, improving output and quality simultaneously”, Taylor expanded.
Similarly, Comar made design-for-manufacturing improve-ments involving insert molding of the electrical contacts on the underside of the recorder and overmolding of the button on its topside.
“It was critical that supply chain not be adversely affected during the implementation of these improvements”, said Lynda Cole. “Our market growth plans could not tolerate any delay. I was very impressed with Comar’s capabilities as all of the design and manufacturing improvements made not only kept our commercial plans on track, they were success-fully and concurrently implemented. Comar has helped us considerably”, added Cole.
delivery, saline flush sy-ringes for intravenous catheters, and both in- vivo and in-vitro diagnos-tics devices.
This industry experience allowed Comar to quickly meet dms-service’s needs.
“My confidence in Comar’s
capabilities remains very high. Their continuing commitment to us has resulted in a true partnership between our compa-nies”, stated Cole.
Moving Forward“We are very pleased to be entrusted by dms-service to assist with the growth of their business. We remain committed to meeting the needs of our medical device and pharmaceutical customers and are strategically positioned to support these industries”, explained Mike Ruggieri, CEO of Comar.
In June of this year, Comar announced its successful recapi-talization with Morgan Stanley Capital Partners (MSCP). “Our new partnership with Morgan Stanley will afford us with a world-class advisory board and additional strategic operating resources to continue our commitment to these industries”, added Ruggieri. n
From Concept to Commercialization Comar is your trusted partner for medical molding & assembly
