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Case study

Polycarbonate for next-gen remote cardiac monitoring system

Near real-time cardiac monitoring plays a vital role in enhancing patient care. Makrolon® 2458 polycarbonate provides the durability and biocompatibility needed to meet stringent medical device standards.
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Task

Develop next-gen remote cardiac monitoring system

Cardiac care can require constant monitoring, especially for patients with arrhythmias. InfoBionic.Ai faced the challenge of creating a remote cardiac monitoring solution that would be FDA-cleared, versatile, and able to deliver near real-time data to physicians, reducing hospital visits and improving patient outcomes.
InfoBionic.Ai’s MoMe ARC® system offers a modular design for real-time patient monitoring to detect cardiac arrhythmias

Our MoMe ARC® system is based on a wireless modular sensor platform that can be configured to suit each patient’s required acuity level—from high acuity diagnostics to simple on-the-go monitoring—for more efficient and comfortable care delivery.

Dave MacCutcheon

Chief Operating Officer, InfoBionic.Ai
Challenge

Find a material the meets stringent medical device standards

InfoBionic.Ai required a material to support the MoMe ARC® system, offering flexibility for high-acuity diagnostics and wearable monitoring. The design needed to combine aesthetic appeal and durability for repeat-use. Materials had to meet FDA standards, including ISO 10993 biocompatibility, and be compatible with secondary manufacturing techniques like laser markingand overmolding. 

The durability, impact resistance and ISO 10993 biocompatibility rating of Makrolon® 2458 were essential for supporting a reusable medical device. It also offered the compatibility with secondary manufacturing processes, like insert molding, overmolding and laser marking, making it an ideal choice for this application.

Emily Shaffer

Healthcare Market Manager, Americas, Covestro
Solution

Makrolon® polycarbonate for durable, impact resistant devices

In collaboration with Pivotal Design and InfoBionic.Ai, Makrolon® 2458 polycarbonate was chosen for its durability, impact resistance, and biocompatibility for the MoMe ARC® system. The material is available in custom-colors, both white and transparent options, allowing seamless functionality and highlighting user interaction points.  Compatibility with both laser marking and overmolding enabled a lower profile form factor, critical for wearable devices, by eliminating labels and integrating sealing and strain relief features.

Covestro’s manufacturing and regulatory expertise helped us in selecting the material with the right balance of aesthetic and functional properties for this application, from color and finish to durability and biocompatibility.

Julian Groeli

Founder and CEO, Pivotal Design, Inc.

Key Benefits

  • Impact resistant Strong yet lightweight
  • Biocompatible Meets several biocompatibility criteria
  • Design freedom For applications that are tough, yet attractive

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