Case study
Enabling Accessible Healthcare Innovation with Polycarbonate
Korion Health's SoundHeart™ electronic stethoscope revolutionizes heart and lung screening using Makrolon 2458®. This collaboration shows how advanced materials overcome complex engineering challenges while meeting stringent healthcare regulatory requirements.
Korion Health needed to develop SoundHeart™, an electronic stethoscope that would democratize heart and lung health screening by making it accessible to individuals without medical training. The device required a material solution that could enable precise acoustic transmission for medical-grade sound quality while meeting biocompatibility standards for direct skin contact. Additionally, the material needed to withstand frequent handling in non-clinical environments and support cost-effective manufacturing for global accessibility. The design also called for accommodating both opaque and translucent design elements within a single material platform.
For decades, the medical community has relied on our materials and expertise to deliver life-enhancing solutions. We’re proud to support a project that empowers people to play an active role in their health.
Heart and lung diseases cause over 20 million deaths annually worldwide, with many preventable through early detection. Traditional healthcare faces barriers of distance, cost, and physician availability, leaving remote communities without access to basic cardiac screening. This crisis demanded an innovative solution bringing medical-grade diagnostics directly to patients' homes.
The material requirements presented complex technical challenges. The device needed biocompatibility certification for skin contact, typically involving lengthy testing processes. Dimensional stability was critical for acoustic precision, as material deformation could compromise sound transmission quality essential for diagnosis. The device required exceptional durability to withstand frequent handling, drops, and moisture in home environments lacking clinical handling protocols.
Manufacturing complexity created additional hurdles. Multiple materials would increase costs and complexity, making the device less accessible globally. The material selection also needed to support FDA 510(k) clearance, requiring established regulatory pathways and comprehensive documentation for market approval.
The material requirements presented complex technical challenges. The device needed biocompatibility certification for skin contact, typically involving lengthy testing processes. Dimensional stability was critical for acoustic precision, as material deformation could compromise sound transmission quality essential for diagnosis. The device required exceptional durability to withstand frequent handling, drops, and moisture in home environments lacking clinical handling protocols.
Manufacturing complexity created additional hurdles. Multiple materials would increase costs and complexity, making the device less accessible globally. The material selection also needed to support FDA 510(k) clearance, requiring established regulatory pathways and comprehensive documentation for market approval.
This device is more than a product—it’s a movement toward inclusive healthcare. It’s designed to empower individuals to own and understand their health data and participate actively in their care.
Covestro's Makrolon® 2458 polycarbonate provided a single-material solution addressing all critical requirements. This advanced grade offered pre-certified biocompatibility, eliminating lengthy testing and regulatory uncertainty. Superior impact resistance protected device integrity while exceptional dimensional stability maintained acoustic precision.
Makrolon® 2458's versatility enabled both opaque and translucent components from one grade, simplifying production and reducing costs. The pre-tested material shortened time-to-market and supported FDA requirements.
Covestro collaborated closely with Bally Design and Hellbender, providing technical support throughout development. This enabled affordable global pricing while maintaining medical-grade functionality and consistent acoustic performance across all manufacturing locations.
Makrolon® 2458's versatility enabled both opaque and translucent components from one grade, simplifying production and reducing costs. The pre-tested material shortened time-to-market and supported FDA requirements.
Covestro collaborated closely with Bally Design and Hellbender, providing technical support throughout development. This enabled affordable global pricing while maintaining medical-grade functionality and consistent acoustic performance across all manufacturing locations.
Key benefits
- Impact resistant: Strong yet lightweight.
- Biocompatible: Meets several biocompatibility criteria.
- Design freedom: For applications that are tough, yet attractive.
