Punch Through

Punch Through is a US-based engineering firm specializing in connected medical devices and complex connectivity solutions. With over 15 years of experience in Bluetooth, WiFi, and cellular technologies, the company provides full-service design and development for MedTech pioneers navigating FDA regulations and cybersecurity requirements.

The firm offers end-to-end multidisciplinary services spanning embedded systems, mobile applications, and cloud infrastructure. Their expertise covers FDA-regulated connected implants and wearables, remote patient monitoring platforms, Software as a Medical Device (SaMD), and Medical Device Data Systems (MDDS). They support development from architecture through compliant delivery for Class II and Class III devices.

Punch Through has delivered over 2 million connected devices and solutions to market. The company is known for LightBlue, a widely-used BLE development tool, and publishes technical guidance on BLE architecture, EMR integration strategies, and FDA cybersecurity compliance for the connected device community.

Choose Punch Through when connectivity is central to your medical device strategy and regulatory compliance is non-negotiable. Their 15-year track record specifically in BLE, WiFi, and cellular protocols for FDA-regulated devices means they've solved the integration challenges, security requirements, and update mechanisms that trip up less specialized firms.

Expect a collaborative partnership with transparent communication and adaptive methodology. Their full-service approach handles architecture, development, and compliant delivery with documented traceability across the entire product ecosystem—critical for FDA submissions and lifecycle cybersecurity management.

Punch Through maintains exclusive focus on connected medical devices and health technology. Their MedTech expertise spans FDA-regulated implants and wearables for disease management, remote patient monitoring platforms for in-hospital and at-home care, Software as a Medical Device (SaMD) for clinical diagnosis and treatment, and Medical Device Data Systems (MDDS) requiring cybersecurity compliance.

The company demonstrates deep understanding of FDA premarket submission requirements, including the new cybersecurity guidance finalized in June 2025, and alignment with standards like ANSI/AAMI SW96 for software security risk management. Their resource center publishes technical guidance on EMR integration strategies, BLE connectivity architecture, and managing regulatory compliance for connected health products.

MedTech innovators developing wirelessly-connected regulated devices—particularly implantables, wearables, or remote monitoring systems—who need partners equally fluent in BLE/WiFi/cellular protocols and FDA compliance pathways. Best fit for teams tackling complex connectivity architectures requiring embedded, mobile, and cloud integration with cybersecurity and update mechanisms built in from the start.