Punch Through Design

Punch Through Design is a US-based engineering firm specializing in connected medical device development with over 15 years of experience in connectivity technologies. The company focuses exclusively on Bluetooth, WiFi, and Cellular-enabled healthcare products, delivering end-to-end development from architecture through FDA-compliant deployment. Their portfolio includes Medical Device Data Systems (MDDS) and Class II and III regulated devices.

The firm provides full-stack engineering services spanning embedded firmware, mobile applications, cloud infrastructure, and EMR integration for connected medical devices. Their technical approach emphasizes secure, reliable connectivity across device ecosystems, with particular depth in Bluetooth Low Energy (BLE) architecture. Punch Through supports regulated medical devices, remote patient monitoring systems, Software as a Medical Device (SaMD), and wellness products.

The company has delivered solutions for notable clients including Synchron (brain-computer interface), Inspire (sleep apnea therapy), and Envoy Medical (cochlear implants). With over 2 million connected devices in market, Punch Through maintains a resource center providing technical guidance on BLE connectivity, EMR integration patterns, and medical device development best practices.

Choose Punch Through Design when wireless connectivity is mission-critical to your medical device and you need proven expertise navigating both technical complexity and FDA regulatory requirements. Their specialized focus on BLE, WiFi, and Cellular architectures makes them particularly suited for implantables, wearables, and therapeutic devices where reliable, secure connectivity directly impacts patient outcomes.

Expect a collaborative partnership with engineers who understand the nuances of medical device connectivity at every layer—from radio protocols and power optimization to mobile SDKs and cloud data pipelines. Their multidisciplinary approach ensures seamless integration across the entire connected product ecosystem while maintaining compliance throughout development.

Punch Through Design focuses exclusively on healthcare and connected medical devices, with particular emphasis on FDA-regulated products. The company serves multiple healthcare verticals including disease management (regulated connected implants and wearables), remote patient monitoring (in-hospital and at-home platforms), Software as a Medical Device (SaMD) for clinical applications, and wellness/consumer health products. Their expertise spans MDDS, Class II, and Class III medical device development with specific capabilities in secure data exchange, EMR/EHR integration, and medical device cybersecurity compliance.

MedTech companies and well-funded healthcare startups developing connected medical devices with wireless connectivity at the core of their product strategy. Organizations typically have $500K+ development budgets and are navigating FDA regulatory pathways requiring compliant software development for Class II or III devices, implantables, or SaMD solutions.