Services & Capabilities
Custom Software & System Integration for Connected Medical Devices
From system architecture to full-stack execution, we engineer for complex, regulated products.
Integrated Expertise for Connected Product Success
Expertise
Connectivity is at the core of everything we build.
Our proficiency in Bluetooth, WiFi, and Cellular technologies is backed by a U.S.-based team that leads development across every part of your connected product ecosystem.
Whether you’re building something new, solving a complex challenge, or improving an existing solution, we bring in the technological expertise to streamline development, reduce risk, and help you focus on what matters most — bringing innovative products to market faster.
How we can help
Reliable Solutions for Your Connected Product Journey
No matter where you are in development, we provide the clarity, expertise, and technical depth needed to bring your connected product to life.
Build a New Connected Product or Solution
Whether you are starting from scratch, refining a prototype, or building a market-ready product, we can bring your vision to life from concept through launch.
Validate Feasibility Through Proof of Concept
When you need to confirm technical, clinical, or connectivity feasibility, we build Proofs of Concept that de-risk your critical paths and inform smarter development decisions.
Revitalize a Struggling Connected Product
When your product hits a roadblock, or a key development challenge threatens your timeline, we’ll step in to diagnose the issue, provide solutions, and help you cross the finish line.
Full Service Design & Development
Whether your solution is a standalone product or part of a larger ecosystem, our integrated end-to-end capabilities can help you achieve the best possible outcome.
Strategy & Planning
Align goals, assess feasibility, and set a smart path forward.
We provide strategic consulting to ensure your project begins with a clear roadmap, addressing technical feasibility, risk, and scalability to set the stage for success.
- Technology Consulting: Technology assessment, feasibility planning, and connectivity audits.
- Technical Review/Gap Analysis: Evaluate system gaps and recommend solutions.
- Platform Strategy: Design secure, scalable platform architectures for connected products.
- Cybersecurity Auditing: Identify vulnerabilities and mitigate risks early.
- Feature & Functionality Auditing: Ensure the roadmap aligns with business goals.
Design & Architecture
Design secure, scalable systems built to support your product’s success.
Our team creates robust architectures that ensure seamless connectivity, secure data flow, and compliance, tailored to complex, regulated environments.
- System Architecture: Blueprint for interconnected systems and device ecosystems.
- Connectivity Architecture: Design for Bluetooth and other wireless integrations.
- Data Management: Architect secure data systems for scalability and reliability.
- Cybersecurity Architecture: Build resilient systems to protect sensitive data.
- Regulatory Compliance: Ensure compliance with healthcare and other industry regulations.
- Risk Management: Proactively identify and address technical risks.
Software & Engineering
Turn your concept into robust, reliable software that is built to scale and last.
We specialize in engineering reliable, scalable systems and software that bring your connected products to life.
- Electronics & Hardware: Robust electronics systems tailored to connected devices.
- Firmware & Embedded: Reliable firmware for seamless hardware-software interaction.
- Mobile Apps: Intuitive, secure applications for iOS and Android.
- Web Apps: Scalable, user-friendly interfaces for web platforms.
- APIs: Seamless integrations for device communication and data exchange.
- Cloud Services: Reliable cloud infrastructures for connected ecosystems.
UX & UI Design
Design intuitive, user-friendly experiences.
Our user-centered approach ensures your connected solution delivers a seamless and intuitive experience for healthcare professionals, patients, and consumers alike.
- UX Research & Strategy: Understand user needs and behaviors to inform design.
- UI Design: Create clear, engaging interfaces tailored to the user.
- Prototyping: Test concepts and refine designs for optimal usability.
- Testing & Validation: Ensure your designs meet user and business requirements.
Testing, Validation & Compliance
Make sure your product works and meets every requirement.
We ensure your product meets rigorous standards for performance, usability, and regulatory requirements through comprehensive testing.
- Triage & Debugging: Identify and fix critical issues quickly.
- Functional Testing: Validate features and ensure proper operation.
- Usability Testing: Assess user experience and ease of use.
- Performance Testing: Test reliability under stress and varying conditions.
- Hardware-in-the-Loop Testing: Simulate hardware behavior in real-world scenarios.
- Compliance Testing: We support IEC 60601 and 47 CFR 15 standards testing.
Risk Management & Documentation
Mitigate risk and catch issues before they cost you.
We handle the complex documentation required to satisfy regulatory bodies and secure product approval, while proactively managing risks throughout the project lifecycle.
- Documentation Creation: Produce regulatory-required reports and Design History Files (DHF) to enable and accelerate regulatory submission.
- Risk Management Documentation: Identify and document risks for compliance and design optimization.
- Standards Adherence: Align with industry standards like IEC 62304 and ISO 14971, critical for healthcare and other regulated environments.
Align goals, assess feasibility, and set a smart path forward.
We provide strategic consulting to ensure your project begins with a clear roadmap, addressing technical feasibility, risk, and scalability to set the stage for success.
- Technology Consulting: Technology assessment, feasibility planning, and connectivity audits.
- Technical Review/Gap Analysis: Evaluate system gaps and recommend solutions.
- Platform Strategy: Design secure, scalable platform architectures for connected products.
- Cybersecurity Auditing: Identify vulnerabilities and mitigate risks early.
- Feature & Functionality Auditing: Ensure the roadmap aligns with business goals.
Design secure, scalable systems built to support your product’s success.
Our team creates robust architectures that ensure seamless connectivity, secure data flow, and compliance, tailored to complex, regulated environments.
- System Architecture: Blueprint for interconnected systems and device ecosystems.
- Connectivity Architecture: Design for Bluetooth and other wireless integrations.
- Data Management: Architect secure data systems for scalability and reliability.
- Cybersecurity Architecture: Build resilient systems to protect sensitive data.
- Regulatory Compliance: Ensure compliance with healthcare and other industry regulations.
- Risk Management: Proactively identify and address technical risks.
Turn your concept into robust, reliable software that is built to scale and last.
We specialize in engineering reliable, scalable systems and software that bring your connected products to life.
- Electronics & Hardware: Robust electronics systems tailored to connected devices.
- Firmware & Embedded: Reliable firmware for seamless hardware-software interaction.
- Mobile Apps: Intuitive, secure applications for iOS and Android.
- Web Apps: Scalable, user-friendly interfaces for web platforms.
- APIs: Seamless integrations for device communication and data exchange.
- Cloud Services: Reliable cloud infrastructures for connected ecosystems.
Design intuitive, user-friendly experiences.
Our user-centered approach ensures your connected solution delivers a seamless and intuitive experience for healthcare professionals, patients, and consumers alike.
- UX Research & Strategy: Understand user needs and behaviors to inform design.
- UI Design: Create clear, engaging interfaces tailored to the user.
- Prototyping: Test concepts and refine designs for optimal usability.
- Testing & Validation: Ensure your designs meet user and business requirements.
Make sure your product works and meets every requirement.
We ensure your product meets rigorous standards for performance, usability, and regulatory requirements through comprehensive testing.
- Triage & Debugging: Identify and fix critical issues quickly.
- Functional Testing: Validate features and ensure proper operation.
- Usability Testing: Assess user experience and ease of use.
- Performance Testing: Test reliability under stress and varying conditions.
- Hardware-in-the-Loop Testing: Simulate hardware behavior in real-world scenarios.
- Compliance Testing: We support IEC 60601 and 47 CFR 15 standards testing.
Mitigate risk and catch issues before they cost you.
We handle the complex documentation required to satisfy regulatory bodies and secure product approval, while proactively managing risks throughout the project lifecycle.
- Documentation Creation: Produce regulatory-required reports and Design History Files (DHF) to enable and accelerate regulatory submission.
- Risk Management Documentation: Identify and document risks for compliance and design optimization.
- Standards Adherence: Align with industry standards like IEC 62304 and ISO 14971, critical for healthcare and other regulated environments.
What Sets Us Apart
Solving the Hardest Parts of Connected Device Development
We specialize in the areas that make or break complex connected products where risks are high and execution matters most.
Connectivity-First
Connectivity isn’t a feature; it’s the backbone of your solution.
Getting connectivity right from the start lays the foundation for success. When done wrong, the headaches multiply, leading to friction, performance issues, and wasted resources. With our team’s deep expertise, your product’s connectivity stays rock-solid throughout its life cycle, helping you avoid costly missteps and unlock its full potential.
Critical Path Risk Mitigation
Overcome the riskiest challenges with clarity and precision.
When the stakes are high, mistakes aren’t an option. We specialize in identifying the critical paths in your development process and the key areas where failure could derail timelines, inflate costs, or stall product success. By addressing these early, we help streamline decisions, reduce uncertainty, and keep your team moving forward with confidence.
Robust Compliance
Seamless development compliance from start to finish.
Navigating the healthcare regulatory landscape is critical for medical device success. We specialize in developing software for MDDS, Class II, and Class III devices, ensuring adherence to FDA requirements, including 510(k) submissions and pathways like IDE or PMA. By seamlessly integrating standards such as IEC 62304, we eliminate compliance bottlenecks and keep your project on track.
World-class security
Stay out of the news headlines with security done right.
Strong security is essential for innovation and trust. When security fails, lives can be at risk, and privacy can be compromised. Whether you’re building a connected medical device or an innovative connected product, we’ll ensure your solution meets the highest safety and privacy standards, protecting people and data against evolving threats.
Future-proofing
Scalability and adaptability for long-term growth and success.
Our forward-thinking, scalable system design ensures your connected product evolves seamlessly as its user base grows. Without proper architectural planning, adding new features can become costly and complex. We ensure your architecture is ready for long-term growth so your product captures future growth in real-time.
Ready to get started with Punch Through?
Wherever you are in development, we make the engagement process clear, flexible, and easy. Here’s what to expect.
Schedule a Discovery Call
Tell us what you’re building. We’ll walk through your goals, timelines, and how our team can help.
Join a Team Consultation
We’ll dig deeper into your technical needs and collaborate on where we can add the most value.
Align on Scope & Kick off
Once aligned, we’ll get moving. You’ll stay informed throughout and finish with a product built to last.
