Medical Device Prototyping
From Idea to Device: End-to-End Prototyping Solutions
Architecture Creation / Selection
In the initial phase of prototyping, selecting the right system architecture is crucial. We evaluate the intended use, critical performance parameters, safety requirements, and cost constraints to determine the optimal design architecture. This includes deciding between microcontroller-based systems, microprocessors, FPGAs, or hybrid architectures. We consider future scalability, power consumption, real-time processing needs, and regulatory constraints like IEC 60601 for electrical safety. Our team ensures that the chosen architecture aligns with both the device’s functionality and its clinical application.
SRS & FRS Creation (System and Functional Requirement Specifications)
Creating a solid foundation for any medical device begins with documenting clear and comprehensive System Requirement Specifications (SRS) and Functional Requirement Specifications (FRS). These documents outline what the system is expected to do (SRS) and how each function will be executed (FRS). At D2R, we use a collaborative process involving clinical, engineering, and regulatory experts to develop traceable and testable requirements. These documents serve as the basis for design verification and validation, ensuring full alignment with ISO 13485, IEC 62304 (for software), and MDR/FDA expectations.
Schematic Development
Once requirements are finalized, our hardware team moves into schematic development. This process involves detailed circuit design, power regulation, filtering, signal routing, and protection circuitry. We take care to select medical-grade components and ensure patient safety through isolation barriers, leakage current limits, and fail-safes. We follow industry-standard design rules and review schematics thoroughly for redundancy, compliance, and testability before moving to layout.
Layout Development
In PCB layout, precision and compliance are key. Our design team develops compact and optimized layouts, taking into account electromagnetic compatibility (EMC), signal integrity, thermal management, and regulatory constraints. We adhere to standards such as IPC-A-600 and IEC 60601 to ensure robustness. Careful planning of layer stack-up, controlled impedance lines, and separation of high and low-voltage domains ensures your device meets both performance and safety benchmarks.
End-to-End Design Verification
D2R provides complete design verification to confirm that the developed prototype meets all specified requirements. This includes electrical testing, firmware/software verification, functional validation, and environmental stress testing. We prepare test protocols, traceability matrices, and verification reports aligned with ISO 13485, IEC 62366, and FDA/CE documentation standards. Design reviews are conducted at multiple stages to identify and mitigate risks early, ensuring that the product is ready for preclinical or clinical evaluation.
Turnkey Project Solutions
Our turnkey services cover the full spectrum of device development, making D2R your one-stop development partner. We manage the entire lifecycle from concept design, prototyping, compliance testing, pilot manufacturing, documentation, and even clinical trial readiness. This approach is ideal for startups or companies without an internal R&D team. Our cross-functional team of engineers, regulatory experts, and designers ensures smooth execution, quicker iterations, and better risk management—all under one roof.
Manufacturing of Bare PCB
For every prototype, the quality of the printed circuit board is foundational. We support clients in sourcing and manufacturing high-quality bare PCBs (rigid, flex, or rigid-flex) from certified partners. These PCBs are built using RoHS-compliant materials, with specific surface finishes (ENIG, HASL, OSP) suited for medical electronics. We manage the Gerber file preparation, stack-up design, and quality inspection (AOI, electrical testing) to ensure that the board meets all technical specifications and industry standards.
Assembly Line (SMD and Through Hole)
We provide full-service PCB assembly using both Surface Mount Technology (SMT) and Through-Hole techniques. Our assembly lines are designed for medical-grade devices with ESD-safe environments and ISO-certified quality protocols. We support low-to-medium volume production runs, ideal for pilot trials, design verification batches, or clinical validation. With automated placement, reflow ovens, manual assembly capabilities, and post-solder inspection, we ensure reliable, production-grade assemblies.
Board Bring-Up
After assembling the PCB, we initiate the board bring-up process—an essential step to ensure that the board functions as expected. This includes power sequencing, clock verification, peripheral validation, and firmware flashing. We perform debugging using tools like oscilloscopes, logic analyzers, and JTAG interfaces. Any anomalies are rectified in real-time to ensure a fully operational board. We also document the bring-up process and initial performance benchmarks.
PoC Development (Proof of Concept)
Before scaling to a production-grade prototype, we help clients build functional Proof of Concept (PoC) units that demonstrate the core features of the medical device. These units are instrumental in early-stage clinical validation, stakeholder presentations, investor pitches, and grant applications. A typical PoC includes the basic hardware platform, essential sensors, basic firmware, and a rudimentary UI. Despite being minimal, these PoCs are built with regulatory foresight and clinical realism in mind.