First-of-Kind Device Development Capabilities
We support medical device startups and established OEMs across the entire development lifecycle, bridging the gap between innovative clinical ideas and repeatable, scalable production.
Concept Development & Feasibility
We evaluate your clinical requirements and convert early-stage concepts into engineered, feasible devices. By conducting early risk assessments and concept development, we help you validate core mechanical and functional assumptions before committing to an expensive final design.
Catheter & Delivery System Design
Our engineers have experience in multi-lumen catheter design, shaft construction, and delivery system integration. We balance the complex physical trade-offs required for interventional oncology tools, ensuring your device meets the demanding dimensional and structural requirements.
Mechanical Design & Material Selection
Minimally invasive oncology devices require precise material performance. We evaluate and select biocompatible polymers, nitinol structures, braided shafts, and specialized coatings to achieve the ideal balance of column strength, kink resistance, and biocompatibility.
Steerable Catheter & Distal-Tip Design
Navigating tortuous vascular and tissue pathways requires control. We design custom steering mechanisms, pull-wire assemblies, and articulating distal tips that provide physicians with predictable torque response, tactile feedback, and precise positioning.
Advanced Prototyping & Iterative Refinement
Utilizing our prototyping lab—equipped with precision lathes, catheter braiders, laser welders, and laminators—we fabricate functional prototypes in-house, dramatically shortening your iteration-test cycles.
Bench Testing, Verification & Validation (V&V) Support
We design and execute custom bench testing to evaluate trackability, pushability, burst pressure, pull strength, and joint integrity. Our team ensures that all design outputs strictly map back to design inputs under ISO 13485 design controls.
Controlled Builds & Low-Volume Manufacturing Support
We conduct pilot builds and low-volume production within our certified ISO Class 7 and Class 8 cleanrooms, ensuring full lot traceability, validated assembly processes, and inspection-ready devices for preclinical and GLP studies.
Contact Rev.1 Engineering for First-Of-Kind Medical Device Development
Breakthrough Medical Technology Development
Developing interventional and therapeutic oncology devices requires focus on precision engineering, precise mechanical feedback, and manufacturability. Whether you are building a novel tumor biopsy system, an ablation catheter, or a targeted drug delivery platform, navigating complex anatomical pathways and stringent regulatory landscapes leaves zero room for error.
Rev.1 Engineering specializes in taking complex, minimally invasive oncology technologies from initial concept through design controls, iterative prototyping, and early-manufacturing or transfer. Our team provides the hands-on engineering, advanced catheter development capabilities, and controlled build infrastructure needed to mitigate design risk and accelerate your path to market.
Types of First-of-Kind Devices We Support
Our engineering team has extensive experience developing specialized delivery systems across a wide range of interventional oncology applications.
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Tumor Biopsy Devices: High-precision tissue acquisition systems engineered for consistent sample recovery and minimal surrounding tissue trauma.
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Image-Guided Intervention Systems: Radiopaque and echogenic catheter systems designed for seamless integration with fluoroscopy, CT, ultrasound, or MRI workflows.
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Ablation Platforms & Catheters: Support structures, cooling pathways, and shaft assemblies for radiofrequency (RF), microwave, and cryoablation devices.
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Targeted Drug Delivery Catheters: Microcatheters and multi-lumen systems engineered for localized delivery and targeted therapeutic infusion.
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Vascular Access Devices: Specialized sheaths and introducers designed to maintain vessel integrity during complex interventional oncology procedures.
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Custom Minimally Invasive Platforms: Novel, new-to-market interventional platforms engineered to solve unconventional clinical access challenges.
Working with Rev.1 Engineering
Engineering Challenges We Solve
Translating a complex oncology concept into a commercial product involves overcoming severe physical and manufacturing constraints. We help development teams solve real-world technical hurdles, including:
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Complex Pathway Navigation: Designing ultra-low-profile shafts that navigate tight, tortuous anatomy without kinking or buckling.
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Precision Under Image Guidance: Incorporating radiopaque markers and specialized materials to ensure high visibility under live imaging without compromising mechanical performance.
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Optimization of Pushability, Trackability & Torque: Fine-tuning braid density, pitch, and wall thickness gradients to deliver 1:1 torque response and smooth pushability.
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Therapeutic Delivery Control: Managing precise fluid flow rates, pressure drops, and deployment forces in micro-scale lumens.
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System & Workflow Integration: Ensuring your device interfaces cleanly with standard guidewires, luer locks, generator consoles, and physician handling preferences.
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De-Risking Early Feasibility: Identifying potential mechanical failure modes early in R&D to prevent costly redesigns during formal regulatory testing.
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Design for Manufacturability (DFM): Streamlining sub-assemblies, simplifying bonding processes, and establishing repeatable manufacturing procedures from day one.
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Regulatory & Quality Assurance: Maintaining complete design history files (DHF) and device master records (DMR) to support FDA 510(k), PMA, or CE Mark submissions.
Why Work with REV.1 Engineering?
Medical device startups and OEMs partner with Rev.1 because we combine the technical sophistication of a large contract manufacturer with the speed and flexibility of an agile R&D firm.
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Deep Minimally Invasive Expertise: Decades of collective experience designing complex catheters, steerable sheaths, and interventional tools.
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Complete Lifecycle Support: We don’t just hand off CAD drawings; we support your project from napkin sketch through clinical builds and commercial manufacturing transfer.
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On-Site Cleanroom: Our 2,000 sq. ft. ISO Class 7 & 8 cleanroom facility allows us to build traceable, clinical-grade units under strict quality controls.
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Manufacturability First: We design with production in mind, ensuring your device can be assembled reliably and cost-effectively at scale.
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Collaborative Engineering Culture: We act as a seamless extension of your internal R&D team, communicating transparently and adapting quickly as project needs evolve.
Our Device Development Process
We follow a structured, phased approach to manage risk, maintain design controls, and keep your timeline moving 2x faster.
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Discovery & Clinical Requirements
We define user needs, target anatomy, performance metrics, and preliminary regulatory pathways. -
Concept & Feasibility
We generate initial designs, evaluate trade-offs, perform analytical modeling, and test early proof-of-concept models. -
Prototype Development & Controlled Builds
We iterate rapidly in our prototyping lab, refining functional designs and building pilot lots in our ISO cleanroom. -
Verification, Validation & Design Refinement
We subject the design to rigorous bench testing, simulated use testing, and formal design verification. -
Manufacturing Planning & Production Transfer
We finalize DFM documentation, build assembly fixtures, train line operators, and transfer the validated process to your chosen commercial manufacturing facility or proceed with low-volume manufacturing in-house to support your needs.