UPNPI: Full-Cycle Services in Medical Device Design and R&D

I. Full-Cycle Development Services

1. Requirement Analysis & Regulatory Strategy

• Assist clients in clarifying clinical needs, and define product positioning through market research and competitive analysis. For example, for portable health monitoring devices, UPNPI optimizes functional design based on user scenarios (e.g., home care) and proactively maps out pathways for FDA 510(k) or EU CE certification.

• Provide regulatory compliance guidance, including alignment with standards such as the ISO 13485 Quality Management System, U.S. QSR 820, and EU MDR/IVDR, to ensure the traceability and integrity of design documentation (e.g., Design History File, DHF).

2. Design & Engineering Development

• Hardware Design: Adopt a multidisciplinary collaboration approach to integrate biosensors (e.g., heart rate and blood oxygen monitoring modules), low-power circuits, and industrial-grade materials, ensuring device stability in complex environments. For instance, UPNPI developed a portable health monitoring device for a medical technology company, integrating biosensors to enable real-time data transmission via cloud platforms.

• Software & Algorithms: Develop customized firmware and mobile applications to support data storage, analysis, and remote monitoring. For example, it optimizes sleep quality assessment models using AI algorithms to enhance detection accuracy.

• Rapid Prototype Validation: Utilize 3D printing and rapid prototyping technologies to create Minimum Viable Products (MVPs). Accelerate iteration cycles through user testing and functional verification. For example, it completes Electromagnetic Compatibility (EMC) testing and biocompatibility evaluations during the prototype phase to reduce the risk of late-stage design changes.

3. Preclinical Testing & Certification Support

• Conduct laboratory testing compliant with Good Laboratory Practice (GLP) standards, covering environmental reliability (e.g., high/low temperature, vibration tests), electrical safety (e.g., compliance with IEC 60601-1), and performance verification (e.g., accuracy, repeatability tests).

• Assist clients in formulating clinical trial protocols and collaborate with Contract Research Organizations (CROs) to complete ethical reviews and patient recruitment. For example, prior to launching an AI-powered educational robot for an AI startup in European and U.S. markets, UPNPI verified the safety and effectiveness of its voice interaction function through clinical research.

4. Mass Production & Supply Chain Management

• Rely on Tier-1 production facilities in Shenzhen (including Class 10,000 cleanrooms) to achieve seamless transition from pilot production to large-scale mass production. For example, through modular design and automated assembly, it increases the monthly production capacity of medical devices to tens of thousands of units while strictly controlling the defect rate to below 0.1%.

• Integrate global supply chain resources to ensure stable supply of critical components (e.g., medical-grade sensors, FDA-certified materials). For instance, it collaborated with international suppliers to provide ISO 10993-compliant silicone tubes for a portable ventilator project.

II. Technological Integration & Innovation Capabilities

1. Biosensors & Internet of Things (IoT)

• Specialize in integrating biometric technologies (e.g., electrochemical and optical sensors) with IoT platforms to enable remote medical monitoring. For example, its wearable devices connect to cloud platforms via Bluetooth, allowing doctors to real-time access patients’ vital sign data and issue alerts for abnormalities.

• Support multimodal data fusion (e.g., comprehensive analysis of heart rate, blood pressure, and exercise data) to provide personalized solutions for chronic disease management.

2. AI & Machine Learning

• Use deep learning algorithms to optimize medical imaging analysis (e.g., X-ray, ultrasound) and disease prediction models. For example, in collaboration with a medical institution, UPNPI developed an AI-aided diagnostic system that identifies diabetic retinopathy by analyzing fundus images, achieving an accuracy rate of 98%.

• Develop edge computing-based local decision engines to reduce reliance on cloud services, improving response speed and data privacy protection.

3. Digitalization & Simulation Technology

• Adopt tools such as Siemens NX for full digital design, and optimize device performance through multiphysics simulations (e.g., fluid dynamics, thermal analysis). For example, during ventilator development, it reduced airflow noise and improved pressure control precision via simulations.

• Build digital twin models to simulate device performance in different clinical scenarios, proactively identifying potential issues and optimizing designs.

III. Typical Cases & Industry Experience

1. Portable Health Monitoring Device

• Project Challenge: The client needed to develop a wearable device certified by the FDA, requiring over 7 days of battery life, IP67 water resistance, and real-time data upload.

• Solution: UPNPI used low-power Bluetooth chips (e.g., Nordic nRF52832) and medical-grade PPG sensors, and extended battery life to 10 days through algorithm optimization. It also designed an ergonomic strap to ensure comfort during long-term wear. The final product obtained FDA 510(k) certification and entered the U.S. market.

2. AI-Aided Diagnostic System

• Project Challenge: A medical institution sought to develop an AI-based skin cancer screening tool, which required processing large volumes of medical images and ensuring high accuracy.

• Solution: The UPNPI team collected 100,000 annotated images to train a Convolutional Neural Network (CNN) model. By integrating transfer learning technology, it reduced inference time to 0.5 seconds per image. The device used an embedded GPU (e.g., NVIDIA Jetson Nano) for on-device processing to avoid data leakage risks. After obtaining CE certification, the system was deployed in multiple clinics across Europe.

3. Home-Use Ventilator

• Project Challenge: The client required a home-use ventilator that is compact, low-noise, and supports remote adjustment, while complying with ISO 80601-2-12.

• Solution: UPNPI adopted oil-free piston pumps and adaptive pressure algorithms, reducing the device size to 1/3 of traditional products and keeping noise below 35 decibels. Via a Wi-Fi module connected to the cloud, doctors can remotely adjust treatment parameters. After obtaining NMPA certification, the product quickly captured 15% of the Chinese market share.

IV. Cooperation Models & Support Resources

1. Flexible Cooperation Models

• Offer ODM (Original Design Manufacturing) and OEM (Original Equipment Manufacturing) services. Clients can choose to participate in the full cycle from concept to mass production, or entrust only specific phases (e.g., PCB design, regulatory filing).

• Launch a "Fast Track" service for startups, shortening the development cycle to 6–8 months through standardized modules and pre-certified components, and reducing initial investment risks.

2. Regulatory & Compliance Support

• Maintain an in-house team of regulatory experts to track global regulatory updates (e.g., FDA’s De Novo classification, EU MDR’s 2025 carbon footprint requirements) and help clients develop forward-looking compliance strategies.

• Provide localized certification services, such as assisting with NMPA registration in China and collaborating with notified bodies (e.g., TÜV SÜD) in Europe, to ensure smooth market access.

3. Long-Term Technical Maintenance

• Provide continuous hardware and software upgrade services, such as adding new sensor functions to medical devices or optimizing algorithms to align with the latest clinical guidelines.

• Establish a dedicated client service platform, reducing equipment downtime and extending service life through remote diagnostics and preventive maintenance.

V. Summary