Real-Time PCR Console

Project Overview

In 2020, the team partnered with a confidential client to develop a real-time PCR console for nucleic acid testing. 

The ODM project required integrating mechanical parts, SMT (surface-mount technology), and final assembly (FATP). 

Target certifications included both CFDA and FDA, with plans to ship globally. 

The console needed to support high-throughput testing while maintaining compact dimensions for lab versatility.

Technical Challenge

Thermal Management: The PCR module required precise temperature cycling (4°C–98°C) without heat dissipation interfering with adjacent electronics.

Regulatory Hurdles: Aligning the design with FDA’s 21 CFR Part 820 and CFDA’s GMP standards demanded rigorous documentation and validation.

Supply Chain Complexity: Coordinating between BJ Site2 (mechanical parts) and Site3 (SMT/FATP) introduced logistical delays.

Our Approach and Solution

Modular Design: Separated the thermal block from sensitive electronics using aerogel insulation, reducing cross-thermal interference by 40%.

Dual Certification Pathway: Conducted parallel testing for FDA and CFDA, leveraging shared requirements (e.g., biocompatibility, risk management) to streamline compliance.

Integrated Logistics: Deployed a digital tracking system to synchronize parts delivery between sites, cutting lead times by 25%.

Results & Outcomes

The PCR console obtained FDA 510(k) clearance and CFDA approval in Q4 2021.

Production scalability reached 10,000 units/month, with a defect rate of <0.1%.

The client expanded orders to include COVID-19 Detection kits (Row 8), utilizing the same manufacturing framework.

The project highlighted our capability in end-to-end medical device production, attracting follow-up ODM/JDM collaborations.