Labfront and Rook Quality Systems: Paving the Way for Medical Device Innovation

Navigating the complex regulatory landscape of medical device development can be daunting to say the least. We at Labfront think researchers already have enough on their plate. That's why we’ve teamed up with Rook Quality Systems (RookQS) to help researchers take inventions from the lab to the public.  This collaboration aims to accelerate the pace of innovation, enhance end-product quality, and lower costs.

Research shouldn't just stay in labs. By partnering with RookQS, we are bridging the gap between research and marketable medical devices. _{- Labfront CEO and Co-Founder Chris Peng}

Quality Assurance with Rook Quality Systems

As an exciting part of the partnership, all paid Labfront accounts now come with a complimentary 30-minute consultation for Software as a Medical Device (SaMD) from RookQS' seasoned regulatory experts.

With their deep industry knowledge and expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity, the RookQS team ensures that innovative health products not only meet but exceed regulatory standards. 

Applications of research findings are vital to improving healthcare systems. Offering free consultations to Labfront's researchers allows us to take a small step toward transforming their research into tangible products. _{- RookQS General Manager, Andrew Wu}

Understanding SaMD

SaMD refers to software intended to be used for one or more medical purposes without being part of a hardware medical device. This software can be used across multiple platforms and devices, and has the potential to transform healthcare delivery. SaMD spans from mobile app monitoring to sophisticated algorithms, such as:

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• Mobile Applications for Health Management: Mobile apps that can track vital signs or blood glucose levels. These apps often sync with external devices (like smartwatches or glucose monitors) to collect health data. Ex: The Dexcom G6 app, which displays real-time glucose levels for people with diabetes.
• Telemedicine Platforms: Software that enables doctors to monitor patients remotely. These platforms often allow doctors to collect data, monitor vital signs, and provide recommendations based on the collected data. Ex: Teladoc, a telemedicine service that provides remote patient care.
• Therapeutic Software: Software designed to aid in therapy, such as cognitive behavioral therapy. Ex: Sleepio uses cognitive behavioral techniques to help people improve their sleep.
• Algorithms for Risk Prediction: Software that can predict patient risks based on health data and inform clinical decision-making. Ex: Google's DeepMind Health’s AI system predicts acute kidney injury up to 48 hours in advance.

From Innovative Research to Market-Ready Product: Hura Imaging's Journey with RookQS

RookQS has found success supporting technologies spun-off from university labs and helped the researchers secure medical device certifications in the major markets. For example, in 2019, Dr. Danny Wang and Hura Imaging set out on an ambitious journey to transform their novel CT perfusion image denoising algorithm into a commercialized SaMD in the U.S. Expert guidance from RookQS proved invaluable to this endeavor.

RookQS facilitated the establishment of effective development processes, enabling productive discussions, and leading all quality and regulatory activities. Their teamwork with Hura Imaging guided them through product modifications, pre-submission consultations, and test program implementations, eventually securing their first US 510(k) clearance within 20 months from the initial engagement. This case study shows just how useful RookQS can be in getting ideas from the lab to the marketplace. 

Looking Ahead with Labfront and Rook Quality Systems

In collaborating with Rook Quality Systems, Labfront reaffirms its commitment to helping the scientific community embrace the future of real-world data. We're optimistic about the potential this partnership holds for researchers, and we can't wait to see the innovations it will bring.

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