Delphi Diagnostics’s Software as a Medical Device (SaMD) is fast tracked with Matrix Connect
Delphi Diagnostics is a diagnostics company based in Houston, Texas. They use groundbreaking machine learning technology to detect asymptomatic cancer earlier than ever when it is easiest to treat. Delphi takes the results of patient samples and runs them through an AI algorithm that helps predict the probability of success of a particular therapy for the individual patient. Their mission is to make this unique form of early cancer screening more accurate, affordable, and available than ever before, eliminating cost as a barrier to this novel form of cancer detection and treatment.
Advantages
The challenge of choosing a trusted SaMD Partner
Software as a Medical Device (SaMD) startups like Delphi face unique challenges in navigating the regulatory process. All companies must undergo a rigorous independent risk analysis in order to obtain FDA approval. One of the main challenges for SaMD companies is controlling costs while simultaneously satisfying several stakeholder audiences and regulatory agencies.
FDA compliance and regulatory approval hinge on secure data collection and accurate reporting. Choosing the wrong data partner increases unacceptable risks with adverse outcomes for patients and physicians.
Delphi therefore needed a potential partner with deep industry experience, high standards for data security certifications, algorithm development flexibility, and superior product output, all with a reasonable cost and timeline.
Matrix Connect is built for SaMD
After searching with their immediate network, Delphi soon learned that Matrix Connect had the experience, technical expertise and the highest levels of data security their company required.
Todd Pappas, Delphi’s Clinical Operations lead, puts it this way, "The security that Matrix Connect has and their expertise in this field was critical to us. Knowing that we were working with an experienced company that was patent protected, ISO 13485 certified, and HITRUST certified was important to us. Matrix Connect was the only solution that checked off all the boxes.”
Delphi’s Value Proposition
Quickly processing patient samples using AI/ML
Seamless algorithm refinement in the cloud
Automatically generate reports for stakeholders
Delivering a fast, compliant solution
Initial conversations with the Delphi team centered around the Matrix Connect as an alternate modular solution. Instead of 6 to 9 months to build a custom solution, Matrix Connect could plug their application into Delphi’s modules and get them up and running with a compliant system in a week or two. Todd commented “They understood that we need development flexibility to host and validate algorithms, provide the workflow, and accommodate changes. Matrix Connect's solution provided all of the above with a startup-friendly rolling cost structure. The clincher was that their framework is already compliant with the medical device industry best practices, too."
“On top of them having the best solution in the industry, with Matrix Connect for me, it's the people. They have built trust with our team, I trust them, and that is invaluable for us.”
Emily Granger, Chief Marketing Officer, Delphi
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