Mayo Clinic Platform working with BD for post-market device surveillance

BD on Monday announced a new collaboration with Mayo Clinic Platform to improve its medical devices using de-identified patient data from Mayo Clinic Platform_Discover.

WHY IT MATTERS
Working with Mayo Clinic, BD will analyze the real-world data in Platform_Discover, mining it with the help of artificial intelligence and machine learning tools to gain insights into how patients experience its medical devices.

The data, much richer than what’s typically gathered in a clinical trial, will help BD improve its existing products and develop new ones. The goal is to enable more detailed post-market surveillance of devices’ safety and security, and to find faster, more efficient paths to market.

The platform’s data will enable predictive modeling, BD says, for more accurate forecasts related to device use. The company will also use the Mayo Clinic data to streamline medical device regulatory submissions.

“Our next generation analytical tools and curated de-identified patient data create a dynamic, privacy-protected environment for discovery that few in the industry can provide,” said Steven Bethke, vice president for product portfolio, Mayo Clinic Platform, in a statement.

“Mayo Clinic Platform_Discover enables medical technology leaders such as BD to derive key insights as they develop solutions for their customers and patients as quickly and safely as possible.”

THE LARGER TREND
Mayo Clinic Platform_Discover, developed with Google Cloud, comprises a vast trove of deidentified longitudinal data – structured and unstructured – from 10 million patients. Its dataset includes more than a billion lab test results, 640 million clinical notes and imaging data such as 3 million echocardiograms.

Since launching Mayo Clinic Platform in 2019, the Minnesota health system has been busy on the AI front, such as the rollout of its Clinical Data Analytics Platform in 2020. In April 2021, it launched a new AI-powered platform helping providers with clinical decision support.  

And this past December, Mayo teamed up with Duke, UC Berkeley and others to create for a novel Health AI Partnership to help guide safer and more effective deployments of artificial intelligence and machine learning tools.

BD takes post-market surveillance for the safety and security of its devices seriously. In 2020, for instance, it launched the BD Cybersecurity Trust Center, where customers, security researchers, third-party component vendors and other external groups also can report a vulnerability or a cybersecurity concern related to a BD software-enabled device.

ON THE RECORD
“For years, randomized control trials have been considered the gold-standard in evaluating safety and efficacy for medical devices, but experts from industry and academia who are examining the tight parameters around clinical trials are seeing added value in leveraging insights from real-world data to truly understand whether we are meeting patients’ needs,” said Lisa Boyle, vice president of global clinical affairs and medical affairs strategy for BD.

“We need to be leveraging real-world evidence, using datasets like those from Mayo Clinic Platform, to understand the many parameters that we wouldn’t normally capture in a clinical trial and understand patients’ care pathways and address the needs of diverse patients in order to establish better solutions for better outcomes and experiences.”

Twitter: @MikeMiliardHITN
Email the writer: [email protected]
Healthcare IT News is a HIMSS publication.

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