To streamline validation and accelerate progress, embrace a cloud-only approach

Most biopharmaceuticals use cloud-based infrastructure at some level. But just how “cloudy” is your business? Many companies are in a hybrid state, on a path from traditional on-premise infrastructure to operating fully in the cloud. That journey can feel arduous, and it may seem easier to pause along the way. But a truly cloud-only approach to biopharmaceutical lifecycle management has the potential to radically accelerate the biopharma lifecycle. This objective is non-negotiable, as many software vendors provide new features only to the cloud and offer only critical updates for their on-premise offering.

Figure 1. Diagram illustrating traditional on-premise infrastructure to operating fully in the cloud. [Courtesy of IDBS.]

Organizations that are moving from an on-premise solution might start their cloud journey with foundational infrastructure, like a co-located data center or cloud-based hosting.…
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New semiconductor design boosts AI computing efficiency

The NeuRRAM chip [Photo by David Baillot for the University of California San Diego]

Medical devices could one day get a boost from a new energy-efficient semiconductor designed with AI computing in mind.

Stanford engineers have developed a new resistive random-access memory (RRAM) chip called NeuRRAM that does AI processing within the chip’s memory, saving the battery power traditionally spent moving data between the processor and storage.

“The data movement issue is similar to spending eight hours in commute for a two-hour workday,” Weier Wan, a recent graduate at Stanford leading this project, said in a news release. “With our chip, we are showing a technology to tackle this challenge.”

They say their compute-in-memory (CIM) chip is about the size of a fingertip and does more work with limited battery power than current chips. That makes the new chip a potential space-saver for medical de…

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Blue Spark’s TempTraq catches fevers faster. Fever prediction is next.

Blue Spark’s TempTraq continuous temperature monitoring patch could one day be used for fever prediction. The patch is 100mm long, 50mm wide, 3mm thick and weighs 5.1 grams. [Photo courtesy of Blue Spark Technologies]

Blue Spark Technologies developed the first wireless continuous temperature monitor patch, TempTraq, to enable faster fever detection than standard manual readings every four hours.

Westlake, Ohio-based Blue Spark is now looking at fever prediction rather than just detecting them.

The R&D team is working on developing an AI neural network model built on the company’s collection of continuous temperature data captured in the cloud, CEO John Gannon said in an interview.

“Taking our existing data, training an AI model to be able to understand and learn what fever profiles and onsets of fevers look like, and then apply that to new patients … we are working tow…

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Google Health hires FDA’s chief digital health officer

Bakul Patel in 2016, when he was the associate director for digital health in the FDA’s Center for Devices and Radiological Health [FDA photo by Michael Ermarth]Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency.

Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn.

Patel recounted highlights of his “incredible journey since 2008” at the FDA, including the introduction of functionality-based regulations in the FDA’s mobile medical apps guidance, working with international agencies to define and regulate software-as-a-medical-device (SaMD), developing the Digital Health Software Precertification (Pre-Cert) Program and launching the Digital Health Center of Excellence.

Patel had only been in his latest role at FDA since February, previously serving as director of the FDA…

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Google Health hires FDA’s chief digital health officer

Bakul Patel in 2016, when he was the associate director for digital health in the FDA’s Center for Devices and Radiological Health [FDA photo by Michael Ermarth]

Former FDA Chief Digital Health Officer Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency.

Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn.

Patel recounted highlights of his “incredible journey since 2008” at the FDA, including the introduction of functionality-based regulations in the FDA’s mobile medical apps guidance, working with international agencies to define and regulate software-as-a-medical-device (SaMD), developing the Digital Health Software Precertification (Pre-Cert) Program and launching the Digital Health Center of Excellence.

Patel had only been in his…

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Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

Tracy Robertson is VP of Digital at Stryker. [Photo courtesy of Stryker]The first day of DeviceTalks Boston closed with a panel of Stryker (NYSE:SYK) executives discussing new tools, technologies and strategies in medtech.

Digital VP Tracy Robertson, Digital, Robotics, and Enabling Technologies President Robert Cohen and Surgical Technologies VP of Digital Innovation Siddarth Satish offered their thoughts on industry trends in healthcare and at the Kalamazoo, Michigan–based orthopedic device giant.

It was only the first question posed to the panel yesterday, which also featured Dave Lively — SVP of Product Management, Vocera (now part of Stryker) — and was moderated by Orthopaedics and Spine Group President Spencer Stiles.

Get the full story at our sister site, Medical Design & Outsourcing.

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Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

The first day of DeviceTalks Boston closed with a panel of Stryker (NYSE:SYK) executives discussing new tools, technologies and strategies in medtech.

Digital VP Tracy Robertson, Digital, Robotics, and Enabling Technologies President Robert Cohen and Surgical Technologies VP of Digital Innovation Siddarth Satish offered their thoughts on industry trends in healthcare and at the Kalamazoo, Michigan–based orthopedic device giant.

It was only the first question posed to the panel, which also featured Dave Lively — SVP of Product Management, Vocera (now part of Stryker) — and was moderated by Orthopaedics and Spine Group President Spencer Stiles. Watch for more from the discussion at Medical Design & Outsourcing.

The following has been lightly edited for space and clarity.

Tracy Robertson is VP of Digital at Stryker. [Photo courtesy of Stryker]

Tracy Robertson: “The one that I think a…
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The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock] Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasdaq: AMZN), Microsoft (Nasdaq: MSFT) and Google (Nasdaq: GOOGL).…

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The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock]

Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasda…

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Amazon Web Services is powering medtech innovation: Its chief medical officer explains

It doesn’t get any bigger than Amazon in the world of cloud computing.

Dr. Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Dr. Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

Get the full story at our sister site, Medical Design & Outsourcing.

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An Amazon cloud conversation with AWS Chief Medical Officer Taha Kass-Hout

Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

This conversation has been edited for clarity and length.

MDO: What d…

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Making biomedical data computable

Vik Nagjee is the vice president of product at nference [Photo courtesy of nference]

Cloud computing can power quantum leaps in human health.

Vik Nagjee, nference

A state-of-the art platform that supports real world evidence (RWE) and health economics and outcomes research can enable breakthroughs at an unprecedented scale.

This is achieved by making the de-identified, transformed information contained within the electronic medical record (EMR) available for data science and analysis at the aggregate and patient level. Add multi-modal data sources such as imaging and electrocardiograms as well as novel data assets like digital pathology and omics data to enrich the EMR data to provide a truly longitudinal view of the patient, and you have the beginnings of a world-class platform.

The keys are privacy preservation, harnessing longitudinal data, data enrichment and a data science platform.

P…
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