May 17, 2020

The National Institutes of Health launches its STRIDES initiative

Big Data
Google
USA
healthcare services
Catherine Sturman
2 min
The emergence of traditional and non-traditional players entering the healthcare industry, the need to adopt new technologies to deliver patient-centere...

The emergence of traditional and non-traditional players entering the healthcare industry, the need to adopt new technologies to deliver patient-centered care is becoming increasingly vital.

The National Institutes of Health now launched its Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative to unlock the advantages of commercial cloud commuting, in order to support researchers and over 2,500 academic institutions in utilising essential digital tools within biomedical advances.

Bringing Google Cloud on board as its first industry partner, the use of cloud technologies will seek to reduce barriers across the biomedical ecosystem, where the duo will establish a robust framework for NIH researchers, whilst harnessing Google Cloud storage, computing, and machine learning tools.

In line its Data Science Strategic Plan , STRIDES will provide essential training for researchers to learn about the latest digital tools. The initiative will also include partnerships with the NIH’s Data Commons Pilot which was launched last year, which is exploring how to share and utilise biomedical data in the cloud and best practices. It awarded 12 research organisations $9mn to run with the pilot.

“The volume of data generated in biomedical research labs across the world is growing exponentially,” said Gregory Moore, M.D., Ph.D., Vice President, Healthcare, Google Cloud.

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“Through our partnership with NIH, we are bringing the power of data and the cloud to the biomedical research community globally. Together, we are making it easier for scientists and physicians to access and garner insights from NIH-funded data sets with appropriate privacy protections, which will ultimately accelerate biomedical research progress toward finding treatments and cures for the most devastating diseases of our time.”

All data will be fully endorsed by the biomedical research community, where it will ensure all data will be Findable, Accessible, Interoperable, and Reusable (FAIR).

“NIH’s initial efforts will focus on making NIH high-value data sets more accessible through the cloud, leveraging partnerships to take advantage of data-related innovations such as machine learning and artificial intelligence, and experimenting with new ways to optimise technology-intensive research,” the company has stated.

“By launching STRIDES, we clearly show our strong commitment to putting the most advanced cloud computing tools in the hands of scientists,” commented Andrea T. Norris, NIH Chief Information Officer and director of NIH’s Center for Information Technology.

“Beyond our partnership with Google Cloud, we will seek to add more industry partners to assure that NIH continues to be well poised to support the future of biomedical research.”

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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