Philips partnership to roll out advanced MRI tech across US
Healthcare giant Philips has partnered with SimonMed Imaging to make its state-of-the-art 3T MRI technology available throughout the US.
SimonMed is a provider of outpatient radiology and MRI services, one of the largest in the country. The partnership will initially enable Philips advanced MRI scanners to be available in SimonMed centres in California, Arizona, Illinois and Colorado.
The state-of-the-art imaging systems will feature software and services to enhance diagnoses such as brain injuries, liver and cardiac disease, and orthopedic injuries.
Philips have stated that the new MRI scanners can deliver superb image quality and perform MRI exams up to 50 per cent faster than their previous systems. New diagnostic techniques have been added that can evaluate brain trauma, making a confident diagnosis easier.
The new imaging technology is expected to reduce the likelihood of rescans compared to their previous scanners. Additionally they have reduced acoustic noise by 80 per cent, added voice guidance and a comfortable table positioning feature to maximise patient comfort.
Kees Wesdorp, Chief Business Leader in Precision Diagnosis at Philips, commented: "Providing our customers with a clear path to precision diagnosis and treatment to help achieve better outcomes at a lower cost of care is at the center of all we do.
"Our advanced MR technology, combined with our advanced integrated radiology workflows, is the latest innovation to further demonstrate our commitment in driving technology to help our forward-thinking customers like SimonMed advance care for their patients.”
The two companies are planning to collaborate further in the future to improve the patient experience by speeding up diagnostic imaging and reducing costs.
“This collaboration with Philips focuses on going beyond routine 3T MRI imaging to deploy the most advanced technology, often only available to an academic center, in accessible and affordable outpatient practice to greatly enhance diagnoses from early post-traumatic brain injuries to the most subtle orthopedic injuries" Dr. John Simon, CEO of SimonMed Imaging said in a statement.
“Patients will literally have access to the entire spectrum of the newest techniques and enhanced diagnoses. Together with Philips, we continue our efforts to see beyond current technology as the rate of change is tremendous, and bring these powerful advancements to help benefit both providers and patients.”
A guide to labelling compliance for medical devices
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.
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.