May 17, 2020

mHealth Could Save Developed World $400bn

mobile health
3 min
mHealth Could Cut Hospital Costs By $400bn
Last week Healthcare Global reported that mHealth could save more than one million lives in Africa according to a report published by GSMA and Pricewat...

Last week Healthcare Global reported that mHealth could save more than one million lives in Africa according to a report published by GSMA and PricewaterhouseCoopers. That same report also suggests that the developed world could save in excess of $400bn by 2017.

As we have reported in the past, there are challenges associated with adopting mHealth solutions, for example regulatory concerns, the expense and time commitment needed to implement new systems, differences of opinion between medical and technology communities and confidentiality questions to name just a few.

However, as doctor shortages mount and hospitals face new mandates related to accountability and electronic records, many in the industry are looking to mobile devices, applications and other programs to improve patient care, lower costs and drive efficiency.

Implemented correction, mHealth solutions can drive efficiency, improve patient care and ultimately save healthcare institutions a lot of money.

Healthcare Global Outlines Four Ways Mobile Health Could Help Cut Costs >>>

Mobile Care For Sudden Health Incidents

Telehealth uptake is increasing at a rapid rate – a recent report estimates it could grow by 55 percent this year alone – and therefore mobile-based solutions are becoming commonplace for immediate care. The GSMA and PwC report estimates that mobile-based care for patients with sudden health incidents could reduce primary and emergency care visits by a massive 10 percent. Already, companies like Sherpaa and Ringadoc let patients reach physicians 24/7 by phone, text or email.

Remote Patient Home Monitoring

In non-emergency situations, mobile technology could also play a role in helping doctors keep tabs on elderly or recently discharged patients remotely. With Sotera Wireless, for example, doctors can monitor patients’ blood pressure, heart rate, respiration rate and other indicators through a flip-phone-sized device worn on a patient’s wrist. GSMA and PwC estimate that remote monitoring technology could lead to elderly care savings of up to 25 percent and improve patients’ quality of life.

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Mobile Access To Electronic Health Records

As more hospitals migrate to electronic medical records (EMR), patient information will increasingly be captured and accessed from mobile devices. PatientSafe, for example, plugs into several EMR systems and lets doctors and nurses log patient information (like temperature, blood pressure, etc.) and manage other workflow tasks from a specially adapted iPod Touch. According to PwC and GSMA, mobile access to electronic health records could lower the administrative burden on hospitals by 20 to 30 percent.

SMS Reminders For Scheduling Appointments (And Taking Medication)

SMS could also play a big role in reducing health costs and improving patient care. Appointment reminder services, like that offered by Medisafe, have been shown to reduce costs and boost patient attendance. Companies like Blueprint Health’s AllazoHealth and AdhereTech use SMS (and other kinds of communication) to remind patients to take their medication after sensors or algorithms note when a patient hasn’t taken medication or is likely to skip it.

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Jul 24, 2021

A guide to labelling compliance for medical devices

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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