May 17, 2020

Why you should invest in the medical device and mHealth market

mHealth
Health Tech
mHealth
Admin
2 min
Over the years, mobile applications in the health care industry have blossomed and are expected to continue to see exponential growth.
The mHealth and medical devices market has steadily grown throughout the years, and according to a new report by Transparency Market Research, the globa...

The mHealth and medical devices market has steadily grown throughout the years, and according to a new report by Transparency Market Research, the global market is expected reach a market value of US$8.03 billion by 2019.

The growth can be attributed to the growing prevalence of communication devices such as tablets, mobile phones and computers in day-to-day lives. It can also be linked to the increasing number of incidences of chronic diseases and a rising geriatric population pool.

RELATED TOPIC: 6 ways to successfully drive an mHealth project

The global mHealth monitoring and diagnostic medical devices market has drastically reduced medical expenses, as they help in monitoring vital parameters for those suffering from diabetes and blood pressure. Additionally, these devices also help monitor heart rate, respiratory rate, and other body monitoring parameters.

Revolutionizing modern health care

mHealth and medical devices help patients access medical information faster than ever before and it has the potential to revolutionize health care systems by driving innovation and improving the way medical services are administered throughout the nation.

Patients with chronic medical conditions, for instance, can become more self-reliant with the adoption of mobile health solutions by living in their own home environment while remote monitoring technology tracks their health status and reports back to their physician.

Expected market growth

According to the report, the global medical device and mHealth market is expected to grow 43.3 percent from 2013 to 2019. The Center for Technology and Aging also reported that the market could help reduce health care expenditure in the U.S. by US$200 billion in the coming 25 years.

RELATED TOPIC: Why pharma companies should invest in Brazil's medical market (and how)

“Presently, the North American region is the largest market in the world, owing to presence of large number of manufacturers, technological advancements, increasing population with smartphones and tablet PCs and growing awareness about the devices and technology,” the analysts stated in the report. “However, Asia-Pacific region is considered as the most promising markets during the forecast period 2013 to 2019. The growth is expected owing to factors such as higher incidence rate of chronic diseases, aging population, increased awareness about the diagnostic devices and rising demand for home-care monitoring systems.”

Johnson & Johnson, LifeWatch AG and Masimo Corporation are a few of the prominent companies in the mHealth monitoring and diagnostic medical devices market.

Knowing that the market is predicted to continue to grow, perhaps investing in it isn’t such a bad bet.

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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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